Vienna, Austria, 24 October 2024: QUANTRO Therapeutics (QUANTRO), a pioneer in the discovery of first-in-class transcription factor targeting cancer treatments, announced today that the company is entering into a strategic research collaboration with the group of Dr. Johannes Zuber, a world-leading expert in functional genetics and one of the co-founders of QUANTRO, at the Research Institute of Molecular Pathology (IMP) in Vienna, Austria. The goal of the collaboration is to investigate the molecular functions of transcription factor complexes that have emerged as promising targets for the development of cancer therapies.
Cancer cells depend on specific transcription factors – proteins that regulate gene expression – to maintain their abnormal behavior. While transcription factors have long been considered “undruggable”, new molecules have been found that trigger their degradation or disrupt interactions with essential co-factors. These advances have led to major breakthroughs in the treatment of some cancer types. However, existing drugs targeting transcription have often been found only through serendipity, while their systematic discovery and development have been hampered by a lack of scalable methods to directly measure transcriptional activity. The new collaboration focuses on expanding QUANTRO’s transcriptomic discovery approach by integrating genetic screening technologies to gain a deeper understanding of how transcription factors interact with co-factors and other regulatory proteins. The Zuber lab at the IMP has developed advanced genetic screening and validation assays to identify and characterize such key co-factors and regulators, thereby complementing QUANTRO’s activities building an innovative proprietary transcription factor targeting R&D pipeline. Dr. Johannes Zuber, Group Leader at the IMP, commented: “A detailed understanding of protein binding partners is essential for developing new drugs and refining existing hits. While finding compounds that bind to transcription factors is relatively straightforward, it is often unclear whether this binding event interferes with co-factor interactions or other critical protein functions. QUANTRO’s time-resolved transcriptomics technology can answer this question with unprecedented precision, and our genetic screens can pinpoint the relevant co-factors.” Dr. Michael Bauer, CEO of QUANTRO, added: “Our transcriptomic discovery platform addresses one of drug discovery’s greatest challenges – making previously ‘undruggable’ targets accessible. With our proprietary technology, we can instantly detect transcriptional changes with high precision, enabling us to focus on direct and immediate transcriptional responses. This partnership will further strengthen our capabilities and understanding of the biology of the targets we are working on by integrating the IMP’s exceptional research expertise and by providing access to complementary know-how and resources. Together, we aim to accelerate drug discovery for currently untreatable diseases.” Meet the QUANTRO management at BIO-Europe in Stockholm, November 4-6 Dr. Michael Bauer, CEO of QUANTRO, will participate in this important industry event and be available for personal meetings to discuss QUANTRO’s innovative approach to transcriptomic drug discovery. To schedule a meeting, please use the conference partnering system or reach out directly to Contact | QUANTRO. About QUANTRO: QUANTRO Therapeutics is a transcriptomic Drug Discovery and R&D company focused on building a highly innovative pipeline of modulators, inhibitors or degraders of transcription factors, transcriptional regulators and cell signaling targets. QUANTRO’s transcriptomic discovery platform is using a novel and proprietary time-resolved gene expression profiling technology to target gene transcription factors, thus far considered un-druggable. The technology is uniquely positioned to quantify changes in gene expression over time with unprecedented precision and sensitivity, overcoming the deficiencies of traditional RT-qPCR based technologies like DRUG-seq, which are limited to only measure RNA abundance, without information on transcriptional activity and dynamics. QUANTRO was founded in 2019 as a spin-out from the prestigious research institutes IMBA and IMP in Vienna, Austria. Since 2020, the company has been supported by Boehringer Ingelheim Venture Fund (BIVF) and Evotec as seed investors. In total, EUR 11 million was earned in milestone-driven tranches in 2020 and 2023, complemented by undisclosed proceeds from a strategic collaboration on selected oncology targets with Boehringer Ingelheim Oncology. Please find more information on our website at www.quantro-tx.com. About the IMP: The Research Institute of Molecular Pathology (IMP) in Vienna is a basic life science research institute largely sponsored by Boehringer Ingelheim. With over 200 scientists from 40 countries, the IMP is committed to scientific discovery of fundamental molecular and cellular mechanisms underlying complex biological phenomena. The IMP is part of the Vienna BioCenter, one of Europe’s most dynamic life science hubs with 2,800 people from over 80 countries in six research institutions, two universities, and 40 biotech companies. For more information, please visit www.imp.ac.at, www.viennabiocenter.org. Contact QUANTRO Therapeutics GmbH Media Contact MC Services AG 24.10.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG. The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
Category Archives: Biotech Companies
Seaport Therapeutics Closes $225 Million Oversubscribed Series B Financing Round
Financing led by General Atlantic with participation from T. Rowe Price Associates, Foresite Capital, Invus, Goldman Sachs Alternatives, Canada Pension Plan Investment Board (CPP Investments) as well as other new investors
Founding investors ARCH Venture Partners, Sofinnova Investments, Third Rock Ventures, and PureTech Health also participated
Proceeds will support key clinical milestones in Seaport’s pipeline of first and best-in-class neuropsychiatric medicines
BOSTON–(BUSINESS WIRE)–Seaport Therapeutics (“Seaport” or the “Company”), a clinical-stage biopharmaceutical company that is advancing novel neuropsychiatric medicines with a proven strategy and team, today announced the closing of an oversubscribed $225 million Series B financing round. The syndicate was led by General Atlantic, a leading global growth investor, with participation from funds and accounts advised by T. Rowe Price Associates, Inc., Foresite Capital, Invus, Goldman Sachs Alternatives, CPP Investments, and other new investors. Founding investors ARCH Venture Partners, Sofinnova Investments, Third Rock Ventures, and co-founder PureTech Health also participated.
The financing brings the total capital raised by Seaport to $325 million since the Company’s launch in April 2024. Seaport will use the proceeds to advance its clinical-stage pipeline of first and best-in-class medicines through important clinical milestones as well as further advance the capabilities of the Glyph™ technology platform, which has demonstrated clinical proof-of-concept.
“We are grateful to have the partnership of this incredible group of new and existing investors who share our commitment of delivering better medicines for those suffering from depression, anxiety and other neuropsychiatric disorders,” said Daphne Zohar, Founder and CEO of Seaport Therapeutics. “Seaport is advancing novel therapeutics that have proven clinical efficacy but had previously been held back by an issue we can now address with our Glyph platform. This financing enables the important clinical work that brings us another step closer to delivering new medicines to make a difference in the lives of patients and their families.”
“We are excited to partner with Daphne Zohar, Steve Paul and the team at Seaport,” said Brett Zbar, M.D., Managing Director and Global Head of Life Sciences at General Atlantic. “We are impressed with the team’s outstanding CNS clinical track record, as well as Seaport’s Glyph platform and innovative pipeline. The approach to clinical development and trial design demonstrates the deep neuropsychiatric expertise around the table, which we believe offers unique advantages that will contribute to Seaport’s success. We look forward to supporting the Company’s next phase of development.”
The programs in Seaport’s pipeline use the Glyph platform, which is designed to enable and enhance oral bioavailability, avoid first-pass metabolism and reduce liver enzyme elevations or hepatotoxicity and other side effects to advance clinically active drugs that were previously hindered by those limitations. The most advanced therapeutic candidate in the pipeline is SPT-300, an oral prodrug of allopregnanolone that is being advanced into a Phase 2b study for major depressive disorder with or without anxious distress that has the potential to be registration-enabling. Allopregnanolone is an endogenous neurosteroid with clinically validated rapid anti-depressant and anxiolytic activity, and SPT-300 retains this activity in an oral form.
“The development of important new neuropsychiatric medicines is often halted due to poor drug-like properties or unacceptable tolerability, challenges that our Glyph platform can now uniquely address,” said Steve Paul, M.D., Founder and Board Chair at Seaport Therapeutics. “For instance, xanomeline was an effective drug that faced tolerability challenges, but once resolved, led to the FDA approval of Cobenfy™ (formerly KarXT) for schizophrenia. With Glyph, we believe each of Seaport’s programs could create similar life-changing value for patients.”
SPT-320, a novel prodrug of agomelatine being advanced into Phase 1 studies for the treatment of generalized anxiety disorder (GAD), has the potential to be the first new mechanism for GAD in decades. SPT-320 uses Glyph to bypass liver first-pass metabolism and thus has the potential to lower the dose and reduce liver exposure while retaining efficacious systemic exposure of agomelatine that has been validated in multiple clinical studies in GAD. The reduction in dose has the potential to eliminate the need for liver function monitoring that has previously held back agomelatine’s development in GAD. SPT-348, a prodrug of a non-hallucinogenic neuroplastogen in development for the treatment of mood and other neuropsychiatric disorders, uses Glyph to create a potential first-in-class treatment. Beyond these programs, Seaport has multiple discovery and preclinical programs underway.
About the Glyph™ Platform
Glyph is Seaport’s proprietary technology platform which uses the lymphatic system to enable and enhance the oral administration of drugs. With the Glyph platform, drugs are absorbed like dietary fats through the intestinal lymphatic system and transported into circulation. The Glyph platform has the potential to be widely applied to many therapeutic molecules that have high first-pass metabolism leading to low bioavailability and/or side effects, including liver enzyme elevations or hepatotoxicity. Seaport exclusively licensed this technology from Monash University based on the pioneering research of the Porter Research Group. Advanced initially at PureTech Health and now at Seaport, Glyph has been applied to create therapeutic candidates for the Company’s pipeline resulting in new intellectual property, including composition of matter. The group and its collaborators have published research in Nature Metabolism, Frontiers in Pharmacology and the Journal of Controlled Release supporting the Glyph platform’s capabilities. See Glyph in action here.
About Seaport Therapeutics
Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce liver enzyme elevations or hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com.
Contacts
Seaport Therapeutics
Shannon Costello
Immunome to Present Poster Highlighting Preclinical Evaluation of IM-1021, a ROR1-Targeted Antibody Drug Conjugate, at the 36th EORTC-NCI-AACR Symposium
BOTHELL, Wash.–(BUSINESS WIRE)–Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced that it will present a poster highlighting preclinical evaluation of IM-1021, a ROR1-targeted antibody drug conjugate (ADC), at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona on October 24, 2024.
Immunome expects to submit an IND for the IM-1021 program to the FDA in the first quarter of 2025.
Following the presentation, a copy of the poster will be made available in the “Events & Presentations” portion of Immunome’s website.
Poster Presentation Details:
Title: Preclinical evaluation of IM-1021, a ROR1-targeted antibody-drug conjugate with a novel topoisomerase I linker payload.
Presenter: Robert Lawrence, Director of Biology, Immunome
Date: October 24, 2024
About Immunome, Inc.
Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025. For more information, visit www.immunome.com.
Cautionary Statement Regarding Forward-Looking Statements
Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We use words such as “will,” “expects,” and similar expressions to identify these forward-looking statements. These forward-looking statements include, but are not limited to, Immunome’s expected timing for submission of an IND for its IM-1021 program and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. These forward-looking statements are based on Immunome’s current expectations and involve assumptions that may never materialize or may prove to be incorrect; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, the risk that Immunome will not be able to realize the benefits of its strategic transactions; the risk that regulatory approvals for Immunome’s product candidates are not obtained, are delayed or are subject to unanticipated conditions; the risk that pre-clinical data may not be predictive of clinical data; the risk that Immunome’s product candidates fail to achieve their intended endpoints; and other risks and uncertainties indicated from time to time described in Immunome’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 12, 2024, and in Immunome’s other filings with the SEC. Except as required by law, Immunome assumes no obligation and does not intend to update any forward-looking statements included in this press release.
Contacts
Immunome Contact:
Max Rosett
Chief Financial Officer
Nurix Therapeutics Expands Its Board of Directors with the Addition of Drug Commercialization Expert Anil Kapur
SAN FRANCISCO, Oct. 16, 2024 (GLOBE NEWSWIRE) — Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced the appointment of Anil Kapur to its board of directors, effective October 15, 2024. Mr. Kapur has over 25 years of executive experience in pharmaceutical and biotech companies across both U.S. and international markets.
“I am delighted to welcome Anil to the Nurix board as we enter this important stage in the company’s development and execute on our plan to advance NX-5948 into pivotal clinical testing in 2025 and prepare for future commercialization,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “Anil has an impressive record of commercial operations excellence and extensive experience launching novel drugs in hematology and oncology with direct relevance to Nurix’s pipeline, including the launch of blockbuster drugs Imbruvica and Darzalex while at Johnson & Johnson. I believe his strategic, marketing, sales and business development insights will be invaluable to Nurix in the years to come.”
Mr. Kapur began his pharmaceutical executive career as Vice President, Commercial Leader Hematology Franchise at Janssen Pharmaceuticals, Johnson & Johnson’s global pharmaceutical strategy organization. As the J&J Joint Commercialization Committee Leader in partnership with Pharmacyclics, Mr. Kapur launched Imbruvica, the first BTK inhibitor for chronic lymphocytic leukemia, achieving an estimated $1 billion in sales within 18 months of launch. Mr. Kapur also led the J&J/Genmab joint commercialization committee and the global team that launched the transformational product Darzalex, the first biologic for multiple myeloma.
“I am excited to join Nurix’s board of directors at this important time as NX-5948 is poised to enter pivotal trials and as we form the strategy for its commercialization,” said Mr. Kapur. “I believe Nurix’s targeted protein degrader drug pipeline has great potential to change the treatment landscape and help patients living with B cell malignancies and beyond.”
As a senior leader in hematology and oncology in both small and large organizations, Mr. Kapur has been responsible for launching significant global brands, building and managing commercial capabilities, driving corporate strategy and managing alliances. Most recently, Mr. Kapur served as Executive Vice President, Corporate Strategy and Chief Commercial Officer at Geron Corporation from December 2019 to August 2024. Prior to Geron, Mr. Kapur served as Chief Commercial Officer at Actinium Pharmaceuticals, Inc., and as Vice President, Head of Early Assets, Biomarkers and External Innovation for Worldwide Oncology Commercialization at Bristol-Myers Squibb. Mr. Kapur is a member of the board of directors of Verastem, Inc., a late-stage development biopharmaceutical company. Mr. Kapur holds a BE in Mechanical Engineering from Birla Institute of Technology in India, an MS in Engineering from Louisiana Tech University, and an MBA from the Fuqua School of Business at Duke University.
About Nurix Therapeutics, Inc.
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative small molecules and antibody therapies based on the modulation of cellular protein levels as a novel treatment approach for cancer, inflammatory conditions, and other challenging diseases. Leveraging extensive expertise in E3 ligases together with proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform, to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin-proteasome system to selectively decrease or increase cellular protein levels. Nurix’s wholly owned, clinical stage pipeline includes targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates activation of multiple immune cell types including T cell and NK cells. Nurix is headquartered in San Francisco, California. For additional information visit http://www.nurixtx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein that do not describe historical facts, including, but not limited to, statements regarding the expected contributions Mr. Kapur will bring to Nurix, Nurix’s plans to advance NX-5948 into pivotal clinical testing in 2025, and the potential for Nurix’s targeted protein degrader drug pipeline to change the treatment landscape in B cell malignancies, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others, the risks described under the heading “Risk Factors” in Nurix’s Quarterly Report on Form 10-Q for the period ended August 31, 2024, and subsequent filings with the SEC. Any of these risks and uncertainties could materially and adversely affect Nurix’s business and results of operations, which could, in turn, have a significant and adverse impact on Nurix’s stock price. Nurix cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Nurix undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made or to reflect the occurrence of unanticipated events.
Contacts:
Investors
Jason Kantor, Ph.D.
Nurix Therapeutics, Inc.
ir@nurixtx.com
Elizabeth Wolffe, Ph.D.
Wheelhouse Life Science Advisors
lwolffe@wheelhouselsa.com
Media
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
Firefly Neuroscience Announces Use of Its Brain Network Analytics Platform in Phase 1 Study of SP-624, the First Potential Treatment Designed for Women with Major Depressive Disorder
- Study to Leverage Firefly’s BNA™ Technology for Biomarker Identification, with Potential Applications for Broader Neurological Research
TORONTO, Oct. 15, 2024 (GLOBE NEWSWIRE) — Firefly Neuroscience, Inc. (“Firefly,” or the “Company”) (NASDAQ: AIFF), an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders, today announced that its FDA-510(k) cleared Brain Network Analytics (BNA™) biomarker discovery AI platform will be used to support Arrivo Bioventures’ (“Arrivo”) Phase 1 exploratory study of its first-in-class SIRT6 activator, SP-624, in healthy volunteers and patients with major depressive disorder (MDD).
The study, which has enrolled its first subject, is designed to evaluate the impact of the epigenetic mechanism of action of SP-624 on neurological pathways and assess changes in various cognitive domains. SP-624 is also currently being studied in a large Phase 2b study in patients diagnosed with MDD, with efficacy in females as the primary endpoint.
“We believe that utilizing Firefly’s BNA™ technology in the SP-624 study will help Arrivo better understand SP-624’s activity and uncover critical biomarkers that may inform future research across neurological conditions,” said Jon Olsen, CEO of Firefly. “Together with Arrivo, this study underscores our shared commitment to advancing targeted treatments for women with major depressive disorder, which continues to be an unmet medical need in mental health.”
In an earlier Phase 2 study of SP-624, Arrivo explored efficacy over placebo during a four week treatment period. In a post-hoc analysis, the company found statistically significant improvement versus placebo consistent across both investigator and patient measures of MDD in female subjects, which was achieved as early as week 2. In male subjects, there were no statistically significant changes detected. While differences in MDD between males and females have long been discussed, these results support recent published literature citing differences in gene expression between males and females with MDD. Using Firefly’s BNA™ technology, Arrivo will also identify target engagement and biomarkers in the Phase 1 study that can be used in future studies across a variety of neurological conditions, including MDD.
“There is a growing body of literature suggesting that targeting SIRT6 can play an important role in multiple neuropsychiatric, neurodegenerative, inflammatory, and metabolic diseases,” said Steve Butts, CEO of Arrivo. “This study should help us in our ongoing efforts to characterize the activity of SP-624 and look for potential biomarkers.”
The Phase 1, single-center, double-blind, randomized, placebo-controlled study is being conducted at Alivation Research with Walt Duffy, M.D., founder, CEO and Chief Medical Officer, as the Principal Investigator.
About Firefly
Firefly (NASDAQ: AIFF) is an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders. Firefly’s FDA-510(k) cleared Brain Network Analytics (BNA™) technology revolutionizes diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Over the past 15 years, Firefly has built a comprehensive database of brain wave tests, securing patent protection, and achieving FDA clearance. The Company is now launching BNA™ commercially, targeting pharmaceutical companies engaged in drug research and clinical trials, as well as medical practitioners for clinical use.
Brain Network Analytics was developed using artificial intelligence and machine learning on Firefly’s extensive proprietary database of standardized, high-definition longitudinal electroencephalograms (EEGs) of over 17,000 patients representing twelve disorders, as well as clinically normal patients. BNA™, in conjunction with an FDA-cleared EEG system, can provide clinicians with comprehensive insights into brain function. These insights can enhance a clinician’s ability to accurately diagnose mental and cognitive disorders and to evaluate what therapy and/or drug is best suited to optimize a patient’s outcome.
Please visit https://fireflyneuro.com/ for more information.
About Arrivo BioVentures
Arrivo BioVentures is propelled forward by its insatiable curiosity and drive to solve complex problems and help millions of patients globally. Working in partnership with investors, innovators, and pharmaceutical companies, Arrivo is always seeking solutions for unmet medical needs. Arrivo has a portfolio of diverse drug candidates with the potential to be first-in-class or best-in-class. Arrivo is based in Morrisville, N.C., on the edge of Research Triangle Park. For more information, visit www.arrivobio.com.
Forward-Looking Statements
Certain statements in this press release and the information incorporated herein by reference may constitute “forward-looking statements” for purposes of the federal securities laws concerning Firefly. These forward-looking statements include express or implied statements relating to Firefly’s management teams’ expectations, hopes, beliefs, intentions, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Firefly will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Firefly’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to development and commercialization of BNA™ technology; risks related to Firefly’s ability to recognize the anticipated benefits of the merger (the “Merger”) with WaveDancer, Inc. (“WaveDancer”); risks related to Firefly’s ability to correctly estimate its operating expenses and expenses associated with the Merger and other events and unanticipated spending and costs that could reduce Firefly’s cash resources; the ability of Firefly to protect its intellectual property rights; competitive responses to the business combination; unexpected costs, charges or expenses resulting from the Merger; potential adverse reactions or changes to business relationships resulting from the completion of the Merger; legislative, regulatory, political and economic developments; and those factors described under the heading “Risk Factors” in the in the registration statement on Form S-4 filed by WaveDancer with the Securities and Exchange Commission on January 22, 2024, as amended, and declared effective on February 6, 2024. Should one or more of these risks or uncertainties materialize, or should any of Firefly’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. It is not possible to predict or identify all such risks. Forward-looking statements included in this press release only speak as of the date they are made, and Firefly does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Arrivo Bio Media Contact
ICR Healthcare
Alexis Feinberg, Vice President
Alexis.feinberg@westwicke.com
Firefly Neuroscience Investor Contacts
KCSA Strategic Communications
Valter Pinto / Jack Perkins
(212) 896-1254
Firefly@KCSA.com
Firefly Neuroscience Media Contact
KCSA Strategic Communications
Raquel Cona, Vice President
(516) 779-2630
Rcona@KCSA.com
invIOs raises €8.2 million in a Series A to finance pipeline progress in immuno-oncology
- Funding secures ongoing pipeline progress and achievement of preclinical and clinical milestones
- Oral small molecule INV501: collaboration with Dana-Farber Cancer Institute (DFCI) making good progress; target validation and details of mechanism of action expected in Q1 2025
- Cell therapy INV441: pre-IND meeting with US FDA successfully completed; first-in-humans study in glioblastoma to start mid-2025 as part of a new collaboration with DFCI
- invIOs management to participate in LSX Inv€$tival Showcase™ in London on November 18th
VIENNA, Oct. 15, 2024 (GLOBE NEWSWIRE) — invIOs GmbH (“invIOs”), a privately held biotechnology company developing novel therapies for cancer, today announced that the company has raised €8.2 million in a Series A fundraising that includes strong participation from existing shareholders and Ligand Pharmaceuticals. Ligand recently acquired APEIRON, the former parent company of invIOs. This funding secures ongoing pipeline progress and achievement of clinical and preclinical milestones through 2025.
Peter Llewellyn-Davies, CEO & CFO of invIOs, said: “We are pleased to have raised these funds, which enables us to move our programs forward as planned. I am particularly grateful for the strong support of existing shareholders, as well as the commitment of our new shareholder, Ligand Pharmaceuticals.”
invIOs also provided an update on recent progress with its two lead anti-cancer programs, INV441 and INV501. The company has collaborations in glioblastoma with the Dana-Farber Cancer Institute (DFCI) for both programs. The collaborations are being led by David Reardon, MD, Clinical Director, Center for Neuro-Oncology at the DFCI and Professor of Medicine at Harvard Medical School. Dr. Reardon is a world-renowned expert in brain cancer, particularly glioblastoma research and treatment.
“We are thrilled with the progress of our collaboration with the DFCI for both our oral small molecule candidate, INV501, and now also our cell therapy candidate, INV441. With these two immune-oncological approaches, we are developing cancer therapies that have the potential to address major unmet needs in treating deadly tumors, and we are excited to continue our work to ultimately improve and save patients’ lives,” commented Romana Gugenberger, PhD, Chief Medical and Scientific Officer of invIOs.
INV501 first-in-class orally available small molecule. In July 2024, invIOs announced the selection of a lead candidate from its family of compounds. Preclinical testing has shown compelling efficacy and safety results with this candidate in both breast cancer and melanoma models, as well as the ability to cross the blood-brain barrier and initiate anti-tumoral immune reactions.
IND-enabling toxicology studies are underway, and manufacturing under GMP conditions is in preparation. Target validation work is planned to be completed and details of the mechanism of action provided in Q1 2025.
INV441 cell therapy. INV441 uses tumor-infiltrating lymphocytes (TILs) that are modified via siRNA inhibiting the immune checkpoint Cbl-b and administered directly to the tumor. This approach has demonstrated strong preclinical proof of concept in murine glioma models. In 2024, invIOs filed important IP around this program. invIOs recently held a pre-IND (Investigational New Drug) meeting with the US Food & Drug Administration (FDA). In the meeting, the FDA provided helpful input for the planned Phase 1 study with INV441 which is planned to be conducted by the DFCI and is expected to initiate in mid-2025.
Meet invIOs management at LSX Inv€$tival Showcase™ in London on November 18th
Peter Llewellyn-Davies, CEO & CFO, and Romana Gugenberger, PhD, Chief Medical and Scientific Officer, will give a company presentation and host 1X1 meetings at this important industry event. To schedule a meeting, please use the conference partnering system or contact: investors@invios.com.
About invIOs
invIOs is a privately held biotech company based in Vienna, Austria, focusing on the discovery and development of novel therapies for cancer. The invIOs team leverages deep expertise in immune system activation to develop individualized and targeted approaches against solid tumors. invIOs is advancing a pipeline of programs encompassing small molecule and cell therapy approaches.
INV501 is a novel small molecule candidate that can selectively enhance T cell mediated anti-tumor immune responses. INV501 is currently in preclinical testing and has demonstrated preclinical proof of concept with strong data in multiple solid tumor indications after oral administration. A lead candidate compound for clinical development has been selected, and IND-enabling studies are ongoing.
EPiC, invIOs’ proprietary cell therapy platform, enables rapid treatment of patients in an out-patient setting. EPiC is a technology platform that allows the creation of personalized cell therapies based on localized processing of a patient’s fresh immune cells. Proof of concept has been demonstrated via initial clinical results from the first asset from the EPiC platform, APN401. INV441, also derived from EPiC, is being developed for the treatment of glioblastoma and is in preclinical testing. invIOs has a collaboration with the DFCI for this program. Another EPiC program, INV451, is a novel CAR-T cell approach against lung cancer being developed with the Medical University of Innsbruck.
For further information, please visit www.invios.com and connect with us on LinkedIn.
Contacts
invIOs
Peter Llewellyn-Davies
CEO/CFO
T +43 1 8656577 0
Email: investors@invios.com
MC Services AG
Dr. Cora Kaiser, Dr. Regina Lutz
T +49 89 210 228 0
US: Laurie Doyle
T +1-339-832-0752
Email: invios@mc-services.eu
Booster Therapeutics Launches to Pioneer New Class of Proteasome Activator Medicines for the Treatment of a Range of Complex Diseases
- $15 million seed financing led by Apollo Health Ventures and Novo Holdings
- New approach aims to expand the ability of therapeutics to degrade harmful proteins in the body
- Booster small molecules re-activate cellular ‘quality control’ machinery of proteasomes, which is impaired in complex diseases
- Dr. Patrick Trojer appointed as Chair of the Board of Directors
BERLIN–(BUSINESS WIRE)–Booster Therapeutics, a biotechnology company pioneering a new class of proteasome activator medicines to treat neurodegenerative and other diseases, launched today with the support of a $15 million financing led by noted life sciences investors Apollo Health Ventures and Novo Holdings. Booster was founded by Dr. Diogo Feleciano, Prof. Dr. Darci Trader, and Apollo Health Ventures, emerging from Apollo’s company creation investment strategy. The company is developing small molecule therapeutics that boost the innate activity of proteasomes to restore the body’s ability to remove a wide range of disease-causing proteins.
“Proteasome activation offers important advantages over more limited conventional protein degradation approaches and provides a powerful lever to combat the effects of the many types of deviant proteins that can accumulate in cells when proteasome function declines through age or disease. The implications for solving major degenerative conditions, such as Parkinson’s and Alzheimer’s, are enormous,” said Dr. Diogo Feleciano, Co-Founder and Chief Scientific Officer. “We’re grateful for the support of our investors, who have enabled us to assemble a world-class team to realize the untapped potential of proteasome activation against a range of difficult-to-treat diseases.”
Proteasomes, the cell’s natural quality control machinery, play a critical role in removing damaged or misfolded proteins. When their function is impaired, misfolded proteins accumulate and increase the risk of serious disease. Booster’s approach is a departure from current targeted protein degradation methods, which tag single disease proteins with the marker protein ubiquitin, leading to their degradation via 26S proteasomes. This can be effective, particularly in diseases driven by a single errant protein. But complex diseases are often driven by multiple protein dysfunctions. To achieve more widespread degradation of unwanted proteins, Booster’s compounds directly activate 20S proteasomes, which naturally recognize disordered proteins without the need for ubiquitin tagging.
“Booster exploits the cell’s universal protein surveillance machinery to drive restoration of protein homeostasis in various disease contexts,” said Dr. Patrick Trojer, Chair of Booster’s Board of Directors and Chief Executive Officer of TRIANA Biomedicines. “The application potential of this therapeutic frontier is highly attractive, and given the broad-spectrum activity of proteasome activators, we see opportunities for both monotherapy and combination approaches where increased proteasome activity may enhance the efficacy of other therapeutics.”
Booster is discovering small molecules through its DGRADX™ platform, which combines proprietary methods for automated high-throughput screening with advanced structural and computational tools. The company has built an extensive library of activator compounds with therapeutic potential and aims to develop a multi-disease pipeline to address proteinopathies.
“Emerging from Apollo’s company creation engine, Booster has made remarkable strides in pioneering this exciting new field of medicine. Booster’s focus on activating the 20S proteasome directly addresses a critical mechanism involved in the cellular stress of aging, offering us a new therapeutic perspective on major disease areas,” said Dr. Marianne Mertens, Partner at Apollo, Managing Director, and Board Member of Booster Therapeutics. “We look forward to working with the team and the strong syndicate to advance toward proof-of-concept and develop a pipeline of potential first-in-class medicines.”
“The pioneering work of Prof. Trader and Dr. Feleciano completely transformed our approach to protein degradation in proteinopathies. Booster’s data support the ability of the 20S proteasome to safely, effectively and specifically degrade a wider set of pathological proteins.” said Dr. João Ribas, Principal at Novo Holdings, Seed Investments and Interim Chief Business Officer and Board Member, Booster Therapeutics. “Proteinopathy is core to many of the most challenging complex diseases, so the potential to address them with a single agent is incredibly promising and could reshape the treatment landscape. We’re excited to join Apollo and help advance this novel therapeutic concept to the clinic.”
About Booster Therapeutics
Booster Therapeutics is pioneering a new class of medicines that activate the cell’s natural quality control machinery to treat a range of complex indications. Booster’s small molecule therapeutics, discovered through the DGRADX™ platform, are designed to directly boost the activity of 20S proteasomes to restore the body’s ability to clear disease-causing proteins. The company is developing a multi-disease pipeline, with an initial focus on neurodegenerative diseases associated with impaired proteasome function such as Parkinson’s disease and Alzheimer’s disease. Booster is based in Berlin, Germany. For more information, visit www.boostertx.com.
About Apollo Health Ventures
Apollo Health Ventures is a transatlantic venture capital firm specialized in developing and investing in data-driven biotechnology and health tech ventures. Apollo Health Ventures invests in game-changing companies at the seed or early stage and builds companies within the aging sector. Apollo’s team consists of entrepreneurs, seasoned biotech investors and scientists with remarkable track records in life science investments and venture creation. www.apollo.vc
About Novo Holdings
Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.
Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novonesis A/S and manages an investment portfolio with a long-term return perspective. Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Principal Investments, Planetary Health Investments and Asia teams, Novo Holdings invests directly in life science companies at all stages of development. In addition, it manages a broad portfolio of Capital Investments, including equities, bonds, fixed income, real estate, and infrastructure assets. As of year-end 2023, Novo Holdings had total assets of EUR 149 billion. www.novoholdings.dk
Contacts
Kit Rodophele
Ten Bridge Communications
617-999-9620
Pfizer’s TALZENNA® in Combination with XTANDI® Prolongs Overall Survival in Phase 3 TALAPRO-2 Trial
- First and only PARP inhibitor plus ARPI combination to demonstrate statistically significant overall survival (OS) benefit in patients with metastatic castration-resistant prostate cancer (mCRPC)
- Results to be shared with global health authorities to potentially update the TALZENNA label
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced positive topline results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in patients with metastatic castration-resistant prostate cancer (mCRPC). Results showed a statistically significant and clinically meaningful improvement in the final OS in all-comers (cohort 1) as well as in those patients with homologous recombination repair (HRR) gene-mutated mCRPC (cohort 2), compared to XTANDI alone.
“The TALAPRO-2 results showed that TALZENNA plus XTANDI is the first and only PARP inhibitor in combination with an ARPI to significantly improve survival in patients with metastatic castration-resistant prostate cancer, regardless of mutation status,” said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. “Pfizer is dedicated to advancing scientific breakthroughs in genitourinary cancers, and these exciting TALAPRO-2 results further highlight our long-standing commitment to improving survival for men with prostate cancer.”
“These overall survival results indicate potentially practice-changing efficacy for TALZENNA in combination with XTANDI for men with metastatic castration-resistant prostate cancer,” said Neeraj Agarwal, M.D., FASCO, Professor and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, University of Utah, and global lead investigator for TALAPRO-2. “Metastatic castration-resistant prostate cancer is the most advanced and aggressive stage of the disease, and the TALAPRO-2 results provide much-needed hope to patients who remain in high unmet need for effective treatment options.”
At the time of the final analysis, the clinically meaningful improvement in radiographic progression free survival (rPFS) was maintained in both cohorts from the prior primary analysis previously reported and published in The Lancet. In addition, the safety profile of TALZENNA plus XTANDI was generally consistent with the known safety profile of each medicine. Detailed results from TALAPRO-2 will be submitted for presentation at an upcoming medical congress. These data will also be shared with global health authorities to potentially support regulatory filings to update and potentially expand the approved label for TALZENNA.
TALZENNA in combination with XTANDI was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with HRR gene-mutated mCRPC in June 2023. The combination was also approved by the European Commission in January 2024 for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated. TALZENNA is the first and only PARP inhibitor licensed in the European Union for use with XTANDI for patients with mCRPC, with or without gene mutations. TALZENNA in combination with XTANDI is now approved in more than 35 countries globally for patients with mCRPC.
About Metastatic Castration-Resistant Prostate Cancer
Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death among men worldwide, with an estimated 1.4 million new cases diagnosed in 2022.1 In the U.S., it is the most common cancer in men.2 mCRPC is a cancer that has spread beyond the prostate gland and has progressed despite medical or surgical treatment to lower testosterone. Approximately 10%–20% of prostate cancer patients develop mCRPC within 5−7 years of diagnosis.3 Between 1.2%–2.1% of all prostate cancer cases globally are mCRPC.4
About TALAPRO-2
The Phase 3 TALAPRO-2 trial is a multicenter, randomized, double-blind, placebo-controlled study that enrolled 1,035 unique patients with mCRPC (who had not received new life-prolonging systemic treatments after documentation of mCRPC) at sites in the U.S., Canada, Europe, South America, and the Asia-Pacific region. The study included two patient cohorts: all-comers (n=805, of whom 169 had HRR mutations and 636 did not) and those with HRR gene mutations (n=399, including 169 patients from Cohort 1 and 230 enrolled in Cohort 2). Patients with castrate testosterone levels were randomized to receive TALZENNA 0.5 mg/day plus XTANDI 160mg/day, or placebo plus XTANDI 160mg/day.
The primary endpoint of the trial was rPFS, defined as the time from the date of randomization to first objective evidence of radiographic progression by blinded independent review, or death, whichever occurred first, in both Cohort 1 (all-comers) and Cohort 2 (those with HRRm). Secondary endpoints included OS, objective response rate (ORR), duration of response (DOR), and prostate-specific antigen (PSA) response.
For more information on the TALAPRO-2 trial (NCT03395197), go to www.clinicaltrials.gov.
About TALZENNA® (talazoparib)
TALZENNA is an oral inhibitor of poly ADP-ribose polymerase (PARP), which plays a role in DNA damage repair. Preclinical studies have demonstrated that TALZENNA blocks PARP enzyme activity and traps PARP at the site of DNA damage, leading to decreased cancer cell growth and cancer cell death.
TALZENNA is approved in the U.S., EU, and multiple other regions for the treatment of adult patients with deleterious or suspected deleterious gBRCAm HER2-negative locally advanced or metastatic breast cancer. In the U.S., TALZENNA is approved in combination with XTANDI for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). In the EU, TALZENNA is approved in combination with enzalutamide for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated.
TALZENNA® (talazoparib) Indication in the U.S.
TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for:
HRR gene-mutated mCRPC:
- In combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Breast Cancer:
- As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.
TALZENNA® (talazoparib) Important Safety Information
WARNINGS and PRECAUTIONS
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with a fatal outcome, has been reported in patients who received TALZENNA. Overall, MDS/AML has been reported in 0.4% (3 out of 788) of solid tumor patients treated with TALZENNA as a single agent in clinical studies. In TALAPRO-2, MDS/AML occurred in 2 out of 511 (0.4%) patients treated with TALZENNA and enzalutamide and in 0 out of 517 (0%) patients treated with placebo and enzalutamide. The durations of TALZENNA treatment in these five patients prior to developing MDS/AML were 0.3, 1, 2, 3, and 5 years, respectively. Most of these patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy.
Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous chemotherapy. Monitor blood counts monthly during treatment with TALZENNA. For prolonged hematological toxicities, interrupt TALZENNA and monitor blood counts weekly until recovery. If counts do not recover within 4 weeks, refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue TALZENNA.
Myelosuppression consisting of anemia, neutropenia, and/or thrombocytopenia have been reported in patients treated with TALZENNA. In TALAPRO-2, Grade ≥3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 45%, 18%, and 8% of patients receiving TALZENNA and enzalutamide. Overall, 39% of patients (199/511) required a red blood cell transfusion, including 22% (111/511) who required multiple transfusions. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 7%, 3%, and 0.4% of patients.
Withhold TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy. Monitor blood counts monthly during treatment with TALZENNA. If hematological toxicities do not resolve within 28 days, discontinue TALZENNA and refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics.
Embryo-Fetal Toxicity TALZENNA can cause fetal harm when administered to pregnant women. Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment with TALZENNA and for 4 months after receiving the last dose.
ADVERSE REACTIONS
In TALAPRO-2, serious adverse reactions reported in >2% of patients included anemia (9%) and fracture (3%). Fatal adverse reactions occurred in 1.5% of patients, including pneumonia, COVID infection, and sepsis (1 patient each).
The most common adverse reactions (≥ 10%, all Grades), including laboratory abnormalities, for patients in the TALAPRO-2 study who received TALZENNA in combination with enzalutamide vs patients receiving placebo with enzalutamide were hemoglobin decreased (79% vs 34%), neutrophils decreased (60% vs 18%), lymphocytes decreased (58% vs 36%), fatigue (49% vs 40%), platelets decreased (45% vs 8%), calcium decreased (25% vs 11%), nausea (21% vs 17%), decreased appetite (20% vs 14%), sodium decreased (22% vs 20%), phosphate decreased (17% vs 13%), fractures (14% vs 10%), magnesium decreased (14% vs 12%), dizziness (13% vs 9%), bilirubin increased (11% vs 7%), potassium decreased (11% vs 7%), and dysgeusia (10% vs 4.5%).
Clinically relevant adverse reactions in <10% of patients who received TALZENNA with enzalutamide included abdominal pain (9%), vomiting (9%), alopecia (7%), dyspepsia (4%), venous thromboembolism (3%) and stomatitis (2%).
Based on animal studies, TALZENNA may impair fertility in males of reproductive potential.
DRUG INTERACTIONS
Coadministration with P-gp inhibitors The effect of coadministration of P-gp inhibitors on talazoparib exposure when TALZENNA is taken in combination with enzalutamide has not been studied. Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a P-gp inhibitor.
Coadministration with BCRP inhibitors Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a BCRP inhibitor. Coadministration of TALZENNA with BCRP inhibitors may increase talazoparib exposure, which may increase the risk of adverse reactions.
USE IN SPECIFIC POPULATIONS
Renal Impairment The recommended dosage of TALZENNA for patients with moderate renal impairment (CLcr 30 – 59 mL/min) is 0.35 mg taken orally once daily in combination with enzalutamide. The recommended dosage of TALZENNA for patients with severe renal impairment (CLcr 15 – 29 mL/min) is 0.25 mg taken orally once daily in combination with enzalutamide. No dose adjustment is required for patients with mild renal impairment. TALZENNA has not been studied in patients requiring hemodialysis.
Please see full U.S. Prescribing Information and Patient Information for TALZENNA® (talazoparib) at www.TALZENNA.com.
About XTANDI® (enzalutamide) and Important Safety Information
XTANDI® (enzalutamide) is an androgen receptor signaling inhibitor. XTANDI is a standard of care and has received regulatory approvals in one or more countries around the world for use in men with metastatic castration-sensitive prostate cancer (mCSPC; also known as metastatic hormone-sensitive prostate cancer or mHSPC), metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC) and nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). XTANDI is currently approved for one or more of these indications in more than 90 countries, including in the U.S., EU, and Japan. Over one million patients have been treated with XTANDI globally.5
Warnings and Precautions
Seizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.
Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.
Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.
Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.
Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo.
Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI.
Adverse Reactions (ARs) the data from the five randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.
In AFFIRM, the placebo-controlled study of metastatic CRPC (mCRPC) patients who previously received docetaxel, Grade 3 and higher ARs were reported among 47% of XTANDI-treated patients. Discontinuations due to ARs were reported for 16% of XTANDI-treated patients. In PREVAIL, the placebo-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to ARs were reported for 6% of XTANDI-treated patients. In TERRAIN, the bicalutamide-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 39% of XTANDI patients and 38% of bicalutamide patients. Discontinuations with an AR as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients.
In PROSPER, the placebo-controlled study of nonmetastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients. Discontinuations with an AR as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients.
In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher ARs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to ARs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients.
In EMBARK, the placebo-controlled study of nonmetastatic CSPC (nmCSPC) with high-risk biochemical recurrence (BCR) patients, Grade 3 or higher adverse reactions during the total duration of treatment were reported in 46% of patients treated with XTANDI plus leuprolide, 50% of patients receiving XTANDI as a single agent, and 43% of patients receiving placebo plus leuprolide. Permanent treatment discontinuation due to adverse reactions during the total duration of treatment as the primary reason was reported in 21% of patients treated with XTANDI plus leuprolide, 18% of patients receiving XTANDI as a single agent, and 10% of patients receiving placebo plus leuprolide.
Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hyperphosphatemia, and hypercalcemia.
Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.
Drug Interactions
Effect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI.
Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI.
Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites.
Please access this link for XTANDI’S US Full Prescribing Information for additional safety information.
About Pfizer Oncology
At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
About the Pfizer/Astellas Collaboration
In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize XTANDI® (enzalutamide). The companies jointly commercialize XTANDI in the United States, and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.
Disclosure Notice
The information contained in this release is as of October 10, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer Oncology, TALZENNA and XTANDI, including their potential benefits, the TALAPRO-2 results and plans to share the results with global health authorities to potentially update the TALZENNA label, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.
Contacts
Media Contact:
+1 (212) 733-1226
PfizerMediaRelations@Pfizer.com
Investor Contact:
+1 (212) 733-4848
MiLaboratories Secures Series A, Raising Total Funding to $10 Million to Revolutionize the World of Genomic Research
The San Francisco-based company with an R&D facility in Bilbao has also unveiled its Platforma.bio Software Development Kit, transforming how biologists analyze genomic data to drive drug discovery and advance adjacent fields in medicine.
- This latest financing bolsters the company’s efforts to transform computational biology on a global scale and empower researchers with innovative tools to accelerate discoveries and advancements in the field
- Led by Kfund with participation from Speedinvest, Acrobator Ventures, Ten13, Somersault Ventures, EGB Capital, and Courtyard Ventures
- Series A capital to be utilized for attracting top-tier talent and expanding into new markets, with a strategic emphasis on the United States
SAN FRANCISCO–(BUSINESS WIRE)–MiLaboratories, a leader in computational biology innovation, is thrilled to announce the successful close of its Series A funding round, led by Madrid-based Kfund, with additional backing from Speedinvest and other prominent international investors. This funding milestone comes alongside the launch of its cutting-edge Platforma.bio Software Development Kit (SDK), a revolutionary tool that streamlines and transforms how biologists build and deliver analytics and insights from next-generation sequencing data.
Empowering Biologists to Overcome NGS Data Challenges and Accelerate Genomic Research
Biotech and pharmaceutical companies often face significant challenges when integrating next-generation sequencing (NGS) technology, particularly regarding computational infrastructure and scalability. One major issue is the biologists’ reliance on bioinformaticians to analyze the vast amounts of genomic data generated by NGS. Since bioinformatics requires specialized skills and computational resources, biologists frequently depend on overburdened bioinformatic teams, creating bottlenecks that delay research and actionable insights.
These challenges, along with data interoperability issues, high scaling costs, and the complexity of managing large datasets, further slow progress in drug discovery and research.
To overcome these hurdles, MiLaboratories has developed a high-performance software platform that empowers biologists to analyze NGS data independently. By providing an intuitive, scalable solution, MiLaboratories reduces the dependency on bioinformaticians, speeds up data processing, and integrates seamlessly with existing systems, accelerating research and fostering greater collaboration in genomics.
Platforma.bio SDK Equips Researchers with Intuitive Tools for Complex Computational Analysis
Platforma.bio offers a user-friendly, UI-centric design that simplifies the use of advanced computational biology tools, making them accessible to scientists without the steep learning curve of traditional systems. Researchers can focus on their work while the platform automates resource management, data handling, and complex processes.
In line with MiLaboratories’ commitment to academic research, the Platforma.bio Software Development Kit (SDK) is accessible from their open marketplace and is free for academic scientists, enabling them to develop custom analytical tools and applications. This open, collaborative approach fosters innovation and accelerates discovery by empowering researchers to tailor solutions to their specific needs.
“We believe that opening our platform to the developer community will accelerate the adoption of modern computational tools, setting the next level of biomedical research,” said Stan Poslavsky, CEO of MiLaboratories. “Today, therapy development is driven by data, algorithms, and AI. Our mission is to make cutting-edge computational advances accessible to researchers as they work towards discovering new drugs.”
Seeking the Talent to Drive Global Market Transformation
With a multi-billion dollar global market potential, MiLaboratories is poised to significantly scale its operations in the coming years by focusing its efforts on attracting top-tier talent and strategically expanding its operations, with a primary focus on the United States.
“Investing in platforms that bridge the gap between developers (in this case bioinformaticians) and business users (in this case biologists) is at the core of what we want to do in our fund. There is tremendous potential in democratizing access to complex data enabling the delivery of immunological insights,” remarked Miguel Arias, General Partner of Kfund.
For additional details about the new Platforma release or the Series A investment round, please reach out to press@milaboratories.com.
About MiLaboratories
MiLaboratories stands at the forefront of computational biology, creating game changing software solutions that redefine the parameters of biological research and development. Committed to innovation and user empowerment, MiLaboratories equips the scientific community with adaptable, cutting-edge tools designed to meet the dynamic demands of bioinformatics and biomedical research.
For more information, visit https://platforma.bio/.
About Kfund
Kfund is a multi-stage, multi-product fund family that supports entrepreneurs in Southern Europe and Latin America. With over €550 million in assets, the fund invests from the pre-seed stage to Series B, offering checks ranging from €100,000 to €15 million.
For more information, visit https://www.kfund.vc/
About Speedinvest
Speedinvest is a leading early-stage venture capital firm with more than €1 billion AuM and 40+ investors based in Berlin, London, Munich, Paris, and Vienna. Our dedicated sector-focused teams are the first to fund Europe’s most innovative technology startups and our in-house operational experts are on hand to offer founders ongoing support with growth, HR, market expansion, and more. Bitpanda, GoStudent, Wayflyer, Open, CoachHub, Schüttflix, TourRadar, Adverity, and TWAICE are among our portfolio of 300+ companies.
For more information, visit https://www.speedinvest.com/
About Acrobator
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Loci Orthopaedics Closes €12.8 Million Series A Financing
- Company developing its innovative InDx Implant System for thumb base joint arthritis
- Focused on a painful and disabling condition with increasing prevalence in patient population
- Funds to support clinical programs, regulatory submissions and future commercialisation
GALWAY, Ireland–(BUSINESS WIRE)–Loci Orthopaedics Ltd, an orthopaedic medical device company, today announced the successful closing of an oversubscribed €12.8 million Series A financing. The financing round was led by new investors Seroba, Johnson & Johnson Innovation, JJDC, Inc., (JJDC) and the European Innovation Council (EIC) Fund.
Loci Orthopaedics develops novel technologies that target major unmet clinical needs in orthopaedics extremities. The company’s primary device, its patented InDx Implant System, is an innovative, evidence-based implant for thumb base joint arthritis. Thumb base joint arthritis is a highly and increasingly prevalent condition which is estimated to actively affect up to 5% of the US and EU population and 100 million people worldwide1. The InDx implant replicates the functional biomechanics of the thumb base joint, with the aim of restoring natural motion for those affected by this painful and disabling condition. InDx’s novel design could address the limitations of current thumb implants which are often unsuccessful and are prone to both dislocation and movement post implantation.
The Series A financing will enable the company to augment the initial clinical investigation, which indicates positive preliminary results, and develop additional clinical data to support regulatory approval applications and future commercialisation in different geographies.
In October 2023, Loci Orthopaedics successfully completed enrolment of a 15-patient clinical study for its InDx Implant System. The Thumb Hemi-Arthroplasty with Natural Kinematics study is designed to evaluate the surgical implantation of the device as well as improvements in pain, grip, and quality of life for those affected by thumb base joint arthritis. Results from the clinical study are expected to be published later this year.
Dr Brendan Boland, Co-Founder and Executive Chairperson, commented: “Thumb base joint arthritis is a painful and disabling condition with a significant unmet clinical need for an effective, evidence-based, surgical solution. With a growing patient population, our InDx Implant System has the potential to provide surgeons and patients with a less invasive and more effective treatment for this condition. This funding will enable us to expand our clinical programs, submit regulatory approval applications in the US and EU and accelerate our efforts towards future commercialisation.”
Barry Russell, CEO, added: “The company is excited to work with three very experienced and well-respected investment groups to help the company bring a promising new solution to market to help the many currently underserved patients and their surgeons with a joint sparing treatment option.”
Maud Lazare, Head of Investor Relations at Seroba, commented: “Orthopaedics extremities is one of the fastest growing areas in orthopaedics, so it is great to work with a company whose innovative solutions may positively disrupt the future treatment landscape for one of the most frequently performed surgeries in this space.”
Svetoslava Georgieva, Chair of the EIC Fund Board, commented: “We are very happy to participate in this funding round. Loci Orthopaedics is disrupting the treatment landscape for one of the most frequently performed surgeries in orthopaedics extremities. The EIC’s unique financing approach, combining grants and equity, provides Europe’s most promising companies with means to develop and scale up their businesses in Europe.”
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Zhang Y, Niu J, Kelly-Hayes M, Chaisson CE, Aliabadi P, Felson DT. Prevalence of symptomatic hand osteoarthritis and its impact on functional status among the elderly: The Framingham Study. Am J Epidemiol. 2002 Dec 1;156(11):1021-7. doi: 10.1093/aje/kwf141. PMID: 12446258.Y |
About Thumb Base Joint Arthritis
Most activities that involve grasping or pinching are possible because of the thumb’s remarkable range of motion. Dexterity, however, comes at a price – an increased risk of osteoarthritis (OA) in the first carpometacarpal (CMC) joint, where the thumb meets the trapezium bone in the wrist. Thumb arthritis is common with aging and occurs when cartilage wears away from the ends of the bones that form the joint at the base of the thumb.
Thumb arthritis can cause severe pain, swelling, and decreased strength and range of motion, making it difficult to do simple tasks, such as turning doorknobs and opening jars. Treatment generally involves a combination of medication and splints. Severe thumb arthritis might require surgery. It is estimated that 5% of the population have symptomatic thumb base joint arthritis which causes significant hand pain and has a major negative impact on quality of life1.
About Loci Orthopaedics
Loci Orthopaedics was founded by Mr Gerry Clarke and Dr Brendan Boland as a concurrent spin-out from the University of Galway (Ireland), University College Cork (Ireland) and KU Leuven (Belgium). The company develops orthopaedic technologies to meet major unmet clinical needs with a primary focus on the orthopaedics extremities market. The company focuses on evidence-based design to ensure that its technologies are physiologically optimal to restore natural movement for superior clinical outcomes. Following the Series A financing, to date the company has raised over €22 million in grant and equity financing. See more information at www.lociorthopaedics.com.
About Seroba
Seroba is a European life sciences venture capital firm based in Dublin, Paris and Milan, investing from its fourth Fund. We focus on value creation through backing cutting-edge Biotech and MedTech innovation that will transform the treatment of unmet medical needs. Our team has deep industry and operational experience and an extensive global network. We like to work with entrepreneurs who share our passion for success and for investors who share the same goal of improving human health while driving financial returns. Follow our story at www.serobavc.com.
About EIC Fund
The European Innovation Council Fund from the European Commission is an agnostic Fund: it invests across all technologies and verticals, and all EU countries and countries associated to Horizon Europe. It provides the investment component of the EIC Accelerator blended finance. The European Investment Bank acts as investment adviser to the EIC Fund. The EIC Fund aims to fill a critical financing gap and its main purpose is to support companies in the development and commercialisation of disruptive technologies, bridging with and crowding in market players, and further sharing risk by building a large network of capital providers and strategic partners suitable for co-investments and follow-on funding. The Fund pays particular attention to the empowerment and support of female founders as well as the ambition to reduce the innovation divide among EU countries.
Contacts
For additional information, please contact Dr Brendan Boland.
T: +353 91 863 775
E: brendan@lociorthopaedics.com
Media Contacts
FTI Consulting
Paddy Berkery / Rugile Nenortaite
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