Category Archives: Biotech Companies

Loci Orthopaedics Closes €12.8 Million Series A Financing

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  • 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.”

1

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

T: +353 86 602 5988 / +353 86 277 9905

E: LociOrthopaedics@fticonsulting.com

Bayer announces positive topline results for NUBEQA® (darolutamide) from Phase III trial in men with metastatic hormone-sensitive prostate cancer (mHSPC)

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  • Phase III ARANOTE trial met primary endpoint, significantly increasing radiological progression-free survival (rPFS) with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT
  • Results were consistent with NUBEQA’s established safety profile with no new signals observed
  • NUBEQA now has positive mHSPC data both with and without docetaxel based on two pivotal Phase III studies
  • Bayer plans to present the pivotal data at a forthcoming scientific congress and discuss these data with the U.S. Food and Drug Administration (FDA) for regulatory approval

WHIPPANY, N.J.–(BUSINESS WIRE)–The Phase III ARANOTE trial, investigating NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of radiological progression-free survival (rPFS). NUBEQA plus ADT demonstrated a statistically significant and clinically meaningful increase in rPFS compared to placebo plus ADT.

Results were consistent with NUBEQA’s established safety profile with no new signals observed. Detailed results from this randomized, double-blind, placebo-controlled trial are planned to be presented at a forthcoming scientific congress.

NUBEQA is currently indicated in the U.S. for the treatment of adult patients with mHSPC in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1

“We are excited to share the positive results from this Phase III trial. Following potential regulatory approval, physicians will be able to tailor NUBEQA treatment plans with or without docetaxel based on individual patient’s needs,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “Today’s results build on the established efficacy and tolerability profile of NUBEQA. We are looking forward to future outcomes of our clinical development program investigating the compound across multiple prostate cancer stages and indications.”

Bayer plans to present the pivotal data at a forthcoming scientific conference and discuss these data with the U.S. FDA regarding submission for regulatory approval.

About the ARANOTE Trial

The ARANOTE trial (NCT04736199) is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of NUBEQA plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). 669 patients were randomized to receive 600mg of NUBEQA twice daily or matching placebo in addition to ADT.

The primary endpoint of this study is radiological progression-free survival (rPFS), as measured as the time from the date of randomization to the date of first documentation of radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival, time from randomization to the date of death from any cause, time from randomization to the date of first castration-resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments.

About NUBEQA® (darolutamide)1

NUBEQA® (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.

NUBEQA is being evaluated in a robust clinical development program, which includes studies across various stages of prostate cancer, including in the Phase III ARANOTE trial evaluating NUBEQA plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC, the ARASTEP Phase III trial evaluating NUBEQA plus ADT versus ADT alone in HSPC patients with high-risk biochemical recurrence (BCR) and no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline, as well as in the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating NUBEQA as an adjuvant treatment for localized prostate cancer with very high risk of recurrence. Information about these trials can be found at www.clinicaltrials.gov.

NUBEQA is currently indicated in the U.S. in combination with docetaxel and ADT for the treatment of adult patients with mHSPC and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) with ADT.1

NUBEQA is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

INDICATIONS

NUBEQA® (darolutamide) is an androgen receptor inhibitor indicated for the treatment of adult patients with:

  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
  • Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

IMPORTANT SAFETY INFORMATION

NUBEQA® (darolutamide) is an androgen receptor inhibitor indicated for the treatment of adult patients with:

  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
  • Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

IMPORTANT SAFETY INFORMATION

Warnings & Precautions

Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA vs. 0.2% receiving placebo. In a study of patients with mHSPC (ARASENS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel vs. 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel vs. 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease.

Seizure – In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving NUBEQA vs. 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of patients receiving NUBEQA with docetaxel, including one Grade 3 event, vs. 0.2% receiving placebo with docetaxel. Seizure occurred 38 to 340 days after initiation of NUBEQA. It is unknown whether antiepileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment.

Embryo-Fetal Toxicity – Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA vs. 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA vs. 3.2% of patients receiving placebo. Fatal adverse reactions in patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common adverse reactions (>2% with a ≥2% increase over placebo), including laboratory test abnormalities, were increased AST, decreased neutrophil count, fatigue, increased bilirubin, pain in extremity and rash. Clinically relevant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease and heart failure.

In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel vs. 42% of patients receiving placebo with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), decreased neutrophil count (2.8%), musculoskeletal pain (2.6%), and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel vs. 4% of patients receiving placebo with docetaxel. Fatal adverse reactions in patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with docetaxel) were constipation, rash, decreased appetite, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures, ischemic heart disease, seizures, and drug-induced liver injury.

Drug Interactions

Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.

Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.

Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.

Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Metastatic Hormone-Sensitive Prostate Cancer

Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide.2 In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, including almost 300,000 cases in the U.S., and about 375,000 died from the disease worldwide.3,4

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately 10% of men will already present with mHSPC when first diagnosed.5,6,7 Men with metastatic hormone-sensitive prostate cancer (mHSPC) will start their treatment with hormone therapy, such as ADT, androgen receptor inhibitor (ARi) plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival.

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

© 2024 Bayer

BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

  1. NUBEQA (darolutamide) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; October 2023.
  2. Hyuna S et al. Ca Cancer J Clin 2021; 71:209–249.
  3. Prostate Cancer: Statistic. Cancer.Net. https://www.cancer.net/cancer-types/prostate-cancer/statistics. Accessed: January 2024.
  4. American Cancer Society. Cancer Facts & Figures 2024. Accessed: January 2024.
  5. Piombino C et al. Cancers (Basel). 2023 Oct 11;15(20):4945.
  6. Helgstrand JT et al. Cancer. 2018;124(14):2931-2938.
  7. Buzzoni C et al. Eur. Urol. 2015;68:885–890.

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Contacts

Sue Ann Pentecost, Tel + 910.221.6446

Email: sueann.pentecost@bayer.com

Artelo Biosciences Receives FDA Clearance of its IND Application for ART26.12, a Selective Fatty Acid Binding Protein 5 Inhibitor

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ART26.12 seeks to address a critical need in painful neuropathies, including chemotherapy-induced peripheral neuropathy for which there is no FDA-approved treatment

Phase 1 trial results expected in the first half of 2025

SOLANA BEACH, Calif., July 15, 2024 (GLOBE NEWSWIRE) — Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic and neurological conditions, today announced that the U.S. Food and Drug Administration (FDA) has issued a “Study May Proceed” letter for the Company’s Investigational New Drug (IND) application for ART26.12, for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). FDA clearance of the ART26.12 IND application enables the Company to initiate its first-in-human Phase 1 single ascending dose study. Study startup activities have been initiated in collaboration with the internationally known contract research organization Worldwide Clinical Trials.

ART26.12 is the lead compound in the Company’s proprietary Fatty Acid Binding Protein (FABP) platform and the first selective FABP5 inhibitor to enter clinical trials. The FABP5 target is an intracellular protein involved in lipid signaling and represents a promising mechanism of action for drug candidates that can modify the cellular lipidome. ART26.12 is being developed as a non-opioid approach to the management of painful neuropathies. The Company’s FABP inhibitor platform, and ART26.12 in particular, has garnered interest from a range of potential partners due to its preclinical demonstation of efficacy, novel mechanism, and strong patent estate.

“Receiving IND clearance validates our development efforts and underscores the potential impact of ART26.12 to improve patients’ lives,” said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “We look forward to sharing the initial clinical results with ART26.12 next year. As the leading company pursuing FABP inhibiton we are committed to building on the unique, lipid-modulating mechanism of our FABP inhibitor platform to address life-altering pathologies for which there are few, if any, safe and effective pharmaceutical treatments.”

About ART26.12

Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids involved in cellular signaling. FABPs are often overexpressed and associated with abnormal lipid signaling in a number of pathologies. ART26.12, Artelo’s lead FABP inhibitor program in clinical development, is a potent and selective small molecule inhibitor of FABP5 being developed as an orally delivered, peripherally acting, non-opioid, new chemical entity for cancer patients suffering from chemotherapy- induced peripheral neuropathy. Invented by Distinguished Professor Iwao Ojima working in collaboration with Professor Martin Kaczocha, both at Stony Brook University, the extensive library of FABP inhibitors was exclusively licensed to Artelo with global rights. Preclinical evidence to date suggest FABP inhibition has broad therapeutic promise for the treatment of multiple cancers, painful neuropathies, cancer bone pain, dermatologic conditions and anxiety disorders.

About CIPN

Chemotherapy-induced peripheral neuropathy (CIPN) is a type of neuropathic pain caused by chemotherapy. Some chemotherapies result in CIPN with 90% frequency. CIPN often results in dose reduction or cessation of the cancer treatment leading to negative impacts on efficacy and survival. Acute CIPN occurs during chemotherapy treatment while chronic CIPN can last months to years. No FDA- approved treatment currently exists for CIPN. A new treatment or preventative intervention for CIPN holds promise to not only address debilitating pain, but also serve as an enabler of essential anti-cancer therapy.

About Artelo Biosciences

Artelo Biosciences, Inc. is a clinical-stage pharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that modulate lipid-signaling pathways. Artelo is advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts, the Company applies leading-edge scientific, regulatory, and commercial discipline to develop high-impact therapies. More information is available at www.artelobio.com and Twitter: @ArteloBio.

Forward Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission, including our ability to raise additional capital in the future. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by applicable securities laws.

Investor Relations Contact:
Crescendo Communications, LLC
Tel: 212-671-1020
Email: ARTL@crescendo-ir.com

XyloCor and SmartCella enter into license agreement for use of the Extroducer to administer novel gene therapy XC001 to the heart

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  • The Extroducer® Infusion Catheter System® enables local delivery of XC001 to the heart without the need for surgery.
  • XC001 has achieved positive Phase 1/2 results in the EXACT Trial validating its transformative potential for treatment of refractory angina in patients who have exhausted available treatment options and have a debilitating quality-of-life.

XyloCor Therapeutics, Inc. (“XyloCor”), a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, and SmartWise, a unit of SmartCella Holding AB (“SmartCella”), have entered into a licensing agreement under which XyloCor has rights to the Extroducer® Infusion Catheter System ®, a first-in-class endovascular device designed to deliver advanced therapies directly into the heart [and hard-to-reach tissues] .  XyloCor plans to deploy the Extroducer to support catheter-based endocardial delivery of its lead gene therapy candidate, XC001 (encoberminogene rezmadenovec), in future clinical studies and commercial use.  

XyloCor and SmartCella enter into license agreement for use of the Extroducer to administer novel gene therapy XC001 to the heart

“This agreement with SmartCella will enable XyloCor to build upon its robust foundation of efficacy and safety data for XC001 by offering the potential for improved safety and ease of delivery without surgery via this novel catheter,” said Al Gianchetti, President and CEO of XyloCor. “Teaming up with SmartCella will help in our effort to optimize patient safety and tolerability while maintaining accurate delivery of XC001 to target areas in the heart for patients with refractory angina. It also opens up the potential to develop XC001 earlier in the coronary artery disease progression for even larger patient groups.”

XC001 is designed to reduce ischemic burden by creating new blood vessels in the heart through the local expression of multiple isoforms of vascular endothelial growth factor (VEGF). With the use of the Extroducer catheter, XyloCor can offer patients a better delivery option for local administration of XC001 directly to the heart, that is less invasive and eliminates potential risks associated with surgical administration.

“We welcome the Extroducer delivery of XC001 as it offers a more efficient method for gene therapy administration for patients with refractory angina,” said Timothy D. Henry MD, Interventional Cardiologist and Director of the Lindner Center, The Christ Hospital, Cincinnati, Ohio. “Preclinical models provide strong evidence that this approach will maintain, or even improve the efficacy when compared to surgical delivery and it should lower the risk of complications that may arise from surgical administration. I am looking forward to initiating the Phase 2b trial of XC001 in patients with refractory angina using this innovative administration approach.”

The recently published EXACT Phase 1/2 trial assessed the use of one-time gene therapy with XC001 as a new therapeutic approach in refractory angina – a debilitating and chronic condition that impacts over one million people in the United States and is growing in prevalence. In the EXACT trial, 42 patients with class II-IV angina were treated with XC001 directly administered to the heart following minimally invasive surgical access. The results demonstrated that treatment with XC001 can be safely administered and achieve durable clinical improvements of exercise duration, and angina frequency, due to a decrease in ischemic burden, as measured by Positron Emission Tomography (PET) imaging. Notably, six months after treatment 43% of patients had no chest pain with ordinary activities and 58% reported no angina episodes at 12-month clinical follow up. XC001 was well tolerated in the patient population and there were no serious adverse events related to the drug.  The Phase 2b trial will be a randomized double-blinded study assessing the safety and efficacy of XC001 administered via the Extroducer® Delivery Catheter in coronary artery disease patients with refractory angina.

“The collaboration underscores the transformative potential of the Extroducer in delivering XC001 therapy for patients with refractory angina. A great example of a powerful combination of delivery system and drug therapy representing a substantial advancement in treatment options. The collaboration with such a distinguished partner as XyloCor marks a significant milestone for our global expansion efforts and will also enable us to further explore and harness the future capabilities of the Extroducer, ultimately expanding the benefits to a greater number of patients in need,” said Niklas Prager, CEO of SmartCella.

Terms of the agreement include a global license to XyloCor for use of the Extroducer for the administration of XC001 and provide for SmartCella to supply catheters to XyloCor in clinical trials and commercial use in exchange for an upfront payment, clinical, regulatory and commercial milestones and a royalty on sales. Total deal value amounts to approximately USD 130 million and mid-single digit royalties.

About XC001

XC001 is designed to promote new blood vessels in the heart that will bypass diseased blood vessels and improve blood flow. By restoring blood flow, chest pain associated with refractory angina may decrease, potentially improving patients’ quality of life by enabling them to engage in daily physical activities that would otherwise cause pain. XC001 is designed to avoid toxicity issues observed with other gene therapies through a strategy of one-time, local administration. This approach allows XC001 to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects.

About Extroducer® Infusion Catheter System

The Extroducer® Infusion Catheter System is a first-in-class endovascular delivery device which enables direct-to-tissue drug delivery. The Extroducer® addresses a significant unmet need in the field of novel therapies, enabling targeted delivery of a wide range of modalities for solid tumor treatment, genetic disorders and tissue repair, to name but a few. Using standard equipment and routine interventional radiology approaches, the Extroducer provides access to hard-to-reach tissues by safely penetrating the vessel wall and delivering payload directly to the target location. Smartwise received U.S. Food and Drug Administration (FDA) clearance under 510(k) for the Extroducer® delivery catheter in June 2022.

About XyloCor

XyloCor Therapeutics, Inc. is a private, clinical-stage biopharmaceutical company developing potential best-in-class gene therapies to transform outcomes for patients with cardiovascular disease. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for whom there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co-founded by Ronald Crystal, M.D., and Todd Rosengart, M.D., has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

About SmartCella

SmartCella, founded in 2014, is an innovative biotechnology company based in Stockholm, Sweden. SmartCella’s vision is to combine first-in-class delivery platforms with cutting-edge cell and mRNA therapies to unleash the full potential of targeted therapies. The company has three main business units, Smartwise, SmartCella Solutions and ProCella. For more information, visit www.smartcella.com.

Epsilogen announces CTA approval for Phase Ib trial of MOv18 IgE in platinum-resistant ovarian cancer

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Phase Ib study expected to initiate in H2 2024

Previously reported Phase I results showed MOv18 IgE to be safe and well tolerated, with evidence of anti-tumour activity

LONDON–(BUSINESS WIRE)–Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, today announces that the Clinical Trial Application for the Phase Ib trial of MOv18 IgE has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

The Phase Ib study is expected to initiate later in 2024 and will evaluate the efficacy of MOv18 IgE in patients with platinum-resistant ovarian cancer (PROC).

Dr Tim Wilson, Chief Executive Officer of Epsilogen, said: “This CTA is another significant milestone for Epsilogen and the clinical development of MOv18 IgE. We look forward to progressing MOv18 IgE into a Phase Ib efficacy study later this year as we continue to demonstrate the potential of IgE antibodies as a new, differentiated class of cancer treatments.”

About MOv18 IgE

MOv18 IgE is an immunoglobulin E (IgE) antibody targeting the folate receptor alpha (FR alpha) antigen. FR alpha is present on a variety of cancers including ovarian, endometrial, lung and triple negative breast cancer. Epsilogen has successfully completed a Phase I safety study of MOv18 IgE in PROC patients. The results of the study, published in Nature Communications, found MOv18 IgE to be safe and well tolerated, with evidence of anti-tumour activity observed. Epsilogen, alongside its partner Lonza, also announced the successful completion of large-scale Good Manufacturing Practice (GMP) manufacturing of MOv18 IgE earlier this year.

About the Phase Ib study

The Phase Ib study is designed to confirm the safety and tolerability of MOv18 IgE and demonstrate efficacy in PROC. Following the dose escalation, an expansion cohort will be recruited to make a preliminary assessment of the anti-tumour activity of MOv18 IgE at a selected dose. In addition, delay to disease progression will be assessed along with a number of translational elements to generate further understanding of MOv18 IgE in the study population.

About Epsilogen Ltd

Epsilogen is a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer. IgE’s natural function is to provide immunological defence against certain parasites. This functionality makes it an ideal treatment of solid tumours due to its strong potency, enhanced tumour access and long tissue half-life.

Epsilogen’s lead product candidate, MOv18 IgE, is the first therapeutic IgE antibody to enter the clinic and encouraging data from a completed Phase I trial demonstrated MOv18 IgE to be safe and well tolerated with early signs of clinical activity. Epsilogen has recently successfully completed large scale GMP manufacture of MOv18 IgE (the first time this has been achieved for an IgE antibody) and will initiate a Phase Ib trial in platinum-resistant ovarian cancer patients later this year. The company is also developing a pipeline of IgE therapies in oncology as well as proprietary platforms including IgE bispecifics and unique IgE/IgG combination antibody molecules (IgEGs) with enhanced functionality.

Epsilogen began operations in 2017 as a spin-out of King’s College London and has attracted venture capital financing from Epidarex Capital, Novartis Venture Fund, 3B Future Health, British Patient Capital, ALSA Ventures and Schroders Capital amongst others. Find out more at epsilogen.com.

Contacts

Communications advisor to Epsilogen Ltd:

Simon Conway

Senior Managing Director

FTI Consulting

epsilogen@fticonsulting.com
+44 (0)20 3727 1000

Genexine Announces Merger with EPD Biotherapeutics to Strengthen Drug Development Pipeline

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  • Merger with EPD Bio, a biotech developing a target protein degrader (TPD) platform technology
  • Jaehyun Choi, Ph.D. founder and CEO of EPD Bio, joins Genexine as head of R&D

SEOUL, South Korea–(BUSINESS WIRE)–Genexine (KOSDAQ: 095700), a publicly-listed, clinical-stage Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of serious unmet medical needs, announced a merger with EPD Biotherapeutics (hereinafter referred to as ‘EPD Bio’), a company developing an innovative targeted protein degradation (TPD) bioPROTAC platform technology, to strengthen its research workforce with expertise in PROTAC technology and enhance Genexine’s drug pipeline.

“Through this merger, Genexine has secured key talent with innovative technology that can lead the global market and at the same time added innovative new drugs based on bioPROTAC technology. Combining EPD Bio’s bioPROTAC technology with Genexine’s clinical and CMC development capabilities will enable us to continue pursuing the development of innovative new drugs that can lead the global market,” said Sungjune Hong, CEO of Genexine.

EPD Bio founder and CEO Dr. Jaehyun Choi, an expert in the field of targeted protein degradation technology, previously worked at Arvinas, a global leader in PROTAC (Proteolysis targeting chimera) technology and held research and scientific positions at Samsung Advanced Institute of Technology and Trillium Therapeutics. Following the merger, Dr. Choi will join Genexine as a representative director in charge of R&D along with EPD Bio’s core research team. Mr. Hong will continue as a representative director overseeing corporate development and business management.

Genexine announced that, at the board of directors meeting held on June 26th, it decided to merge with EPD Bio through a small-scale merger. The merger ratio is 1:6.1924079, and Genexine will issue new shares to the existing shareholders of EPD Bio according to the merger ratio. Detailed merger procedures are scheduled to be completed by early October.

EPD Bio is developing EPDegTM, an mRNA-based bioPROTAC technology that can overcome the limitations of existing small molecule- based PROTAC technology. The platform creates fusion-protein degraders delivered as mRNA-LNP whereby they remove the dependence on tissue specific expression of E3 ligase. As a unique technology with a potential to be first-in-class, it can generate a diverse pipeline of TPDs for multiple undruggable targets in different disease indications. EPD Bio has been receiving significant attention from the industry domestically and internationally as EPD Bio won the ‘Korea Startup/Biopharma Acceleration Program 2023’ led by the Korea Health Industry Development Institute and Takeda Pharmaceutical which supports domestic bio pharmaceutical companies to discover and develop innovative technologies.

RM Global Partners LLC acted as Genexine’s strategic advisor.

About Genexine

Genexine, Inc. is a publicly traded, clinical-stage biotechnology company focused on developing and commercializing immunotherapeutics and next-generation long-acting biologics. Its primary technology platforms are Therapeutic DNA vaccine technology and hyFc® fusion technology. The company has multiple products in clinical development including several undergoing Phase 3 registration trials. The company’s proprietary pipeline includes GX-188E (tirvalimogene teraplasmid) for head and neck cancer and cervical cancer, GX-I7 (efineptakin alfa) for multiple cancers, GX-H9 (eftansomatropin alfa) for Pediatric Growth Hormone Deficiency and GX-E4 for CKD-induced anemia, among others. Genexine has established multiple partnerships with global companies in order to expedite product development and commercialization and create significant value. Genexine is listed on the Korean exchange (KOSDAQ: 095700) and is headquartered in Seoul, Korea. Genexine is committed to the well-being and care of patients worldwide. For more information about Genexine, please visit at www.genexine.com.

About EPD Bio

EPD Bio is an early-stage biotech company dedicated on developing novel engineered protein degraders that selectively degrade the most undruggable disease-causing proteins that cannot be targeted by current small molecule-based PROTAC (PROteolysis TArgeting Chimera). The company was founded in 2021 and is based in Seoul, South Korea.

Contacts

Investor Contact:
Genexine Inc.

Jongsoo Lee, Investor Relations

jongsoo.lee@genexine.com

Kyuri Kim, Investor Relations

kyuri.kim@genexine.com

Genentech Provides Update on Phase II/III SKYSCRAPER-06 Study in Metastatic Non-Squamous Non-Small Cell Lung Cancer

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– SKYSCRAPER-06 evaluating tiragolumab plus Tecentriq and chemotherapy did not meet the primary endpoints of progression-free survival at primary analysis and overall survival at first interim analysis –

– The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy compared to the comparator arm –

– Safety was consistent with previous studies, however we intend to halt the trial due to reduced efficacy compared to the comparator arm –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the Phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial (first-line) treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (nSq NSCLC), did not meet its primary endpoints of progression-free survival (PFS) at its primary analysis with a hazard ratio (HR) of 1.27 [95% CI: 1.02,1.57] and overall survival (OS) at its first interim analysis with a HR of 1.33 [95% CI: 1.02, 1.73], which was immature. The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat population, which includes Phase II and Phase III cohorts. The overall safety profile remains consistent with the safety profile previously observed for the combination of tiragolumab plus Tecentriq and chemotherapy, and no new or unexpected findings were identified. Based on these results, patients and investigators will be unblinded and we intend to halt the study. A communication will be sent to the investigators and results will be shared with health authorities and subsequently presented at an upcoming medical meeting.

“These results are disappointing as it was our hope that this combination might yield improved outcomes for people living with metastatic non-squamous lung cancer,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are thankful to all of the patients and healthcare professionals involved in the study, and we will leverage the learnings to inform our scientific understanding of the anti-TIGIT pathway and new avenues in cancer research.”

Ongoing Phase III studies are investigating treatment settings and indications distinct from SKYSCRAPER-06. Based on today’s results, we will evaluate any relevant changes needed to the ongoing tiragolumab program.

About SKYSCRAPER-06 study

SKYSCRAPER-06 is a global Phase II/III, randomized, placebo-controlled and double-blinded study evaluating tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy as an initial (first-line) treatment versus pembrolizumab and chemotherapy in 542 people with non-squamous non-small cell lung cancer. Primary endpoints are overall survival (OS) and progression-free survival (PFS).

About tiragolumab

Tiragolumab is an investigational novel immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint which suppresses the immune response to cancer. Based on preclinical research, tiragolumab is thought to work as an immune amplifier with other cancer immunotherapies such as Tecentriq® (atezolizumab). The TIGIT pathway is distinct but complementary to the PD-L1/PD-1 pathway. Dual blockade with tiragolumab and Tecentriq may help overcome immune suppression and restore the immune response.

About Tecentriq® (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Indications

Tecentriq is a prescription medicine used to treat adults with:

Adults with a type of lung cancer called non-small cell lung cancer (NSCLC).

  • Tecentriq may be used alone as a treatment for their lung cancer:

    • to help prevent their lung cancer from coming back after their tumor(s) has been removed by surgery and they have received platinum-based chemotherapy, and
    • they have stage 2 to 3A NSCLC (patients should talk to their healthcare provider about what these stages mean), and
    • their cancer tests positive for “PD-L1.”
  • Tecentriq may be used alone as their first treatment when their lung cancer:

    • has spread or grown, and
    • their cancer tests positive for “high PD-L1,” and
    • their tumor does not have an abnormal “EGFR” or “ALK” gene.
  • Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as their first treatment when their lung cancer:

    • has spread or grown, and
    • is a type called “non-squamous NSCLC,” and
    • their tumor does not have an abnormal “EGFR” or “ALK” gene.
  • Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as their first treatment when their lung cancer:

    • has spread or grown, and
    • is a type called “non-squamous NSCLC,” and
    • their tumor does not have an abnormal “EGFR” or “ALK” gene.
  • Tecentriq may be used alone when their lung cancer:

    • has spread or grown, and
    • if they have tried chemotherapy that contains platinum, and it did not work or is no longer working.
    • if their tumor has an abnormal “EGFR” or “ALK” gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.

It is not known if Tecentriq is safe and effective when used in children for the treatment of NSCLC.

Important Safety Information

What is the most important information about Tecentriq?

Tecentriq can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. Patients can have more than one of these problems at the same time. These problems may happen anytime during their treatment or even after their treatment has ended.

Patients should call or see their healthcare provider right away if they develop any new or worse signs or symptoms, including:

Lung problems

  • cough
  • shortness of breath
  • chest pain

Intestinal problems

  • diarrhea (loose stools) or more frequent bowel movements than usual
  • stools that are black, tarry, sticky, or have blood or mucus
  • severe stomach-area (abdomen) pain or tenderness

Liver problems

  • yellowing of the skin or the whites of the eyes
  • severe nausea or vomiting
  • pain on the right side of their stomach area (abdomen)
  • dark urine (tea colored)
  • bleeding or bruising more easily than normal

Hormone gland problems

  • headaches that will not go away or unusual headaches
  • eye sensitivity to light
  • eye problems
  • rapid heartbeat
  • increased sweating
  • extreme tiredness
  • weight gain or weight loss
  • feeling more hungry or thirsty than usual
  • urinating more often than usual
  • hair loss
  • feeling cold
  • constipation
  • their voice gets deeper
  • dizziness or fainting
  • changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems

  • decrease in their amount of urine
  • blood in their urine
  • swelling of their ankles
  • loss of appetite

Skin problems

  • rash
  • itching
  • skin blistering or peeling
  • painful sores or ulcers in mouth or nose, throat, or genital area
  • fever or flu-like symptoms
  • swollen lymph nodes

Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Patients should call or see their healthcare provider right away for any new or worse signs or symptoms, including:

  • Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
  • Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
  • Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
  • Persistent or severe muscle pain or weakness, muscle cramps
  • Low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

  • chills or shaking
  • itching or rash
  • flushing
  • shortness of breath or wheezing
  • dizziness
  • feeling like passing out
  • fever
  • back or neck pain

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if patients undergo transplantation either before or after being treated with Tecentriq. A healthcare provider will monitor for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider will check patients for these problems during their treatment with Tecentriq. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may also need to delay or completely stop treatment with Tecentriq if patients have severe side effects.

Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:

  • have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
  • have received an organ transplant
  • have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • have received radiation treatment to their chest area
  • have a condition that affects their nervous system, such as myasthenia gravis or Guillain-Barré syndrome
  • are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq. Females who are able to become pregnant:

    • A healthcare provider should do a pregnancy test before they start treatment with Tecentriq
    • They should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq
  • are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into the breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq.

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used alone include:

  • feeling tired or weak
  • decreased appetite
  • nausea
  • cough
  • shortness of breath

The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

  • feeling tired or weak
  • nausea
  • hair loss
  • constipation
  • diarrhea
  • decreased appetite

Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.

Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.

Please see http://www.Tecentriq.com for full Prescribing Information and additional Important Safety Information.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Media Contact:

Nicolette Baker (650) 467-6800

Advocacy Contact:

Meg Harrison (617) 694-7060

Investor Contacts:

Loren Kalm (650) 225-3217

Bruno Eschli +41616875284

GSK and CureVac to Restructure Collaboration into New Licensing Agreement

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  • GSK acquires full rights to develop, manufacture and commercialize globally mRNA candidate vaccines for influenza and COVID-19, including combinations
  • CureVac receives €400 million upfront and up to an additional €1.05 billion in development, regulatory and sales milestone payments as well as tiered royalties; all previous financial considerations from the prior collaboration agreement replaced
     

London UK; TÜBINGEN, Germany/BOSTON, MA, USA – July 3, 2024 – GSK plc (LSE/NYSE: GSK) and CureVac N.V. (Nasdaq: CVAC) today announced they have restructured their existing collaboration into a new licensing agreement, allowing each company to prioritize investment and focus their respective mRNA development activities.

Since 2020, GSK and CureVac have worked together to develop mRNA vaccines for infectious diseases. Through this collaboration, GSK and CureVac currently have vaccine candidates for seasonal influenza and COVID-19 in Phase 2 and avian influenza in Phase 1 clinical development. All candidates are based on CureVac’s proprietary second-generation mRNA backbone. Data generated to date for these candidate vaccines are promising and demonstrate their potential to be best-in-class new vaccines.

Under the terms of the new agreement, GSK will assume full control of developing and manufacturing these candidate vaccines. GSK will have worldwide rights to commercialise the candidate vaccines. The agreement represents the latest step in GSK’s ongoing investment in vaccine platform technologies, matching the best platform to each pathogen to develop best-in-class vaccines. mRNA is an adaptable vaccine technology with demonstrated application in emerging and constantly changing viral pathogens due to its ability to support rapid strain change. GSK continues to develop and optimize its mRNA capabilities through investments and partnerships, including in AI/ML-based sequence optimisation, nanoparticle design and manufacturing.

CureVac will receive an upfront payment of €400 million and up to an additional €1.05 billion in development, regulatory and sales milestones and tiered royalties in the high single to low teens range. The new agreement replaces all previous financial considerations from the prior collaboration agreement between GSK and CureVac. CureVac further retains exclusive rights to the additional undisclosed and preclinically validated infectious disease targets from the prior collaboration together with the freedom to independently develop and partner mRNA vaccines in any other infectious disease or other indication. CureVac’s ongoing patent litigation against Pfizer/BioNTech is unaffected by the new agreement.

Tony Wood, Chief Scientific Officer, GSK said: “We are excited about our flu/COVID-19 programs and the opportunity to develop best-in-class mRNA vaccines to change the standard of care. With this new agreement, we will apply GSK’s capabilities, partnerships and intellectual property to CureVac’s technology, to deliver these promising vaccines at pace.”

Alexander Zehnder, Chief Executive Officer, CureVac said: “The collaboration with GSK has been instrumental in developing promising, late clinical-stage vaccine candidates, leveraging our proprietary mRNA platform. This new licensing agreement puts us in a strong financial position and enables us to focus on efforts in building a strong R&D pipeline.”

Completion of the new agreement remains subject to certain antitrust and regulatory approvals and customary closing conditions.

About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

About CureVac
CureVac (Nasdaq: CVAC) is a pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized cancer vaccine product candidates. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.

CureVac Media Contact
Patrick Perez, Junior Manager Public Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1831
patrick.perez@curevac.com

CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com

 

4Moving Biotech welcomes Luc Boblet as Chief Executive Officer to lead next phase of growth

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LILLE & PARIS, France–(BUSINESS WIRE)–4Moving Biotech (4MB), a clinical-stage subsidiary of 4P-Pharma specializing in immuno-inflammation and osteoarthritis, is pleased to announce the appointment of Luc Boblet as Chief Executive Officer. The company, having successfully completed its Phase I clinical trial and a preparatory in silico Phase 2 analysis, looks to Luc Boblet’s seasoned expertise in biotech entrepreneurship and strategic development to guide the forthcoming stages of clinical proof of concept and early market access.

Luc Boblet, a biotech entrepreneur with two decades of experience, joins 4MB following his tenure at Egle Therapeutics, where his leadership was essential in advancing novel immunotherapies and securing a robust Series A funding backed by a big pharma strategic alliance. His previous roles included founding and leading companies such as H-IMMUNE – acquired by HiFiBIO – and Pathoquest, where he excelled in driving innovation, closing fundraising and forging strategic partnerships as instrumental catalyst of growth.

“Luc’s appointment comes at a turning point for 4Moving Biotech as we have concluded a milestone Phase I trial for our leading drug candidate and are advancing strategic discussions with the FDA, toward potential accelerated approval” said Revital Rattenbach, founder and CEO of 4P-Pharma and co-founder of 4Moving. “His track record in steering biotech ventures and his strategic approach to partnerships will be invaluable as we advance our clinical programs and explore opportunities for pharma co-development and partnership.”

As CEO of 4Moving Biotech, Luc Boblet’s immediate focus will be on overseeing the design and implementation of the development strategy for the upcoming Phase II clinical trials, as well as cultivating partnerships that align with the company’s vision for growth and patient access to innovative treatments.

Luc Boblet, CEO of 4Moving Biotech said: “The opportunity to lead 4Moving Biotech at this juncture is one that is aligned with my commitment to bringing pioneering therapies for untreated severe diseases. The company’s progress in drug development and the potential to significantly improve patient outcomes in osteoarthritis is a strong foundation for future success. I am looking forward to applying my experience in corporate strategy business development to deliver our value proposal and establish meaningful partnerships.”

About 4Moving Biotech

4Moving Biotech, a subsidiary of 4P-Pharma, is dedicated to developing advanced first in class therapies in the field of immuno-inflammation and osteoarthritis. With a commitment to improving patient care, 4MB is actively engaged in the clinical development of novel treatments poised to enhance quality of life for patients worldwide.

Biography of Luc Boblet, CEO of 4Moving Biotech.

Luc Boblet is a serial biotech entrepreneur with 20 years of experience in entrepreneurship, business development, corporate finance and early drug development. Luc is coming from Egle Therapeutics, spin out of Institut Curie dedicated to developing novel Regulatory T-cells based immunotherapies for oncology and autoimmune diseases, he has co-founded in early 2020. As a founding CEO, he built Egle Tx with a vision to become a game changer in the field of Tregs immunomodulation catalyzed by strategic alliance with Takeda Pharmaceutical and backed by 45M€ Series A from a high-quality syndicate of renowned international investors. Before creating Egle Tx, Luc co-founded and ran H-IMMUNE, start-up spun out of French Nuclear Agency (CEA), developing novel anti-check-point immunotherapies against T-effector and Tregs for oncology. He paved H-IMMUNE corporate path through partnerships with Pierre Fabre Laboratories and Norther Biologics and have exited H-IMMUNE through an acquisition by HiFiBIO in 2018. Before co-founding H-IMMUNE, Luc co-founded and ran Pathoquest, a start-up company spun out of Institute Pasteur, which develops disruptive unbiased NGS-based diagnostics in the field of infectious diseases. Under his guidance, Pathoquest raised two VC-backed rounds of financing, closed strategic collaborations and corporate partnerships with leading pharma companies (CERBA Laboratories and Covance), and launched several clinicals trials in France and the U.S.

From 2011 to 2015, he served on the board of directors of the BioAster Technological Research Institute.

He started his career in technology transfer, consulting in finance and business development for toxicogenomics R&D. Luc Boblet holds a biotech engineering degree, master’s degree in Virology and has been trained as a PhD in Virology from University Paris VII.

About 4Moving Biotech

Incorporated in mid 2020 as a spin-off of 4P-Pharma, 4Moving Biotech is a clinical stage biotechnology company dedicated to the development of the Disease-Modifying Osteoarthritis Drug (DMOAD). Its mission is to provide a sustainable therapeutic solution to the significant unmet medical need of osteoarthritis. The company is headquartered at the Pasteur Institute in Lille, France.

Website: https://www.4movingbiotech.com/
LinkedIn: https://fr.linkedin.com/company/4moving-biotech
X: https://twitter.com/4Moving_Biotech

The only version of the 4Moving Biotech press release that is legally binding is the one in its original language. Translations must always be compared to the source text, which will establish precedence. The press release text resulting from a translation should not be considered official in any way.

Contacts

Press:
Emmanuel Dadje

Communication Manager – emmanuel.dadje@4P-Pharma.com
+33 6 30 06 12 13

Marea Therapeutics Launches with $190 Million to Accelerate a New Generation of Medicines for Cardiometabolic Diseases

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Leveraging large-scale human genetics to advance clinical-stage pipeline of first-in-class treatments that target critical, unaddressed and genetically validated causes of cardiometabolic diseases

Lead program, MAR001, is a first-in-class ANGPTL4 inhibitor in Phase 2 clinical development aiming to address the untreated lipid and metabolic drivers of cardiovascular events in high-risk patients

Company incubated by Third Rock Ventures with distinguished scientific founders and leading investor syndicate including Sofinnova Investments, Forbion, Perceptive Xontogeny Venture Fund, venBio, Omega Funds, Alpha Wave Global and Surveyor Capital (a Citadel company)

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Marea Therapeutics, a clinical-stage biotechnology company incubated by Third Rock Ventures to develop a new generation of medicines for cardiometabolic diseases, launched today with $190 million in combined Series A and B financings. The Series A round was led by Third Rock Ventures and the Series B round was led by Sofinnova Investments and co-led by Forbion, Perceptive Xontogeny Venture Fund and venBio, with the participation of Alpha Wave Global, Omega Funds, Surveyor Capital (a Citadel company) and founding investor Third Rock Ventures. This financing will fund the company’s MAR001 Phase 2 development plan and further progression of additional pipeline programs.

“Marea aims to transform the way cardiometabolic diseases are treated by leveraging large-scale human genetics and expertise in adipose function and biology to pursue genetically validated targets focusing on central – but unaddressed – drivers of cardiometabolic disease risk,” said Josh Lehrer, M.D., M.Phil., FACC, chief executive officer of Marea. “This approach could be the next frontier for patients with cardiometabolic disease who remain at very high risk, despite currently available therapies.”

“With initial clinical validation, world-class scientific founders and investors, and an experienced board and leadership team, Marea is poised to become a premier cardiometabolic disease company,” said Jeffrey Tong, Ph.D., board member and partner, Third Rock Ventures. “We aim to accelerate a new generation of medicines, including MAR001, that treat key unaddressed drivers of cardiometabolic disease, potentially providing important new therapeutic options for millions of patients.”

Targeting Cardiometabolic Diseases at their Source

Marea’s lead program, MAR001, is a monoclonal antibody that targets ANGPTL4, a protein that is highly expressed in adipose tissue. By inhibiting ANGPTL4 and thereby preferentially augmenting adipose tissue lipoprotein lipase (LPL) activity, MAR001 aims to lower remnant cholesterol, improve adipose tissue and metabolic function, and reduce cardiovascular events. Remnant cholesterol is carried by triglyceride-rich lipoproteins, is highly atherogenic, and drives cardiovascular events independent of classical risk factors like LDL cholesterol, diabetes or obesity1. There are currently no available targeted therapies to lower remnant cholesterol and improve metabolic function.

Human genetics has demonstrated ANGPTL4 as a highly promising therapeutic target to lower remnant cholesterol with loss of function alleles leading to remnant cholesterol clearance, improved triglyceride distribution, improved insulin sensitivity, and protection from both cardiovascular disease and type 2 diabetes all via an adipose specific mechanism.

Preclinical models with MAR001 demonstrated reduction in triglycerides, remnant cholesterol and ectopic fat (storage of triglycerides in tissues other than adipose tissue), and improved insulin sensitivity. MAR001 has demonstrated strong Phase 1 results and is in Phase 2 clinical development for adults with metabolic dysfunction.

“ANGPTL4 human genetics shows the potential to essentially reverse the adipose dysfunction responsible for the metabolic syndrome- which is not adequately treated by current therapies including weight loss and LDL cholesterol treatment. More than five million cardiovascular patients in the U.S. alone have elevated remnant cholesterol putting them at risk for a heart attack,” said Ethan J. Weiss, M.D., co-founder and chief scientific officer of Marea. “MAR001 has the potential to provide unique benefit to these patients by correcting the underlying adipose dysfunction leading to both elevated remnant cholesterol and metabolic dysfunction.”

“In a Phase 1 trial, a single dose of MAR001 significantly lowered remnant cholesterol levels and improved metabolic biomarkers. We are very excited about this compound’s potential,” said Maha Katabi, Ph.D., general partner, Sofinnova Investments. “Led by renowned experts in genetics and cardiometabolic diseases, Marea is well positioned to advance MAR001 and other pipeline programs, potentially unlocking a new era in cardiovascular care.”

Marea is also advancing a pipeline of additional candidates aimed to address additional untapped nodes driving cardiometabolic diseases.

Management and Organization

Marea is led by a dynamic team of scientists and company builders with deep know-how and experience in human genetics, adipocyte biology and cardiometabolic disease drug development.

Marea founders include:

  • Charles Homcy, M.D., partner emeritus, Third Rock Ventures
  • Sir Stephen O’Rahilly, M.D., FRS, professor of clinical biochemistry and medicine, University of Cambridge
  • Joshua Rabinowitz, M.D., Ph.D., professor of chemistry & integrative genomics, Princeton University
  • Ethan J. Weiss, M.D., chief scientific officer

Marea management team members include:

  • Christine Garrett, Ph.D., chief strategy officer
  • Mark Joing, MBA, chief development operations officer
  • Josh Lehrer, M.D., M.Phil., FACC, chief executive officer
  • Ethan J. Weiss, M.D., scientific founder and chief scientific officer

Marea board members include:

  • Ted Love, M.D., chairman, former president and chief executive officer of Global Blood Therapeutics (acquired by Pfizer) and chairman, Biotechnology Innovation Organization (BIO)
  • Antoine Boulanger, Ph.D., principal, Forbion
  • Jung Choi, MBA, entrepreneur in residence, Third Rock Ventures
  • Chris Garabedian, venture portfolio manager, Perceptive Advisors
  • Maha Katabi, Ph.D., general partner, Sofinnova Investments
  • Josh Lehrer, M.D., M.Phil., FACC, chief executive officer
  • Aaron Royston, M.D., managing partner, venBio
  • Jeffrey Tong, Ph.D., partner, Third Rock Ventures

“With its focused scientific approach and differentiated first-in-class development programs, Marea has the potential to become a leading company in the cardiometabolic disease space,” said Dr. Love. “I am thrilled to partner with this talented board and management team to advance MAR001 and other programs for patients who are in need of breakthrough cardiometabolic disease therapies.”

About Marea

Marea Therapeutics is a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardiometabolic diseases. The company’s lead program, MAR001, is in Phase 2 clinical development to lower remnant cholesterol in adults with metabolic dysfunction and high risk for cardiovascular disease. Marea is led by a dynamic team of scientists and company builders with deep know-how and experience in cardiometabolic diseases, human genetics and adipocyte biology. To learn more, please visit www.mareatx.com and follow us on LinkedIn and X.

1 https://doi.org/10.1161/CIRCIMAGING.121.012615Circulation: Cardiovascular Imaging. 2021;14:e012615

Contacts

Media:

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Katie Engleman

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Investors:

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Steve Klass

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