Category Archives: Biotech Companies

Coave Therapeutics Launches coAAV-CSF-01, a Novel CNS-Targeted Gene Therapy Vector for Neurodegenerative and other CNS Diseases

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New breakthrough data from studies with Coave’s ALIGATER™-engineered AAV2-based capsid coAAV-CSF-01 (S01coAAV2) demonstrates improved brain tissue transduction and safety following intra-cerebrospinal fluid administration in non-human primates

Data selected for Late-Breaking Abstract at ASGCT 2025

Paris, France – May 9, 2025 – Coave Therapeutics (“Coave”), a company pioneering the future of genetic medicines, today announced the launch of coAAV-CSF-01, a novel CNS-targeted gene therapy capsid developed using its proprietary ALIGATER™ platform. New breakthrough data from studies evaluating the vector (research code S01coAAV2) have been selected for presentation as a Late-Breaking Abstract at the 2025 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting, to be held May 13-17, in New Orleans, LA, USA.

The data highlight the therapeutic potential of coAAV-CSF-01 (S01coAAV2) to transform central nervous system (CNS) gene therapy delivery. In non-human primate (NHP) studies, coAAV-CSF-01 was administered via intra-cerebrospinal fluid (intra-CSF) routes, including intracisternal magna (ICM) and intracerebroventricular (ICV). The results demonstrated higher transgene expression in targeted brain regions and a better safety profile using coAAV-CSF-01 compared to AAV9.

Key findings with coAAV-CSF-01 include:

  • 100-fold higher transgene expression in the cortex and 10,000-fold increase in the hippocampus compared to AAV9 at the same dose
  • Comparable CNS biodistribution and expression at one-fifth the dose of AAV9
  • Significantly reduced peripheral transduction (including strong liver de-targeting) and peripheral nerve safety, addressing key safety concerns in CNS gene therapy

“These exciting new data from coAAV-CSF-01 represent a major step forward in CNS gene therapy,” said Lolita Petit, CSO of Coave Therapeutics. “In non-human primates, the vector achieved robust brain transduction via intra-CSF delivery – a route long viewed as promising but historically constrained by limited efficacy and off-target effects. The enhanced biodistribution and improved safety demonstrated in these studies support its potential in developing new genetic medicines for neurodegenerative and neurodevelopmental CNS disorders.

“Furthermore, the vector was developed using our proprietary ALIGATER™ platform, enabling modular modification of AAV2 and other capsids to optimize tissue targeting and therapeutic performance – potentially opening the door to broader therapeutic applications. Together, the data position coAAV-CSF-01 as a potentially transformative advance in gene therapy delivery.”

coAAV-CSF-01 is part of Coave’s growing portfolio of proprietary AAV capsids engineered to optimize gene delivery in challenging therapeutic areas. The ALIGATER™ platform enables chemical conjugation-based modification of AAV vectors (coAAVs), offering a modular and scalable approach to enhance tissue targeting and transduction efficiency.

Late-Breaking Poster Presentation Details:

  • Title: Enhanced CNS transduction and safety of S01coAAV2 (coAAV-CSF-01) following intra-cerebrospinal fluid (CSF) administration in cynomolgus macaques
  • Session: Late-Breaking Abstracts
  • Date/Time: Thursday May 15, 2025, 4:30 – 6pm CDT
  • Location: New Orleans
  • Presenter: Julien Spatazza, Senior Director, Discovery & Preclinical Research at Coave Therapeutics

Coave’s abstract (#LBA78) can be viewed on ASGCT’s website (https://annualmeeting.asgct.org/).

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About ALIGATER™
Coave’s proprietary ALIGATER™ (Advanced Vectors-Ligand Conjugates) platform is a breakthrough technology addressing key limitations in the delivery of genetic payloads to extra-hepatic tissues, including limited tissue specificity, delivery efficiency and safety. ALIGATER™ enables conjugation of targeting ligands, such as small molecules, peptides, or antibody fragments, on AAV or non-viral vectors, offering superior delivery efficiency, tissue specificity and safety profile for a broad range of diseases. Importantly, the platform streamlines the manufacturing process by avoiding prior AAV capsid modifications. These capabilities will enable Coave to develop best-in-class gene therapies designed for specific indications.

About Coave Therapeutics
Coave Therapeutics is a genetic medicine company pioneering the development of innovative solutions to enhance the precision, safety, efficacy and manufacturability of genetic medicines. With its proprietary ALIGATER™ platform, Coave is at the forefront of addressing challenges in gene therapy delivery to extra-hepatic tissues, creating a robust pipeline targeting CNS, neuromuscular and eye diseases.

Headquartered in Paris, France, Coave Therapeutics is backed by leading international life sciences investors. For more information about the science, pipeline, and people, please visit coavetx.com and follow us on LinkedIn.

CONTACTS

Coave Therapeutics
Rodolphe Clerval, CEO
contact@coavetx.com

MEDiSTRAVA
Sylvie Berrebi, Mark Swallow
coavetx@medistrava.com

4Moving Biotech Secures €7.6M France 2030 Grant for Pioneering First-In-Class Disease-Modifying Osteoarthritis Drug

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  • France 2030 validates 4Moving Biotech’s scientific pioneering approach
  • This strategic support positions the 4P004 drug candidate at the forefront of knee osteoarthritis innovation
  • This additional funding accelerates 4P004’s development toward market launch by 2030

LILLE, France & PARIS–(BUSINESS WIRE)–4Moving Biotech (4MB), a spin-off of 4P-Pharma developing the first potential disease-modifying drug (DMOAD) for knee osteoarthritis, announces that it has been awarded €7.6 million in funding under the France 2030 plan to accelerate the clinical development of its lead candidate, 4P004, currently in a Phase 2a trial.

France 2030 is a highly selective and strategic initiative by the French government designed to fast-track the next generation of breakthrough innovations. 4MB’s selection is a significant endorsement, granted through a rigorous, multi-stage evaluation process by leading scientific, clinical, and technological experts.

This recognition highlights the robust scientific foundations of the 4P004 program and its potential to deliver a truly transformative therapy for OA’s unmet medical need and significant socio-economic impact with over 600 million people worldwide, including 10 million in France.

“We are honored by the renewed confidence through the France 2030 program,” said Revital Rattenbach, Co-founder and President of 4MB. “This highly competitive grant is a powerful validation of the scientific strengths of our 4P004 program and its potential to address one of the most pressing unmet medical needs.”

This additional funding will accelerate the 4P004 INFLAM MOTION Phase 2a clinical study, a GLP-1 analog designed to harness anti-inflammatory, analgesic, anti-catabolic, and anabolic effects across all joint tissues. The trial’s primary objective is to evaluate the efficacy of a single intra-articular injection of 4P004 in reducing knee pain while also assessing structural improvements via contrast-enhanced MRI and exploring novel biomarkers for disease progression and delayed need for total knee replacement.

“4MB gains extended momentum through The France 2030 grant marks an important milestone in the 4MB roadmap,” said Luc Boblet, CEO of 4MB. “With our phase 2a already initiated, this funding strengthens the value of our work, from early-stage discovery to clinical stage, and highlights the need to bring transformative therapies for patients suffering from OA”.

With the support of the France 2030 initiative, 4MB is fully equipped to deliver clinical proof-of-concept on time, as a critical inflection point that will unlock the next stage of development and reveal the full potential of 4P004 as a first-in-class DMOAD, creating significant attractiveness for future partnerships.

About 4MB

Incorporated in mid-2020 as a spin-off of 4P-Pharma, 4MB 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

The France 2030 investment plan

France 2030 is unprecedented in its scale: €54 billion is being invested so that our businesses, our schools, our universities and our research organizations fully succeed with their transitions in these strategic sectors. The challenge is to enable them to respond in a competitive way to the world’s future ecological and attractiveness challenges, and to showcase the future champions of our sectors of excellence. France 2030 is defined by two overarching objectives, which will see 50% of expenses given over to the decarbonization of the economy, and 50% to emerging key players, those at the forefront of innovation, without neglecting the environment (in the sense of the “Do No Significant Harm” principle).

France 2030 is being implemented collectively: designed and deployed in consultation with economic, academic, local and European key players to establish strategic guidelines and decisive action. Project holders are invited to submit their entries via the current application process, which is a demanding and selective one, to benefit from state support.

France 2030 is being led by the French General Secretariat for Investment, in charge of France 2030, on behalf of the Prime Minister, and in partnership with the relevant government ministries.

France 2030 is being implemented by the French National Research Agency (ANR), the French Agency for Ecological Transition (ADEME), Bpifrance and the Caisse des Dépôts et consignation (CDC).

More information : france2030.gouv.fr | @SGPI_avenir

About Bpifrance

Bpifrance is the French national investment bank: it finances businesses – at every stage of their development – through loans, guarantees, equity investments and export insurances. Bpifrance also provides extra financial services (training, consultancy) to help entrepreneurs meet their challenges (innovation, export…).

For more information, please visit: https://www.bpifrance.com/ Follow us on Twitter: @Bpifrance – @BpifrancePresse and LinkedIn

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 Dadjé

Communication Manager

+33 6 30 06 12 13

Secretome Therapeutics Granted FDA Fast Track Designation for STM-01, a Neonatal Cardiac Progenitor Cell Therapy for HFpEF

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DALLAS–(BUSINESS WIRE)–Secretome Therapeutics, a pioneering company in the field of regenerative medicine, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to STM-01, the company’s neonatal cardiac progenitor cell (nCPC) therapy, for the treatment of Heart Failure with Preserved Ejection Fraction (HFpEF).

HFpEF is a debilitating condition affecting millions of patients worldwide, characterized by impaired heart relaxation and elevated left ventricular (LV) filling pressure despite a normal or near-normal ejection fraction. With limited disease-modifying treatments available, HFpEF remains a significant unmet medical need in cardiovascular medicine.

“The FDA’s decision to grant Fast Track designation to STM-01 highlights the critical need for innovative therapies to address HFpEF, a condition with limited treatment options,” said Vinny Jindal, President and CEO of Secretome Therapeutics. “This designation marks a pivotal regulatory milestone as we prepare to initiate our Phase 1 clinical trial. It provides us with an opportunity to expedite the development of STM-01 and advance our mission of delivering a first-in-class regenerative therapy for patients in need.”

The FDA’s Fast Track program is designed to facilitate the development and expedite the regulatory review of therapies that address serious conditions with unmet medical needs. With this designation, Secretome Therapeutics will benefit from increased interactions with the FDA, including the potential for priority review and a rolling submission of its Biologics License Application (BLA) for STM-01.

About Secretome Therapeutics

Secretome Therapeutics is developing therapies derived from neonatal cardiac progenitor cells (nCPCs) to address life-threatening cardiovascular diseases and conditions driven by inflammation. Our lead drug is STM-01, a first-in-class cellular therapy designed to reduce inflammation, inhibit fibrosis, and support tissue repair in DCM and HFpEF. We are also developing STM-21, a secretome-based therapeutic in preclinical development for inflammatory conditions, including skin wounds and co-morbidities of diabetes.

About STM-01

STM-01 is an investigational, allogeneic neonatal cardiac progenitor cell (nCPC) therapy to improve cardiac function in patients with HFpEF and other inflammatory-driven cardiovascular diseases. Preclinical studies have demonstrated that STM-01 has the potential to reduce inflammation, inhibit fibrosis, and support cardiac tissue repair. A Phase 1 clinical trial is preparing to be launched evaluating safety and preliminary efficacy of STM-01 in HFpEF.

Contacts

Vinny Jindal
President and CEO

info@secretometx.com
https://secretometherapeutics.com/

Tune Therapeutics Completes Over $175M in Series B Financing to Advance Field-Leading Epigenome Editing Programs

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Strong investor syndicate backs clinical-stage Hepatitis B program while advancing pioneering gene-tuning platform

DURHAM, N.C. & SEATTLE–(BUSINESS WIRE)–Leading epigenome editing company Tune Therapeutics (Tune) today announced the completion of over $175M in financing led by New Enterprise Associates, Yosemite, Regeneron Ventures and Hevolution Foundation.

“It is deeply gratifying to have seen this platform and company evolve so far,” said Tune Co-Founder Dr. Charles Gersbach, whose research at Duke University formed the basis for Tune’s TEMPO epi-editing platform. “Tune has already achieved a global landmark in the field, in the clinical application of epi-editing to a common and chronic disease. Thanks to the support of our investors, we anticipate the development of many more new epi-editing therapies in the years to come.”

The funding will accelerate the development of the company’s existing pipeline, currently anchored by Tune-401 – its clinical-stage epigenetic silencing drug for chronic Hepatitis B (HBV). It will also support the development of additional gene, cell, and regenerative therapy programs already underway at Tune, and to progress its broader mission of bringing the power and versatility of epigenetic therapies to bear on common and chronic diseases.

“We are incredibly proud to see Tune progress successfully into the clinic,” said Reed Jobs, Founder and Investor at Yosemite. “The Yosemite team has been an enthusiastic backer of Tune from the beginning, as we feel that few technologies have the biological power of epigenetic medicine to transform disease outcomes for the better. The range of potential applications and indications is vast and will only continue to expand.”

“To date, modern medicine and pharmacology has done much to extend our lifespans, but far less for our active healthspans,” explains William Greene, Chief Investment Officer at Hevolution Foundation. “Chronic diseases of ageing are accelerating in incidence, prevalence, and severity, and current approaches are simply inadequate. It is our belief that epigenetic editing may prove to be the transformative modality we need to enable a new era of regenerative medicine.”

Since its founding in 2021, Tune has made impressive strides in the development and application of its novel and potentially transformative epigenome editing platform. At the 2023 ASGCT conference, Tune announced a global first in the field: the durable repression of a therapeutically relevant gene (PCSK9) in non-human primates using genetic tuning. This gene repression was accompanied by an enduring reduction of LDL cholesterol levels that is still ongoing almost 2 years after a single, transient delivery of the epi-silencing construct. Later that year, the company unveiled Tune-401, a first-in-class epigenetic silencer for chronic Hepatitis B, a condition that impacts over 250 million people, and is the leading cause of liver cancer worldwide.

In November of 2024, Tune announced it was moving to the clinical stage, having received approval to begin clinical trials in New Zealand, and subsequently in Hong Kong – supported by world-renowned hepatologists and Principal Investigators Dr. Ed Gane and Dr. Man-Fung Yuen, respectively. With its lead program now in the clinic, Tune is leveraging this momentum to enhance its platform capabilities and develop its other gene and cell therapy programs.

“With this renewed support, we are well-positioned to advance our HBV clinical program, to invest in our platform, and to expand our pipeline,” said Akira Matsuno, Co-Founder, President and CFO of Tune Therapeutics. “We are grateful to all our investors for their deep confidence in our team and approach, backed by compelling data that continues to underscore the transformational potential of epi-editing as a therapeutic modality.”

About Tune Therapeutics

Armed with its powerful and innovative genetic tuning platform (TEMPO), Tune Therapeutics aims to bring gene, cell, and regenerative therapies into a new era of human medicine – expanding their range of application to common and chronic diseases.

About Tune-401

Tune-401 is a first-in-class investigational product candidate for treating Hepatitis B (HBV) infection. Tune-401 utilizes the company’s versatile, modular TEMPO platform to epigenetically silence viral HBV intDNA and cccDNA necessary for sustained HBV infection. Lipid nanoparticle technology for Tune-401 has been provided by Acuitas Therapeutics Inc.

Contacts

Glenn Murphy, Director of Communications: glenn.murphy@tunetx.com

 

 

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Merus and Biohaven Announce Collaboration to Co-Develop Three Novel Bispecific ADC Programs

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NEW HAVEN, Conn. and UTRECHT, The Netherlands and CAMBRIDGE, Mass., Jan. 12, 2025 (GLOBE NEWSWIRE) — Biohaven Ltd. (NYSE: BHVN) and Merus N.V. (Nasdaq:MRUS), today announced a research collaboration and license agreement to co-develop three novel bispecific antibody drug conjugates (ADCs), leveraging Merus’ leading Biclonics® technology platform, and Biohaven’s next-generation ADC conjugation and payload platform technologies.

Under the terms of the agreement, Biohaven is responsible for the preclinical ADC generation of three Merus bispecific antibodies under mutually agreed research plans. The agreement includes two Merus bispecific programs generated using the Biclonics® platform, and one program under preclinical research by Merus. Each program is subject to mutual agreement for advancement to further development, with the parties then sharing subsequent external development costs and commercialization, if advanced.

”We’re excited to collaborate with Biohaven, leveraging their broad range of linker/payload and conjugation technologies, and expertise with the research and development of ADCs, to rapidly advance bispecific antibody candidate ADCs based on the Merus Biclonics® platform,” said Peter B. Silverman, Chief Operating Officer of Merus. “We believe that the combination of our Biclonics® technology, validated by the recent FDA approval of Bizengri® and continued clinical success with petosemtamab, together with the Biohaven suite of ADC technologies, has the potential to generate new and differentiated bispecific therapies with greater potency and selectivity over currently available monoclonal ADC approaches.”

“We believe this collaboration with Merus will accelerate our ability to create highly differentiated multispecific ADCs, leveraging Biohaven’s innovative conjugation and payload technologies to deliver optimized ADCs with the potential to significantly benefit patients across various cancer types through an enhanced efficacy and safety profile,” added Brian Lestini, President, Oncology of Biohaven.

Pursuant to the transaction, Merus will receive an upfront payment and license fee at ADC candidate nomination of the first program, with Merus to assume the preclinical bispecific antibody generation cost, and Biohaven to assume the preclinical ADC generation cost. Thereafter, upon mutual agreement to advance each program, the parties plan to share further development and commercialization costs.

About Merus
Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus’ website and LinkedIn.

About Biohaven
Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven’s extensive clinical and nonclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA (spinocerebellar ataxia); myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules and antibody drug conjugates for cancer. For more information, visit www.biohaven.com.

Merus Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential preclinical and clinical development of any bispecific ADC under the parties’ agreement, the commercial potential of such programs, any future payments Merus may receive under the agreement, the potential of leveraging Biohaven’s broad range of linker/payload and conjugation technologies; Biohaven’s expertise with the research and development of ADCs; the collaboration’s potential to rapidly advance bispecific antibody candidate ADCs based on the Merus Biclonics platform; our belief that the combination of our Biclonics technology has been validated by the recent FDA approval of Bizengri® and continued clinical success with petosemtamab; the potential of the collaboration to generate new and differentiated bispecific therapies with greater potency and selectivity over currently available monocloncal ADC approaches; and the ability to create highly differentiated multispecific ADCs, leveraging Biohaven’s innovative conjugation and payload technologies to deliver optimized ADCs with the potential to significantly benefit patients across various cancer types through an enhanced efficacy and safety profile; and our belief in the merits of the parties’ technologies and capability to develop new therapeutics. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the volatility in the global economy, including global instability, including the ongoing conflicts in Europe and the Middle East; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.

These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended September 30, 2024, filed with the Securities and Exchange Commission, or SEC, on October 31, 2024, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Multiclonics®, Biclonics® and Triclonics® are registered trademarks of Merus N.V.

Biohaven Forward-Looking Statement
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “continue”, “plan”, “will”, “believe”, “may”, “expect”, “anticipate” and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven’s planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven’s product candidates; and the effectiveness and safety of Biohaven’s product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven’s filings with the Securities and Exchange Commission, including within the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

CONTACT: Merus Investor and Media Inquiries:

Sherri Spear
Merus N.V.
SVP Investor Relations and Strategic Communications
617-821-3246
s.spear@merus.nl

Kathleen Farren
Merus N.V.
Assoc. Director IR/Corp Comms
617-230-4165
k.farren@merus.nl

BioHaven Investor and Media Inquiries:

Investor Contact:
Jennifer Porcelli
Vice President, Investor Relations
jennifer.porcelli@biohavenpharma.com
+1 (201) 248-0741

Media Contact:
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
+1 (312) 961-2502

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Immunis Closes $25 Million Series A-1 Financing Round

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IRVINE, Calif.–(BUSINESS WIRE)–#ClinicalTrials—Immunis, Inc., a clinical-stage biotech developing multi-active biologics for age and disease-related immune dysregulation, has closed a $25 million Series A-1 financing round to fund two Phase 2 clinical trials. Follow-on investments from all major existing investors, notably, Remiges Ventures, Continuum Health Ventures and BOLD Capital Partners were joined by new investments from LifeSpan Vision Ventures and JLS Fund among others, including a leading global insurance company.

Mitigating muscle loss and improving metabolic function as we age are unmet medical needs. Following a successful Phase 1/2a clinical trial demonstrating the safety, tolerability and suggestive efficacy of IMM01-STEM in people with age-related muscle atrophy, the FDA granted permission to proceed with a Phase 2 clinical trial testing the efficacy of IMM01-STEM in ameliorating muscle loss and reversing metabolic dysfunction in sarcopenic, overweight and obese elderly people.

“Our Phase 1/2a data in nine elderly patients showed our therapy to be safe with no serious adverse events. Additionally, patients experienced striking improvements in quality-of-life measures related to physical function and pain as well as a clinically relevant increase in gait speed,” says Mark Cabato, Chief Business Officer of Immunis. “By running randomized, controlled studies in elderly populations with degenerative disease and metabolic dysfunction, we hope to demonstrate IMM01-STEM’s broad applicability in multiple medical conditions.”

Preclinical studies of Immunis’ novel therapy in aged mouse models of muscle disuse atrophy and metabolism were published in two notable journals, GeroScience and Aging Cell. The multi-active therapy was shown to reverse muscle atrophy, improve muscle function, enhance metabolism and decrease body and liver fat. Immunis is currently the leading biotech with the most advanced stem cell-derived multi-active biologic in human clinical trials.

“We are grateful for the support of our Board and investors for our mission to maximize health and minimize disease through the development of novel, stem cell-derived therapies,” adds Cabato.

About Immunis Inc.

Immunis is a private biotechnology company developing a novel immunomodulatory multi-active product for the various manifestations of age and disease-related immune decline. The investigational product line leverages Immunis’ leading-edge capabilities in multi-active secretome technology to deliver a product of all natural, all human immune modulators in their natural relative physiological concentrations. For additional information about Immunis’ Phase 1/2a clinical trial please visit: https://immunisbiomedical.com/clinical-trials/

Cautionary Note Regarding Forward-Looking Statements

This communication contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as applicable. Forward-looking statements include, but are not limited to, statements regarding our plans, beliefs, expectations and assumptions, as well as other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only of the date as of which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry which includes projections that are based on several assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions. This communication is neither an offer to sell nor a solicitation of an offer to buy any of the securities described herein.

Contacts

contact@immunisbiomedical.com

 

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Oxford Cancer Analytics Raises USD$11M in Series A Funding to Transform Early Lung Cancer Detection and Enable Curative Treatments

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Dr. Heinrich Roder, expert in lung cancer proteomics liquid biopsy, appointed as Senior Vice President of Research and Development at OXcan

OXFORD, England & TORONTO–(BUSINESS WIRE)–#AI—Oxford Cancer Analytics (OXcan), the medtech company developing blood tests for early cancer detection using advanced proteomics and AI, today announced it has raised US$11 million in Series A funding from global investors, including in-field institutional investors in disease detection and diagnostics. The funding round was led by We Venture Capital and Cross-Border Impact Ventures with participation from return investors Eka Ventures, and Civilization Ventures, and new investors DigitalDx Ventures, Macmillan Cancer Support (Innovation Impact Investment Portfolio), Aurelium Ventures, OKG Capital, and prominent angel investors. This investment positions the company to develop and globally commercialize its new generation of minimally invasive liquid biopsy blood tests for the early detection of lung cancer.

OXcan has also appointed Dr. Heinrich Roder as Senior Vice President, Research & Development. With over two decades of experience in lung cancer liquid biopsy and commercialization, Dr. Roder will further advance OXcan’s lung cancer blood test for deployment.

OXcan’s protein-based blood test identifies molecular signatures for high-risk lung cancer patients, leveraging a diverse global biobank to ensure worldwide scalability. Using advanced proteomics and AI, it fills an unmet niche in the liquid biopsy space by offering a protein-based blood test with high accuracy to detect cancers with the highest mortality burden.

Since 2023, OXcan has formed global partnerships, collaborating with over 20 healthcare centers across three continents to develop and deploy its technology.

About Oxford Cancer Analytics

Oxford Cancer Analytics (OXcan) is on a mission to drastically transform cancer early detection and management to impact millions of lives worldwide. OXcan’s multidisciplinary team is developing a new generation of liquid biopsy blood tests using cutting-edge proteomics and explainable machine learning approaches that can detect the deadliest cancers early, when they can still be cured. This blood test can be conducted in an affordable, minimally invasive, and routine manner with superior accuracy and localization capacity in large populations. OXcan has applied their biomarker discovery and validation platform starting from lung cancer, the leading cause of cancer mortality worldwide, and achieved ISO13485 certification status. For additional information, visit oxcan.org.

Contacts

Media contact:
Jodi Echakowitz

Boulevard Public Relations

jodi@boulevardpr.com
+1 416-271-7250

 

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Verdiva Bio, a New Clinical-Stage Cardiometabolic Company, Launches with Over $410M in Series A Financing to Advance Next-Generation Therapies

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  • Developing a broad portfolio of oral and injectable treatments with best-in-class potential to treat obesity, cardiometabolic disorders, and related complications
  • Groundbreaking potential of once-weekly oral GLP-1 and oral amylin therapies for weight loss and maintenance
  • Differentiated and clinically validated proprietary oral delivery technology designed to enable patient-friendly dosing, greater scalability, and broader patient access
  • Co-founded by Khurem Farooq and former members of the Aiolos Bio team with Mr. Farooq named Chief Executive Officer (CEO) and Mark Pruzanski named Chairman of the Board
  • Financing co-led by Forbion and General Atlantic, with participation from RA Capital Management, OrbiMed, Logos Capital, Lilly Asia Ventures, and LYFE Capital

LONDON & SAN FRANCISCO–(BUSINESS WIRE)–Verdiva Bio Limited (“Verdiva” or “the Company”) today announced its launch as a clinical-stage biopharmaceutical company focused on developing innovative therapies for obesity and other cardiometabolic disorders. The Company is advancing a portfolio of next-generation oral and injectable treatments with first-in-class or best-in-class potential. Verdiva launches with an oversubscribed Series A financing of $411M, co-led by Forbion and General Atlantic, with additional participation from RA Capital Management, OrbiMed, Logos Capital, Lilly Asia Ventures, and LYFE Capital (collectively, “the Investor Group”).

Khurem Farooq, formerly the CEO of Aiolos Bio and Gyroscope Therapeutics, will serve as Chief Executive Officer leading an experienced team of drug developers and biotech company builders. “People living with obesity and its complications deserve better options at each stage of their treatment journey, including oral therapies with less frequent dosing regimens, the potential for improved efficacy and tolerability, and innovative combination therapies in pursuit of healthier weight loss and, equally importantly, maintenance of metabolically healthy weight. We created Verdiva Bio to accelerate the development of differentiated medicines that address these significant unmet medical needs,” said Farooq.

Addressing Verdiva’s lead asset, Farooq noted, “Our most mature program has the potential to be a first-in-class, once-weekly oral treatment for obesity and weight loss maintenance that could dramatically improve patient access and affordability.”

Developing a broad portfolio of oral and injectable treatments

Verdiva acquired global development and commercialization rights outside of greater China and South Korea to their industry-leading portfolio from Sciwind Biosciences in 2024. Verdiva plans to advance the development of these next-generation therapies via a mix of monotherapy and combination programs, including:

  • A phase 2-ready, potential first-in-class, once-weekly oral GLP-1 receptor agonist
  • A potential first-in-class, once-weekly oral amylin agonist for use as monotherapy or in combination with an oral GLP-1 agonist
  • A long-acting, subcutaneous amylin agonist for use as monotherapy or in combination with a proprietary GLP-1 peptide

Senior leadership team

Dr. Mohamed Eid, MD, MSc, MHA joins Verdiva Bio as Chief Medical Officer from Boehringer Ingelheim, where he was Head of Clinical Development and Medical Affairs for cardiovascular, kidney, and metabolic medicines in the US. Previously, Dr. Eid held senior clinical, medical, and regulatory roles at Novo Nordisk.

Dr. Eid notes, “We are excited by the potential of our innovative, investigational medicines. These programs represent next-generation potential against multiple targets and are anticipated to improve treatment adherence and offer a more sustainable solution for maintaining weight loss. Furthermore, by applying our clinically validated, oral delivery technology, we are confident that we can deliver highly efficacious and well tolerated therapies at markedly lower doses.”

In addition, the Company announced the appointment of several other leadership positions, including:

  • Dr. Jane Hughes, Chief Scientific Officer, formerly CSO of Aiolos Bio and Gyroscope Therapeutics
  • Dr. Tapan Maniar, Chief Business Officer, formerly CBO of Aiolos Bio and Principal at Bain Capital Life Sciences
  • Ashley Taylor, Chief Technology Officer, formerly CTO of Aiolos Bio and Head of Network Strategy at Roche/Genentech

In conjunction with the Company’s launch, Mark Pruzanski was named Chairman of the Board. A physician and entrepreneur with over 30 years of life sciences experience, Dr. Pruzanski previously served as Chairman and CEO of Versanis Bio (acquired by Eli Lilly) and was the founder and CEO of Intercept Pharmaceuticals.

“This significant Series A financing will be used to progress the clinical development of our existing assets as well as to expand our industry-leading cardiometabolic portfolio, and we are grateful to this top-tier investor syndicate for their support,” said Dr. Pruzanski.

Substantial Series A financing

The Series A financing was co-led by Forbion and General Atlantic. “We are thrilled to co-lead Verdiva’s Series A financing and support its mission of transforming lives by accelerating innovation in cardiometabolic health,” said Wouter Joustra, General Partner at Forbion, and Brett Zbar, Managing Director and Global Head of Life Sciences at General Atlantic. “With a proven leadership team, a pipeline of potential next-generation oral therapies, and a clear vision for tackling some of the most pressing global health challenges, we both believe Verdiva Bio is well-positioned to deliver groundbreaking innovations and advance these promising therapies through clinical development and beyond.”

About Verdiva Bio

Verdiva Bio is committed to developing next-generation therapies to help people living with obesity, cardiometabolic disorders, and related complications achieve better outcomes via more patient-friendly therapeutic options. Verdiva’s most advanced therapy is VRB-101, an oral GLP-1 peptide in clinical development that has demonstrated best-in-class efficacy potential in a phase 1 study in Australia, which also confirmed the viability of once-weekly dosing. The Company is also developing a portfolio of amylin molecules, including oral and subcutaneous agonists, and other undisclosed programs that offer the potential for enhanced efficacy, improved tolerability, and healthier weight loss. The Verdiva team will harness the emerging science in gut-brain biology and leverage their history of successful drug development to advance novel therapeutic options aiming to transform the lives of millions living with obesity worldwide.

For more information, please visit www.verdivabio.com.

Contacts

Verdiva Bio
Tapan Maniar, CBO

Peter MacBride, VP, Strategy & Communications

info@verdivabio.com

Vigo Consulting (Media)
Melanie Toyne-Sewell

+44 7890 022 814

Rozi Morris

+44 7740 859 962

VerdivaBio@VigoConsulting.com

 

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Serina Therapeutics Secures $10 Million Financing to Continue Advancing Lead IND Candidate into Phase 1 Clinical Trial in Advanced Parkinson’s Disease Patients

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HUNTSVILLE, Dec. 02, 2024 (GLOBE NEWSWIRE) — Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company, today announced a $10 million equity financing with strategic shareholder JuvVentures (UK) Limited. The transaction provides Serina with funding to continue advancing SER-252 (POZ-apomorphine), enabled by its proprietary POZ Platform™ drug optimization technology, into a Phase 1 clinical trial in advanced Parkinson’s disease patients in the second half of 2025.

Under the terms of the funding agreement, Serina will issue one million shares of common stock at $10 per share, a 120% premium to the closing price on November 26, 2024. The financing will be delivered in two tranches: the first $5.0 million tranche was received November 27, 2024, and the second $5.0 million tranche by January 31, 2025. Serina filed a Form 8-K with the SEC on December 2, 2024 that provides additional information regarding this transaction.

About SER-252 (POZ-apomorphine)

SER 252 is an investigational apomorphine therapy developed with Serina’s POZ platform and designed to provide continuous dopaminergic stimulation (CDS). CDS has been shown to reduce the severity of levodopa-related motor complications (dyskinesia) and enable greater on time, with reduced off time, in advanced Parkinson’s patients. SER-252 leverages strategic partner Enable Injections’ enFuse™ wearable drug delivery platform to enhance patient comfort and convenience, providing CDS to patients via an easy-to-administer, long-acting subcutaneous injection without skin reactions.

About the POZ Platform™

Serina’s proprietary POZ technology is based on a synthetic, water soluble, low viscosity polymer called poly(2-oxazoline). Serina’s POZ technology is engineered to provide greater control in drug loading and more precision in the rate of release of attached drugs delivered via subcutaneous injection. The therapeutic agents in Serina’s product candidates are typically well-understood and marketed drugs that are effective but are limited by pharmacokinetic profiles that can include toxicity, side effects and short half-life. Serina believes that by using POZ technology, drugs with narrow therapeutic windows can be designed to maintain more desirable and stable levels in the blood.

Serina’s POZ platform delivery technology has potential for use across a broad range of payloads and indications. Serina intends to advance additional applications of the POZ platform via out-licensing, co-development, or other partnership arrangements, including the non-exclusive license agreement with Pfizer, Inc. to use Serina’s POZ polymer technology for use in lipid nanoparticle drug (LNP) delivery formulations.

About Serina Therapeutics

Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and other indications. Serina’s POZ PlatformTM provides the potential to improve the integrated efficacy and safety profile of multiple modalities including small molecules, RNA-based therapeutics and antibody-based drug conjugates (ADCs). Serina is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology.

For more information, please visit https://serinatherapeutics.com.

Cautionary Statement Regarding Forward-Looking Statement

This release contains forward-looking statements within the meaning of federal securities laws. These statements are based on management’s current expectations, plans, beliefs or forecasts for the future, and are subject to uncertainty and changes in circumstances. Any express or implied statements in this press release that are not statements of historical fact, including statements about the potential of Serina’s POZ polymer technology, are forward-looking statements that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed for any drug or vaccine candidates in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for any drug or vaccine candidates in any jurisdictions, which will depend on a myriad of factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such drug or vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any drug or vaccine candidates; and competitive developments. These risks as well as other risks are more fully discussed in the company’s Annual Report on Form 10-K for the year ended December 31, 2023, the company’s Current Report on Form 8-K that was filed with the SEC on April 1, 2024, and the company’s other periodic reports and documents filed from time to time with the SEC.

The information contained in this release is as of the date hereof, and Serina assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

For inquiries, please contact:

Investor.relations@serinatherapeutics.com
(256) 327-9630

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Albus Health Device Detects Early Warning Signs of Child Asthma Attacks Up To Five Days Before Onset

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Albus Health Device Detects Early Warning Signs of Child Asthma Attacks Up To Five Days Before Onset

Research presented at British Thoracic Society Winter Meeting demonstrates potential for revolutionary shift in respiratory care

Technology set to transform respiratory clinical trials: single device delivers continuous endpoint data across multiple parameters with minimal patient burden

OXFORD, UK; November 29, 2024 — Albus Health, the healthcare technology company pioneering monitoring of nocturnal health parameters including cough and breathing patterns, announces results from a clinical study at the British Thoracic Society Winter Meeting 2024 this week. The data revealed that Albus Home, the company’s AI-powered, innovative non-contact monitoring device with advanced algorithms, can detect warning signs of asthma attacks in children up to five days before they occur, potentially transforming how respiratory conditions are managed globally.

The groundbreaking study, conducted at Birmingham Children’s Hospital and Royal Brompton Hospital, demonstrated that the Albus Home device successfully identified significant changes in children’s respiratory health days before they required emergency steroid treatment for asthma attacks. This early warning window could provide crucial time for medical intervention, potentially preventing emergency hospitalisations and improving patient outcomes.

“For the first time, we have technology that can reliably monitor children while they sleep, without any disruption to their normal routine,” said Dr. Prasad Nagakumar, Director for Research at Birmingham Children’s Hospital and lead researcher on the study. “The device’s ability to detect changes up to five days before an attack represents a potential paradigm shift in asthma management, offering a window of opportunity for early intervention that simply hasn’t existed before.”

Night-time symptoms are crucial early warning signs of respiratory disease deterioration, yet until now, healthcare providers have remained blind to at-home symptoms while patients and carers often identify deterioration too late. The Childhood Home Asthma Monitoring Project (CHAMP) study recruited 100 children with asthma. The researchers analysed 47 asthma attacks across 28 children, finding that nocturnal cough frequency and respiratory rate began increasing five days before attacks occurred. In earlier studies, the device achieved clinical-grade accuracy, with 98.3% accuracy in respiratory rate measurement and 99% correlation in cough detection against gold standards.

Following insights from the study and feedback from participants and carers, Albus has developed a next-generation device that also measures heart rate, sleep parameters and air quality metrics. The device’s unique set of sensors, along with Bluetooth, Wi-Fi, and cellular connectivity, unlocks unprecedented opportunities in remote patient monitoring.

“This study validates our mission to revolutionise respiratory care through passive monitoring and early detection,” said Mikesh Udani, CEO of Albus Health. “Our technology has the potential to transform both patient care and clinical trials for several chronic diseases. By providing objective, continuous monitoring data, we can help pharmaceutical companies demonstrate response to treatment more efficiently while generating valuable insights for future drug development.”

The ability to detect and measure these subtle respiratory changes with such precision represents a major advance for both patient care and drug development. While current clinical trials rely heavily on subjective symptom reporting and limited spot-checks of respiratory function, the Albus Home device provides continuous, real-world data throughout the night – exactly when respiratory symptoms typically worsen. This has significant implications for respiratory drug development, where poor quality data collection and unreliable symptom reporting often necessitate larger, longer, and more expensive clinical trials. The Albus Home device offers pharmaceutical companies the ability to capture objective respiratory and sleep endpoints continuously, which can be used to bring new classes of therapies to asthma patients, monitor patient outcomes for post approval studies, and expand indications and labels for existing drugs.

Albus Home has already been deployed commercially to collect real world evidence on treatment response in a US-based Phase IV trial by a major pharmaceutical company. Albus is in advanced negotiations with several additional partners, highlighting strong industry confidence in the technology’s potential to transform both patient care and clinical research. Albus is now focused on expanding its clinical evidence base and set of parameters monitored, while scaling its platform to address the growing global burden of respiratory disease.

For more information about Albus Health and its unique respiratory monitoring technology, visit www.albushealth.com.

This study was funded through The Artificial Intelligence in Health and Care Award, one of the NHS AI Lab programmes. The competitive award scheme is run by DHSC. The AI Award has made funding available to accelerate the testing and evaluation of artificial intelligence technologies which meet the aims set out in the NHS Long Term Plan. In addition to Birmingham Women’s and Children’s Hospital and the Royal Brompton Hospital, partners include Imperial College London, Asthma + Lung UK, and Health Innovation Oxford.

About Albus Health

Albus Health, a spin-off from the University of Oxford, is pioneering nocturnal respiratory insights through its advanced non-contact monitoring system. The company has developed a revolutionary technology that addresses significant unmet needs in both clinical trials and respiratory care, where the inability to reliably monitor patients whilst they are in bed leads to missed early warnings of severe attacks and compromised clinical development data. The company’s bedside device combines proprietary hardware with advanced AI algorithms to deliver automated, clinical-grade insights with unprecedented accuracy in real-world settings. With its first pharmaceutical contract secured and multiple trials underway at leading institutions, Albus Health is positioned to transform respiratory care from reactive to predictive, while significantly enhancing the efficiency of global respiratory clinical trials. The company’s initial focus on respiratory conditions provides a clear path to commercial success, with potential for expansion into other chronic conditions through its established hardware and software platforms.

For Media enquires:

Sukaina Virji, Kate Hall

Albus@icrhealthcare.com

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