Category Archives: Biotech Companies USA

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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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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Zarminali Health Launches with $40M in Seed Funding to Transform Pediatric Care through Nationwide, Multi-specialty Practice Group

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New model for outpatient pediatric care combines seamlessly coordinated primary and specialty care with cutting-edge technology to transform the patient and family experience, and address physician burnout

CHICAGO, Nov. 20, 2024 (GLOBE NEWSWIRE) — Zarminali Health, the first outpatient pediatric destination purpose-built to provide modern, seamlessly coordinated primary and specialty care nationwide, today announced $40M in seed financing led by General Catalyst. The company will leverage the latest healthcare technology and an integrated approach to both primary and specialty care that alleviates family burdens and revitalizes patient and clinician experiences. This substantial funding, including a venture debt facility, will fuel the company’s go-to-market vision and continue to support the opening of its initial locations in fall 2024 and beyond.

Pediatric care today is long overdue for change. The current system is highly fragmented, and the disconnect between primary care providers, specialists, and ancillary services places the responsibility of navigating the healthcare system and complex care coordination squarely on families. Meanwhile, pediatricians are overburdened with high caseloads and unsustainable administrative tasks, clinical teams are under-supported with manual processes and outdated technology, and pediatric specialists remain siloed from primary care teams. All of these factors and inefficiencies exacerbate clinician burnout and hinder access to timely care for one of the most vulnerable populations in the country: children.

Zarminali was formed to deliver a renewed promise for pediatric care by streamlining care journeys for families, improving health outcomes for children, and enabling pediatric clinicians to focus on delivering quality care to their patients. Founded by Danish Qureshi, co-founder and former President and COO of LifeStance Health (NASDAQ: LFST), the company’s mission is directly informed by Danish’s personal experiences coordinating care for a child with an autoimmune disorder, and the many instances of breakdown in care across pediatric specialists.

“Zarminali is being painstakingly designed by parents like myself who have struggled against the current flaws of our healthcare system and know that every child deserves amazing care, from birth to adulthood,” said Qureshi. “After navigating the broken system with my daughter, I wanted to apply my experience transforming outpatient mental healthcare at LifeStance to improving pediatric care on a national scale. This initial funding round is an immense validator and kickstarts our mission to create a world where every child’s health journey is seamlessly coordinated, where advanced technology enhances every interaction, and where our clinicians and team members support each family every step of the way.”

“Pediatrics has long been overlooked, and we deeply share in Zarminali Health’s belief that our children and families deserve better care,” said Holly Maloney, Managing Director of General Catalyst. “With a strong founding team, collaborative care model, and advanced technology, we believe the team is on the right path to transform pediatric healthcare nationwide.”

Zarminali Health’s early team is a highly motivated and experienced group determined to improve pediatric care for all stakeholders. With backgrounds from other scaled national healthcare startups such as VillageMD (Walgreens and the Cigna Group), the team brings years of direct operating experience to tackle the challenges of pediatric care delivery. Additionally, Zarminali Health added its first independent board member in Brandon Kerns, bringing direct, relevant experience from Landmark Health (acquired by United Healthcare), Carebridge (acquired by Elevance), and Main Street Health.

To learn more about Zarminali Health, and how the company is transforming pediatric care, visit: https://zarminali.com/

About Zarminali Health
Zarminali Health, Inc. is building the nation’s leading pediatric multispecialty group, focused on supporting families to shape healthy futures for their children – from birth through adulthood – by completely transforming the way pediatric care is delivered nationwide. Zarminali is tackling today’s challenges of increased administrative burden on clinicians and a siloed approach to pediatric care through intentional design of care delivery, enhanced by leading technology and collaborative, expert care teams. We are leading the way towards a healthier future for pediatric patients and a happier future for pediatric clinicians nationwide. Visit zarminali.com for more information.

About General Catalyst
General Catalyst is a global investment and transformation company that partners with the world’s most ambitious entrepreneurs to drive resilience and applied AI. We support founders with a long-term view who challenge the status quo, partnering with them from seed to growth stage and beyond. With offices in San Francisco, New York City, Boston, Berlin, Bangalore, and London, we have supported the growth of 700+ businesses, including Airbnb, Anduril, Applied Intuition, Commure, Glean, Guild, Gusto, Helsing, Hubspot, Kayak, Livongo, Mistral, Ramp, Samsara, Snap, Stripe, Sword, and Zepto.

Media Contact
LaunchSquad for Zarminali Health
zarminalihealth@launchsquad.com

Steritas Announces Collaboration with argenx to Advance Evidence for Novel Steroid-sparing Therapeutics

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First-in-class steroid-toxicity outcome assessments licensed by argenx to support development of novel steroid-sparing therapeutics for autoimmune diseases

BOSTON–(BUSINESS WIRE)–Steritas LLC., a company dedicated to enhancing care for steroid-treated patients, today announced a licensing agreement with argenx, a global immunology company, for use of its STOX® Suite of steroid-toxicity clinical outcome assessments (COAs) across argenx’s development programs for differentiated immunology therapeutics.

The STOX Suite comprises first-in-class digital instruments that provide a standardized and validated measure of the full scope of steroid-toxicity. The COAs can be applied in research and at the point-of-care to demonstrate the safety and efficacy of new steroid-sparing treatments, and to enable clinicians to optimize treatment, taper steroid usage, and improve patient outcomes.

Under the terms of the multi-year agreement, argenx will incorporate the full STOX Suite as an innovative approach across its Immunology Innovation Program, including in clinical trials, health economics and outcome research, and real-world evidence. The strategic collaboration aims to strengthen the body of research evaluating chronic steroid usage in clinical groups and large populations, and to support development of argenx’s differentiated portfolio of novel antibody-based, medicines for the treatment of autoimmune diseases.

Following the first clinical use of cortisone in 1948, steroids have been used in almost all areas of medicine and are still considered first-line treatment for a wide range of conditions caused by inflammation, despite modern improvements in therapy options. The detrimental impact of long-term steroid use has led to an urgent need to research, monitor and reduce the use of steroids in patients and populations. Recognition of this need led to the development of the Glucocorticoid Toxicity Index (GTI), the first validated COA for quantifying steroid-toxicity, and forming the foundations of Steritas’ STOX Suite.

“Unmasking the damage of long-term steroid use is essential to countering this hidden epidemic – not only when developing new therapies for autoimmune disease, but also for other chronic conditions in which steroids are the standard of care.” commented Martha Stone, CEO at Steritas. She added: “This multi-year agreement with argenx to use the STOX Suite across its entire research program is recognition that steroid-toxicity is a vital area of study, with significance in routine patient care. This bold move by argenx to hold steroids accountable after more than 75 years of overuse will help alleviate patient suffering and healthcare burden.”

“Our pipeline of precision therapeutics is designed to bring relief to patients, both from the burden of the disease they are living with and the burden of existing treatments,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. “Collaborating with Steritas to better understand the often profoundly negative impact of long-term steroid use is yet another way that argenx is focusing on the real-world impact our medicines can have for the patients we serve. We are grateful for the partnership with the Steritas team and look forward to deepening the body of evidence in favor of innovative steroid-sparing treatments.”

“Evaluating the burden of steroids in the different conditions we treat is generating important data about the extent of their use and detrimental long-term effects,” said Glenn Phillips, Ph.D., Global Head, VP HEOR, argenx. “Steritas has been a great partner in helping us explore and better understand the measurable negative impact of long-term steroid use and the potential benefit to patients of reducing the burdens associated with steroid-toxicity.”

Contacts

Lily Jeffery

Zyme Communications

Tel: +44 (0) 7891 477378

Email: lily.jeffery@zymecommunications.com

Cancer Targeted Technology Receives Fast Track $2.4M Grant to Develop an Innovative PSMA-Targeted Small Molecule Drug Conjugate for Prostate Cancer

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SEATTLE–(BUSINESS WIRE)–Cancer Targeted Technology (CTT), a privately-held Seattle-based biotechnology firm focusing on cancer diagnostics and therapeutics, announced that the National Cancer Institute awarded the Phase I portion ($400K) of the fast track Phase I/II ($2.4M) Small Business Innovation Research (SBIR) grant to develop a new drug to treat metastatic prostate cancer. The grant focuses on a promising new prodrug, CTT2274, that targets Prostate-Specific Membrane Antigen (PSMA) on prostate cancer and is designed to release a toxic drug, MMAE, within the cell that takes up the prodrug. PSMA is over-expressed on prostate cancer and expression increases as the cancer metastasizes and becomes castrate resistant. CTT’s unique phosphoramidate-based agents, bind irreversibly to PSMA and unlike other agents targeting PSMA, this distinctive mode of binding enhances uptake and internalization by tumor cells, leading to increased accumulation of the therapeutic payload and improved efficacy.

Studies to date using CTT2274 treatment of mice bearing human prostate tumors have shown remission of tumor growth and an overall increase in survival. In addition, because of the prodrug release within the tumor cells, safety of the drug, at doses that are effective at inhibiting or reversing tumor growth, is excellent. In the Phase I portion of the grant, to be completed in Q2 2025, CTT will conduct additional non-clinical efficacy studies and manufacturing optimization. In Phase II of the grant, to be completed in Q2, 2026, CTT will conduct additional manufacturing and safety assessments necessary to advance CTT2274 to an Investigational New Drug (IND) application. These IND studies will support the initial clinical trial in metastatic prostate cancer planned for 2026.

“CTT2274 has a unique structure and linker that maximizes tumor uptake and allows for release of the chemotherapeutic drug only within the tumor cell thus minimizing potential side effects from the chemotherapy. No other prodrug like this is being developed for prostate cancer and CTT2274 holds great promise as a future treatment for men suffering from prostate cancer.” stated Dr. Beatrice Langton-Webster, CEO of CTT and Principal Investigator on the grant. Visit CTT’s website at http://www.cancertargetedtechnology.com to learn more about CTT2274.

Contacts

Dr. Langton-Webster at bealw@cancertargetedtechnology.com

Adicet Bio Presents Clinical Biomarker Data for Off-the-Shelf CAR T Cell Therapy in an Oral Session at the American College of Rheumatology (ACR) Convergence 2024

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-Data demonstrate characteristics essential for treatment of autoimmune diseases, including robust tissue homing and complete CD19+ B cell depletion in secondary lymphoid tissue

-Results highlight the potential benefits unique to gamma delta 1 CAR T cell therapy and ADI-001’s potential as a best-in-class off-the-shelf cell therapy for autoimmune diseases

-The company is pursuing ADI-001 in a basket study across six indications including lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV)

REDWOOD CITY, Calif. & BOSTON–(BUSINESS WIRE)–Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic, gamma delta T cell therapies for autoimmune diseases and cancer, today announced that clinical biomarker data from the ADI-001 Phase 1 GLEAN trial which demonstrates robust tissue homing, significant CAR T cell activation, and complete CD19+ B cell depletion in secondary lymphoid tissue will be featured in an oral session at ACR Convergence 2024 in Washington, D.C., November 14-19.

“We believe the key to advancing care for autoimmune patients is to develop a therapeutic candidate that demonstrates robust tissue homing, complete CD19+ B cell depletion in tissue, and superior drug exposure in secondary lymphoid tissue with a positive safety profile. We are proud to share data and analyses, including clinical biomarker data, at ACR that support the potential of ADI-001 in autoimmune diseases,” said Francesco Galimi, M.D., Ph.D., Chief Medical Officer. “After activating clinical trial sites for LN and receiving investigational new drug application (IND) clearances to pursue additional autoimmune indications, we are committed to advancing ADI-001 in a basket study across six autoimmune indications. This strategy highlights our focus on addressing the significant unmet medical needs of patients who urgently require innovative and effective new treatment options.”

A summary of the results is reported below:

  • ADI-001 demonstrated significant levels of CAR T cell activation and tissue exposure in lymph node biopsies in the GLEAN trial, representing a range of 27-64% of total cellular material detected by ddPCR in evaluable biopsies at the 1E9 dose, and exceeding levels previously reported for patients who received autologous alpha-beta CAR T therapies. CAR T cells detected in tissues also demonstrated a robust activation profile, based on in situ levels of granzyme B.
    • Recently published studies have demonstrated depletion of CD19+ plasmablasts, memory B cells and naïve B cells in peripheral blood using anti-CD20 targeted antibodies, however, these CD20-targeted antibody modalities failed to fully deplete B cells within secondary lymphoid tissue.
  • Concurrent with ADI-001 tissue trafficking and activation, complete depletion of CD19+ B cells within analyzed lymph node tissue was also observed. These results support ADI-001’s potential for achieving complete B-cell depletion in peripheral blood and within tissues.

Details of the oral presentation

Title: ADI-001: An Allogeneic CD20-targeted γδ CAR T Cell Therapy with Potential for Improved Tissue Homing in Autoimmune Indications

Session Name: Abstracts: Miscellaneous Rheumatic & Inflammatory Diseases II

Abstract Number: 1866169

Presenting Author: Monica Moreno, Ph.D.

Date and Time: November 19, 2024; 12:00 p.m. – 12:15 p.m. ET

About ADI-001 in Autoimmune Diseases

ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy targeting B-cells via an anti-CD20 CAR. ADI-001 was granted Fast Track Designation by the FDA for the potential treatment of relapsed/refractory class III or class IV lupus nephritis (LN). Adicet is exploring the potential of ADI-001 in a basket study across six indications including lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV).

For more information about becoming a study site, please email clinicaltrials@adicetbio.com or visit https://www.adicetbio.com/hcp/autoimmune/.

About the Phase 1 Clinical Trial

The Phase 1 study has four separate arms, enrolling LN and SLE patients into one arm, SSc patients into a second arm, IIM and SPS patients in a third arm and AAV patients into a fourth arm. Enrolled patients will receive a single dose of ADI-001. The dose-limiting toxicity window is 28 days with response and safety assessments conducted on Day 28 and during the follow-up period on months 3, 6, 9, 12, 18 and 24. The primary objectives of the study are to evaluate the safety and tolerability of ADI-001. Secondary objectives include measuring cellular kinetics, pharmacodynamics, changes in autoantibody titers, and appropriate disease activity scores in each indication.

About Adicet Bio, Inc.

Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.

Forward-Looking Statements

This press release contains “forward-looking statements” of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: the potential safety, tolerability and efficacy of ADI- 001 in multiple autoimmune indications; the potential for ADI-001 to be best-in-class allogenic cell therapy for autoimmune diseases; and the clinical development of ADI-001 in LN, SLE, SSc, IIM, SPS and AAV.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global economic conditions and public health emergencies on Adicet’s business and financial results, including with respect to disruptions to our preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet’s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet’s product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet’s ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Adicet’s most recent annual report on Form 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC), as well as discussions of potential risks, uncertainties, and other important factors in Adicet’s other filings with the SEC. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law.

Contacts

Adicet Bio, Inc.
Investor and Media Contacts

Investors:
Anne Bowdidge

abowdidge@adicetbio.com

Janhavi Mohite

Precision AQ

212-362-1200

janhavi.mohite@precisionaq.com

Media:
Kerry Beth Daly

kbdaly@adicetbio.com