Evotec SE

DSMB supports advancement for Sernova’s clinical trial Study is on track to meet key clinical trial endpoints LONDON, Ontario and BOSTON, April 01, 2025 (GLOBE NEWSWIRE) -- Sernova Biotherapeutics, (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a leading regenerative medicine company focused on developing it’s Cell Pouch Bio-hybrid Organ as a functional cure for type 1 diabetes (T1D), today provided an update on its ongoing clinical trial in patients with T1D. Yesterday, on March 31, the Data and Safety Management Board (DSMB) for Sernova’s Phase 1/2 clinical trial, conducted a scheduled annual data review. The DSMB has sanctioned the enrollment of the final patient in Cohort B. In addition, following consultation with the DSMB, Sernova is preparing to advance to Cohort C of the trial in H2 2025. The primary endpoint of our ongoing Phase 1/2 clinical trial is the demonstration of safety and tolerability of islet transplantation into Cell Pouch for the treatment of T1D in patients with hypoglycemia unawareness and a history of severe hypoglycemic episodes. Based on the clinical data that Sernova has acquired to date, and the endorsement of safety from the DSMB, we believe we are on track to achieve this endpoint. Upon conclusion of Cohort C, Sernova plans to launch a T1D clinical trial of the Cell Pouch™ Bio-hybrid Organ with induced pluripotent stem cell (iPSC) islet-like clusters in collaboration with Evotec. We believe that Sernova’s Cell Pouch™ Bio-hybrid Organ, that is pre-vascularized prior to islet transplantation, is the only implantable and retrievable cell containment system for islet engraftment and function currently in U.S. clinical trials. Data from the ongoing trial has demonstrated islet cell survival in T1D patients from one year to more than five years as well as the ability to support insulin independence following protocol specified treatment. In addition, there has been no evidence of detrimental fibrosis of the Cell Pouch on histological analysis. “We have collected a significant amount of data in our ongoing clinical trial and results to date suggest that we are tracking towards meeting our key clinical endpoints,” said Jonathan Rigby, President and CEO of Sernova Biotherapeutics. “We have made a great deal of strategic, operational and financing progress over recent months and as a type 1 diabetic myself, I am truly excited about the potential of our T1D Cell Pouch™ Bio-hybrid Organ and look forward to advancing our clinical trial to a positive conclusion.” ABOUT SERNOVA BIOTHERAPEUTICS Sernova Biotherapeutics is a clinical-stage company developing regenerative medicine therapeutics combining its Cell Pouch with human donor cells or stem-cell derived islet like clusters in collaboration with Evotec to create a Bio-hybrid Organ to treat T1D. A Bio-hybrid Organ is comprised of non-biomaterials, such as the Cell Pouch, integrated with living tissues to replace the function of a compromised organ. This innovative approach aims to deliver a potentially revolutionary treatment for patients with chronic diseases, initially focusing on T1D and thyroid disorders. FOR FURTHER INFORMATION, PLEASE CONTACT: David Burke VP, Investor Relations (917) 751-5713 Email: David.Burke@sernova.com Website: https://sernova.com/ The TSX has not reviewed this news release and does not accept responsibility for the accuracy or adequacy of this news release. FORWARD-LOOKING INFORMATION This press release contains forward-looking statements within the meaning of applicable Canadian securities laws. Forward-looking statements in this press release include our expectations that Sernova is on track to meet its primary endpoint, will launch a clinical trial with Evotec iPSC derived islet-like clusters in 2026, that Sernova will advance to Cohort C in the current trial, our belief that a functional cure requires a pre-vascularized containment device and our belief that Sernova is the only company to demonstrate islet cell survival for more than 5 years in a clinical trial with a pre-vascularized cell containment system. With respect to the forward-looking statements contained in this press release, Sernova has made numerous assumptions regarding, among other things: the company’s ability to secure additional financing on reasonable terms, or at all; and the ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch, including the timing and results of those trials. A more complete discussion of the risks and uncertainties facing Sernova appears in Sernova’s Annual Information Form for the year ended October 31, 2024, filed with Canadian securities authorities and available at www.sedarplus.ca, as updated by Sernova’s continuous disclosure filings, which are available at www.sedarplus.ca. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Sernova disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

Boston, Massachusetts, March 26, 2025 – Dewpoint Therapeutics Inc. – the leading biotechnology company in transforming condensate biology into medicine, announced today the publication of two abstracts accepted for presentation at the American Association of Cancer Research (AACR) Annual Meeting, taking place in Chicago, IL, between April 25-30, 2025. “We are excited to share promising results from our oncology pipeline, that demonstrate profound pre-clinical effects produced by condensate modulating compounds (c-mods). These c-mods alter the oncogenic functions of the ‘holy grail’ targets MYC and beta catenin through novel mechanisms of action that leverage our unique expertise in condensate biology”, said Dr. Ameet Nathwani, Dewpoint’s Chief Executive Officer. Dewpoint will present the following two posters: About Dewpoint Therapeutics   Dewpoint is the leading biotech company in the application of biomolecular condensate biology towards the development of a new generation of therapeutics to address diseases of high unmet need. The realization that a vast range of conditions are regulated by or arise from the dysfunction of condensates has provided new possibilities for modulating the function of high-value targets previously deemed ‘undruggable,’ opening unexplored avenues to identify hundreds of novel therapeutic targets. Dewpoint’s proprietary AI/ML-powered state-of-the-art platform underlies a drug discovery pipeline that spans multiple therapeutic areas, including oncology, neurodegenerative, cardiopulmonary, and metabolic diseases. Through collaborations with Bayer, Novo Nordisk, Evotec, and Mitsubishi Tanabe Pharma Corporation, Dewpoint pushes the boundaries to accelerate the translation of condensate biology into medicine for patients suffering from difficult-to-treat diseases. Learn more at Dewpointx.com and follow us on  LinkedIn. About Condensates   Condensates are membraneless organelles that form dynamically throughout the cell via a process called phase separation. These subcellular compartments organize and concentrate molecules within cells to enable a diversity of key biochemical processes. The dysregulation of biomolecular condensates has been observed in many diseases, including cancer, diabetes, cardiopulmonary and neurological disorders. Condensate-modulating drugs (c-mods) potentially provide novel therapeutic options for complex diseases and historically undruggable targets. Learn more about condensate science at Condensates.com. 

In a note to clients, William Blair analysts described the latest updates on DNL343 as “disappointing but largely expected following the previous update on the failed study.”\n Denali Therapeutics’ amyotrophic lateral sclerosis (ALS) drug has racked up another clinical miss this year, leaving the company to mull the asset’s future.The therapy, dubbed DNL343, is designed to activate the protein complex eIF2B, protecting neurons by preventing further aggregation of the TDP-43 protein. A phase 2/3 readout from a Massachusetts General Hospital trial at the start of the year showed that DNL343 was unable to slow ALS progression compared to placebo after 24 weeks or improve secondary outcomes like muscle strength and respiratory function.At the time, Denali pinned its hopes on additional analyses of the trial data assessing the drug\'s effect on neurofilament light (NfL)—a biomarker of neuronal damage—as well as specific subgroups of patients and longer-term treatment data.But the biotech announced in a Securities and Exchange Commission filing March 5 that these additional analyses hadn’t demonstrated a treatment effect on NfL in either the 24-week trial or in a 28-week open-label treatment extension.As a result, Denali is moving to halt the extension arm of the trial, with the data to be presented at a future medical meeting.The company isn’t quite ready to abandon the drug, however. For now, the biotech said it “intends to assess potential future development opportunities for DNL343.” Denali isn’t the only company to struggle in ALS. The same Massachusetts General Hospital trial also evaluated AbbVie and Calico’s eIF2B agonist, called fosigotifator, which was equally unsuccessful.The continuing failure of DNL343 may have implications for Bristol Myers Squibb, which paid Evotec a $20 million option fee to license an eIF2B candidate in 2021. BMS’ phase 1 pipeline includes an eIF2B activator that is in development in Alzheimer’s disease.In a note to clients, William Blair analysts described the latest updates on DNL343 as “disappointing but largely expected following the previous update on the failed study.”The analysts are more focused on Denali’s Hunter syndrome enzyme replacement therapy, tividenofusp alfa (tivi), also known as DNL310. A phase 1/2 study last month showed the treatment met its primary safety endpoints and reduced key biomarkers of the disease.“Much more relevant to our investment thesis will be updates in 2025 on the accelerated approval BLA filing (still on track for early 2025) for tivi to treat Hunter syndrome and potential acceptance and approval in late 2025 or early 2026,” the analysts added.