Sernova Biotherapeutics Provides Update on Phase 1/2 Clinical Trial of Cell Pouch™ Bio-Hybrid Organ for Treatment of Type 1 Diabetes

Rhea-AI Summary

Sernova Biotherapeutics (SEOVF) has received DSMB approval to advance its Phase 1/2 clinical trial for type 1 diabetes treatment using the Cell Pouch™ Bio-hybrid Organ system. The trial's Data and Safety Management Board has authorized enrollment of the final patient in Cohort B, with plans to progress to Cohort C in H2 2025.

The primary endpoint focuses on demonstrating safety and tolerability of islet transplantation into Cell Pouch for T1D patients with hypoglycemia unawareness. The company reports being on track to achieve this endpoint based on current clinical data.

The Cell Pouch™ system, described as the only implantable and retrievable cell containment system for islet engraftment in U.S. clinical trials, has shown islet cell survival in patients ranging from one to five years, with demonstrated ability to support insulin independence. Following trial completion, Sernova plans to initiate a new clinical trial using iPSC islet-like clusters in collaboration with Evotec.

Positive

• DSMB approval confirms safety profile and allows trial advancement
• Demonstrated islet cell survival for up to 5+ years
• Successfully achieving insulin independence in treated patients
• No evidence of detrimental fibrosis in Cell Pouch
• Only implantable and retrievable cell containment system in US clinical trials

Negative

• Trial still in early Phase 1/2 stage
• Final results not yet available
• Commercial launch timeline not specified

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.

FAQ

What are the latest DSMB findings for Sernova's (SEOVF) Phase 1/2 diabetes trial?

The DSMB has approved enrollment of the final patient in Cohort B and supported advancement to Cohort C in H2 2025, confirming the trial's safety progress.

How long has Sernova's Cell Pouch shown islet cell survival in T1D patients?

Clinical data shows islet cell survival ranging from one year to more than five years, with demonstrated ability to support insulin independence.

What is the primary endpoint of Sernova's (SEOVF) current Phase 1/2 trial?

The primary endpoint is to demonstrate safety and tolerability of islet transplantation into Cell Pouch for T1D patients with hypoglycemia unawareness.

What are Sernova's (SEOVF) plans after completing the current trial?

Sernova plans to launch a T1D clinical trial of the Cell Pouch with iPSC islet-like clusters in collaboration with Evotec.