Sernova Biotherapeutics announced today that its ongoing Phase 1/2 clinical trial evaluating the Cell Pouch Bio-hybrid Organ for type 1 diabetes (T1D) treatment has received positive feedback from the Data and Safety Management Board (DSMB), allowing the company to proceed with key trial advancements.
Following a scheduled annual data review on March 31, the DSMB has sanctioned the enrollment of the final patient in Cohort B of the trial. Additionally, Sernova is preparing to advance to Cohort C in the second half of 2025, marking significant progress in the development of what could potentially become a functional cure for T1D.
"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."
Clinical Trial Design and Progress
The primary endpoint of Sernova's Phase 1/2 clinical trial focuses on demonstrating the safety and tolerability of islet transplantation into the Cell Pouch for treating T1D patients with hypoglycemia unawareness and a history of severe hypoglycemic episodes. Based on data collected thus far and the DSMB's endorsement of safety, the company believes it is on track to achieve this endpoint.
The Cell Pouch technology represents a significant innovation in the field of regenerative medicine for diabetes treatment. According to Sernova, their device is the only implantable and retrievable cell containment system for islet engraftment and function currently in U.S. clinical trials that is pre-vascularized prior to islet transplantation.
Promising Clinical Outcomes
Data from the ongoing trial has yielded several encouraging findings:
- Demonstrated islet cell survival in T1D patients ranging from one year to more than five years
- Ability to support insulin independence following protocol-specified treatment
- No evidence of detrimental fibrosis of the Cell Pouch on histological analysis
These results suggest that the Cell Pouch Bio-hybrid Organ may offer a durable solution for patients with T1D, potentially eliminating the need for daily insulin injections and continuous glucose monitoring.
Future Development Plans
Upon conclusion of Cohort C, Sernova plans to launch a new T1D clinical trial of the Cell Pouch Bio-hybrid Organ with induced pluripotent stem cell (iPSC) islet-like clusters in collaboration with Evotec. This next phase represents an important evolution in the technology, potentially addressing the limited supply of donor islet cells by using stem cell-derived alternatives.
Technology Platform
The Bio-hybrid Organ approach combines non-biomaterials, such as the Cell Pouch, with living tissues to replace the function of a compromised organ. For T1D patients, this means integrating the implantable Cell Pouch with islet cells that can produce insulin in response to blood glucose levels.
This innovative approach aims to deliver a potentially revolutionary treatment for patients with chronic diseases, with Sernova initially focusing on T1D and thyroid disorders.
About Type 1 Diabetes
Type 1 diabetes affects millions worldwide and is characterized by the autoimmune destruction of insulin-producing beta cells in the pancreas. Current standard treatments include daily insulin injections or insulin pump therapy, along with continuous glucose monitoring. However, these approaches require constant management and do not prevent long-term complications associated with imperfect glucose control.
Patients with hypoglycemia unawareness, the target population in Sernova's current trial, face particularly high risks as they cannot detect dangerous drops in blood sugar levels, which can lead to severe hypoglycemic episodes that may result in seizures, coma, or even death.
About Sernova Biotherapeutics
Sernova Biotherapeutics (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH) is a clinical-stage regenerative medicine company developing therapeutic solutions for chronic diseases. The company's Cell Pouch technology platform, combined with human donor cells or stem cell-derived islet-like clusters, aims to create a functional cure for conditions like T1D.
The company continues to advance its clinical programs while working to secure the necessary financing and partnerships to bring this potentially transformative technology to patients in need.
