Sernova Shares New Positive Phase I/II Trial Data on Islet Survival and Function

Sernova Corp., a clinical-stage biotechnology company, has revealed promising interim data from its ongoing Phase I/II clinical trial. This study is evaluating the safety, tolerability, and efficacy of the Sernova Cell Pouch Transplant System, which contains donor islets, in individuals with type 1 diabetes (T1D). The data was presented by Dr. Piotr Witkowski, a leading expert in pancreatic and islet transplantation, during the 2024 European Association for the Study of Diabetes (EASD) Annual Meeting in Madrid, Spain.

The trial's Cohort A involved six patients who received both the Cell Pouch and donor islets. All participants in this cohort achieved sustained insulin independence after receiving islet transplants both into the Cell Pouch and intraportally. Notably, the first patient treated maintained insulin independence for over four years, with blood sugar levels in the non-diabetic range. After more than five years, the patient's Cell Pouches containing the transplanted islets were removed due to unrelated health issues that necessitated the cessation of immune suppression.

Histological data from the explanted Cell Pouches showed that even after five years, the islets were abundant, well-vascularized, and producing insulin, glucagon, and somatostatin. Pathological examinations confirmed there was no detrimental fibrotic tissue, degradation, or change in the architecture of the Cell Pouch.

Dr. Witkowski expressed his excitement about the findings, emphasizing that this evidence of healthy, well-vascularized islets five years post-transplant marks a significant advancement in developing a retrievable cell therapy for T1D. Jonathan Rigby, Sernova’s President and CEO, highlighted the importance of this data, which he believes could pave the way towards a functional cure for T1D.

The Phase I/II trial is a U.S.-based, single-arm, multi-cohort study. It assesses the safety, tolerability, and efficacy of the Cell Pouch in combination with human-donor islets in individuals aged 18-65 with T1D who experience severe hypoglycemic episodes and are eligible for donor islet transplantation. The trial consists of two cohorts so far: Cohort A with six patients using the first-generation 8-channel Cell Pouch and Cohort B with seven patients using an optimized 10-channel Cell Pouch, which has a 50% greater islet capacity.

Participants in the trial receive the Cell Pouch subcutaneously. After approximately six weeks, allowing for the establishment of stable immunosuppression, islets are transplanted into the prevascularized tissue chambers formed by the Cell Pouch. Safety and efficacy are monitored for 12 months following the last islet transplant. Patients still dependent on insulin after six months may qualify for a third transplant via the portal vein, and those retaining implants will be followed for at least three years.

Secondary efficacy endpoints of the trial include continuous glucose monitoring, production of C-peptide, insulin use, HbA1c levels, and the frequency of severe hypoglycemic episodes.

Sernova’s Cell Pouch Transplant System aims to provide a 'functional cure' for insulin-dependent diabetes. The company is also collaborating with Evotec to develop an implantable, off-the-shelf therapy using induced pluripotent stem cells (iPSCs) to create islet-like clusters. This partnership aims to provide a scalable cell source for treating millions of patients with insulin-dependent diabetes. Additionally, Sernova is developing cell therapies for other chronic diseases like hypothyroid disease and hemophilia A.

This new data offers hope for T1D patients and reinforces Sernova's commitment to advancing its cell therapy technologies towards providing a functional cure for chronic diseases.

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