Sernova Reports New Insulin-Free Patient and Completion of Cohort 2 Enrollment in Type 1 Diabetes Trial

Sernova Corp., a biotechnology firm at the clinical stage, has announced significant advancements in its Phase I/II clinical trial for Type 1 Diabetes (T1D). This trial, utilizing Sernova’s proprietary Cell Pouch System™ combined with human donor islet transplants, has seen remarkable patient outcomes, marking a notable development in diabetes treatment.

As of now, seven patients across Cohorts 1 and 2 have achieved insulin independence post-transplantation. This pioneering trial is being conducted at the University of Chicago and has recently completed the enrollment of its second cohort, with the final patient enrolled on June 24, 2024. Initially, all participants were reliant on multiple daily insulin injections, with average HbA1c levels exceeding 6.5%. These patients also had a history of severe hypoglycemic events and undetectable plasma levels of C-peptide, indicating negligible natural insulin production.

The initial seven patients have maintained insulin independence and experienced no severe hypoglycemic episodes. They have exhibited sustained HbA1c levels within the non-diabetic range (below 6.5%) and continuous insulin production as measured by plasma C-peptide. This trial focuses on Sernova’s Cell Pouch technology, which shows that insulin independence can be achieved with lower islet masses than traditionally used, underscoring the efficacy of the islet grafts within the Cell Pouch system in maintaining favorable blood glucose control.

Sernova is unique as the only company to report positive patient outcomes in a T1D clinical trial using an implantable delivery system with full payload containment and retrievability capabilities. Interim data indicate that the Cell Pouch is generally safe, well-tolerated, and contributes to T1D reversal when used in conjunction with donor islets. This may reduce long-term complications associated with diabetes, such as heart disease, kidney failure, blindness, and amputations. The company plans to release additional results for the remaining five patients in Cohort 2 later this year.

Cynthia Pussinen, CEO of Sernova, expressed her enthusiasm, noting that the trial's progress is promising and represents a transformative step in T1D treatment. Achieving sustained insulin independence and maintaining HbA1c levels in the non-diabetic range, along with a reduction in severe hypoglycemic events, suggests a potential functional cure for T1D. Sernova remains dedicated to enhancing its Cell Pouch technology to improve patients' lives globally.

The company continues to collaborate with leading academic, pharmaceutical, and clinical institutions to extend the reach and impact of its technology. With ongoing and future trials, Sernova aims to offer a scalable solution not only for insulin-dependent diabetes but also for other chronic diseases.

Sernova Corp. is developing therapeutic cell technologies for chronic conditions, including diabetes, thyroid disease, and blood disorders like hemophilia A. Its leading technology, the Cell Pouch System, is a novel, implantable device designed to create a natural, vascularized tissue environment for the long-term survival and function of therapeutic cells. This system has shown promise as a functional cure for T1D in ongoing clinical studies.

Sernova has also partnered with Evotec to develop an implantable, off-the-shelf iPSC-based islet replacement therapy. This collaboration aims to provide an unlimited supply of insulin-producing cells to treat millions of diabetic patients. The Cell Pouch System's application extends to treatments for hypothyroid disease and hemophilia A, showcasing its versatile potential in medical therapy.

In summary, Sernova’s advances in its clinical trials signify crucial breakthroughs in treating insulin-dependent diabetes, potentially offering a functional cure and improving the quality of life for many patients.