Sernova Announces Positive Updated Phase 1/2 Clinical Data on Cell Pouch System™ at American Diabetes Association 82nd Scientific Sessions 2022

Rhea-AI Summary

Sernova Corp. (OTCQB:SEOVF) presented promising clinical data on its Cell Pouch System for treating type 1 diabetes at the ADA 82nd Scientific Sessions. The Phase 1/2 trial revealed that three of six patients achieved insulin independence for over 2 years, with positive serum C-peptide values indicating active insulin production. The Cell Pouch has been well tolerated, with implantation durations exceeding 35 months. Future trials will focus on optimizing patient outcomes and utilizing a higher-capacity Cell Pouch. The company aims to provide a functional cure for insulin-dependent diabetes.

Positive

• Three patients attained insulin independence for over 2 years, 6 months, and 3 months.
• Positive serum C-peptide values confirmed insulin production from islet grafts.
• The Cell Pouch showed a favorable safety profile and is well tolerated.
• Ongoing trials are set to optimize the Cell Pouch implantation and expand patient treatment options.

Negative

• Three additional patients did not maintain optimal immunosuppression, delaying their further treatment.

• Researchers from the Dr. Piotr Witkowski Laboratory at the University of Chicago presented updated data on six patients with type 1 diabetes and hypoglycemia unawareness
  
• The first three patients have been insulin independent for over 2 years, 6 months, and 3 months, respectively
• Those first three patients with islets transplanted into the Cell Pouch™ subsequently presented positive serum C-peptide values confirming active insulin production by the Cell Pouch islet grafts
• The Cell Pouch was well tolerated with implant durations exceeding 35 months

LONDON, Ontario, June 06, 2022 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in regenerative medicine cell therapeutics, today announced the presentation of clinical data from its Phase 1/2 clinical trial supporting the potential of its proprietary Cell Pouch System to provide a ‘functional cure’ for insulin-dependent diabetes. The updated data from the ongoing study being conducted by Piotr Witkowski, M.D., Ph.D. at the University of Chicago, were presented as an oral podium presentation at the American Diabetes Association (ADA) 82^nd Scientific Sessions, held from June 3-7, 2022, at the Ernest N. Morial Convention Center in New Orleans, LA.

The presented data, from the Dr. Piotr Witkowski Laboratory at the University of Chicago, reviewed the six patients who lived with long-standing insulin-dependent type 1 diabetes (T1D) and hypoglycemia unawareness prior to study treatment who underwent both Cell Pouch implantation and islet transplantation. Graft function was measured by blood glucose, patient insulin usage, and C-peptide, a widely used measure of islet function. The first three patients achieved complete and sustained insulin independence. Three additional patients on study did not maintain optimal immunosuppression, which has now been resolved enabling those patients to receive further protocol-defined islet transplants.

Key findings from interim clinical update:

• Surgical implantation of the Cell Pouch was found to be generally well tolerated with a favorable safety profile
• All patients who had favorable immunosuppression achieved complete insulin independence
  • The first three transplanted patients presented positive serum C-peptide values confirming active insulin production after islet transplantation into the Sernova Cell Pouch
  • Supplemental marginal dose islet transplantation via the portal vein was sufficient to allow those three patients to achieve and maintain insulin independence for over 2 years, 6 months, and 3 months, respectively
  • Insulin independent patients have HbA1c in the normal range: 5.0, 5.2, and 5.2%, respectively
• Dr. Witkowski further optimized outcomes in the ongoing clinical trial:
  • Replacing patients’ own plasma with serum as the islet suspension medium
  • Decreasing the concentration of islet suspensions transplanted to Cell Pouch resulted in greater stimulated C-peptide
  • The Cell Pouch implantation procedure was optimized with two shorter incisions to minimize infection risk and enhance healing
  • Implementing a higher capacity Cell Pouch System, that has been developed by Sernova, will provide approximately 50% more volume to accommodate more islets at the optimal concentration for use in future implantation procedures

“Despite some advances in the diabetes space, insulin-dependent diabetes patients continue to require numerous injections daily, and for those with hypoglycemia unawareness, it can be increasingly life threatening. We are committed to developing a ‘functional cure’ to potentially free patients from the life-limiting burdens of this disease,” said Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “We are encouraged by the data demonstrating our Cell Pouch System has been well tolerated and multiple patients remain insulin independent. We remain on track to further dose the three aforementioned subjects and to implement the higher capacity Cell Pouch System in the next implanted patients.”

The incidence of T1D in the U.S. (in ages 0 to 64 years) is estimated to be 64,000 cases annually, with a predicted prevalence of 5 million people by 2050^1,2. The annual direct cost of healthcare expenditures and lost income from T1D has been estimated as $16 billion³. Sernova’s Cell Pouch System is designed to address this vastly expanding need by providing a ‘functional cure’ for the millions of people afflicted by insulin-dependent diabetes worldwide. Sernova is also addressing the life-threatening complication of hypoglycemia unawareness (HU) in patients with T1D. HU is a person’s inability to recognize the symptoms of low blood sugar before it becomes severe enough to be incapacitating or even fatal. About 1 in 5 people with T1D report experiencing hypoglycemia unawareness⁴.

Dr. Piotr Witkowski, Director of Pancreatic Islet Transplantation Program at University of Chicago and study Principal Investigator added, “The data coming out of the Cell Pouch and islet transplantation trial show incredible promise for insulin-dependent diabetes patients. I am excited about the potential impact on the field and look forward to seeing continued progression of the data from this trial.”

Sernova recently entered into a global strategic partnership with Evotec A.G., a Nasdaq listed biotechnology company, to develop an implantable off-the-shelf induced pluripotent stem cell (iPSC) -based beta cell replacement therapy, which will provide Sernova with an unlimited supply of insulin-producing cells, circumventing any potential future islet supply issues. Sernova is also working to eliminate the need for chronic immunosuppression with cell transplants by incorporating technology developed by Dr. Alice Tomei’s laboratory at the University of Miami, to protect cells from immune system recognition.

For more information on the ongoing clinical study, go to clinicaltrials.gov (NCT03513939).

¹Rogers MAM, Kim C, Banerjee T, Lee JM. Fluctuations in the incidence of type 1 diabetes in the United States from 2001 to 2015: a longitudinal study. BMC Med. 2017;15(1):199. Published 2017 Nov 8. doi:10.1186/s12916-017-0958-6

²Dabelea D, Mayer-Davis EJ, Saydah S, et al. Prevalence of type 1 and type 2 diabetes among children and adolescents from 2001 to 2009. JAMA. 2014;311(17):1778-1786. doi:10.1001/jama.2014.3201

³American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care. 2018;41(5):917-928. doi:10.2337/dci18-0007

⁴Reno CM, Litvin M, Clark AL, Fisher SJ. Defective counterregulation and hypoglycemia unawareness in diabetes: mechanisms and emerging treatments. Endocrinol Metab Clin North Am. 2013;42(1):15-38. doi:10.1016/j.ecl.2012.11.005

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY

Sernova Corp is a clinical-stage biotechnology company that is developing regenerative medicine therapeutic technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders like hemophilia A. Sernova is currently focused on finding a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell-Pouch System^TM, a novel implantable and scalable medical device which forms a natural environment in the body for long-term survival and function of therapeutic cells that release necessary proteins or factors missing from the body to treat chronic diseases. Sernova’s Cell Pouch System has already shown it can potentially provide a ‘functional cure’ to people with type 1 diabetes in an ongoing Phase I/II study at the University of Chicago. Sernova is also working on technology with the University of Miami to cloak the implant from the immune system, to eliminate the need for immunosuppressives to protect the cells from immune system attack. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC-based (induced pluripotent stem cells) beta cell replacement therapy. This partnership provides Sernova an unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova is also gearing up to be in the clinic in two programs that utilize its Cell Pouch System – an implantable cell therapy for benign thyroid disease resulting from thyroid gland removal and an ex-vivo lentiviral factor 8 gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com

Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577

Media:
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and/or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

FAQ

What are the results from Sernova's Phase 1/2 clinical trial for the Cell Pouch System?

The trial showed that three patients achieved insulin independence for over 2 years, and positive serum C-peptide values confirmed active insulin production.

How does the Cell Pouch System impact type 1 diabetes treatment?

The Cell Pouch System aims to provide a functional cure for insulin-dependent diabetes, reducing the need for insulin injections.

What future steps is Sernova planning after the initial trial results?

Sernova plans to optimize the Cell Pouch implantation procedure and increase the capacity of the device in future trials.

What is the significance of C-peptide levels in diabetes treatment?

C-peptide levels indicate active insulin production, which is crucial for assessing the effectiveness of diabetes treatments.

What potential challenges does Sernova face with the Cell Pouch System?

Challenges include ensuring optimal immunosuppression for all patients and addressing any regulatory hurdles that may arise.