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- Type 1 diabetes (T1D) Cohort 2 patient data demonstrates favorable islet engraftment and long-term survival of human donor islets in the Cell Pouch
- First treated Cohort 1 patient in the T1D clinical trial to celebrate four years of insulin independence and normalized HbA1c
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With recent positive findings in post-surgical hypothyroidism large animal study, Sernova anticipates filing an Investigational New Drug (IND) application in 2024
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Additional chronic disease indications identified for further pipeline expansion with a focus on endocrine disorders
LONDON, Ontario; BOSTON, Massachusetts - TheNewswuire - April 2, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the development of regenerative medicine cell therapies for treatment of chronic diseases, today provided a business update. Following a review of the company’s therapeutic pipeline and emerging opportunities for its Cell Pouch system platform technologies, Sernova confirms key priorities including its lighthouse program in insulin dependent Type 1 Diabetes plus its intention to advance an IND filing for its post-operative hypothyroidism program.
Data from a patient in Cohort 2 of the company’s lead clinical program for insulin dependent Type 1 diabetes (T1D) confirms histologic evidence of long-term (one year) robust survival of abundant human donor islets throughout the Cell Pouch. Additional Cohort 2 findings are specific to an advanced immunosuppression regimen planned for use in its upcoming Phase I/II trial with stem cell-derived islets under co-development with Evotec.
Cohort 2 patients treated with an advanced immunosuppression protocol avoided graft rejection and experienced minimal side effects in comparison to those patients observed in Cohort 1. None of the six patients in Cohort 2 treated with the advanced regimen have tested positive for donor specific antibodies (DSAs), a marker of graft rejection, in comparison to three of six patients who developed DSAs under the conventional immunosuppression regimen in Cohort 1. Ancillary medication, used in some Cohort 2 patients, demonstrated highly favorable graft survival and function for islets transplanted to the Cell Pouch and has been integrated into the updated regimen and implemented for all subsequent patient trial enrollments. The company anticipates reporting additional data from Cohort 2 of its ongoing Phase 1/2 clinical trial of its expanded 10-channel Cell Pouch during the second half of the year at major medical conferences.
Sernova is pleased to report that this month marks the four-year anniversary of the first patient in Cohort 1 of this Phase 1/2 study who will celebrate insulin independence and normalized blood sugar levels, based on two transplants of human donor islets to the Cell Pouch plus a marginal portal vein top up.
“Based on the favorable results we are observing in ongoing pre-clinical studies, we have concluded that our hypothyroidism program represents another compelling opportunity by which to improve patients’ lives. We look forward to completing our pre-clinical work, engaging with regulatory agencies, and preparing for an IND filing later this year, with the goal of advancing a second indication into the clinic, further demonstrating the Cell Pouch as a drug delivery vehicle platform technology. Also of note, in addition to allowing for long term payload survival, our Cell Pouch has powerful containment and retrievability capabilities that we expect will have tremendous value for pharmaceutical companies looking to treat patients with cell therapies,” said Cynthia Pussinen, Chief Executive Officer of Sernova.
“In parallel with these activities, and our ongoing hemophilia A work, we have identified several high value indications with unmet medical needs that could potentially benefit from our platform Cell Pouch technology, with an initial focus on endocrine disorders. In the coming months, we will be conducting commercial assessments to prioritize those areas where we can best extend our reach to more patients while creating enduring value for our shareholders. I am excited for what we are poised to achieve this year and look forward to providing further updates in the future,” Ms. Pussinen concluded.
ABOUT SERNOVA AND ITS CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead technology, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells.
On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago.
Sernova partnered with Evotec to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s development pipeline that uses its Cell Pouch System also includes: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
Tel: +1 519-902-7923
Email: christopher.barnes@sernova.com
Website: www.sernova.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.sedarplus.ca 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.
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