AgeX Therapeutics, Inc. (“AgeX”: NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, and Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH), a clinical-stage regenerative medicine therapeutics company, announced today a research collaboration where Sernova will utilize AgeX’s UniverCyteTM gene technology to generate immune-protected universal therapeutic cells for use in combination with Sernova’s Cell PouchTM for the treatment of type I diabetes and hemophilia A. The goal is to eliminate the need for immunosuppressive medications following Cell Pouch cell transplantation.
The research collaboration will evaluate whether Sernova’s pluripotent stem cell-derived pancreatic islet beta cells engineered with AgeX’s UniverCyte technology can evade human immune detection. The complementary combination of technologies could enable the transplantation of therapeutic cells in patients with type I diabetes in an off-the-shelf manner using Sernova’s Cell Pouch, without human leukocyte antigen (HLA) tissue matching or concurrent administration of immunosuppressive medications. With a similar intent, pluripotent stem cell-derived or adult donor-derived human Factor VIII-releasing cells modified with AgeX’s UniverCyte will be evaluated in Sernova’s hemophilia A program.
Under the terms of the agreement, Sernova has been granted a time-limited, non-exclusive research license by AgeX. A commercial license for Sernova to utilize UniverCyte to engineer cellular products for therapeutic and commercial purposes may be negotiated between the companies pending successful study outcomes.
The UniverCyte technology aims to mask therapeutic cells derived from pluripotent stem cells or adult donors from human immune detection to allow for off-the-shelf cellular products without the need for immunosuppressant medications which may have potent side effects, or HLA-matching between donor and patient. UniverCyte uses a novel, modified form of HLA-G, a potent immunomodulatory molecule, which in nature protects an unborn child from their mother’s immune system. In almost all human cells, native HLA-G expression is silenced after birth. AgeX’s modified HLA-G shows evidence of being resistant to this silencing, thereby potentially allowing for long-term, stable and high expression of the immunomodulatory effect.
Sernova plans to utilize the universal therapeutic cells generated through this research collaboration with its Cell Pouch System, a proprietary, scalable, implantable macro-encapsulation device, which, upon implantation, incorporates with tissue and forms highly vascularized chambers. These chambers become a natural environment in the body to house and favor long-term survival and function of therapeutic cells. The Cell Pouch System has shown initial safety and efficacy indicators in an ongoing Phase I/II clinical study at the University of Chicago and in a preclinical model of hemophilia A when assessed with human cells corrected to produce Factor VIII.
“We are thrilled with our collaboration with Sernova, which is at the forefront of cellular therapies for diabetes and hemophilia and is already in the clinic for the former. The combination of AgeX’s UniverCyte to cloak cells from a patient’s immune system and Sernova’s Cell Pouch technologies to permit cells to function long-term upon transplantation would be a landmark for regenerative medicine. This deal marks another important step in AgeX’s collaboration and licensing strategy to work with the very best people, companies and institutions in the world of regenerative medicine,” said , Chief Operating Officer of AgeX.
“We look forward to working with AgeX and its outstanding team as we continue to identify and evaluate technologies complementary to Sernova’s therapeutic platform and expand our immune protection offerings. AgeX’s UniverCyte technology is a significant advancement in the field of cell therapy and a perfect fit with Sernova’s Cell Pouch technologies and therapeutic pipeline with its potential benefit over current immunosuppressive strategies for regenerative medicine therapeutics,” said Dr. Philip Toleikis, President and CEO of Sernova Corp.
ABOUT AGEX THERAPEUTICS
AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem® and UniverCyte™ manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeX’s revolutionary longevity platform induced Tissue Regeneration (iTR™) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem® is AgeX’s delivery technology to stably engraft PureStem cell therapies in the body. AgeX’s core product pipeline is intended to extend human healthspan. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.
For more information, please visit www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.
ABOUT SERNOVA CORP
Sernova Corp is developing regenerative medicine therapeutic technologies using the Cell Pouch System, a medical device and immune protected therapeutic cells (i.e., human donor cells, corrected human cells and stem-cell-derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com.
FORWARD-LOOKING STATEMENTS FOR AGEX
Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the “Risk Factors” section of AgeX’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. In addition, there can be no assurance that Sernova’s planned use of AgeX’s UniverCyteTM gene technology will successfully generate immune-protected universal therapeutic cells for use in combination with Sernova’s Cell PouchTM for the treatment of type I diabetes and hemophilia A or any other disease, and there can be no assurance that AgeX and Sernova will enter into a commercial license for the use of UniverCyteTM in a therapeutic or other product. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
FORWARD-LOOKING STATEMENTS FOR SERNOVA
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements including those related to the potential of Univercyte combined with Sernova’s technologies are not guarantees of future performance, and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the date such statements were made, which include our beliefs about the effect on company operations of the COVID-19 virus and conduct and outcome of discussions, clinical programs, and our clinical trials. 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.
Link to the Business Wire press release found here.