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Sernova and Evotec Enter into an Exclusive Global Strategic Partnership for iPSC-Based Beta Cell Replacement Therapy to Develop and Commercialize a ‘Functional Cure’ for Diabetes

·8 minuto per la lettura
Sernova Corp.
Sernova Corp.
  • Partnership Leverages Sernova’s Proprietary Cell Pouch System™ with Evotec’s iPSC-Based Insulin-Producing Beta Cells

  • Partners to Develop and Commercialize an Off-The-Shelf Cell Replacement Therapy for Treatment of Patients with Insulin-Dependent Diabetes

  • Evotec to Make Strategic Equity Investment of CAD $27 M / €20 M in Sernova

  • Sernova / Evotec Joint Conference Call and Webcast at 8:30 am EDT May 17, 2022

LONDON, Ontario, May 17, 2022 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE/XETRA:PSH), a clinical-stage company and leader in regenerative medicine cell therapeutics, and Evotec SE (FSE: EVT; NASDAQ: EVO), a global pharmaceutical and life science company, and leading developer of iPSC cell technologies for therapeutic applications, are pleased to announce an exclusive global strategic partnership to develop a best-in-class cell therapy treatment for people living with insulin-dependent diabetes. The two Companies will combine and leverage their respective technologies and scientific expertise to develop an implantable iPSC-based (induced pluripotent stem cells) beta cell replacement therapy to provide an unlimited insulin-producing cell source to treat patients with insulin-dependent diabetes.

The collaboration agreement is a transformative partnership that combines Sernova’s Cell Pouch System technologies, which has demonstrated Phase 1/2 clinical proof-of-concept using human donor islets, with Evotec’s iPSC-based beta cells. Incorporating Evotec’s insulin-producing, ethically-derived beta cells within Sernova’s Cell Pouch platform creates the potential to provide a ‘functional cure’ for millions of people suffering from diabetes using a cGMP controlled and scalable off-the-shelf product.

With its long-standing beta cell development program, Evotec has demonstrated the ability to reliably produce an unlimited supply of high quality, stable, human iPSC-derived beta cells using its proprietary process for producing islet-like clusters in a quality-controlled scalable bioreactor process. These islet-like clusters have now been proven to be functionally equivalent to primary human islets in their ability to normalize blood glucose using in vivo models of type 1 diabetes (T1D).

The partnership provides Sernova a global exclusive option to license Evotec’s iPSC-based beta cells for use in treating both type 1 and type 2 diabetes. In addition to entering into the collaboration agreement, Evotec has made a strategic equity investment of €15M and will make a further investment of €5M. Specifically, concurrently with the entering into the collaboration agreement, Evotec acquired a total of 12,944,904 common shares at a price of CAD $1.57 per share for gross proceeds to Sernova of $20,323,500. In addition, pursuant to an unconditional purchase warrant, Evotec will acquire, on or before August 31, 2022, a further 2,709,800 common shares at a price of CAD$2.50 per share for gross proceeds of $6,774,500. All of the securities issued to Evotec are subject to a four month hold period.

Further to the collaboration and Evotec’s strategic equity investment, Dr. Cord Dohrmann, Chief Scientific Officer of Evotec will join Sernova’s Board of Directors.

Dr. Philip Toleikis, President, and Chief Executive Officer of Sernova, commented, “In tandem with our current clinical islet cell program, Sernova entered into multiple pharmaceutical research collaborations to identify the highest quality and most compatible iPSC cell technology, and validate the cells preclinically within our Cell Pouch System. Evotec is an iPSC powerhouse having dedicated many years and substantial resources to developing high quality and stable stem cell technologies for multiple therapeutic applications. In every sense, both as a global strategic partner and as an iPSC expert, Evotec has exceeded all our expectations and Dr. Dohrmann’s appointment to Sernova’s Board adds significant regenerative medicine depth and cell therapy expertise. Today’s announcement of this joint iPSC beta-cell partnership completes the three pillars of our diabetes cell therapy platform. Alongside our clinically validated Cell Pouch System and recently acquired conformal coating immune protection technology, this now establishes a total regenerative medicine cell therapy solution for insulin-dependent diabetes.”

Dr. Cord Dohrmann, Chief Scientific Officer of Evotec, commented, “We searched long and hard for the right partner. Sernova clearly ticks all boxes with their clinically validated Cell Pouch™ technology, which fits perfectly to Evotec’s iPSC-based beta cells. Together we will progress a highly differentiated first-in-class beta cell therapy into clinical development with the common goal to bring a truly transformative therapy to insulin-dependent diabetic patients. The synergies of Evotec’s and Sernova’s technologies puts Sernova in position to become the world’s leader in beta cell replacement therapy. Our equity investment underlines our strategic interest in this collaboration with Sernova. I am very much looking forward to collaborating with Sernova on the project as well as contributing to their Board of Directors.”

Sernova has acquired an option for an exclusive global license to Evotec’s Induced Pluripotent Stem Cell (iPSC)-based Beta cells to treat patients with insulin-dependent diabetes. From an operational perspective, the preclinical development program(s) will be jointly funded by Sernova and Evotec until IND acceptance. Sernova has the right to exercise its option for an exclusive global license upon IND filing. Evotec will contribute its cell manufacturing capabilities through research, development and product commercialization and will decide in the future on the joint funding of clinical development. Upon commercialization, there will be a profit-sharing arrangement between the two companies, with the split being dependent on Evotec’s participation in funding the clinical development program.

Joint Sernova / Evotec Conference Call and Webcast Details:

Date: Tuesday, May 17, 2022
Time: 8:30 am EDT
US Toll Free: 1-877-704-4453
International: 1-201-389-0920
Conference ID: 13730121
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1550130&tp_key=3de87cce1d

A simultaneous slide presentation will be available via the above webcast link.

ABOUT SERNOVA CORP AND THE CELL POUCH SYSTEM CELL THERAPY PLATFORM

Sernova Corp is developing regenerative medicine therapeutic technologies using 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.

The Cell Pouch, as part of the Cell Pouch System, is a proprietary, scalable, implantable macro- encapsulation device solution designed for the long-term survival and function of therapeutic cells. After implantation, the device incorporates with tissue, forming highly vascularized, native tissue chambers for the transplantation and function of therapeutic cells, that release proteins and hormones as required to treat disease.

The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase 1/2 clinical trial study at the University of Chicago. Encouraging interim results have been presented at several international scientific conferences.

For more information, please visit www.sernova.com

ABOUT EVOTEC AND iPSC

Induced pluripotent stem cells (also known as iPS cells or iPSCs) are a type of pluripotent stem cell that can be generated directly from adult cells. The iPSC technology was pioneered by Shinya Yamanaka’s lab in Kyoto, Japan, who showed in 2006 that the introduction of four specific genes encoding transcription factors could convert adult cells into pluripotent stem cells. He was awarded the 2012 Nobel Prize along with Sir John Gurdon “for the discovery that mature cells can be reprogrammed to become pluripotent”. Pluripotent stem cells hold great promise in the field of regenerative medicine. Because they can propagate indefinitely, as well as give rise to every other cell type in the body (such as neurons, heart, pancreatic and liver cells), they represent a single source of cells that could be used to replace those lost to damage or disease.

Evotec has built an industrialised iPSC infrastructure that represents one of the largest and most sophisticated iPSC platforms in the industry. Evotec’s iPSC platform has been developed over the last years with the goal to industrialise iPSC-based drug screening in terms of throughput, reproducibility and robustness to reach the highest industrial standards, and to use iPSC-based cells in cell therapy approaches via the Company’s proprietary EVOcells platform.


For further information contact:

Corporate and Investors:
Sernova Corp
Christopher Barnes
Tel: (519) 858-5126
christopher.barnes@sernova.com
www.sernova.com

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

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

FORWARD-LOOKING INFORMATION

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 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 conduct and outcome of clinical trials, and the development of new technologies, cell therapy solutions and or products. The information disclosed represents results from one patient and may not be representative of all study patients or of the final study results. 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.