Pluristyx Announces License Agreement with Humacyte to Develop BioVascular Pancreas using iPSCs
Pluristyx and Humacyte have entered into a license agreement to develop the BioVascular Pancreas (BVP) using Pluristyx’s clinical-grade PluriBank™ induced Pluripotent Stem Cell (iPSC) line. This agreement allows Humacyte to utilize Pluristyx’s panCELLa™ platform, which generates 'hypoimmune' cells for clinical implantation. The partnership aims to create insulin-producing cells to integrate with Humacyte’s Acellular Tissue Engineered Vessel (ATEV™), potentially revolutionizing type 1 diabetes treatment. The BVP is designed to deliver and sustain insulin-producing islets inside the body. The Acellular Tissue Engineered Vessel and BVP are investigational and not yet approved by the FDA or other regulatory bodies.
PluriBank™ iPSCs are derived from regulatory-compliant donors and have undergone extensive characterization, expansion, and banking to ensure purity, identity, and genetic integrity. This collaboration aligns with Pluristyx's goal of providing safer and more effective cell therapies.
- Humacyte gains access to Pluristyx’s PluriBank™ iPSC line, enhancing their ability to develop insulin-producing cells for the BioVascular Pancreas.
- Pluristyx's panCELLa™ platform allows for the generation of 'hypoimmune' cells, potentially improving clinical implantation outcomes.
- PluriBank™ iPSCs are highly characterized and regulatory-compliant, ensuring patient safety.
- The collaboration targets a significant medical need by aiming to revolutionize type 1 diabetes treatment.
- The BioVascular Pancreas and Acellular Tissue Engineered Vessel are still investigational and not yet approved by the FDA or any international regulatory agency.
Insights
The collaboration between Pluristyx and Humacyte represents a promising development in the field of cellular therapies for diabetes. By utilizing Pluristyx’s PluriBank™ induced Pluripotent Stem Cell (iPSC) line, Humacyte aims to manufacture insulin-producing cells for their BioVascular Pancreas (BVP™) product candidate. This strategic move could potentially address a significant medical need for type 1 diabetes patients, as the BVP is designed to allow the delivery and survival of insulin-producing cells within the body.
The unique aspect here is the use of Pluristyx’s panCELLa™ platform, which generates 'hypoimmune' cells, reducing the risk of immune rejection—a common challenge in cellular therapies. Furthermore, the FailSafe® and iACT™ genetic modifications promise improved safety and efficacy by ensuring the cells’ purity, identity and genetic integrity.
This collaboration is particularly noteworthy because it harnesses the strengths of both companies—Pluristyx's expertise in iPSC technology and Humacyte’s innovation in bioengineered human tissues. While the BVP product is still investigational and not yet approved by regulatory agencies like the FDA, the potential for transforming diabetes treatment is significant. Investors should monitor the progress of clinical trials and regulatory milestones closely as these will be key indicators of future success.
The license agreement between Pluristyx and Humacyte is a strategic alliance that could have substantial financial implications for both companies. For Pluristyx, this partnership expands the market application of their PluriBank™ iPSCs, potentially unlocking new revenue streams. Humacyte, on the other hand, stands to benefit from accelerated development timelines and reduced costs associated with sourcing high-quality starting materials for their BioVascular Pancreas (BVP) candidate.
From a financial perspective, investors should keep an eye on the collaboration’s milestones and any subsequent funding rounds or partnerships. Successful clinical trials and eventual regulatory approval can lead to significant valuation uplifts. Additionally, Humacyte’s ability to scale the commercial production of BVP will be important in determining long-term revenue potential.
It's also worth noting that the agreement involves custom clinical gene editing, hinting at a high level of commitment and collaboration between the two companies. This could lead to future joint ventures or expanded agreements, further strengthening their market positions.
“The combination of Humacyte’s Acellular Tissue Engineered Vessel (ATEV™) with insulin-producing cells derived from Pluristyx’s best-in-class iPSC lines brings us one step closer to curing insulin dependent diabetes,” said Dr Benjamin Fryer, Pluristyx’s CEO. “We are excited to assist therapeutic developers in using clinical-grade PluriBank™ iPSC starting materials to bring Tomorrow’s Cell Therapies, Today®.”
The License Agreement grants Humacyte access to Pluristyx’s PluriBank™ cell lines for application in their BioVascular Pancreas development program. Pluristyx is also performing custom clinical gene editing on the iPSC line to generate a universally applicable line for all patients. The BVP is designed to revolutionize type 1 diabetes treatment by enabling delivery and survival of insulin-producing islets inside the body. The Acellular Tissue Engineered Vessel and the BVP are investigational products and have not been approved for sale by the Food and Drug Administration or any international regulatory agency.
About Pluristyx
Pluristyx, through its panCELLa™ platform, offers a portfolio of unique iPSC-based technologies, proprietary genetic engineering, and related tools, products, and services to provide end-to-end support throughout our customer’s product lifecycle. Pluristyx is the pioneering provider of immune system-tolerated and safety switch-enabled gene-edited iPSC and cell therapy solutions, accelerating customers’ path to clinic, and providing the best, fastest, and widest route to commercialization for cell-based therapeutic products. For more information on Pluristyx, please visit www.pluristyx.com.
About Humacyte
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessels, is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm vessel for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm vessel for urgent arterial repair following extremity vascular trauma also has received RMAT designation. The Acellular Tissue Engineered Vessel also received priority designation for the treatment of vascular trauma by the
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Pluristyx Contact:
Peter Yu
Director, Sales and Marketing
Info@pluristyx.com
Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com
Source: Pluristyx
FAQ
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