Trestle Bio Announces Research Collaboration with Humacyte
Trestle Biotherapeutics, Inc., today announced a research collaboration with Humacyte, Inc. ((HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale. Trestle Bio is a preclinical stage company developing bioengineered kidney tissues for patients suffering from end stage renal disease (ESRD). The collaboration will explore technology synergies for bioengineering vascularized organs for transplantation.
The aim of the recently announced research collaboration and material transfer agreement is for the two companies to explore potential avenues of technology integration. The collaboration offers both groups the opportunity to expand their own R&D programs while exploring the interaction of Trestle Bio's biofabricated human kidney tissues with Humacyte's acelluar tissue engineered vessel-tyod (ATEV™), with a goal of generating a human bioengineered kidney with vascular perfusion.
Trestle Bio is pioneering the development of an implantable bioengineered kidney tissue for patients living with ERSD. Once implanted, Trestle Bio's stem cell-based, biofabricated human kidney tissues will be designed to provide sufficient levels of renal function to take ESRD patients off dialysis, delay their need for organ transplantation, and become the technological foundations from which transplantable bioengineered organs are biomanufactured to address the global organ shortage.
Humacyte recently received FDA approval for ATEV™ for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein grafting is not feasible.
Globally, there are more than 800 million patients who suffer from chronic kidney disease (CKD). In the US, there are 125,000 new diagnoses of kidney failure made each year and there are approximately 600,000 patients who depend on dialysis for survival. There are approximately 100,000 patients on the transplant waiting list, and while kidney transplantation remains the only definitive treatment option for ESRD patients, there is a significant and persistent organ shortage resulting in just 25,000 successful transplants, annually.
Of the announcement, Laura Niklason, M.D., Ph.D., Humacyte Founder and CEO, said, "Trestle is doing cutting edge work in a field that desperately needs innovation and risk-taking. We are excited to explore ways in which our teams can work together to catalyze the development of new solutions for addressing kidney failure."
Ben Shepherd Ph.D., Trestle Bio's co-founder and CEO, stated, "We have been following Humacyte closely for some time now and I think it's fair to say that they are really the gold standard for developing an FDA-approved regenerative medicine product. We've been highly focused on developing our kidney stem cell biology and biofabrication programs, and this is a natural progression for us. The broad application of Humacyte's ATEV technology to treat kidney disease patients is clear, and we're excited to collaborate with Humacyte to start bringing these engineering concepts to life."
About Trestle Biotherapeutics
Trestle Biotherapeutics, Inc. is a preclinical stage company developing bioengineered tissues for patients living with end stage renal disease. Once implanted, these bioengineered stem cell-derived tissues will take patients off dialysis, delay their need for transplantation, and one day become replacement organs. Learn more at trestlebio.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 product candidates, a portfolio of acellular tissue engineered vessels (ATEVs), are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application for the ATEV in the vascular trauma indication was approved by the FDA in December 2024. 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 ATEV 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 ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. For more information, visit www.Humacyte.com.
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Trestle Bio Contact:
Ben Shepherd
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