September 29, 2017
Investment to Fund Development of Humacyte’s Human Acellular Vessel (HAV) For a Broader Patient Population Using a Comparative Study of Arteriovenous Fistula
RESEARCH TRIANGLE PARK, N.C. – Humacyte, an innovator in biotechnology and regenerative medicine, has received a $14.1 million award from the California Institute for Regenerative Medicine (CIRM). Funding will support a new clinical trial comparing the Human Acellular Vessel (HAV, or HUMACYL®) to arteriovenous fistulas, the standard of care for creating vascular access in patients undergoing hemodialysis. Through this study, Humacyte will investigate HUMACYL as a conduit for hemodialysis in a broader population of patients with End-Stage Renal Disease (ESRD) who require renal replacement therapy. Humacyte’s ongoing Phase III study, HUMANITY®, compares the HAV to plastic (sPTFE) grafts in ESRD patients who are not candidates for fistulas.
Arteriovenous fistulas are the preferred surgical method for establishing vascular access in patients who require hemodialysis, due to a lower rate of infection and clot formation, and better outcomes compared to other current types of vascular access. Humacyte will assess the the efficacy and safety of the HAV compared to arteriovenous fistulas, when used as a conduit for hemodialysis. Unlike Humacyte’s pivotal HUMANITY trial, this new study population includes subjects with ESRD who require hemodialysis treatment and who are candidates for an arteriovenous fistula. In this new trial, evaluable subjects will be monitored for 24 months postimplantation.
“This significant and incremental investment from CIRM further validates the potential of our bioengineered human acellular vessel’s capabilities as a more durable and safe vascular access option for patients requiring dialysis treatment,” said Jeffrey H. Lawson, M.D., Ph.D., Chief Medical Officer of Humacyte. “Based on the early promising signals from our Phase II study results published in The Lancet last year, and the positive data that we expect from our ongoing Phase III trials comparing the HUMACYL to ePTFE grafts, we envision broader opportunities for HUMACYL beyond an alternative to synthetic grafts, starting with this newest study comparing our product to arteriovenous fistulas.”
Humacyte expects results from the current pivotal HUMANITY trial data in late-2018. Based on this data, Humacyte plans to submit a Biological License Application for the HAV to the U.S. Food and Drug Administration (FDA). Following FDA’s agreement in June on a Special Protocol Assessment for Humacyte’s new study comparing HAV to fistula, Humacyte plans to conduct this new study at 20 U.S. sites among 240 evaluable subjects. The company hopes that the data from this new study will show surgeons that the HAV is an efficacious and safe alternative for patients who are a candidate for a new or replacement fistula, as well as those for whom a fistula is not the best option. In March 2017, Humacyte was granted the Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA to expedite the development and review of HUMACYL as a vascular access option for patients in need of life-sustaining hemodialysis.
“CIRM recognizes the challenges faced by more than 465,000 patients in the U.S. undergoing hemodialysis procedures with few effective vascular access options available to them, and we deeply appreciate this significant support,” said Carrie S. Cox, Chairman and Chief Executive Officer of Humacyte. “This additional funding enables Humacyte to explore the use of our innovative technology to treat a broader range of patients suffering from ESRD that need hemodialysis as a life-saving treatment. With HUMACYL, we hope to realize our vision to provide better healthcare options for patients through a more durable, biological alternative, while lowering the costly and deadly risk of infection and higher rates of abandonment of current synthetic alternatives.”
In 2016, Humacyte announced that it received a grant of $9.9 million from CIRM for its ongoing Phase III HUMANITY study. CIRM’s mission, under the authority of Proposition 71, is to accelerate cell-based treatments to patients with unmet medical needs. CIRM has $3 billion in funding and approximately 300 active programs in its portfolio.
Humacyte is also investigating its HAV as a lower extremity arterial bypass vessel in patients with peripheral arterial disease (PAD). The company is also continuing its efforts to advance the development of future pipeline products that may improve treatment outcomes for patients requiring vascular repair or replacement.
Humacyte, Inc., a privately held company founded by Dr. Laura E. Niklason, M.D., Ph.D., in 2004, is a medical research, discovery and development company with clinical and pre-clinical stage investigational products. Humacyte is primarily focused on developing and commercializing a proprietary novel technology based on human tissue-based products for key applications in regenerative medicine and vascular surgery. The company uses its innovative, proprietary platform technology to engineer human, extracellular matrix-based tissues that can be shaped into tubes, sheets, or particulate conformations, with properties similar to native tissues. These are being developed for potential use in many specific applications, with the goal to significantly improve treatment outcomes for many patients, including those with vascular disease and those requiring hemodialysis. The company’s proprietary technologies are designed to create off-the-shelf products that, once approved, can be utilized in any patient. The company web site is www.humacyte.com. All statements, other than statements of historical fact, included in this announcement are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “will”, “anticipate”, “expect”, “believe”, “intend” and “should” or the negative of these terms or other comparable terminology. These statements relate to future events or Humacyte’s clinical development programs, reflect management’s current beliefs and expectations and involve known and unknown risks, uncertainties and other factors that may cause Humacyte’s actual results, performance or achievements to be materially different. Except as required by law, Humacyte assumes no obligation to update these forward-looking statements.
At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies. With $3 billion in funding and approximately 300 active stem cell programs in our portfolio, CIRM is the world’s largest institution dedicated to helping people by bringing the future of cellular medicine closer to reality. For more information go to www.cirm.ca.gov.