Humacyte Combines with Alpha Healthcare in Latest Biopharma SPAC
Laura Niklason, founder, president and CEO of Humacyte (Humacyte)
Durham, NC-based Humacyte successfully completed its business combination with Alpha Healthcare Acquisition Corp., a special purpose acquisition company (SPAC) sponsored by Constellation Alpha Holdings.
SPACs have been on the increase. BioSpace reported that in 2020, there was a 250% increase in SPAC mergers. SPACs allow companies to list on a stock exchange faster than a traditional initial public offering (IPO). Other recent SPACs include Prenetics and Artisan Acquisition, and Gemini Therapeutics, and Nautilus Biotechnology.
The combined company out of the Humacyte SPAC will be called Humacyte and is expected to trade shares of common stock and warrants on the Nasdaq Global Select Market under the ticker symbols HUMA and HUMAW, respectively.
From the Business Companion, Humacyte had received gross proceeds of about $245 million, including a $175 million PIPE (Private Investment in Public Equity) financing and $70 million of cash held in the former AHAC trust account. PIPE investors included Fresenius Medical Care, OrbiMed, Monashee Investment Management, Alexandria Venture Investments, UBS O’Connor, Morgan Creek Capital, and several other healthcare-focused funds.
“Humacyte is poised to make commercial-scale bioengineered tissues a reality for patients. We enter the next phase of our transformation of regenerative medicine as a robust public company, evaluating our first-in-class bioengineered HAVs in numerous indications,"said Laura Niklason, founder, president and chief executive officer of Humacyte.
"We set out with the lofty goal of changing the practice of medicine, and we are closer than ever today thanks to the unwavering commitment of our employees, our partners and our investors. I am confident that we have the right team, including the appointment of Kathleen Sebelius as chair of our board, to deliver on the promise of our breakthrough science.”
The company focuses on developing Human Acellular Vessels (HAVs). They are engineered off-the-shelf replacement vessels and are made by seeding vascular cells from a qualified cell bank onto a polymer mesh in a bioreactor bag. The cells grow and develop new tissue, growing into a tube-shaped vessel structure.
This bioengineered vessel is decellularized to create the HAV, an extracellular matrix that keeps the biomechanical properties of the vessel, but any cellular components that could make an immune response are removed. The HAV can then be shipped, store, and immediately available when needed.
On August 11, Humacyte published laboratory and preclinical data demonstrating their technology to engineer a biovascular pancreas as a way to transplant pancreatic islet cells for the long-term treatment of type 1 diabetes. The publication demonstrated that pancreatic islet cells embedded in the outer matrix of an acellular vessel could result in a working biovascular pancreas (BVP). And their lab data showed that the resulting BVP after it was implanted as an arterial graft allowed for enough islet cells to survive that it overcame the limitation of insufficient oxygen transfer that historically has limited islet transplantation.
In their preclinical study in nude rats, the BVP restored animals to near-normal glycemia durably for 90 days after transplantation. Similar research in a pig model indicated the BVP was scalable to near-human-sized recipients.
The company’s technology is being evaluated in two Phase III trials in AV access and in a Phase II/III trial for vascular trauma. It is the first product the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation. It also received the FDA Fast Track designation.
Niklason and the company’s current executive team will continue to run the company. Kathleen Sibelius, former Secretary of the Department of Health and Human Services and chief executive officer of Sebelius Resources, was appointed Chair of the Board of Directors.
Sibelius said, “Humacyte is a pioneer both in the field of regenerative medicine and as a woman-founded biotech company, where an innovative culture and world-class science have come together to make a meaningful difference for patients and the practice of medicine. With a validated HAV platform technology and vast potential application, compelling data, a well-defined regulatory pathway, and scalable, proprietary commercial-scale manufacturing capability, Humacyte has all the ingredients to revolutionize patient care.”