Cambridge, Mass.-based Elevatebio LLC has triple-pronged plans for its $170 million series B round, which the company said will be directed toward manufacturing cell and gene therapies, enabling new technology platforms, and pursuing therapeutics.
The firm’s business model centers on an effort called Basecamp that puts together single- and multiproduct enterprises in cell and gene therapies by providing founders with centralized, bench-to-bedside capabilities. Included the offerings are scientists, manufacturing know-how, and drug development as well as expertise in commercialization.
CEO David Hallal told BioWorld the company has “been extremely busy since we launched less than a year ago. We’ve been able to rapidly build out core functions of Basecamp. We have nearly completed the development and construction of the centralized, 140,000-square-foot cell and gene therapy innovation hub in Waltham, Mass. The office space and process and research development labs are operational with a cGMP manufacturing expected to come online in 2021.”
Areas of focus for Elevatebio include immunotherapy, regenerative medicine and viral-based in vivo gene therapy. The company followed up a hefty series A round of $150 million with news of its first effort: a Houston-based startup making allogeneic cell therapies to battle viral pathogens. The Baylor College of Medicine spinout, called Allovir, said it would use its $120 million series B financing to initiate multiple pivotal studies for its lead product, Viralym-M, while also advancing a second candidate to the clinic. Fidelity Management and Research Co. led the financing of Allovir, joined by new-to-Elevatebio investors Gilead Sciences Inc., of Foster City, Calif., and Invus. They invested alongside initial backers F2 Ventures, Redmile Group, Ecor1 Capital and Samsara Biocapital. Leerink Partners Co-investment Fund LLC also chipped in.
The EMA has granted orphan drug designation to Viralym-M, also known as ALVR-105, as a potential treatment of viral diseases and infections in patients undergoing hematopoietic stem cell transplant (HSCT). Viralym-M is described as an allogeneic, off-the-shelf, multivirus-specific T-cell therapy, being developed for the treatment and prevention of viral diseases caused by six commonly occurring bugs in immunocompromised people: BK virus, cytomegalovirus, human herpes virus-6, Epstein Barr virus, adenovirus and JC virus. Viralym-M also has gained priority medicines, or PRIME, designation from the EMA and regenerative medicine advanced therapy status from the FDA – one of only seven therapies to win both. Allovir plans to kick off phase III pivotal and phase II proof-of-concept studies with Viralym-M in 2020.
Earlier this month, Allovir made known the expansion of its research and development collaboration with Baylor to include the discovery and development of allogeneic, off-the-shelf, virus specific T-cell therapies to combat SARS-CoV-2, the virus that causes COVID-19. With Allovir’s technology, the virus-specific T-cell therapy may also address other coronavirus (CoV) strains including SARS-CoV, MERS-CoV, and also the endemic CoVs that commonly afflict immunocompromised patients. Allovir aims to develop a therapy for CoVs that can be used as a stand-alone treatment or incorporated into the company’s multi-respiratory virus investigational therapy, ALVR-106, designed to address other life-threatening community-acquired respiratory viruses.
Also established and launched was Highpassbio, a company dedicated to advancing novel targeted T-cell immunotherapies. The lead product is an engineered T-cell receptor therapy for HA 1-expressing tumors, intended to treat and potentially prevent the relapse of leukemia following hematopoietic stem cell transplant. The approach and ensuing product emerged from Fred Hutchinson Cancer Research Center.
In place, too, is a 10-year alliance between Massachusetts General Hospital (MGH) and Elevatebio. The pact provides the hospital with preferred access to Basecamp research, process development and the manufacturing facility in Waltham, Mass., for development and production of cell and gene therapies developed at MGH. In return, the hospital made an investment in Basecamp, the facilities and staff of which will support a spectrum of programs. As part of the arrangement, the parties will jointly identify cell and gene technologies from university labs and other external sources.
“We’ve begun to pull several other portfolio companies across a wide variety of technologies, including AAV-based technologies, CAR Ts, and more T-cell receptor T-cell therapies,” Hallal said. Details are due later this year. The series B financing includes new Elevatebio investors The Invus Group, Surveyor Capital, EDBI and Vertex Ventures, who joined existing supporters in the round.
HSCT and COVID-19 came together in a call hosted with key opinion leaders (KOLs) by SVB Leerink analyst Mani Foroohar and colleagues. The intent was to gauge the “evolving clinical impact” of the pandemic virus. “In the near term, both KOLs believe patients will be treated with non-transplant standard of care where possible with transplantation or experimental therapies reserved for life-threatening cases (malignancies, neurocognitive disorders) due to capacity constraint.” Surprisingly enough, both were “optimistic that supply chains and clinical trial enrollment would ‘snap back’ for ex vivo treatment, early in the flattening of the COVID-19 diagnosis curve in the U.S.,” Foroohar wrote in a report.
Specifically, the KOLs suggested that, for ex vivo clinical trials – those by such firms as Avro Bio Inc., Bluebird Bio Inc. and Rocket Pharmaceuticals Inc. – especially those for which sites have already collected a substantial supply of banked cells, as in the case of Bluebird, “are likely to be transplanted first” when COVID-19 infection becomes less severe. “For CAR T and other treatments that are more urgent, if cells have already been collected and frozen, patients will be treated ahead” of the flattened curve in virus diagnosis, in their view.