Little more than a week after corralling $150 million to create and build a portfolio of cell and gene therapy companies, Elevatebio Inc. is revealing its first play, backing a Houston-based startup making allogeneic cell therapies to battle viral pathogens. The Baylor College of Medicine spinout, Allovir, will use a new $120 million series B financing to initiate multiple pivotal studies for its lead product, Viralym-M, in the next 12 months, 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. and Invus. They invested alongside initial backers of the platform, F2 Ventures, Redmile Group, Ecor1 Capital and Samsara Biocapital. Leerink Partners Co-investment Fund LLC also invested.

David Hallal, Elevatebio's CEO, told BioWorld that the new Cambridge, Mass.-based portfolio player is not just operating Allovir (with him as CEO) but is also a "major owner" of the Houston-headquartered startup's shares. "We're probably on a path to an IPO," he said. (See BioWorld, May 14, 2019.)

Born as Viracyte LLC, a name retired for its new and more unique moniker, Allovir's lead candidate is Viralym-M (ALVR-105), an allogeneic, off-the-shelf T-cell therapy targeting six common viral pathogens in immunocompromised individuals: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpes virus 6 and John Cunningham, or JC virus. "At least 90 percent of stem cell transplant recipients who are immunocompromised after their transplants will be infected with at least one of these pathogens. But more than 60 percent have problems with two or more," Ann Leen, Allovir's co-founder and chief scientific officer, told BioWorld.

During its Viracyte days, the company had already run a positive phase II proof-of-concept study showing greater than 90% of patients who failed conventional treatment and received Viralym-M met a predefined criteria for complete or partial clinical response. Furthermore, most met the criteria with complete elimination of detectable virus in the blood and resolution of major clinical symptoms, according to the study, the results of which were published in the Journal of Clinical Oncology in 2017.

Allovir is also developing a second allogeneic, off-the-shelf T-cell therapy, ALVR-106. It targets four common community-acquired respiratory viruses: respiratory syncytial virus, influenza, parainfluenza virus and human metapneumovirus. Expectations are that it could move into a basket proof-of-concept study in the next 12 months, Hallal said.

Both products are sourced from a group of donors representing a partial human leukocyte antigen (HLA) match to therapy recipients.

"It's a pipeline in each product," Hallal said. "In each cell therapy, you could treat multiple viral-associated diseases impacting any type of patient that is immunocompromised — whether it's a bone marrow transplant patient, a solid organ transplant patient... we've thought about primary immune deficiencies and the high value we can provide to newborns, too," and more, he said.

Allovir has exclusive, worldwide, sublicensable rights to the intellectual property surrounding its therapies from Baylor. Baylor, in turn is due ongoing maintenance fees, additional clinical and regulatory milestone payments, and royalties on net sales of successfully marketed products incorporating the licensed IP.

In joining Elevatebio, Leen said she saw a way for Allovir to take the next step. "We realized internally we had taken the product as far as we could go," she said. "We needed to bring on expertise and really round out the approach we were taking to be able to facilitate reaching our ultimate goal, to commercialize," she said.

Leen, who is also a professor of pediatrics at Baylor, has also appreciated the agility and collaborative nature of Elevatebio's team. Hallal accompanied her on a roadshow to raise the series B round. Now, together with a new board member from F2 Ventures and a board observer from Gilead joining its journey, Allovir's team will work to advance its inventions through multiple registration and proof-of concept studies.

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