AlloVir is working to develop an allogeneic cell therapy to control infections in immunocompromised patients, typically after they undergo organ transplants.
Houston-based AlloVir just closed on a Series B financing worth $120 million. The Series B was led by Fidelity Management and Research Company and joined by Gilead Sciences, F2 Ventures, Redmile Group, Invus, EcoR1 Capital, Samsara BioCapital, and Leerink Partners Co-Investment Fund.
AlloVir is now an ElevateBio portfolio company. This partnership provides AlloVir with fully integrated bench-to-bedside capabilities to accelerate the development and commercialization of our allogeneic, off-the-shelf, multi-virus specific T-cell immunotherapies,” stated Ann Lean, AlloVir co-founder, chief scientific officer and professor of pediatrics at Baylor College of Medicine.
ElevateBio’s business model is creating and operating cell and gene therapy companies via partnerships. That business model includes BaseCamp, a centralized R&D and manufacturing organization.
According to Crunchbase, AlloVir had previously raised $39 million, $9 million in August 2017 as a grant from the Cancer Prevention and Research Institute of Texas and a $30 million venture round in September 2018.
AlloVir is working to develop an allogeneic cell therapy to control infections in immunocompromised patients, typically after they undergo organ transplants. Lean told Xconomy that AlloVir collects blood from third-party donors whose T-cells have been exposed to viruses. The company then grows those cells in its laboratory to develop its antiviral therapy.
“We grow an immune system outside the body to administer to these patients to control these infections,” Lean told Xconomy.
The company does not perform genetic engineering on the T-cells. Instead, they search for donors whose immune systems have been exposed to the appropriate viruses and utilizes a screening process like that used to identify bone marrow donors. Once the T-cells are grown in the lab, they are screened again for safety issues.
The lead product, Viralym-M, was tested in a Phase II trial of 38 patients. The results were reported on August 22, 2017. The product is described as an “off-the-shelf, third-party T-cell product that can simultaneously treat up to five viral infections in patients with severely depressed immune systems.”
In the trial, Viralym-M demonstrated a 92% overall clinical response after a single infusion. It also showed efficacy against all five targeted viruses with the following cumulative response rates: 100% for BK virus; 94% for cytomegalovirus; 71% for adenovirus; 100% for Epstein-Barr virus; and 67% for human herpesvirus-6.
Thirty-one of the patients were tested for only one virus and seven were treated for multiple simultaneous infections.
The company is planning a Phase III clinical trial of Viralym-M in 2020 in bone marrow transplant patients with hemorrhagic cystitis, inflammation and bleeding in the bladder caused by chemotherapy, radiation, infection, and exposure to dyes and insecticides.
“Over many years, AlloVir’s world-leading scientists have developed a highly innovative pipeline of allogeneic, off-the-shelf, T-cell therapies being studied to treat and prevent many devastating and life-threatening virus-associated diseases,” stated David Hallal, AlloVir’s chief executive officer and co-founder of ElevateBio. “Following successful meetings with the FDA, we are delighted to be working with the medical community to plan and initiate pivotal Phase III studies for Viralym-M and advance ALVR106 into the clinic over the next 12 months.”
Its second allogenic, off-the-shelf multi-virus specific T-cell therapy is ALVR106, which targets four community-acquired respiratory viruses: respiratory syncytial virus, influenza, parainfluenza virus, and human metapneumovirus.
AlloVir will join a new facility ElevateBio is constructing in Cambridge, Mass., and be co-located in Houston and Cambridge.
ViraCyteis in the process of changing its name to AlloVir to avoid trademark issues with biotech companies ViaCyte and VeraCyte.
