ViraCyte, LLC, a clinical stage biopharmaceutical company developing cellular immunotherapies for severe infections, announced publication of positive data from a Phase 2 clinical trial evaluating its most advanced T-cell immunotherapy product, Viralym-M. The results were reported by ViraCyte lead investigators at Baylor College of Medicine in the Journal of Clinical Oncology.
Viralym-M is an “off-the-shelf”, 3rd party T-cell product that can simultaneously treat up to five viral infections in patents with severely depressed immune systems. In this report, Dr. Ifigeneia Tzannou and colleagues describe administration of Viralym-M in 38 stem cell transplant patients with 45 different viral infections. All patients had either failed, not responded to, or were unable to tolerate standard antiviral therapy.
Viralym-M achieved a 92% overall clinical response after a single infusion and demonstrated efficacy against all five targeted viruses with the following cumulative response rates in infections refractory to standard therapy: 100% for BK virus (n=16), 94% for cytomegalovirus (n=17), 71% for adenovirus (n=7), 100% for Epstein-Barr virus (n=2) and 67% for human herpesvirus-6 (n=3). Thirty-one patients were treated for a single viral infection and seven patients were treated for multiple simultaneous infections. Notably, rapid disease alleviation was reported in patients with BK-associated hemorrhagic cystitis (BK-HC), which can cause incapacitating pain, significant blood loss, and potentially renal failure. There are no current FDA-approved therapies for BK-HC. Viralym-M infusions were safe with only two cases of new onset grade 1 graft-versus-host disease observed, both of which resolved with standard treatment.
Dr. Ann Leen, Chief Scientist at ViraCyte remarked, “The compelling results from this study demonstrate the high safety profile and broad-spectrum efficacy of Viralym-M in these patients and will strongly position our discussions with the FDA as we progress towards a pivotal clinical trial for potential licensure of Viralym-M.”