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Posoleucel
Posoleucel (Viralym-M, ALVR105): A multi-virus specific T cell therapy (VST) targeting six devastating viruses
Posoleucel targets six devastating viral pathogens: adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus 6 (HHV-6), and JC virus (JCV), and has the potential to transform care for transplant recipients.
Life-threatening viral infections and diseases post transplantation
The immune systems of individuals undergoing potentially life-saving transplantations – the two most common types of which are allogeneic hematopoietic cell transplant (HCT) and solid organ transplant (SOT) – are suppressed or eliminated to prevent rejection of the transplanted cells or organs, leaving the patient highly prone to devastating viral infections or diseases, which can cause end-organ damage and mortality.
Allogeneic HCT conditioning regimens often require the complete elimination of a patient’s own stem cells, leaving patients without a functioning immune system and in a severely immunocompromised state post HCT. For 90% of allogeneic HCT patients, their suppressed immune system allows viruses that were previously in a latent state to reactivate, with more than 60% of HCT patients experiencing reactivation of more than one potentially fatal virus.
Currently, there are limited therapies for most viral infections in the post-transplant setting. The standard of care treatments have limited efficacy and are associated with significant toxicity.
Restoring Immunity with Posoleucel (Viralym-M, ALVR105)
Posoleucel is designed to restore T cell immunity in patients during the time of severe immune compromise between conditioning and reconstitution of patients’ immune systems. By providing this immunologic bridge, posoleucel may substantially reduce or prevent virus-associated morbidity and mortality and dramatically improve patient outcomes, potentially transforming the management of transplant patients.
Posoleucel has the potential to fundamentally transform care for transplant patients, as well as individuals who are at high risk for opportunistic viral infections by reducing or preventing disease morbidity and dramatically improving patient outcomes.
Posoleucel is Designed to Treat and Prevent Viral Diseases Until the Patient’s Own Immune System Recovers
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(a) Post 100 day data for proportion of patients with viral detection is from Huang, et al., as Hill et al. only measured out to 100 days. 1. Kedia et al., J Stem Cell Res Ther 2013. 2. Ison, Hirsch. Clin Microbiol Rev. 2019. 3. Hill et al, Blood 2017. 4. Huang et al, Biol Blood Marrow Trans 2017. 5. Stern L et al. Front Immunol. 2018;9:1-18. 6. Hill CID 2018.
Clinical Studies and Development Program
Posoleucel was evaluated in a Phase 2 open-label, proof-of-concept study, in which 58 allogeneic HCT patients with treatment-refractory infections were treated with posoleucel. In this study, 95% of patients who received posoleucel demonstrated a predefined clinical response. Treatment with posoleucel was generally well-tolerated. In a Phase 2 multi-virus prevention trial, posoleucel demonstrated a substantial reduction in the expected rate of clinically significant viral infections or diseases, with 88% of patients remaining free of clinically significant infections caused by any of the six viruses that posoleucel targets through the Week 14 primary endpoint.
Posoleucel has been granted PRIority MEdicines (PRIME) and Orphan Medicinal Product designations from the EMA, and Orphan Drug Designation and three Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA).
To explore the clinical benefits of posoleucel, AlloVir is conducting three Phase 3 registrational studies in immunocompromised HCT patients for the treatment and prevention of life-threatening viral diseases in children and/or adults. We also are exploring posoleucel in SOT patients and completed a Phase 2 proof-of-concept trial in kidney transplant recipients.
Learn more about posoleucel clinical trials here.