Advanced clinical-stage immunotherapy company AlloVir Inc. (ALVR:NASDAQ), which is focused on developing off-the-shelf allogeneic T-cell therapies to treat and prevent viral diseases, today announced that "the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead investigational multi-virus-specific T cell therapy, posoleucel, for the prevention of clinically significant infections and disease from six devastating viruses that commonly impact high-risk adult and pediatric patients following allogeneic hematopoietic cell transplant (allo-HCT) – adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpes virus-6 (HHV-6) and JC virus (JCV)."
The firm noted that today's announcement marks the third time that the FDA has issued RMAT designation for posoleucel, an achievement which it said is an unprecedented regulatory distinction amongst cell and gene therapies. The company advised that the latest approved indication was based upon the potential for posoleucel to address significant unmet medical needs facing immunocompromised allo-HCT patients.
The company mentioned that previously the FDA awarded RMAT designation for posoleucel for use in treating both hemorrhagic cystitis (HC) caused by BKV in adults and children and adenovirus infection following allo-HCT.
The firm noted that the European Medicines Agency (EMA) has also granted posoleucel PRIority Medicines (PRIME) designation for the treatment of serious infections with AdV, BKV, CMV, EBV and HHV-6.
Allovir's Chief Regulatory and Safety Officer Ercem Atillasoy, M.D. commented, "The receipt of three RMAT designations for a single therapy is unprecedented. Posoleucel's three RMAT designations reflect the strength of AlloVir's multi-virus platform and its potential both to deliver an important treatment option for immunocompromised patients who currently have none, and to transform the management of allo-HCT patients with a multi-virus prevention approach."
The company claimed that "posoleucel has the potential to fundamentally transform the landscape for allo-HCT by preventing life-threatening viral diseases and infections, either as a prophylactic therapy in high-risk patients or as a preemptive therapy in patients who have already reactivated one or more of the six viruses targeted by posoleucel." The firm pointed out that there are about 40,000 allo-HCT patients yearly who would benefit from posoleucel T cell therapy since approximately 90% of allo-HCT patients reactivate at least one of the six potentially deadly viruses.
AlloVir stated that the most recent RMAT designation was based on initial data collected in a Phase 2 study of posoleucel as a preventative measure against life-threatening infections from six common viruses following allo-HCT. Of the 26 patients enrolled in the trial who were given posoleucel, only 3 were found to have clinically significant infections through week 14 in the study and 21 of the 24 patients who reached the week 14 primary endpoint were shown to have remained free of clinically significant infections.
The company explained that its leading product called posoleucel is currently in the later stages of development as "an off-the-shelf, multi-virus specific T cell therapy targeting six viral pathogens in immunocompromised individuals: adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpes virus-6 (HHV-6) and JC virus (JCV)."
The firm advised that posoleucel is currently being evaluated in three separate pivotal Phase 3 clinical studies for three specific indications including treatment of AdV infection, treatment of virus-associated HC and prevention of infections and disease caused by posoleucel's six target viruses.
AlloVir is a clinical-stage cell therapy company based in Waltham, Mass. that is focused on finding and developing allogeneic T-cell therapies to treat and prevent life-threatening viral diseases in children and adults with weakened immune systems. The firm's off-the-shelf, virus-specific T Cell (VST) therapy candidates are currently being developed and tested to targeting 12 distinct devastating viruses. The firm is conducting multiple mid- and late-stage clinical trials across its product portfolio including a global Phase 3 multi-virus prevention trial that commenced in March 2022 and is now enrolling patients.
Allovir started the day with a market cap of around $353.6 million with approximately 65.4 million shares outstanding and a short interest of about 6.0%. ALVR shares opened 27.5% higher today at $6.90 (+$1.49, +27.54%) over yesterday's $5.41 closing price. The stock has traded today between $6.32 and $8.51 per share and is currently trading at $6.40 (+$0.99, +18.30%).
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