AlloVir Inc ALVR provided an update on its three Phase 3 clinical trials with posoleucel, an investigational off-the-shelf multi-virus-specific T cell therapy, which targets six viral pathogens in immunocompromised individuals: adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV).
The company will discontinue its three global Phase 3 posoleucel studies – for prevention of clinically significant infections or diseases by multiple viruses, treatment of virus-associated hemorrhagic cystitis (vHC), and treatment of adenovirus (AdV) – following allogeneic hematopoietic cell transplant (allo-HCT).
The company determined following three pre-planned analyses by three independent Data Safety Monitoring Boards (DSMBs), each of which recommended stopping its respective trial for futility after a review of the data suggesting that each study was unlikely to meet its primary endpoint.
No safety concerns were observed or raised by any of the DSMBs.
AlloVir is in the process of notifying regulatory agencies and clinical trial investigators involved in these trials of the findings.
"While we are disappointed by the unexpected outcome of these trials, we are encouraged by the apparent safety profile of posoleucel," said Diana Brainard, CEO.
"In light of the DSMB recommendations, we will discontinue the prevention, vHC, and AdV Phase 3 trials. We will continue to analyze the data from these studies to understand any variables that may have impacted outcomes or any apparent subpopulation benefits."
AlloVir will review strategic alternatives for the company and its portfolio of virus-specific T-cell therapies. Such alternatives may include a merger, sale, divestiture of assets, licensing, or other strategic transaction.
As of September 30, 2023, AlloVir had cash, cash equivalents, and short-term investments of $213.3 million.
Price Action: ALVR shares are down 64.4% at $0.83 during the premarket session on the last check Friday.
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