The US FDA has cleared AlloVir’s (NASDAQ:ALVR) Investigational New Drug (IND) application for ALVR106. ALVR106 is the company’s off-the-shelf, allogeneic virus specific T-cell therapy (VST) that targets diseases or infections caused by influenza, respiratory syncytial virus, human metapneumovirus (hMPV), and parainfluenza virus (PIV).
ALVR106 receives IND clearance in respiratory viruses
Following the grant of the IND, the company will now initiate the Phase 1/2 proof-of-concept clinical trial in autologous and allogeneic hematopoietic stem cell transplant patients having infections resulting from PIV, influenza, hMPV, or RSV. The company’s Chief Regulatory and Safety Officer, Ercem Atillasoy said that respiratory viruses are among the common morbidity and mortality causes in hematopoietic stem cell transplant patients. Ercem said that based on the company’s evidence from preclinical trials, ALVR106 has the potential of transforming the prevention and treatment of respiratory infections. As a result, ALVR106 could significantly minimize mortality and morbidity related to the infections. Further Ercem added that the IND clearance for ALVR106 will help the company advance its third program into clinical studies to explore the power of AlloVir’s proprietary VST platform.
It is important to note that respiratory tract infections caused by influenza, hMPV, RSV, and PIV are a public health concern and are found in around 40% of allogeneic HSCT patients. The viral infections usually progress to serious lower respiratory tract infections from upper respiratory tract infections and often are associated with 20-45% of mortality in HSCT patients.
AlloVir to commence Phase 1/2 proof-of-concept trial in 2021
The company had previously indicated that they will initiate the proof of concept study in 2021. AlloVir is assessing the COVID-19 pandemic’s impact on diagnosis, incidence as well as treatment of respiratory viral infections that ALCR106 targets. According to in vitro data, ALVR106 demonstrated antiviral activity against all the targeted viruses with no or limited activity against the non-virus infected cells. The pre-clinical results support ALVR106’s potential for antiviral benefits and its safety to patients. Besides ALVR106, AlloVir is also advancing several mid-and late-stage programs across its portfolio using its proprietary and innovative tech platforms.