EpicentRx announced that the U.S. FDA has cleared the investigational new drug (IND) application for AIM-001, an oncolytic adenovirus that is enhanced with a TGF-β (beta) trap transgene. EpicentRx plans to begin clinical trials with AIM-001 this year.
Cancer cells overexpress TGF-β, an immunosuppressive protein, to circumvent or thwart immune surveillance and cancer immunotherapy. The effect of AIM-001 is potentially three-fold: 1) it lyses and kills tumor cells, thus releasing signals to activate T-cell responses, 2) it overexpresses TGF-β trap transgene, neutralizing TGF-β and reprograming the tumor microenvironment from immunosuppressive to immunostimulatory, and 3) since TGF-β is a master regulator of fibrosis, the TGF-β trap may reduce the fibrotic stroma and enable better penetration of anticancer therapies.
EpicentRx anticipates that AIM-001 will not only demonstrate single agent activity, but also ‘turn up the heat on cold tumors’ and, in combination with both chemotherapy and immune checkpoint therapies, yield synergistic anti-tumor responses.