PsiOxus Therapeutics’ Clinical Trial Application for NG-348, an “armed” oncolytic virus for the treatment of solid tumors, has been approved, triggering a $15 million milestone payment from development partner, Bristol-Myers Squibb.

“This is an exciting development since NG-348 is the first candidate from PsiOxus’ systemically delivered, intravenous platform of tumor gene therapy to achieve regulatory approval for use in human clinical trials,” said John Beadle, M.D., chief executive officer, PsiOxus. “PsiOxus is pleased to have successfully completed preclinical and manufacturing activities in support of this CTA and now looks forward to clinical investigation of this first armed oncolytic virus by Bristol-Myers Squibb.”

Under the December 2016 agreement, BMS paid PsiOxus $50 million upfront, and PsiOxus is eligible to receive development, regulatory and sales-based milestones of $936 million, as well as royalties on sales. Following the completion of preclinical development by PsiOxus, BMS is solely responsible for global clinical development and commercialization activities related to NG-348.

PsiOxus’ oncolytic virus therapy uses modified adenovirus that selectively replicate within tumor cells and not within normal tissue. Such viruses stimulate an inflammatory response in the tumor, which results in the accumulation of tumor infiltrating lymphocytes. NG-348 uses PsiOxus’ Tumor-Specific Immuno-Gene Therapy (T-SIGn) platform to “arm” the virus with two additional immuno-therapeutic transgenes.