PsiOxus Therapeutics, announced the clinical trial application (CTA) for NG-348, an ‘armed’ oncolytic virus for the treatment of solid tumours, has been approved and per the licensing agreement between the parties, Bristol-Myers Squibb will make a US $15 million milestone payment to PsiOxus
Under the terms of the December 2016 agreement, Bristol-Myers Squibb granted PsiOxus an upfront payment of $50 million. In aggregate, PsiOxus is eligible to receive development, regulatory and sales-based milestones of $936 million, as well as royalties on net sales.
“This is an exciting development since NG-348 is the first candidate from PsiOxus’ systemically delivered, intravenous platform of tumour gene therapy to achieve regulatory approval for use in human clinical trials,” said Dr John Beadle, CEO at 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.”
Following the completion of pre-clinical development by PsiOxus, Bristol-Myers Squibb is solely responsible for global clinical development and commercialisation activities related to NG-348.
In June 2016, Bristol-Myers Squibb and PsiOxus entered into an exclusive clinical collaboration to study enadenotucirev, PsiOxus’ systemically administered ‘unarmed’ oncolytic adenovirus therapeutic, in a multi-cohort clinical trial.
PsiOxus’ oncolytic virus therapy uses modified adenovirus that selectively replicate within tumour cells and not within normal tissue.
Such viruses stimulate an inflammatory response in the tumour microenvironment, which results in the accumulation of tumour infiltrating lymphocytes.
NG-348 uses PsiOxus’ proprietary Tumour-Specific Immuno-Gene Therapy (T-SIGn) platform to ‘arm’ the virus with two additional immuno-therapeutic transgenes.
NG-348 is designed to drive T-cell immune responses locally within the tumour microenvironment. It is a transgene-modified variant of PsiOxus’ enadenotucirev virus that encodes two immunomodulatory membrane-integrated T-cell-engaging proteins that expressed together on the surface of infected tumor cells, activate tumour-infiltrating T-cells in an antigen independent manner.