Vaxiion Therapeutics, a clinical stage biotech company based in California, has initiated a phase 1 clinical trial of its recombinant bacterial minicell-based oncolytic immunotherapy VAX014 for the treatment of non-muscle invasive bladder cancer (NMIBC).
The development comes following the conclusion of a 30-day review of the investigational new drug application (IND) of VAX014 by the US Food and Drug Administration (FDA).
According to Vaxiion Therapeutics, VAX014 is designed to selectively target a pair of cell-surface integrin heterodimers associated with non-muscle invasive bladder cancer.
The phase 1 trial of the oncolytic immunotherapy will assess its safety, tolerability and initial anti-tumor activity in non-muscle invasive bladder cancer patients. The early-stage trial will be a multi-center open label dose escalation study with dose expansion.
Matthew Giacalone – Vaxiion President said: “Advancing our first product candidate into clinical trials is a major milestone, signifying Vaxiion’s transition to a clinical stage company. We are now one step closer to achieving our ultimate goal of filling the unmet needs existing in the gaps of the current non-muscle invasive bladder cancer treatment algorithm.”
VAX014 had shown repeatedly demonstrated durable anti-tumor immunotherapeutic activity in preclinical models of non-muscle invasive bladder cancer and other types of cancer, resulting in overall tumor regressions and development of long-term anti-tumor immunologic memory.
The oncolytic immunotherapy was shown to be well tolerated after repeat dose administration in the clinically relevant dose range during its nonclinical safety studies.
The first-in-human phase 1 clinical trial of VAX014 includes two segments – a dose escalation segment and a dose expansion segment.
VAX014 is the first clinical product candidate developed from the recombinant bacterial-minicell delivery platform of Vaxiion Therapeutics.