On April 18, 2019 Vaxiion Therapeutics, the industry leader in bacterial minicell-based targeted therapeutics, reported that the U.S. Food and Drug Administration (FDA) has concluded its 30-day review of the Investigational New Drug application (IND) for VAX014, and the company will now initiate a Phase 1 clinical trial for the treatment of non-muscle invasive bladder cancer (NMIBC) (Press release, Vaxiion Therapeutics, APR 18, 2019, View Source [SID1234535209]). VAX014 is a first-in-class recombinant bacterial minicell-based oncolytic immunotherapy that is engineered to selectively target a pair of NMIBC-associated cell-surface integrin heterodimers.

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The study is a multi-center open label dose escalation with dose expansion Phase 1 trial evaluating the safety, tolerability, and initial anti-tumor activity in patients with NMIBC.

"Advancing our first product candidate into clinical trials is a major milestone, signifying Vaxiion’s transition to a clinical stage company," said Vaxiion President, Matthew Giacalone. "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."

In preclinical models of NMIBC and other cancer types, VAX014 has repeatedly demonstrated durable anti-tumor immunotherapeutic activity resulting in complete tumor regressions and the development of long-term anti-tumor immunologic memory. In nonclinical safety studies, VAX014 was well tolerated following repeat dose administration in the clinically relevant dose range.

This first-in-human Phase 1 study will consist of two segments: a dose escalation segment and a dose expansion segment. Additional information about the trial can be found at View Source

VAX014 is the first clinical product candidate generated from Vaxiion’s proprietary recombinant bacterial-minicell delivery platform.