SAN DIEGO–(BUSINESS WIRE)–Vaxiion Therapeutics, the industry leader in bacterial minicell-based
targeted therapeutics, today announced 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). 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
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
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 https://clinicaltrials.gov/ct2/show/NCT03854721.
VAX014 is the first clinical product candidate generated from Vaxiion’s
proprietary recombinant bacterial-minicell delivery platform.
Vaxiion Therapeutics is a clinical stage San Diego-based biotechnology
company. Leveraging its closely related pair of proprietary
first-in-class bacterial minicell-based delivery platforms, Vaxiion is
developing and advancing novel, next generation oncology products. For
more information about Vaxiion Therapeutics, please visit www.vaxiion.com.
Matt Giacalone, Ph.D., MBA
(858) 792-0799 xt.200