On January 10, 2022 Vaxiion Therapeutics, the industry leader in bacterial-minicell based cancer immunotherapies, reported the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug application (IND) for VAX014 for investigational use in the intralesional treatment of solid tumors refractory to standard treatment options. VAX014 is a first-in-class recombinant bacterial minicell-based oncolytic immunotherapy (Press release, Vaxiion Therapeutics, JAN 10, 2022, View Source [SID1234598541]).
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Vaxiion will soon initiate a multi-center, open label Phase 1 dose escalation study to evaluate the safety, tolerability, and initial antitumor activity in both treated and untreated lesions following intralesional administration of VAX014. The upcoming Phase 1 study is not restricted by indication, allowing for assessment of safety and activity of VAX014 across multiple injectable solid tumor types.
"Expanding the clinical footprint of VAX014 to treat a more diverse range of solid tumor types is a logical next step and a major milestone in the development plan for VAX014," said Vaxiion CEO, Matt Giacalone. "But most importantly, we are now in a position where we can explore treating patients with intractable disease. Our strong preclinical data suggest VAX014 has certain immunologic advantages over existing viral-based oncolytic therapies which could translate to better treatment outcomes for eligible patients."
Intralesional administration of VAX014 in preclinical models utilizing immunologically "cold" and "immune excluded" solid tumors consistently demonstrates durable, immune-dependent clearance of treated tumors. These studies have also demonstrated systemic immune-dependent activity against untreated secondary tumors (abscopal effect) coinciding with development of antitumor immunologic memory.
VAX014 is the first clinical product candidate generated from Vaxiion’s proprietary recombinant bacterial-minicell delivery platform. An ongoing Phase 1 study of VAX014 for the intravesical treatment of non-muscle invasive bladder cancer has demonstrated VAX014 to be safe and well tolerated with early indications of antitumor activity.