11 January 2022 - - The US Food and Drug Administration has cleared US-based bacterial-minicell based cancer immunotherapies provider Vaxiion Therapeutics' Investigational New Drug application for VAX014 for investigational use in the intralesional treatment of solid tumors refractory to standard treatment options, the company said.

VAX014 is a first-in-class recombinant bacterial minicell-based oncolytic immunotherapy.

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.

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.

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.