Drug intelligence / Profile preview

VAX014

Development stage
Phase 1
Lead developer
Vaxiion Therapeutics
Modality
Recombinant Proteins and Enzymes, Oncolytic Viruses → Oncolytic Therapeutics, Nanoparticles → Drug Delivery Systems
Administration
Intravesical, Intratumoral
01

Overview

VAX014 is a first-in-class, clinical-stage oncolytic immunotherapy based on recombinant bacterial minicells (rBMCs). It is designed to selectively target and bind to tumor cells expressing un-ligated α3β1 and/or α5β1 integrins, which are commonly overexpressed in many solid tumors. Upon binding, VAX014 delivers a pre-formed oncolytic protein toxin payload—perfringolysin O (PFO)—which destabilizes tumor cell membranes leading to rapid cell lysis. In addition to direct oncolysis, the therapy incorporates bacterial di-cyclic nucleotides (di-cGMP) and short hairpin tRNAs that act as agonists for the STING and RIG-I pathways, respectively. This dual mechanism not only induces tumor cell death but also stimulates innate immune responses and promotes adaptive antitumor immunity. Preclinical studies have demonstrated both local and systemic antitumor effects—including abscopal responses—and durable immunological memory following treatment. VAX014 is being developed primarily for non-muscle invasive bladder cancer (NMIBC), with ongoing Phase 1 trials in this indication, as well as broader development for other solid tumors[1][2][3][4][5][6][7].

Other names
recombinant bacterial minicells VAX014
02

Targets

ITGA5:ITGB1 (Integrin α5β1)α3β1 (Integrin alpha 3 beta 1)STING (Stimulator of interferon genes protein)

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