​​VAX014​ is a first-in-class tumor-targeted oncolytic agent based on Vaxiion's proprietary rBMC technology. VAX014 is highly differentiated from traditional oncolytic viral therapies and works by specifically targeting and delivering a novel fast-acting pre-formed oncolytic protein toxin directly to tumor cells that express either α3β1 or α5β1 integrin(s), both commonly found to be selectively expressed in many solid tumor types. Tumor cells expressing either integrin subtype quickly internalize VAX014 into the endosomal/lysosomal pathway. The rBMC carrier is then degraded, releasing the oncolytic protein payload of VAX014, resulting in tumor cell lysis and downstream immunotherapeutic effects within a matter of hours following administration. VAX014 has demonstrated clinical activity and immune-dependent antitumor activity in multiple preclinical models.

About Vaxiion Therapeutics

Vaxiion Therapeutics is a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapies. Our lead product, VAX014, is a novel alternative to oncolytic viral therapy and is currently undergoing clinical trials for the local treatment of bladder cancer. Based on the observed clinical activity in bladder cancer patients and strong additional preclinical data, the company will soon initiate a clinical trial for local delivery of VAX014 to other solid tumor types. 

Vaxiion proprietary drug delivery system is based on its recombinant bacterial minicell (rBMC) technology platform.  rBMCs are small, chromosomeless (i.e., non-living and non-infectious), spherical bacterial particles engineered to encapsulate, target, and deliver a wide array of therapeutically relevant molecules (including protein toxins, small molecule drugs, RNAi, plasmids, peptides, and imaging agents) directly to cancer cells. Vaxiion's rBMCs are also engineered to contain immune-attenuated bacterial endotoxin, making them suitable for parenteral use.  rBMC-based products, including VAX014, are generated using simple, commercially scalable, cGMP-compliant microbial fermentation, downstream purification, and proprietary sterilization processes.  

Vaxiion is currently investigating VAX014 for the topical treatment of non-muscle invasive bladder cancer (NMIBC) in a multi-center Phase 1 trial. VAX014 has demonstrated an acceptable safety profile and evidence of clinical antitumor activity in this indication. Propelled by encouraging early results in the NMIBC trial, Vaxiion is finalizing a second IND for the intralesional treatment of advanced solid tumors with a target submission date in the third quarter of 2021.   

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Preclinical studies of VAX014 following local administration have demonstrated remarkable results in multiple in vivo tumor models conducted in immune competent mice. Treatment of established immunologically cold tumors (devoid of immune cells) with VAX014 quickly leads to local tumor inflammation followed by immune infiltration and complete immune-mediated tumor clearance. Tumor clearance(s) is durable, tumor specific, and leads to protective systemic antitumor immunologic memory. In experimental models where mice bearing multiple tumors are treated locally by intratumoral injection of one tumor with VAX014, immune-mediated clearance of both treated and untreated tumors is observed, indicating VAX014 facilitates in situ immunization against the treated tumor type. When combined with systemic immune checkpoint blockade therapy, protective systemic antitumor effects improve to a point where nearly all study subjects demonstrate complete response.