FDA approves Vaxiion's candidate treatment VAX014 research new drug application

recently, theof the United States announced(http:// that the U.SFDA(http://has approved itsapplication for a new drug
(http:// IND) of its candidate therapy, VAX014this is the first clinical candidateproduct(http://developed by the company's proprietary rBMC delivery platformThe company will now launch a Phase I clinical study (NCT03854721), a multicenter open label, dose increment, and dose expansion study that will assess the safety, tolerability, and initial anti-tumor activity of VAX014 for treatment of non-muscle-invasive bladder cancer (NMIBC) patientsVAX014 is a recombinant exicotic bacteria microcellular that is injected and given, and has been engineered to express the invasin from pseudo-tb Yersiniatuberi, selective Target and deliver a new type of rapidly acting bacterial protein toxin perfringolysin O (PFO) to express two types of oncology-related isolyglutine subtype alpha3 beta1 or alpha 5 beta1 of urinary tract cancer cellsThe mechanism of action of VAX104 is the rapid penetration of the target cytoplasmic membrane and simultaneous induction of apoptosisIn preclinical models of NMIBC and other cancer types, VAX014 repeatedly showed long-lasting anti-tumor immunotherapy activity, leading to complete tumor subsiding and long-term anti-tumor immunomemory formation, a single bladder infusion can effectively prevent tumor implantation, significantly improving experimental animal survival In non-clinical safety studies, VAX014 showed good tolerance after repeated administration within the clinically relevant dose range 　　Today, Vaxiion has developed a stable set of bacterial strains that induce microcellular production, including key genetic modifications that make the manufacture of rBMC products reliable, repeatable and scalable