(Business Wire)  Batu Biologics announced today publication in the Journal of Translational Medicine of the rationale and preclinical data for Batu’s flagship immunotherapeutic product, ValloVax™. ValloVax™ is a therapeutic vaccine that stimulates an immune response against the tumor vasculature for solid tumors. Batu Biologics has recently filed an Investigational New Drug Application (IND designation # 16296) with the Food and Drug Administration (FDA) seeking clinical approval to initialize a Phase I study for Non-Small Cell Lung Cancer (NSCLC).

The publication, which is available at no cost at http://www.translational-medicine.com/content/pdf/s12967-015-0441-0.pdf, describes the feasibility and proposed methods of inducing immunity against the tumor endothelium as well as a summary of efficacy and safety studies conducted for the ValloVax™ platform. Immunological targeting of the tumor vasculature remains a desirable approach for cancer therapeutics because of a.) immune accessibility via the blood supply and b.) collateral damage to tumor cells via the activation of coagulation mechanisms. Batu believes that this novel approach to choking tumors of their blood supply will provide the best clinical benefit for late-stage patients with lung cancer.

Co-authors and collaborators for the publication include Dr. Amit N. Patel, Director of Clinical Regenerative Medicine and Tissue Engineering at the University of Utah, Dr. Santosh Kesari, Director of Neuro-Oncology at the UC San Diego Moores Cancer Center, and Dr. Wei-ping Min, Professor, Department of Immunology, University of Western Ontario.

“We are excited about the positive signals for efficacy and safety we have observed in our preclinical data,” said Samuel C. Wagner, President and CEO of Batu Biologics. “Moving forward, the next milestone is securing clearance to initiate our Phase I dose-escalation study at the University of Utah. We expect to complete the additional IND-enabling experiments by the end of the second quarter of 2015, with the plan of securing IND clearance shortly thereafter.”