SAN DIEGO--(BUSINESS WIRE)--Batu Biologics, a biotechnology company focusing on developing therapies that target the Achilles Heel of Cancer: the tumor blood vessels, announced today the filing of an Investigational Drug Application (IND) with the U.S. Food and Drug Administration (FDA) for its lead immune therapy, ValloVax. Once the IND is approved, Batu Biologics will proceed with a Phase I/II clinical trial for non-small cell lung cancer.
ValloVax is a polyvalent cancer vaccine that stimulates an immune response against the tumor-associated blood vessels, seeking to cut off the blood supply required for sustainable tumor growth. In preclinical testing, ValloVax was shown to inhibit new blood vessel formation in melanoma, breast, and lung cancer mouse models. Batu Biologics plans to expand clinical trials to additional indications in the future.
The proposed Phase I/II clinical trial will assess safety with signals of efficacy in advanced lung cancer patients who have failed chemotherapy. Three escalating doses of ValloVax will be administered with 5 patients per group. Batu Biologics will be working with the University of Utah to conduct the trials and plans to initiate dosing of patients in early 2015.
“We are very enthusiastic about completing this important developmental milestone in the growth of Batu Biologics. Given the recent success of checkpoint inhibitors and other immunotherapies, we are excited to present this novel approach to a non-toxic approach to cancer," said Samuel Wagner, CEO of Batu Biologics. “In our opinion targeting tumor angiogenesis utilizing an active immunological approach will provide patients with the best tools to fight this devastating disease.”
Within 30 calendar days of the IND filing, FDA will notify Batu Biologics of any questions it has or protocol revisions it requests which may delay this timing. Batu Biologics plans to work with the FDA review team to address any questions or requests that arise within this 30-day window.