Batu Biologics Inc., a biotechnology company developing a cancer vaccine that targets a tumor's blood vessels, announced 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 and 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 five 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.
Within 30 calendar days of the IND filing, the FDA will notify Batu Biologics of any questions it may have or protocol revisions it may request.