Batu Biologics Strategy for FDA Approval of Lung Cancer Immunotherapy Featured in San Diego Business Journal

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July 27th, 2014

Batu Biologics announced today that it’s President and CEO, Samuel C. Wagner, was featured in the weekly business publication, the San Diego Business Journal. The article, which was published in the July 21st edition, discussed the company’s strategy in developing its immunotherapeutic lung cancer vaccine, ValloVax, for which FDA Investigational New Drug (IND) submission is planned in Q1 of 2015.

The article described how the company has been started and funded by former principals of Medistem Inc Dr. Alan Lewis and Thomas Ichim, subsequent to the $26 million purchase of Medistem by the NYSE-traded company Intrexon. Additionally, the article described the current donation-based crowdfunding campaign, which may be viewed at the following link:

“The donation-based crowdfunding campaign provides non-dilutive capital to the company which accelerates our ongoing preclinical lung cancer immunological experiments needed for FDA IND submission,” stated Samuel C. Wagner.

Tumor immunotherapy offers the possibility of using the patient’s immune system to seek and destroy tumor cells without harming non-malignant cells. Tumor vaccines are currently in development for lung cancer, and one tumor vaccine is approved by the FDA for prostate cancer (Provenge).

The vaccine that Batu Biologics is developing, ValloVax, is different than conventional tumor vaccines. Instead of stimulating the immune response to kill the lung cancer itself, ValloVax stimulates the immune system to kill the blood vessels that feed the tumor.

This approach is potentially superior to conventional tumor vaccines since:

a) The blood vessels of tumors do not mutate since they are not part of the tumor, therefore the possibility of drug resistance is significantly reduced (Boehm et al. Nature 390:404, 1997).

b) For every one blood vessel cell that is killed, there are approximately 100-300 tumor cells that die, therefore the tumor blood vessel may be seen as the “Achilles Heel” of the tumor (Folkman Sci Am 275:150, 1996).

c) The blood vessels are directly in contact with the immune system, therefore killing of tumor associated blood vessels is theoretically more feasible than killing of tumor cells within the tumor. Tumors are known to have areas lacking oxygen and possessing fibrotic tissue, which does not allow access to immune cells (Folkman, Antiangiogenesis Therapy, In Principles and Practice of Oncology, Lippincott-Raven, 1997).


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