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TMCNet:  Batu Biologics Files Patent Covering New Use of Approved Drug for Decreasing Cancer Immunotherapy Toxicity

[May 09, 2014]

Batu Biologics Files Patent Covering New Use of Approved Drug for Decreasing Cancer Immunotherapy Toxicity

SAN DIEGO --(Business Wire)--

Batu Biologics announced today filing of US patent #61/990231 covering the use of a commercially available drug, currently in use for other indications, for decreasing toxicity of immunotherapies such as interleukin-2. The patent is based on data demonstrating that the dosage of various cancer immune therapies is limited by toxicity of the therapy to the blood vessels of the patient, resulting in vascular leak syndrome, sepsis and death. Batu Biologics, through a series of in vitro and in vivo experiments, demonstrated that the dose of interleukin-2, a prototypic immunotherapy, can be increased by up to 100% when utilized together with the existing drug.

"Several years ago, the promise of immunotherapy was just a dream. Today, with the FDA approval of Provenge, the market entry of immunological checkpoint inhibitors, and the highly encouraging results of the CAR-T cell trials, immunotherapy of cancer is undergoing a renaissance," commented Samuel Wagner, President and CEO of Batu Biologics. "Although the majority of efforts in the industry are concentrated on developing novel treatment in the field of immunotherapy, relatively little work is being conducted on reducing toxicity of these agents. Our new data and patent application covers a niche, whose importance will become increasingly recognized as more and more immunotherapeutics enter the market: how to combat induced toxicity to enhance efficacy and safety."


Interleukin-2, the only immunotherapeutic drug which has been able to cure patients with Stage IV melanoma, is characterized by extreme toxicity, which is primarily caused by pathological changes that it induces on the blood vessels of the patients. Interestingly, other immunotherapies induce similar changes and toxicities. The new application of the approved drug to reduce toxicity is anticipated to allow for higher dose escalation of immunotherapeutic drugs.

"In the context of chemotherapeutic approaches to cancer, the dose limiting toxicity is bone marrow suppression, which resulted in the development of hematopoietic stimulatory agents. These agents, such as Neupogen and Neulasta, have sales in the billions of dollars per year, and act to allow oncologists to use doses of chemotherapy that were previously considered impossible to use, due to toxicities," stated Andy Kim, Vice President of Scientific Research for Batu Biologics. "What we are developing is a novel means of reducing toxicity of immunotherapeutics, which will hopefully allow for higher concentrations and more effective results."

About Batu Biologics: Batu Biologics is a preclinical biopharmaceutical company focusing on developing and commercializing allogeneic cell therapies in the area of immune modulation. Our products are centered around the idea of creating or breaking immune tolerance. The company is currently in the preclinical stages of drug development for its two flagship products: Immstem and Vallovax. Batu Biologics has filed two provisional patents in the field of cancer immunotherapy and plans to significantly expand its IP in 2014.

Laboratory Address:
Janssen Research and Development
3210 Merryfield Row
San Diego, CA (News - Alert) 92121


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