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 Development3210
Merryfield RowSan Diego, CA 92121
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