Buffalo, New York: This joint venture biotech company, Innovative Immunotherapy Alliance S.A., will be based in Cuba and will be operated jointly by CIM’s commercial affiliate, CIMAB S.A., and by a Roswell Park subsidiary, GBCT II LLC. The company will:
Focus on conducting additional U.S. research studies on CIMAvax and the other products over the first five years;
Seek U.S. FDA approval upon demonstration of successful outcomes in advanced-phase clinical testing for the products;
Seek patent protection for discoveries arising from development of the four cancer drugs, seek sub-licensing opportunities for the entity’s intellectual property rights, collaborate on research and share improvements on the intellectual property on a reciprocal basis with CIM and CIMAB; and
In the long term, facilitate the import and distribution of products into the U.S., either directly or through sublicensing arrangements, upon regulatory approval to benefit U.S. patients.
This initiative will move forward in accordance with permissions issued by the Office of Foreign Assets Control of the Department of Treasury, the Bureau of Industry and Security of the U.S. Department of Commerce and the U.S. FDA. Clinical studies are the first step toward FDA approval of new therapies. With the access to additional treatments under this joint venture, Roswell Park expects to initiate additional clinical trials, enrolling more than 100 patients in the U.S. within the next three years with plans for additional clinical studies to follow.
Aside from CIMAvax, these cancer drugs have never been studied before in U.S. patients. The Cuban phase II and phase III clinical trials of CIMAvax have shown increased overall survival and improvement in quality of life for patients with non-small cell lung cancer.
This new joint venture gives Roswell Park access to CIMAvax-EGF and three additional cancer drugs — unique approaches to treating some of the most deadly and burdensome cancer types both in the U.S. and globally — for U.S. patients and researchers. The milestone marks another step toward researching, developing and eventually commercializing promising cancer drugs for the benefit of patients in the U.S.
Nearly $4 million in donations is funding Roswell Park’s initial CIMAvax clinical trials.
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