Roswell Park to lead U.S./Cuba biotech venture

Posted at 4:07 PM, Sep 26, 2018
and last updated 2018-09-26 16:07:36-04

The first-ever biotech venture between the U.S. and Cuba will happen right here in Western New York.

Governor Andrew Cuomo was in Buffalo Wednesday to announce the formation of Innovative Immunotherapy Alliance S.A., a partnership between Roswell Park Comprehensive Care Center here in Buffalo, and the Center for Molecular Immunology in Cuba.

Gov. Cuomo first announced the partnership back in April 2015 during his trade mission to Cuba. Gov. Cuomo says the formation of the Innovative Immunotherapy Alliance S.A. will advance the research and development of new cancer medications that may prolong and enhance survival for thousands of cancer patients here in the U.S.

This new joint venture gives Roswell Park access to a Cuban-developed treatment called CIMAvax-EGF and three additional cancer drugs -- IL-2 mutein, VSSP and another investigational immunotherapy that targets tumor-associated gangliosides.

Cuban doctors have found success using CIMAvac-EGF to treat lung cancer. Roswell Park researchers believe that CIMAvax-EGF may also prove effective as a treatment for other cancers, such as head and neck, colon, breast, prostate and pancreas cancers.

Researchers believe CIMAvac-EDF, along with the other acquired treatments can enhance the body's innate cancer-fighting self-defense system, both alone and in combination with other treatments.

U.S. research into those therapies is already underway.

Following the 2015 trade mission, Roswell Park became the first medical institution to initiate FDA-authorized testing of CIMAvax-EGF in the United States. Governor Cuomo announced the launch of the groundbreaking clinical trial of CIMAvax — a Cuban-developed lung cancer treatment — in October 2016. This innovative clinical study is currently underway at Roswell Park. Researchers presented preliminary phase I results yesterday at a scientific conference. Phase II is expected to begin late this year.

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.

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.

Nearly $4 million in donations is funding Roswell Park’s initial CIMAvax clinical trials.

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