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Gov. Andrew Cuomo announces initial results from the first North American clinical study of CIMAvax-EGF as a cancer treatment. (Photo courtesy of the governor's Flickr page)
Gov. Andrew Cuomo announces initial results from the first North American clinical study of CIMAvax-EGF as a cancer treatment. (Photo courtesy of the governor's Flickr page)

Cuomo announces first biotech venture between US, Cuba to research & develop new cancer treatments

Press Release

Wed, Sep 26th 2018 11:20 pm
Roswell Park partnership with Havana-based Center for Molecular Immunology, established during Cuomo's 2015 trade mission to Cuba, moves forward
New joint venture, Innovative Immunotherapy Alliance S.A., gives Roswell Park access to 3 additional cancer drugs not previously accessible to US patients or researchers
Gov. Andrew M. Cuomo on Wednesday announced Roswell Park Comprehensive Cancer Center has formed the Innovative Immunotherapy Alliance S.A., the first-ever biotech venture between the U.S. and Cuba. The announcement marks a significant milestone of progress following Cuomo's landmark trade mission to Cuba in April 2015, where he facilitated this historic partnership between Roswell Park and the Center for Molecular Immunology. This step will advance the research and development of new cancer medicines that may prolong and enhance survival for thousands of U.S. patients.
"This historic venture with Cuba will provide Roswell Park access to innovative cancer-fighting drugs that could revolutionize treatments and put us one step closer to eliminating the threat of cancer once and for all," Cuomo said. "By bringing the best and brightest together from across the world, New York is forging a path as a leader in modern medical research and advancement."
This new joint venture gives Roswell Park access to CIMAvax and three additional cancer drugs — unique approaches to treating some of the deadliest and burdensome cancer types both in the U.S. and globally — for U.S. patients and researchers. These four drugs are currently approved for patient use in other countries. The milestone marks another step toward researching, developing and eventually commercializing promising cancer drugs for the benefit of patients in the U.S.
"Roswell Park Comprehensive Cancer Center is an integral part of Buffalo and a world-class institution that has been leading the fight against cancer for generations," Lt. Gov. Kathy Hochul said. "The researchers and staff at Roswell Park work every day to save lives and deliver compassion to those who need it the most. This strategic research collaboration between Roswell Park and the leading medical minds of Cuba will deliver new opportunities for life-saving treatments, providing hope to millions of Americans."
Following the 2015 trade mission, Roswell Park became the first medical institution to initiate FDA-authorized testing of CIMAvax in the U.S. 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 with announcement of preliminary phase one results presented at a scientific conference yesterday; initiation of the phase two portion of the initial study is anticipated for late 2018.
In Cuba, many patients treated with CIMAvax have lived significantly longer with improved quality of life and minimal side effects, compared to lung cancer patients who did not receive the drug in combination with standard chemotherapy. Roswell Park researchers believe CIMAvax may also prove effective as a treatment for other cancers, such as head and neck, colon, breast, prostate and pancreas cancers, as well as for the prevention of primary lung cancers.
The joint biotech venture has access to CIMAvax and three additional Cuban-developed cancer immunotherapy treatments not previously accessible to U.S. patients or researchers: IL-2 mutein, VSSP and another investigational immunotherapy that targets tumor-associated gangliosides. These four immunotherapies are innovative treatment approaches designed to enhance the body's innate cancer-fighting self-defense system, alone or in combination with other immunotherapies. While these agents are still investigational therapies in the U.S., evidence to date strongly suggests that all four are worthy of further study in several cancer types. Roswell Park and its partners are committed to working together to determine their true potential for controlling cancer and improving patient outcomes.
Empire State Development President, CEO and Commissioner Howard Zemsky said, "New York state's leadership in cutting-edge medical research is emblemized by Buffalo's Roswell Park Comprehensive Cancer Center, now a partner in the first-ever U.S.-Cuba biotech venture and in the advancement of new medicines to prolong and save lives."
Department of Health Commissioner Dr. Howard Zucker said, "Each year, nearly 110,000 New Yorkers learn they have cancer, and tragically around 35,000 die from this debilitating disease. Under the leadership of Gov. Cuomo, we're harnessing the tremendous resources here at Roswell Park and reaching around the world to stay at the forefront in the fight against cancer."
Roswell Park President and CEO Candace S. Johnson, Ph.D., said, "This is a momentous step forward on one of our most significant undertakings. With the establishment of this company, we are entering a critical new phase of Roswell Park's collaboration with these innovative Cuban scientists. Our goal is to develop these promising cancer therapies as quickly and effectively as possible so that they can benefit the greatest number of U.S. patients."
Chief of Strategy, Business Development and Outreach at Roswell Park Thomas Schwaab, M.D., Ph.D. said, "It's incredibly rewarding to see our collaboration reach this crucial juncture. Innovative Immunotherapy Alliance S.A. will provide the support, expertise and infrastructure that will make it possible for Roswell Park to study these drugs and get them to U.S. patients. We believe these unique immunotherapies have the potential to change the landscape of cancer treatment, and we are proud to partner with our CIM colleagues to advance development of these therapies as quickly and effectively as possible."
Congressman Brian Higgins said, "This joint venture brings together leaders in breakthrough research to expedite delivery of promising treatment to those facing cancer. For 120 years, this country's first national comprehensive cancer center, Roswell Park, has led the way in innovative cancer treatment and care benefiting patients around the world. This is yet another milestone in Roswell Park's tradition of delivering hope to those afflicted with cancer and those who love them."
New York State Sen. Tim Kennedy said, "Roswell Park Comprehensive Cancer Center continues to lead the nation not only in providing thorough, outstanding care, but in developing cutting-edge, innovative research and therapies, and this new partnership will only elevate that trailblazing spirit. I look forward to witnessing the advancements that are born out of this collaboration, and thank Gov. Cuomo and Roswell Park President Candace Johnson for prioritizing health and hope for all New Yorkers."
Assemblywoman Crystal Peoples-Stokes said, "I am excited and proud of the collaborative efforts and findings that Roswell Park Comprehensive Cancer Center has accomplished alongside Cuban research. I'm hopeful that these numerous cancer therapies have the potential to have a revolutionary industrywide and local economic impact, but most importantly that Roswell is successfully able to extend time that patients get to spend with their loved ones."
Erie County Executive Mark Poloncarz said, "Roswell Park is internationally known for cutting-edge research and this new partnership will take that research to the next level, breaking barriers and exploring new fronts in the fight against cancer. Cancer knows no boundaries, and this promising partnership demonstrates Roswell Park's determination to not only beat this scourge, but to be at the forefront of the world effort in doing so."
Buffalo Mayor Byron Brown said, "Buffalo is proud of its growing health sciences sector. Under Gov. Cuomo's leadership, the Buffalo Niagara Medical Campus is fulfilling its potential as a source of groundbreaking research and economic growth. Dr. Candace Johnson's team at Roswell Park has accomplished something special and I am confident that people here, and around the world, will benefit from this first-in-the-nation partnership."
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 two and phase three clinical trials of CIMAvax have shown increased overall survival and improvement in quality of life for patients with non-small cell lung cancer.
Akin Gump Strauss Hauer & Held LLP, a law firm with expertise in international business and U.S.-Cuba trade matters, provided legal guidance that helped support establishment of the joint venture. Nearly $4 million in donations is funding Roswell Park's initial CIMAvax clinical trial.
For more information, visit RoswellPark.org/CIMAvax.
Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer's grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in upstate New York. Learn more at www.roswellpark.org, call 1-800-ROSWELL(1-800-767-9355) or email [email protected].

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