Gov. Cuomo Announces Landmark Roswell Park Study Bringing Cuban Lung Cancer Vaccine to U.S. Patients, Approval of License Authorizing U.S.–Cuba Commercial Partnership

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Spurred by NYS Trade Mission to Cuba in 2015, Buffalo cancer center will conduct a clinical trial with CIMAvax-EGF, groundbreaking immunotherapy for lung cancer developed in Cuba — becoming the first American center to receive FDA authorization to sponsor a clinical trial offering a Cuban-made therapy to U.S. patients — and will work to speed this and other innovative therapies to patients worldwide through a historic new business venture with Cuban research institute

Dr. Candace Johnson highlighting historic new trial, biotech partnership at Roswell Park Cancer Institute

With Roswell Park at the forefront of world-renowned medical research, we are this much closer to making a breakthrough that will combat cancer and save lives.

New York Gov. Andrew Cuomo today announced that a partnership formed during his historic New York State Trade Mission to Cuba last year has resulted in a milestone of international collaboration: the launch of a U.S. clinical trial of a Cuban immunotherapy developed by the Center of Molecular Immunology (CIM) for lung cancer. Buffalo, N.Y.-based Roswell Park Cancer Institute has received authorization from the U.S. Food and Drug Administration (FDA) to begin offering the lung cancer treatment vaccine CIMAvax-EGF® to a limited number of patients through a clinical trial, making the National Cancer Institute-designated comprehensive cancer center the first American institution to receive FDA permission to sponsor testing of a Cuban medical therapy in the United States. Roswell Park has also received authorization from the U.S. Department of the Treasury to establish a joint business venture with the CIM, which will be the first U.S.–Cuban joint venture licensed to undertake research, development, manufacture and marketing of biotech products.

“This groundbreaking trial at Roswell Park is the result of our historic partnership with Cuba, and is a testament to New York’s storied legacy as a national leader in progress and innovation,” Governor Cuomo says. “With Roswell Park at the forefront of world-renowned medical research, we are this much closer to making a breakthrough that will combat cancer and save lives. This latest milestone marks another chapter in Buffalo’s success story, and we look forward to seeing the impacts of this partnership resonate in New York and across the nation.”

CIMAvax-EGF was developed over the course of 25 years by researchers at the CIM, which is located in Havana, Cuba. Gov. Cuomo’s April 2015 trade mission enabled Roswell Park and the CIM to come together through a formal agreement and fast-tracked their collaboration. The new study, expected to open in November 2016, represents a convergence of the strategic visions of both state and federal leaders.

“We are grateful to Governor Andrew Cuomo for setting us on the path to this momentous announcement and to the White House and the federal departments of State, Commerce, Treasury and Health & Human Services for working with us on this, supporting and enlightening our path toward this collaborative relationship. This would not have happened without the vision of Governor Cuomo, who brought New York state leaders to Cuba, foreshadowing the enhanced collaborations between our two countries,” says Roswell Park President and CEO Candace S. Johnson, PhD.

“The goals of this clinical trial — to speed and enrich the best ideas for defeating cancer — align perfectly with the White House’s bold Cancer Moonshot effort, led with such inspiration and vision by Vice President Biden. The promise of our collaborative research, the affinity that grew between Roswell Park and the Center for Molecular Immunology in Cuba and the pace at which our collaboration has grown are testaments to the fact that these are the right steps at the right time,” adds Dr. Johnson, who, along with Kelvin Lee, MD, Jacobs Family Chair in Immunology at Roswell Park, was invited to take part in Gov. Cuomo’s 2015 trade mission to Cuba.

“This is a day we have been working toward for many years,” says CIM Director Agustín Lage, MD, PhD. “Our partnership with Roswell Park will allow us to learn things about our vaccine faster than what we could achieve working on our own, and we believe it is the best and quickest path for helping a great number of people both in Cuba and the U.S.”

The Roswell Park–CIM joint venture initiative, negotiation and establishment of which is now authorized by a new license from the Office of Foreign Assets Control, will enable expanded collaborative research and development activities in the U.S. and Cuba on the part of CIMAB S.A., the commercial arm of the CIM, and Roswell Park subsidiary Global Biotechnology & Cancer Therapeutics (GBCT).

“This is a historic time with historic opportunities to break down barriers and combine efforts,” says Thomas Schwaab, MD, PhD, an immunologist and urologic oncologist who serves as Chief of Strategy, Business Development and Outreach at Roswell Park and a founding member of GBCT. “Roswell Park and the CIM have so much to learn from one another. The whole goal of our groundbreaking clinical and commercial collaborations is to unite ideas and resources to maximize the possible benefits for patients worldwide, as quickly as possible.”

Roswell Park will be the only site for the new clinical trial, a phase I/II study of CIMAvax-EGF in combination with another immunotherapy, the checkpoint inhibitor nivolumab (Opdivo®). The study, which will be funded largely by donations through the Roswell Park Alliance Foundation, will take roughly three years to complete, and will enroll approximately 60–90 patients. Studies have shown that nivolumab, the approved second-line standard therapy, is comparatively effective in treating lung cancer recurrence. The Roswell Park study, to be conducted under the leadership of Principal Investigator Grace Dy, MD, will assess whether these two immunotherapies are more effective when given together as a combination.

“Lung cancer is the leading cause of cancer-related death in the United States, with a five-year survival rate of only 17 percent, and rates that are even lower for the many whose disease is already at an advanced stage when they’re diagnosed. We need to be able to offer patients something that improves these odds,” says Dr. Dy, Chief of Thoracic Oncology in the Department of Medicine at Roswell Park. “We’re at an early stage in the development of this vaccine, which has never before been given to U.S. patients, so we have a lot to learn through this study, but the evidence so far is encouraging.”

More than 4,000 lung cancer patients have been treated with CIMAvax-EGF in worldwide clinical trials. The most recent, a randomized phase III study conducted by CIM scientists, showed that patients treated with the vaccine had significantly improved overall survival and quality of life compared to lung cancer patients who did not receive the vaccine, and with minimal side effects. CIMAvax is an approved therapy not only in Cuba but also in Bosnia and Herzegovina, Colombia, Paraguay and Peru.

Roswell Park researchers believe that CIMAvax-EGF may one day prove effective in preventing primary lung cancers — and possibly as a treatment for other cancers, such as head and neck, colon, breast, prostate and pancreas cancers.

“Because this is the first U.S. clinical trial of CIMAvax, we have to focus our efforts at this early stage on seeing whether the vaccine works as well in our patients as it seemed to in the Cuban studies, and how it works in combination with nivolumab,” says Roswell Park’s Dr. Lee, one of the key figures in forging the collaboration with the CIM. “But what we find so intriguing is the possibility that CIMAvax might actually help to prevent some cancers from developing — particularly in people who are at high risk of developing lung cancer — and that it might also be effective against some other cancers. Those are things we may look into down the road, but we need to start at step one with this first study.”

Congressman Brian Higgins says, "Roswell Park Cancer Institute is a special place, home to the best medical professionals and researchers fighting alongside those diagnosed with cancer each and every day. The new partnership between Roswell Park Cancer Institute and CIM, supported by Governor Cuomo, has the potential to revolutionize lung cancer treatment – giving more people the care and hope they deeply deserve and need. This partnership shows what is possible when the talent and ambition of doctors and researchers is combined with a will to improve the world around us – and it’s happening right here in Buffalo.”

Lieutenant Governor Kathy Hochul says, “Today’s announcement is further evidence that the eyes of the world are on Buffalo like never before, bolstered by strategic investments and international relationships. By reaching across borders and bringing together the brightest minds in the medical research field, this first-in-the-nation project brings the real potential to save lives.”

Assemblywoman Crystal Peoples-Stokes says, “New York has a long history of leadership in pioneering innovative medical research, and this latest momentous project puts New York on the forefront of the latest advancements in medical care and cancer treatment. Thanks to Governor Cuomo’s commitment to the global exchange of ideas, patients in need will be able to access this potentially life-saving treatment. Today’s announcement will bring new hope to patients and families in New York, and I look forward to seeing other states follow Governor Cuomo’s inspiring leadership on this issue.”

Mayor Byron Brown says, “The future of New York State depends on us building a strong and healthy generation today. The Buffalo region, with unprecedented attention from New York State, has established itself as a capital of innovation and expertise in every sector from biology to technology – and now, we are a home for hope. I applaud Governor Cuomo for bridging the partnership between Roswell Park and CIM as they work to further development of this promising treatment for cancer, and pledge my continued support in advancing our collective fight against cancer for a brighter tomorrow.”

Empire State Development President, CEO & Commissioner Howard Zemsky says, “When I travelled to Cuba last year with Governor Cuomo and Dr. Johnson, we were eager to facilitate relationships between New York State and Cuba and today we can proudly say that our historic New York Trade Mission to Cuba may save lives. As the first American center to receive FDA authorization to sponsor a clinical trial of a Cuban immunotherapy, Roswell Park will be helping to lead the fight against cancer.”

To learn more about the new clinical trial of CIMAvax-EGF and nivolumab for patients with advanced non-small cell lung cancer, please visit RoswellPark.org/cancer-vaccine or call 1-877-ASK-RPCI (1-877-275-7724).

For an online version of this release, please visit: https://www.roswellpark.org/media/news/gov-cuomo-announces-landmark-roswell-park-study-bringing-cuban-lung-cancer-vaccine-us

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The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit http://www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org. Follow Roswell Park on Facebook and Twitter.

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