Three years after the U.S. and Cuba restored their diplomatic relations, the first biotech joint venture between institutions from the two countries has launched with the mission of bringing some novel, Cuban-developed cancer immunotherapies to the U.S.

Buffalo, New York-based Roswell Park Comprehensive Cancer Center has unveiled a biotech partnership with Havana-based Center for Molecular Immunology. Dubbed the Innovative Immunotherapy Alliance, the JV gains access to CIMAvax-EGF, a lung cancer vaccine already approved in Cuba, along with three additional Cuban-made cancer immunotherapies.

"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," Roswell Park President and CEO Candace Johnson, Ph.D., said in a statement.

CIMAvax has been developed in the U.S. since 2016 under an agreement the two institutions reached back in 2015 following a Gov. Andrew Cuomo-led New York State trade delegation trip to Cuba. Prior to that, it had been greenlighted by Cuban medical authorities after tests in Cuba showed a survival benefit for advanced non-small cell lung cancer (NSCLC) patients.

Preliminary results from an ongoing phase 1/2 demonstrated that a combination of the cancer vaccine and Bristol-Myers Squibb’s anti-PD-1 drug Opdivo was safe, well tolerated and set for further study in advanced NSCLC, Roswell Park recently reported.

"[B]ecause we also saw durable responses to this combination in patients who would have low probability of therapeutic benefit from immune checkpoint inhibition therapy, such as those whose tumors expressed low levels of PD-L1 … it appears that these two immunotherapies have the potential to work better in combination than they do on their own," Roswell Park’s Grace Dy, M.D., who led the study, said.

The other three CIM-made immuno-oncology assets wrapped into the JV are VSSP, a nanoparticle initially developed to boost vaccine response; an IL-2 mutein agent; and a preclinical agent that targets gangliosides, which are associated with many cancer types. Based in Cuba, Innovative Immunotherapy Alliance will provide the support, expertise and infrastructure for Roswell Park to study these drugs and get them to U.S. patients, said Thomas Schwaab, M.D., PH.D., Roswell Park’s chief of strategy, business development and outreach, in a statement. 

Roswell Park now expects to initiate additional clinical trials under the joint venture, eyeing to test those drugs on more than 100 patients in the U.S. within the next three years. The phase 2 portion of the CIMAvax study is planned for later this year.

Editor's Note: This story has been corrected to show that racotumomab is not the ganglioside-targeting candidate included in the JV.

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