Just-Announced U.S. and Cuba Biopharma Venture Sees Fruit in Lung Cancer Study

U.S. Cuba Flags

A three-year-old cancer research alliance between U.S. and Cuban scientists is bearing fruit. A Cuban-developed lung cancer treatment combined with Bristol-Myers Squibb’s anti-PDL1 Opdivo shows promise in treating patients who would not likely benefit from immune checkpoint inhibition.

Put into motion three years ago but formally launched this week, The Innovative Immunotherapy Alliance SA, a partnership between the Roswell Park Cancer Institute of Buffalo, New York and Cuba's Center for Molecular Immunology, is testing the Cuban-developed lung cancer drug CIMAvax-EGF, an epidermal growth factor (EGF)-depleting immunotherapy.

On Wednesday Roswell Park released initial findings from a Phase I/II clinical trial that showed that CIMAvax-EGF is “safe, well tolerated and worthy of further study.” The trial paired the Cuban-developed medication with the checkpoint inhibitor Opdivo in 13 patients with advanced non-small cell lung cancer.

Grace Dy of the Roswell Park Comprehensive Cancer Center, reported that Opdivo and CIMAvax can be used at their recommended single-agent doses together safely. Dy said the initial results showed “durable responses to this combination in patients who would have a low probability of therapeutic benefit from immune checkpoint inhibition therapy.”

“It appears that these two immunotherapies have the potential to work better in combination than they do on their own,” Dy said in a statement.

Dy noted that the initial results are from a small study and there is still a long way to go to verify their conclusions.

“These early hints of clinical activity encourage us to continue exploring this combination approach,” Dy added.

The alliance began three years ago during the administration of former President Barack Obama, who pushed to thaw relations between the two countries. Following that push for a closer working relationship, multiple companies from the U.S. looked to partner with a Cuban biotech/pharma combine. In 2012 Cuba created a government-backed biotech-pharma combine, called BioCubaFarma. The combine has a mission to manufacture medicine and equipment and provide hi-tech services. In 2015 a group of New York-based biopharma leaders, including Regeneron Pharmaceuticals, Inc.’s top executive Leonard Schleifer and Gov. Andrew Cuomo made plans to visit the island nation to bolster the chance for a collaboration.

The Cuban-U.S. venture provides Roswell Park access to CIMAvax-EGF, as well as access to three additional cancer drugs. Roswell Park called the medications “unique approaches to treating some of the most deadly and burdensome cancer types both in the U.S. and globally.” The research center became the first medical institution to initiate U.S. Food and Drug Administration-authorized testing of CIMAvax-EGF in the United States.

CIMAvax-EGF has been used in Cuba for a while. Roswell Park noted that in Cuba, many patients treated with CIMAvax have “lived 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 that CIMAvax-EGF 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.

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