Researchers prepare to test Cuban lung cancer vaccine

When the borders between the United States and Cuba opened, so did the door to collaboration, and now American researchers are optimistic about beginning clinical trials on a Cuban lung cancer vaccine.

The vaccine, CimaVax, has been in development in Cuba for about 25 years and is now in its third clinical trial there. It specifically targets non-small-cell lung carcinoma, one of the most common forms of lung cancer accounting for about 85% to 90% of cases, according to the American Cancer Society.

In 2011, researchers from the Roswell Park Cancer Institute (RPCI) began working with researchers at the Center for Molecular Immunology in Havana, and in 2015 a deal was reached to bring CimaVax to the U.S. for U.S. Food and Drug Administration (FDA) inspection and eventually clinical trials.

While the vaccine is not a preventive vaccine in the traditional sense-given in childhood to prevent development of the disease-it could be used in high-risk patients or in those who have previously had lung cancer removed.

According to RPCI, the vaccine works by targeting the epidermal growth factor required for cancer to survive, effectively starving the cancer cells and slowing their spread, therefore prolonging the patient’s life.

So far, RPCI says CimaVax has been administered to 5,000 patients across the world in previous clinical trials, including 1,000 Cubans. Data from those trials have revealed prolonged survival times in treated patients-increasing survival time from 7.55 months in unvaccinated patients to 18.53 months in vaccinated patients.

“The bottom line is that this vaccine works and the ease of administration-a shot in the shoulder once per month-combined with the inexpensive cost could make it a very attractive option in the United States,” Kelvin Lee, MD, Jacobs Family Chair in Immunology at RPCI, tells Medical Economics

RCPI is currently working on preparing an Investigational New Drug application and expects to submit it to the FDA sometime in spring, anticipating a phase I clinical trial to begin in late 2016. However, the FDA’s review process could take 12 months to 18 months, and Lee says it could be 5 years before trials are completed.

Although the road ahead is still long, Lee says he is optimistic about what CimaVax could mean for cancer care.

“We hope to test the vaccine in combination with an FDA-approved immune modulator in patients with advanced lung cancer to establish safety and how effective it is at shrinking tumors and controlling tumor growth,” Lee says. “There’s also reason to believe that CimaVax may have efficacy against other EGF-expressing cancers-including colon, head and neck, prostate, breast and pancreatic cancers-and perhaps in secondary prevention. It’s these possibilities that are especially exciting, so we’re eager to move forward with this work.”

RPCI is also working on other agreements with the Center for Molecular Immunology in Havana to study a second vaccine that may target blood cancers, two monoclonal antibodies developed in Havana, and participate in a large-scale trial of a medication that is showing efficacy against a number of cancer types.