International Elevated Thought Conference

 Introducing Cimavax

 

Amid a historic normalizing of relations between the United States and Cuba, a potentially game-changing step was recently taken in the field of lung cancer research.

When thinking about cutting-edge scientific innovation, Cuba may not immediately come to mind. Relations between the United States and the small island nation to the south of Florida grew tense during the height of the Cold War, and the two countries have been locked in a trade embargo since 1962. Only very recently have diplomatic relations thawed, opening the door for collaboration.

 

A mystery to generations of Americans, Cuba is often thought of as being stuck in a bygone era. Having made multiple trips to Cuba over the last three years, I can tell you that is not the case.

 

Cuba’s high-quality biotech sector is thriving, led in part by the Center for Molecular Immunology (CIM) in Havana. I visited the CIM in April 2015 as part of a group that included Roswell Park Cancer Institute’s (RPCI) President and CEO Candace Johnson, PhD, and New York Governor Andrew Cuomo. Following face-to-face meetings with CIM representatives and researchers, an agreement was finalized to bring their lung cancer vaccine, CIMAVax, to RPCI and the United States for clinical testing and U.S. Food and Drug Administration (FDA) inspection.

 

Potential Impact

 

So, what is CIMAvax? First and foremost, let me immediately clear up a potential misconception — CIMAvax, in its current form, is not the type of vaccine that would be administered to children to prevent them from some day getting lung cancer.

Rather, CIMAvax is intended for lung cancer patients and for those at high risk for the disease, including smokers and patients who may have had lung cancer removed surgically. Unlike other immunotherapies, CIMAvax does not target cancer directly and it is not personalized. Rather, the vaccine targets a growth factor (EGF) necessary for the cancer to survive. By targeting and effectively depleting this growth factor, the cancer starves and its progress slows, prolonging patients’ lives.

 

 

To date,

 

 CIMAvax has been administered to 5,000 patients across the world, including 1,000 Cubans. Expansive clinical trials have been underway for some time now, with published data showing prolonged life (especially in patients <60 yrs old, with a mean overall survival of 18.53 months in the vaccinated patients compared to 7.55 months for the unvaccinated patients) when compared to standard care, with minimal vaccine-related toxicity.

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.

 

Where It Currently Stands

 

Unfortunately, bringing a vaccine like CIMAvax to the United States doesn’t just happen overnight. In addition to research and clinical testing, which is extensive in its own right, CIMAvax must also receive FDA approval.

Roswell Park is preparing paperwork for the FDA as we speak. We hope to have the initial paperwork process wrapped up within the next two or three months so the FDA can begin its inspection.

 

 

 

 

International Elevated Thought Conference 2017