Where Does CIMAvax Currently Stand?
Roswell Park is launching the first clinical trial in the U.S. to study the CIMAvax-EGF ® vaccine, a lung cancer treatment. The study is not yet open.
Nearly one year later, as a result of President Obama’s historic visit, Cuba is back in the news and CIMAvax is receiving renewed attention. One of the most frequently asked questions about this vaccine is, “When will it be available for lung cancer patients in the U.S.?”
As I mentioned in a previous Cancer Talk blog post, this is not a quick process. Importing a new cancer therapy from another country, particularly a country with which the U.S. has only recently restored diplomatic ties, takes time.
Despite that, I’m pleased to report significant progress. We have already taken a giant first step in the form of our initial meeting with the U.S. Food and Drug Administration (FDA). In addition to being supportive of our CIMAvax endeavor, the FDA’s experts provided positive feedback and helpful suggestions to RPCI’s investigational new drug (IND) application. We are now moving toward finalizing our IND document, which is expected to be anywhere from 500-1000 pages in length.
The clinical trials that we hope to perform in the United States are written and are advancing through various stages of the necessary approval process. Additionally, we are continuing our collaboration with the Center for Molecular Immunology (CIM) in Havana, and are sending a team for another visit and further plant inspection. I remain cautiously optimistic that, barring any unforeseen regulatory issues, we can bring CIMAvax to the U.S. for clinical testing by the final quarter of 2016.
The timing of this process, as it relates to current political matters, is quite fortuitous. Earlier this year, Vice President Biden revealed his “cancer moonshot” plan and President Obama has since taken massive steps toward repairing America’s relationship with Cuba.
Roswell Park has a vested interest in both undertakings and because of that, we find ourselves at a rather remarkable intersection involving the current U.S. presidential administration. We will continue to watch these two initiatives closely as they continue to gain momentum, all while seeking other avenues and ways to tap into Cuba’s innovative biotech sector.
Cuba is one of the unique incubators in the world for medical research and the CIM is at the center of it all. Home to some of the world’s most creative and dedicated scientists, the CIM is constantly testing therapies with the potential to deal a serious blow to cancer, as well as a variety of other ailments including heart disease and brain injury.
Roswell Park is also on track to acquire a second, and equally exciting, cancer vaccine from the CIM. Racotumomab targets a molecule that appears only on cancer cells, creating a very specific target against a broad variety of cancers including lung, head and neck, prostate, colon, breast, lymphoma and multiple myeloma. Initial trials for racotumomab are highly encouraging, displaying safety for the patient and effectiveness against cancer. It’s another vaccine that we plan to bring to the United States sometime over the next 24 months for clinical testing, and we have CimaVax to thank.
Think of CIMAvax as a vehicle serving to help us understand the regulatory environment behind bringing important Cuban cancer therapies to the United States. CIMAvax is the first vaccine to go through this process and it’s blazing a trail for every other vaccine that follows.