Roswell Park Cancer Institute launches trial to test Cuban lung cancer vaccine

Roswell Park Cancer Institute launched a clinical trial that will assess CIMAvax-EGF, a novel Cuban-developed immunotherapy for lung cancer.

This is the first time an American center received FDA authorization to sponsor a clinical trial offering a Cuban-made therapy to U.S. patients. Researchers are working to accelerate the process of this and other innovative therapies to patients worldwide through a historic new business venture with the Cuban research institute.

Candace S. Johnson

HemOnc Today spoke with Candace S. Johnson, PhD, president and CEO of Roswell Park Cancer Institute, about the collaboration with Centro de Inmunologia Molecular in Havana; the effort to conduct a trial to test the lung cancer vaccine; and how this initiative may lay the groundwork for future U.S.-based investigations and improve access to those therapies.

Question: How did Roswell Park Cancer Institute’s collaboration with Centro de Inmunologia Molecular in Havana come about?

Answer: Roswell Park and Centro de Inmunologia Molecular have been collaborating informally since 2011, when one of their scientists reached out to us to see if we were interested in hearing more about the CIMAvax-EGF vaccine for lung cancer. We were intrigued, and so wowed by the science and the creativity of their approach — instead of going after the tumor itself, let’s target the growth factor that is feeding it. So, we kept talking and beginning an academic exchange. In spring 2015, New York Gov. Andrew Cuomo invited us on his trade mission to Cuba. No other U.S. state had done anything like this, and at the end of that trade mission, we signed a formal agreement with Centro de Inmunologia Molecular that fast-tracked our partnership. It was truly a visionary moment that initiated the momentum that propelled us to where we are today.

Q: Why did Roswell Park want to launch a CIMAvax-EGF trial in the United States?

A: We need to do better for our patients. Lung cancer is the leading cause of cancer-related death in the United States. Too many people are diagnosed with very advanced disease, and they need better therapy options. One of the most exciting things about CIMAvax is that we think it may one day not only help us to treat lung cancer, but possibly prevent it. We hope that CIMAvax and our collaborations with Centro de Inmunologia Molecular will change the game in lung cancer, and perhaps other cancers, too. It is incredibly promising but had never been studied in the U.S. before, so we thought it was important to bring this therapy here and test it in the American population.

Q: Can you describe the process you had to go through to obtain approval for this trial?

A: First, we had to seek special permission from the U.S. government — specifically, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) — to bring CIMAvax into the United States. We received such a license from OFAC in 2014, and that is when we started our preclinical research with CIMAvax. Then we had to reach out to the FDA to get permission for our clinical trial. That part really was very straightforward, and it was not all that different from the process we go through with any investigational new drug application for a new therapy. In between all of this, we made a number of visits to Cuba with our own teams to get our questions answered and start thinking about how to design the best trial.

Q: Can you describe how the vaccine works, as well as the promise it has shown for treating patients elsewhere in the world?

A: CIMAvax has significantly prolonged the survival of patients with lung cancer, as demonstrated in a Clinical Cancer Research paper the Centro de Inmunologia Molecular team published in 2015. The vaccine, which was developed for the treatment of advanced non–small cell lung cancer, is unique in how it works. Instead of going after the tumor itself, it targets an epidermal growth factor (EGF) needed by lung cancer cells. It is their food source. They get addicted to the EGF and need it to survive. The beauty of that simple approach is that the vaccine is inexpensive to produce and easy to administer, even in rural settings where physicians are hard to come by. It is given as a monthly intramuscular injection and has very few side effects. More than 5,000 patients have been vaccinated worldwide already. When you look at the worldwide lung cancer burden and the impact of smoking across the globe, the possible impact is monumental. That is why we were eager to get these studies underway and explore the possibility that CIMAvax may work well — not only as a treatment, but possibly as a cancer prevention measure.

Q: What type of further testing will the vaccine undergo at Roswell Park? Can you describe how the vaccine will be studied?

A: The study will be led by Grace Dy, MD, chief of thoracic oncology at Roswell Park Cancer Institute, and will assess the safety and efficacy of CIMAvax in combination with another immunotherapy checkpoint inhibitor, nivolumab (Opdivo, Bristol-Myers Squibb). Nivolumab is the approved second-line therapy for patients with recurrent lung cancer. This initial trial of CIMAvax will be a combined phase 1/phase 2 study that will enroll up to 90 patients. We expect the trial to take at least 3 years.

Q: Is there reason to believe the vaccine ultimately could be used to preve nt lung cancer in those at high risk?

A: Yes. We are very optimistic that this vaccine has the potential to not only treat advanced lung cancer but may offer the chance to prevent the disease in those at high risk for lung cancer. CIMAvax targets the tumor’s food source, the EGF protein, and it is called a vaccine because of the way it harnesses the body’s own natural immune defenses.

Q: Considering lung cancer is the leading cause of cancer mortality in the United States, what impact do you think this vaccine could have?

A: The science tells us that this vaccine is unique, that there is nothing like it anywhere else in the world and that it has the potential to help tens of thousands or maybe millions of people. There are more than 1 billion smokers worldwide. Not all lung cancers are caused by smoking, but it is a factor in the vast majority of lung cancer cases globally. We see 1.82 million new cases of lung cancer and 1.59 million deaths annually from this disease. That amounts to 19% of all cancer deaths. The toll this takes both in terms of human life and the financial costs on families and on health systems is devastating. We are hoping that CIMAvax can make a difference and help to reverse these impacts.

Q: Is it possible the vaccine could be effective in other tumor types?

A: Yes. Our team believes CIMAvax may be effective against other types of epithelial cancers, including head and neck, colon, breast, prostate and pancreas cancers. Depending on what we learn with the initial studies, we expect to look at those possible additional applications in later studies down the road.

Q: Cuba has developed other medical treatments that are not yet available in the United States. Might this initiative lay the groundwork for future U.S.-based investigations or improved access to those therapies?

A: Yes. Centro de Inmunologia Molecular scientists have created a number of innovative therapies, not just for cancer but for many other serious and common diseases and medical conditions, including Heberprot-P, a therapy they developed for diabetic foot ulcers. They have developed a number of vaccines and monoclonal antibodies. We are interested in how some other therapies might improve outcomes for patients in the U.S. and elsewhere, and we are now starting to look at a few of them in the lab. – by Jennifer Southall

For more information:

Candace S. Johnson, PhD, can be reached at Roswell Park Cancer Institute, Elm and Carlton streets, Buffalo, NY 14263; email: candace.johnson@roswellpark.org.

Disclosure: Johnson reports no relevant financial disclosures.