CIMAvax Lung Cancer Vaccine Coming to the US From Cuba

Cuba is well known in the US for high quality cigars and rum, but less widely appreciated is the innovative research carried out in Cuba’s Center for Molecular Immunology. That could change if clinical studies of the cancer vaccine CIMAvax go well. The therapeutic cancer vaccine was developed to treat patients with lung and other cancers by a team of researchers at the Cuban research center led by Agustin Lage Davila, MD, PhD.

Researchers from Roswell Park Cancer Institute in Buffalo accompanied Governor Andrew Cuomo on a visit to Havana, the first such visit by a state governor since the decades-old Cuban embargo was lifted. The group finalized an agreement to bring CIMAvax to the US, where they can begin the process for FDA approval. Candace Johnson, MD, CEO of Roswell Park Cancer Center, hopes to get approval to start clinical trials in 6 to 8 months, she told Wired magazine. Since 2011, cancer patients in Cuba have had access to CIMAvax free of charge.

The therapeutic vaccine has a novel mechanism of action in targeting epidermal growth factor (EGF) and depleting circulating levels. Overactivation of signalling by the EGF receptor (EGFR) plays a role in many cancers, including lung cancer. Many treatments act to disrupt signaling by binding to the receptor or inhibiting the EGFR’s tyrosine kinase site. Using an innovative approach, the therapeutic vaccine CIMAvax stimulates an immune response specific to EGF and induces EGF deprivation, thereby disrupting oncogenic signalling by EGFR. To render autologous EGF immunogenic, the protein was conjugated to immunopotentiating protein P64k from Neisseria meningitidis.

Pooled data from three phase I/II randomized trials that included 83 patients with lung cancer and at least one prior chemotherapy treatment, showed that patients who received the vaccine had a mean overall survival significantly greater than the control arm (9.13 vs  4.85 months, P < .02).¹ Another phase II trial of 80 patients showed that vaccinated patients under the age of 60 had significantly improved survival (11.57 vs 5.33 months, P < .02).²

The vaccine is cheap to produce and studies show that it has a good safety profile. Observed side effects include tremors, headache, constitutional symptoms, and arthralgia. Autoimmunity has not been observed.² Dr. Johnson in an interview with Buffalo Business First expressed interest in CIMAvax’s potential for treating later-stage lung cancer as well as other applications.³

“Our hope is that it may have value in prevention because it is so nontoxic. This drug could have applications for preventing reoccurrence and applications for people who are at high-risk for lung disease.”

References:

• Gonzalez G, Crombet T, Neninger E, et al. (2007). Therapeutic vaccination with epidermal growth factor (EGF) in advanced lung cancer: analysis of pooled data from three clinical trials. Human Vaccine. Jan-Feb; 3(1): 8-13.
• Neninger EV, de la Torre A, Osorio MR, et al. (2008). Phase II randomized controlled trial of an epidermal growth factor vaccine in advanced non-small-cell lung cancer. Journal of Clinical Oncology, Mar 20; 26(9):1452-8.
• Kline A. (2015). Roswell Park CEO has high hopes for Cuban lung cancer vaccine. Buffalo Business First.