CIMAvax reportedly works by stimulating the body’s own immune system to attack epidermal growth factor, a naturally occurring protein that can feed cancerous tumors.
Since 2011, the vaccine has been available for free to the public in Cuba. It also has been approved for use in Peru. According to media reports, the vaccine shows promise as a novel way to treat late-stage lung cancer, but it has yet to gain approval from the U.S. Food and Drug Administration (FDA). Havana’s Centro de Inmunologia Moleculogia Molecular (CIM) and Roswell Park seek to replicate research and development carried out in Cuba under U.S. gold standards for medical R&D.
Roswell Park applied to the US Office of Foreign Assets Control, received a license, and has begun its R&D collaboration. The collaboration includes importing research samples; applying for US Food and Drug Administration approval for US clinical trials for the vaccine; carrying out early-phase clinical trials at Roswell Park to assess safety and efficacy; and, if all goes well, fostering future partnerships between CIM and US firms interested in further development and commercialization of the vaccine. Other anti-cancer immunotherapies developed by CIM also are being studied at Roswell Park.
According to Roswell Park, CIMAvax has been administered to 5,000 patients across the world, including 1,000 Cubans – as of last year. 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.
Another industry player, Bioven, a late-stage biopharmaceutical company focused on cancer, has announced regulatory approval from the FDA to enroll U.S. patients in its on-going, international Phase III trial of its novel immunotherapy, EGF-PTI, in non-small cell lung cancer (NSCLC). EGF-PTI, which was initially developed in Cuba as CIMAvax-EGF, is an immunotherapy that targets the epidermal growth factor/epidermal growth factor receptor (EGF/EGFR) pathway implicated in tumour growth.
Bioven intends to include around five U.S. study centers in the Phase III trial following notification from the FDA that the regulatory review of the Company’s Investigational New Drug filing is complete.
The planned lead investigator for the trial in the U.S. is Dr Ross Camidge, the Director of the Thoracic Oncology Clinical and Clinical Research Programs at the University of Colorado.
Bioven’s Phase III trial is seeking to further establish the safety and efficacy of EGF-PTI in inoperable, late-stage NSCLC. A total of 418 patients will participate in the trial, the primary endpoint of which is overall survival. Up to 30 patients are expected to be enrolled in the U.S.
EGF-PTI’s mode of action is to induce the generation of anti-EGF antibodies, which bind with EGF circulating in the blood to prevent the EGF binding with the EGF receptor. In this way, EGF-PTI neutralizes the EGF/EGFR pathway to the uncontrolled cell division of tumor growth. A biomarker based on the concentration of EGF in the blood is being used to identify patients for recruitment into the trial, whose inclusion criteria also include an assessment of EGFR and other gene mutations. This biomarker was identified by a retrospective analysis of Cuban, Malaysian and European data.
Dr Marianne Nicholson, consultant medical oncologist at Aberdeen Royal Infirmary, Scotland, is the trial’s principal investigator.
Bioven holds exclusive rights to EGF-PTI in territories including Europe, ASEAN and Australasia along with the first right of refusal in the Middle East. Bioven continues in dialogue with Cuba’s CIM in connection with US marketing rights.