Report review: " Governor Cuomo Announces First-Ever Biotech Venture Between U.S. and Cuba to Research and Develop New Cancer treatments"
The report in Cuba Standard on September 26th, 2018, of the arrangement between the Centro de Inmunología Molecular (CIM) and Roswell Park Comprehensive Cancer Center around CIMAvax-EGF and other experimental cancer drugs to be set up in Havana’s port of Mariel, reflects well on CIM’s assembly of superior intellectual capacity, the originality of much of its work, and its importance in differentiating Cuba’s scientific accomplishments over the rest of Latin American.
Indeed, when CIMAvax-EGF was devised some 24 years ago(1) CIM became, to our knowledge, the first in the world to have a passive (monoclonal antibody) and active (vaccine) immunotherapy to the same target – EGF. Hugely impressive. Both the monoclonal antibody (Mab), nimotuzumab, and the vaccine, CIMAvax-EGF, were joint ventured to CIMYM, the cancer-focused JV subsidiary in Canada of YM BioSciences, in 1995 and 2000, respectively. In 2005, Toronto-based YM became the first organization in history to treat US patients with FDA clearance for a Cuban-origin drug and is the first to achieve approval from the US Office of Foreign Assets Control to import Cuban medications. It did so treating children suffering from inoperable brain cancer – diffuse intrinsic pontine glioma – in US centers signed to conduct the trials that included MD Anderson, Memorial Sloan Kettering, Johns Hopkins , and Vanderbilt.
Roswell’s proposed combination of CIMAvax-EGF with the more recently-discovered checkpoint inhibitors, in this case the Mab “nivolumab”, is an important advance on the YM Phase II monotherapy trials with the CIMAvax-EGF of ~20-year ago conducted in the UK and Canada, and the new protocol mirrors the numerous trials in the US that are attempting to improve the efficacy of the checkpoint inhibitors that have already been launched. There are a plethora of trials underway at this time to broaden the effect of checkpoint inhibitors and expand their use beyond the limited applications at present so that Roswell’s initiative, while interesting, should definitely not the considered as "game changing” and enthusiasm for its prospects must be tempered with the recognition that more than 85% of cancer therapies in early-stage development fail to achieve FDA approval. Readers may also wish to be mindful that there are a reported 61,158 oncology drugs in current development suggesting a highly competitive environment populated by the most prestigious cancer research hospitals in the world and hundreds of well-financed corporations a number of which have market capitalization's that exceed Cuba's GDP of ~$90 billion. It may also be of interest to readers that Roswell links the $4 million worth of donations to its 13-patient Phase I trial, and we would caution that the allurement of the claimed novelty of the arrangement with Cuba and CIM might be tempered with understanding that a Phase I oncology trial would typically cost in the range of $25,000/patient.
As to the novelty, the September 26th statement by NY Governor Cuomo that the arrangement is "historical" and "a historic step" is hyperbole based on embarrassingly-poor preparation in omitting YM BioSciences’ and YM USA’s joint ventures with CIM from 1995 to 2011, YM becoming a US-listed public company and, probably more importantly, that YM's joint ventures were Canadian and US-based, omitting the numerous complications that will attend a Cuba-based joint venture in the container port of Mariel.
Whilst being supportive of all initiatives in the rapidly-changing world of cancer immunotherapy, we are mindful of being cautious about any euphuistic or overarching expectations for cancer therapies in research. Since approval from the FDA typically follows large, randomized Phase III trials that require many years of testing, and Roswell’s Phase II trial will probably not generate a report before 2022, expectations should be modest and caution paramount. Finally, the combination, if successful, of two off-patent drugs will require remarkable intellectual property skills for the result to extract economic value.