Lung cancer: One vaccine, new opportunities
It is not just a question of diplomatic and political relations. With the opening of the dialogue on Dec. 17, new opportunities seem to open in multiple spheres for a coming together of Cuba and the United States.
Within this range, Cuban biotechnology — whose prestige has been consolidating for more than three decades — is an issue of interest.
The first therapeutic vaccine against lung cancer, CIMAvax-EGF, which has been utilized clinically for 20 years as a safe and effective product, recently made headlines on the island when it was announced that the Center for Molecular Immunology (its creator and producer) and the Roswell Park Institute in New York signed an accord for its future use in the United States.
On both sides of the Straits of Florida, the expectation that this signing has generated has been rising. On one hand, there is the extremely interesting context of the thaw, when changes are made and openings are expected. On the other is lung cancer (although new results show that the vaccine can be used in other situations), which is among the world’s top diseases in terms of incidence and mortality.
In fact, lung cancer in Cuba is the first cause of death by cancer for men and women, according to the 2014 Health Statistics Annual.
Beyond the media coverage, it should be understood that this accord is barely the first step on a long journey that could lead, as hoped for, to the approval and commercialization of the vaccine in the U.S. market.
To do this, U.S. researchers must first gain the approval of the U.S. Food and Drugs Administration to begin the necessary clinical studies.
What the Cuban Center for Molecular Immunology (CIM) and the Roswell Park Institute have just signed, according to Gryssell Rodríguez Martínez, products manager of CIMAB S.A., exclusive marketer for CIM’s biopharmaceutical products, “is an accord of confidentiality to initiate the mailing of documents and the exchange of technical and scientific information (how the vaccine is produced, toxicity data, result of previous tests), with a view to preparing the application for the start of clinical studies in the United States.”
From the success of these exchanges will come a possible future commercialization, which would be the final stage in the process. And the commercialization still must overcome many barriers that might arise in the future.
Arlhee Díaz Miqueli, CIMAB’s regional commercial manager, says that, because the U.S. market is the world’s largest from the biotechnological standpoint since it has the largest number of marketing companies in that sector, the opportunity to penetrate it is very attractive to Cuba.
“For Cuba, it is a challenge to bring its products to the First World, mainly to the United States, a country with high regulatory standards. Besides, it would represent one more step toward breaking the economic blockade with our products.”
This is the first accord signed with the Roswell Park Institute but the second approach in a journey that began in 2004.
That year, says Gryssell Rodríguez Martínez, there was a similar exchange with another U.S. company that failed and went bankrupt because one of its own vaccines failed to meet official criteria in clinical tests. We had begun our collaboration with the preparation of the paperwork, which we repeat now with [Roswell Park], documents that will enable us to begin clinical tests and, later, apply for regulatory action.”
CIMAVax-EGF, which is a promising alternative, offers Cuba multiple opportunities. Recently, the Fifth International Workshop on this biotechnological product confirmed its efficacy against advanced lung cancer. Studies showed that it is a safe vaccine, with low levels of toxicity, and good tolerance. It has an impact on survival and improvement in the patients’ quality of life, plus sustainable costs of production and storage.
“This is a novel therapeutical strategy, capable of generating antibodies from the patient himself against the epidermal growth factor EGF, the principal molecule that activates the receptor of epidermal growth factor EGFr, a receptor that intervenes in the processes of carcinogenesis,” says the CIM’s official announcement about the abovementioned workshop.
The therapeutic action begins when the antibodies generated by CIMAvax-EGF against the EGF inhibit the activation of EGFr and halt the proliferation of tumor cells. Consequently, the progress of the disease is controlled, survival increases and the quality of life for the patients improves significantly.
In other words, the vaccine “slows down” the epidermal growth factor in the body without reducing its levels to zero.
This way, the EGF, which is in charge of growing skin, organ cells and tumor cells, does not disappear altogether but concentrates on normal functions and stops promoting the growth of sick cells.
It could be said, then, that the mission of CIMAVax-EGF is to turn the cancer into a manageable chronic disease and deprive the disease of the synonym of death, for the 5 million people that, according to the World Health Organization, die every year of it.
The immunogen, which has so far benefited more than 3,000 patients, mostly Cubans, became part in 2015 of the basic basket of medications on the island. This will facilitate its use at all levels of the national health system, especially in primary care.
According to Gryssell Rodríguez Martínez, the vaccine has been registered for the treatment of lung cancer in Cuba, Perú and Paraguay. It is expected that this year it will be registered in two other hemispheric nations. Actions are being taken to incorporate it into markets such as Asia and Africa.
To Beatriz García, regional commercial manager of CIMAB, there are many advantages and challenges to this product, “which has reached a certain level of development, with clinical tests in Phase Three that have permitted its acceptance in three countries.”
“The vaccine has broad demand in the market, given that the incidence and mortality of cancer is very high, even in regions like Europe and Asia.”
This month, the vaccine is undergoing a multinational clinical test in 70 sites in the United Kingdom, Malaysia, Thailand, some countries in Southeast Asia, Poland, Spain and other countries in Europe. The Cuban health authorities continue to press for authorization of tests in other countries in the Old Continent.
“The expectation is to end Phase Three of the tests in 2018, with positive results,” García said. “That could mean a high-standard registration in the future in an important market, and that would mean its distribution not only in Europe but also in other territories, such as Asia.”
An increase in the market would also imply an increase in the productive capacity that would allow covering the national demand and the demand of the markets of interest. The CIM is already working in projects for foreign investment in the Special Development Zone of Mariel (ZDEM), a swift, efficient and safe way to broaden these capabilities.
One of those projects is the construction of a Biopharmaceutical Production Plant operating as a joint venture. This would be an industrial biotechnological installation for the production of as much as 10 kilograms of therapeutic proteins for the treatment of cancer and other chronic diseases. Said facility will cover an area of approximately 6,000 square meters and will be situated in the ZDEM.
According to the project, with an approximate cost of $30 million, the net value estimated for the plant would be $49.3 million, with a return rate of 40 percent, which makes the investment recovery period 3.7 years.
Some restrictions over the medical equipment and the research were lifted by President Obama, but for the collaboration between Cuba and the U.S. on issues of scientific research and biotechnology to receive the necessary momentum, the U.S. Congress will have to agree to lift the economic blockade.
For now, facing the so-called silent epidemic of the 21st Century, Cuba and the United States are starting to dialogue and the first therapeutic vaccine against lung cancer. CIMAVax-EGF, is the leading player.
