Mundo Sano

Recently, I noted the announcement of the successful completion of a Phase II trial of a cancer vaccine called racotumomab (with the more-easily-pronounced product name of Vaxira) in which the number of advanced non-small cell lung cancer patients reaching two years’ survival was tripled from 8 to 24% (FierceVaccines article).  The idea of using a vaccine to amplify the immune system and slow the progression of cancer seems sound to me, given my amateur understanding that some small fraction of the trillions of cells that make up an average human body are deviating into abnormal, precancerous growth all the time and the most likely it is the immune system that keeps us from having cancer all the time by identifying and removing the bad actors (however the scientific jury is still out, e.g., Swann and Smyth 2007).  A number of companies have been developing products based on this theory, but as was reported by FB Vaccines from the June American Society for Clinical Oncology annual meeting, progress has been slow and (another FierceVaccines article).

What caught my attention was that Vaxira resulted from an Argentina-based international collaboration of public institutions and private companies called Investigacion Desarrollo Innovacion (IDI ) and that the origin of the product, eighteen years ago, was the Molecular Immunology Center in Havana, Cuba (Financial Times article).  Here’s what else I found out:

Target:  non-small cell lung cancer is catch-all category for most types of lung cancers (about three-fourths of all lung cancer diagnoses), has a high mortality rate (86%), and is the cause of death for some 1.4 million people worldwide (WHO 2008 cancer facts ).

Technology:  the vaccine is based on a unique “anti-idiotype” approach.  Unlike most vaccines in which the target itself is administered to stimulate the immune response, the antigen in this approach is a monoclonal antibody mimic of the target.  For Vaxira, the target is a part of a cell membrane component (a ganglioside) that is unique to several human tumors.  It is injected to mice to produce an antibody which is put into other mice to yield an antibody to an anti-body (and anti-idiotypic antibody).  It is this second antibody that is used as the vaccine and the resulting human immune response is theoretically highly specific to the tumor antigen (for more on the science, see Vazquez et al. 2013 and the diagram at Recombio Products).  It is not clear to me how the immune response stops the cancer; Vazquez et al. implied the tumor cells are the target, but a quote by the scentific director of IDI indicated it stops new blood vessel formation (IDI).  I’m also not sure how the vaccine is produced at scale, possibly it is via a standard monoclonal production method (e.g., Li et al. 2010).

Funding of development:  according to the Financial Times article, the funding for developing the product cost about $100 million of which 60% was from Grupo Insud, a family-run Argentinean conglomerate of agri- and bio-businesses (Insud), and the remainder given “in kind” (non-cash assistance) by the Cuban government.  More costs are to come since a Phase III trial is underway according to IDI.

Commercialization:  IDI has licensed the rights to Vaxira geographically to a number of companies:  Elea Laboratories (Argentina and a Insud company), Eurofarma (exclusive license in Brazil and semi-exclusive rights for the rest of the continent), Innogene Kalbiotech (Korea, Taiwan, India, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Singapore, Thailand and the Philippines), and Recombio (Europe and the rest of the American and Asian countries).  The therapy will be priced at $20,000 per course (Financial Times article) which is substantial, but low relative to US pricing of similar immunotherapies for cancer (Dendreon’s Provenge for prostate cancer is priced at $90,000).  From this price and a use that requires a hospital setting (15 doses over twelve months in conjunction with standard therapy), I surmise the initial market will be self-pay/insured patients at the best-equipped hospitals.  The vaccine has been approved in Argentina and Cuba and soon will be approved in Mexico, Brazil, Uruguay and Turkey (IDI).  It’s not said if US approval will be sought, and that may require an exemption from the Treasury Department since Cuban products are embargoed.

Global health perspective:  I found no indication of a commitment by IDI or its licensees to making Vaxira accessible or affordable to non-self-pay or well-insured patients.  Interestingly, Insud is the backer of one of the most prominent public/global health foundations in South America, Mundo Sano (“Healthy World”), but the foundation’s focus is mostly on research into neglected, communicable diseases like Chagas, malaria, and dengue, and not the neglected, non-communicable diseases like cancer (Mundo Sano).  However, the foundation has been involved in at least one program for improving access to essential medicines.  Over the past several years, it worked with two Argentinean pharma companies and the government to start commercial production of the main drug used to treat Chagas, which afflicts about 11 million poor in the Americas, and the companies are now the world’s only source of the drug (Mundo Sano 2012 Symposium).  According to a Smartplanet blog, Insud’s CEO expects the vaccine’s development costs to be recouped in five years.  Whether IDI, Insud, and the licensees have a plan for making the vaccine more widely available, e.g., through tiered pricing or subsidy, after covering their costs remains to be seen.

 

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