by Patrick Cox
February 27, 2017
As Trump shakes up the White House, pharma and biotech are on edge. While the media talks about Obamacare, it turns out that Trump’s new FDA chief could have a bigger impact on health care and associated markets. The story here is that a company in liberal Northern California may have the most to gain from a Trump FDA.
Mount Tam Biotechnologies (MNTM), named for the highest peak of the Marin Hills, is located on the campus of the nonprofit Buck Institute. The Buck was the world’s first institute founded to research aging. Today, it’s a leader in the emerging field of geroprotection.
The term “geroprotection” is replacing “life extension” among scientists. One reason is that many people associate “life extension” with pseudosciences and health fads. Many also assume it means prolonging the frailty and suffering that comes at the end of life (think Howard Hughes).
Biogerontologists don’t want to extend suffering. Rather, their goal is to protect us from the medical and financial effects of aging. They want to extend the healthy portion of our lives (our health spans) for as long as possible. This is known as morbidity compression.
A few decades ago, this goal was science fiction. Most scientists did not think that simple drugs could extend health spans. That’s no longer the case.
Longer Health Spans Are Possible
The cause of this change in attitude is simple. It is the enormous body of research regarding the mTOR gene and the mTOR pathways.
The Buck Institute has played a major role in that research, acquiring significant legal rights to the drug rapamycin. This drug extends health spans in animals via the mTOR gene pathways. Now, those rights are licensed to Mount Tam.
Studies show that mice given rapamycin in their diets live about 15% longer than untreated mice. Let’s put those results into perspective. If we were to put an end to atherosclerosis and cancer in humans, it would extend lifespans by less than 10%.
Even when rapamycin is given to mice that are old, the animals are rejuvenated. They exhibit the traits of younger animals. They show slightly less (but still significant) increases in health spans as the mice that were treated earlier in life.
This rapamycin mTOR gene research is changing the science of medicine. To get an idea of the scope, I searched Google Scholar for rapamycin and got more than a quarter of a million results.
Upending the Old Model for Treating Disease
Increasingly, gerontologists think that age-related diseases are caused by the breakdown of our biological control systems. The immune system is one such control system… and it can be modified using rapamycin. This implies that we could treat other systems to prevent or delay age-related disease.
In spite of this, medicine is still based on the old disease model. Doctors wait for a disease to appear and then treat it. Regulators approve drugs to help treat full-blown diseases. This needs to change.
But the move from a disease cure to a disease prevention model is quite complex. One reason is that proving a drug prevents serious disease is much harder than showing improvement.
Investors have been even slower to catch on to this new paradigm. That’s why the biotech executives that I know think it’s financial suicide to suggest that a drug has anti-aging properties.
This may be the reason that Mount Tam is silent about the geroprotective impacts of its rapalogs, despite the massive body of research. Rapalogs are variations (or analogs) of the rapamycin molecule genetically engineered to reduce unwanted side effects. Based on this patent application, it seems Mount Tam has produced a rapamycin analog without the side effects that would deem it unsafe to regulators.
We have reason to think that both Mount Tam rapalogs would be geroprotective. Rapamycin has, in fact, been used off-label to treat the autoimmune disorder lupus with success.
Mount Tam executives, including the former CEO of the Buck Institute Brian Kennedy, PhD, are not promoting geroprotection as a possible application of its platform. You can imagine that this must be hard for someone who has spent his scientific career pursing anti-aging therapies.
Instead, Mount Tam’s drug candidates are moving forward aimed at systemic lupus erythematosus and cancer. This makes sense because investors know about these diseases… and the potential payoffs.
But President Trump just might change things.
Trump’s FDA May Support Geroprotection
One of Trump’s leading candidates for FDA chief is Jim O’Neill. He has stated that he is committed to an accelerated approval pathway for geroprotectors.
Another candidate, Joseph Gulfo, supports the approval of drugs based on biomarkers instead of actual lifespan data. In other words, a safe drug that makes you medically younger according to blood and other tests could be approved.
Less is known about a third candidate, Dr. Scott Gottlieb, but he does support FDA reform as well.
In the end, Trump’s views on drug approval reform are likely to be more important than those of any FDA chief. And Trump has clearly been listening to billionaire advisor and life-extension advocate Peter Thiel. Thiel believes, as I do, that the only way to fix our medical system is to keep people healthier longer.
This puts Mount Tam in a unique position. Recently, the company signed an agreement with the Buck to license all applications of rapamycin analogs. This includes geroprotection. And behind the scenes, the company seems to be preparing for an FDA change that would support geroprotection. (CEO Richard Marshak has confirmed this to me.)
There are other geroprotectors in development, but rapamycin enjoys distinct scientific respect because of the mTOR research.
— This Company with Anti-Aging Drug Is Secretly Preparing for Trump’s New FDA originally appeared at Mauldin Economics.