Chris Collins’ Indictment Reveals Dark Side of Immunotherapy

MIS416 was touted as a miracle drug that could potentially cure a severe form of multiple sclerosis. But it might have been hyped up too quickly.

chris collins rep new york ny immunotherapy mis416 secondary progressive multiple sclerosis spms innate australia insider trading fraud

Tom Williams/Getty

Federal prosecutors say a New York congressman who passed an insider trading tip to his son was spurred by news from a biopharmaceutical company that an experimental drug hailed as a possible miracle cure for a form of multiple sclerosis had failed its latest clinical trial.

The company was the Australian-based firm Innate Immunotherapeutics, where Collins served on the board of directors and was the top shareholder. As The Daily Beast reported earlier this year, Collins’ involvement with the company was rife with ethical issues.

At the time, Innate was focused on the creation of a single immunotherapy product aimed at treating an advanced, debilitating condition called secondary progressive multiple sclerosis, or SPMS.

The product was called MIS46 and it could have been immensely valuable—to investors and to patients suffering from SPMS.

Multiple sclerosis is a neurodegenerative disease that affects how the brain talks to the body, and vice versa. When a person wants respond to some stimuli through movement—like look in the direction of a loud sound or scratch an itch—the brain-body connection is activated. MS inhibits this brain-body communication highway by turning the body's immune system against the central nervous system, a complex network running between the brain, spinal cord, and nerves.

The prospect of harnessing the human body to heal itself instead of subjecting it to toxins is tempting to researchers—and investors—the world over.

The immune system’s attack instigates inflammation that destroys myelin, which can be thought of as a fatty insulating product that hugs and blankets nerves. As that process progresses, the nerves themselves start to break down. Eventually, the inflammation can even reach cells that double as factories for myelin, completely destroying the ability for the central nervous system to communicate with the brain.

At this point, patients start to experience symptoms, which can vary depending on lifestyle and genetics but include fatigue, trembling, halted speech, muscle pain and loss, an inability to perform basic motions, and vision difficulties.

The disease is incurable, and researchers have many theories but no idea as to why it affects certain people.

Several treatment options emerged, and numerous drugs have been used to delay the inevitable breakdown of myelin and its destruction of the central nervous system: Copaxone, Tysabri, and more, many with ugly side effects.

A 2012 New York Times article profiled a patient who resorted to an unusual method: blowing a small balloon within a vein between the body and brain to improve blood and iron flow and prevent blockages that could cause the toxic myelin breakdown.

Which brings us back to SPMS, the secondary phase of multiple sclerosis that Innate was involved in. Some patients with MS swing back and forth between flare-ups and less severe recovery phases. These remissions might seem good, but they can also indicate that the patient has SPMS, an indicator the disease is transforming into a more debilitating form that will inevitably lead to reduced motor function.

Not all MS patients develop SPMS, and the variant of the disease is as much of a mystery in terms of origin, trigger, and treatment. The only apparent pattern is that increasingly severe relapses mean a greater chance that nerves are in the last stages of damage.

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It’s a terrible disease—one that Collins and Innate Immunotherapeutics stood to make a fortune on by capitalizing on immunotherapy as a possible treatment for SPMS.

Therapies for rare and hard-to-treat diseases can be gold mines. Millions of people suffer from MS and some are either in the throes of SPMS or about to develop it. And highly targeted immunotherapy is incredibly expensive, with a single treatment cycle costing tens of thousands of dollars.

The immune system’s direct effect on the central nervous system makes immunotherapy—in which doctors puppeteer the immune system and coax it or fool it into behaving a certain way—especially promising for SPMS sufferers.

Doctors have tried a slew of hard-to-pronounce medical treatments—beta-interferon, glatiramar acetate, monoclanal antibodies, dimethyl fumerate, fingolimod—to reduce inflammation and slow the brain-body breakdown, turning to other pharmaceuticals to treat muscle spasms and fatigue.

But MIS416 offered a new approach as futuristic as its name -- and new hope for patients. Documents kept by the National Institutes of Health describe it as a vaccine adjutant and a “non-toxic microparticle.”

In simpler terms, it’s a substance designed to elicit a specific immune response—either killing foreign invaders or reversing the immune system’s mistaken attack on itself—by parading around as an antigen, a toxic substance that the immune system would naturally attack.

In 2009, MIS416 was hailed by pharmaceutical watchgroups as “promising” and potentially helpful in diseases as wide-ranging as HIV, tuberculosis, and malaria. By 2012, Innate was crowing about early results, citing an 80 percent improvement rate in symptoms.

This increasingly coherent research around symptomatic relief, especially for those with secondary progressive forms of Multiple Sclerosis, is an exciting and extremely positive move in the right direction for those with MS and their families.

But in June 2017, MIS416 failed in clinical trials in New Zealand, when researchers could not show any noticeable differences in neuromusculoskeletal performance compared to placebos. Innate passed on the bad news to its board of directors, and Collins allegedly broke the law by sharing the inside info with his son, allowing him and associates to dump Innate stock before the results were publicly announced, tanking the share price.

Innate has since turned its focus to Focal Adhesion Kinase, or FAK, inhibitors that could help treat pancreatic and ovarian cancer and idiopathic pulmonary fibrosis. But despite Innate’s failure of MIS416, immunotherapy remains a thrilling frontier that extends well beyond the realm of cancer, where it’s had the most success. It’s even been tested on peanut allergies.

The prospect of harnessing the human body to heal itself instead of subjecting it to toxins is tempting to researchers—and investors—the world over. But as Collins’ indictment shows, that lure can also have a dark side.