Pretend for one moment that all refrigerants in the world evaporate and there is no longer any way to store food in the summer. Fresh fruit would still exist. Chickens would still exist. You’d lose out on ice cream and frozen pizza rolls, but for the most part, food would still be here. There would just be no way to keep it cool and preserved.
Now ask yourself who would be able to eat. The short answer is, people close enough to the source to get it before it goes bad. But transporting food to the outer reaches of society, especially in August, would mean that much of the abundantly available food being shipped would spoil in transit. There would still be plenty of food around, it’s just that a lot of people wouldn’t be able to receive it in when they need it.
Drug companies deal with this dilemma all the time. In fact, it’s one of the most vexing troubles in biotech: how to get medicines to people where refrigeration is out of the question. Exactly how bad is the problem? Christopher Schaber, CEO of Soligenix at 29 Emmons Drive, says as much as half of all vaccines en route to the sick don’t make it to them.
Another statistic, according to a report Soligenix released in May: The vaccine market is a $21 billion annual enterprise and 98 percent of all vaccines require refrigeration. That’s $20.6 billion. And kindergarten math will tell you how much money is lost when half of those meds die in transit.
Temperature changes in transport and storage can take out a batch of vaccines faster than your unrefrigerated countertop can ruin bananas. And these changes can come from broken refrigerators, overheated trucks, or even someone leaving a package of vaccine on a dock. Any of these can render a liquid vaccine useless in a couple of hours.
Stunningly, amid this worldwide problem, the solution Soligenix has at its disposal is usually overlooked in favor of the company’s impressive and promising pipeline of drugs for, perhaps fittingly, typically overlooked illnesses. The company’s development of drugs for pediatric Crohn’s, cutaneous T-cell lymphoma, and oral mucositis have all gotten the attention of industry publications and investors, and rightly so. These drugs promise to rein in two relatively rare diseases and one devastating side-effect of cancer treatment.
But we’ll come back to that. The overlooked process Soligenix has developed with the University of Colorado is called ThermoVax, a method of stabilizing alum-based vaccines at temperatures above the refrigeration level. The process essentially powders volatile liquid vaccines that can later be reconstituted in the field, often with water. This drastically reduces or eliminates the need for cold-chain processing, manufacturing, and distribution of vital-but-volatile compounds. That’s not just good for getting vaccines to people who need them, it also drastically cuts down on the cost of getting a drug from the lab into someone’s body. According to the company’s May report, it’s a $200 million investment to establish and maintain a cold-chain operation.
The roots of ThermoVax itself stem from the aftermath of terrorism. In 2003 there was a series of ricin mail attacks that, while not ultimately deadly, managed to shut down several U.S. Senate offices as a precaution. (Fans of the TV show Breaking Bad will also know ricin’s reputation as an untraceable toxin perfect for poisoning meddlesome corporate executives.) Ricin powder is serious stuff — few grains inhaled or injected can kill a healthy adult.
It’s also not that hard to make. Ricin, after all, comes from castor beans, which are abundant. The good news is that a ricin vaccine exists. The bad news is that the vaccine is an extremely volatile liquid, Schaber says.
“Out of tragedy always comes a call to action,” he says. “As you’re confronted with the development of products, you look for solutions.”
Soligenix, which at the time was called DOR Biopharma (the name changed in 2009), looked for ways to stabilize the ricin vaccine and found the ThermoVax process. This process has since been applied to vaccines for Ebola (a project with the University of Hawaii) and human papilloma virus (HPV.)
These diseases are not the types Soligenix develops drugs to treat. Rather, the company’s contribution to biodefense vaccines, Ebola, and HPV lies in stabilizing drugs so that more of them can reach their intended patients. But the company’s attention to the panoply of drugs and how to make them more available is at the heart of its business model. It is a rather unusual model that in part develops orphan drugs for rare conditions and in part taps into government-funded biodefense research money.
As CEO, Schaber is also the guy who finds and secures government grants. And he’s good at his job. Soligenix has more than $57 million in government money to use alongside its private-investment money for therapeutics — and that includes $2.7 million from the National Institute of Allergy and Infectious Diseases that Soligenix just got in mid-August to further advance its ricin vaccine work.
Money for its therapeutic programs is also coming in. Despite a second quarter that finished lower than the first, Soligenix in early August entered into a $10 million equity purchase agreement with Kodiak Capital Group, Kingsbrook Opportunities Master Fund, and River North Equity to fund its Phase III studies on T-cell lymphoma and pediatric Crohn’s, plus its Phase II studies regarding oral mucositis.
Of those three diseases, Schaber has the most direct view of pediatric Crohn’s. Two of his brother’s sons have the disease, which is far less common in children than adults. There are about 100,000 children affected with Crohn’s in America, compared to more than 1 million adults. Both Schaber’s nephews were diagnosed before turning 10 and both are now teens. “Kids get lost in the overall discussion of Crohn’s,” he says. “But it’s often more aggressive in children. And the two forms are different.”
The drug for oral mucositis is looking to combat a nasty side effect of chemotherapy, particularly in cancers of the head and neck. Chemo and radiation going directly into the head and neck pummel the body’s immune system, especially in the warm, wet mouth. Oral mucositis is often the result, and its symptoms are a mouthful of blisters, sores, and lesions that make it too painful for sufferers to so much as drink. As a result, Schaber, says, a lot of cancer patients, particularly older ones, stop their treatments because the cure is far worse than the illness.
Phase II studies for mucositis are in the works and Schaber expects answers after clinical trials by the end of this year. Data sets for Soligenix’s cutaneous T-cell lymphoma and pediatric Crohn’s drugs are expected by the ends of 2016 and 2017, respectively.
Part of what makes Soligenix capable of running so many different kinds of programs lies in the structure of the company itself. Schaber says “There are no silos,” meaning that all 20 of the company’s full-time staff, like himself, have to play more than one instrument.
This, he says, is reflected in the company’s perch on the conservative/risk-taking scale. He compares the company’s project breadth to a portfolio, where some programs are more conservative and others take chances. A lot of it is faith, he says. And a lot of it is the inherent gambler anyone in pharma needs to be.
“In biotech, there’s always a level of risk,” he says. “If you’re risk-averse, you don’t want to be in life sciences.”
Risk-taker or not, Schaber has a well-stacked deck. His staff is made of numerous veterans of the biotech industry who have been in the development segment and also understand how to deal with regulatory bodies like the FDA or European agencies.
Schaber himself is a veteran of the regulatory arm of biotech. This, along with his scrappy upbringing, has made him a genuine force in the pharma game. Born and raised in South Philadelphia, Schaber grew up blue-collar. His father was a machinist and his family was the hard-work type. He was the first to go to college, at Western Maryland College, which was paid for by a football scholarship. He’s of course an Eagles fan, and his son is now playing football in high school. Schaber studied chemistry, business, and economics at Western Maryland.
Schaber later got his master’s in pharmaceutics from Temple and his Ph.D. in pharmaceutical sciences from Union Institute & University in Cincinnati. He began his career in 1989 in process development, manufacturing drugs, but was lured into regulatory affairs, which he did with Liposome and Elkins-Sinn until 1994. He then became director of regulatory affairs and operations at Ohmeda until 1996, when he co-founded Acute Therapeutics (now Discovery Laboratories) and served as its VP of regulatory compliance. He stayed with Discovery — and grew it into a $150 million enterprise — until he joined DOR in 2006.
Schaber admits he doesn’t have much of an outside-the-lab life beyond being a dad and trying to stay in shape. Like most biotech CEOs, he has a lot to focus on and a lot he’s proud of. His 25 years in the business have contributed to lives saved, including those of children suffering certain respiratory illnesses.
He is equally proud of where Soligenix is going, poised as it is to fix uncommon, but terrible illnesses and assist in the treatments of acquired diseases that have cures, but not a great track record of getting to patients on time.
In five years, he of course hopes to be telling the great story of market drugs Soligenix has developed and the lives those medicines have saved and aided. “We’re going to keep driving, so long as the data drives us,” he says. “Ultimately, it’s the lives we save. That’s what it’s all about.”
Soligenix (SNGX), 29 Emmons Drive, Suite C-10, Princeton 08540; 609-538-8200; fax, 609-452-6467. Christopher J. Schaber, CEO. www.soligenix.com.