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Sooch aims to duplicate at Gemphire the golden touch she had at ProNAi

Monday, December 15, 2014   (0 Comments)
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Mina Sooch, who raised the largest round of venture capital in state history in April for Plymouth Township-based ProNAi Therapeutics Inc., is at it again, hoping to raise another big chunk of venture capital for another early-stage drug company, Northville-based Gemphire Therapeutics Inc.

When the year began, Sooch was president and CEO of ProNAi. As it ends, she has the same titles at Gemphire. The company was formed as a Delaware C corp last month to bring to market gemcabene, a drug licensed from Pfizer Inc.

In September, Sooch left ProNAi as part of its plan to go public early next year. To prepare for life as a public company, ProNAi recruited a veteran of publicly traded biotechs, Nick Glover, as president and CEO. He had been president and CEO of YM BioSciences Inc., a developer of cancer drugs that traded on the New York and Toronto stock exchanges before being acquired by Gilead Sciences Inc. for $510 million last year.

ProNAi's quick ascension from being a long-struggling pharmaceutical company to the hottest biotech company in the state grew out of a presentation last December at the annual meeting of the American Society of Hematology of results of phase-two U.S. Food and Drug Administration human trials of a cancer drug with the working name of PNT2258.

The 12 patients in the study had late-stage non-Hodgkin's lymphoma that had been treated unsuccessfully with conventional therapies including radiation. Four went into remission and tumors shrank in 10 of the 12. 

Sooch hopes to catch lightning in a bottle again with Gemphire, which she joined six weeks after leaving ProNAi. 

"I looked at opportunities locally and at interesting opportunities nationally," she said. "I looked at Harvard spinoffs and I looked at San Diego. I spent a lot of time kicking tires. I wanted to lower the risk of whatever I was going to do." 

In the end, staying here and joining Gemphire — which at the time was known as Michigan Life Therapeutics LLC — made the most sense and had the least risk. 

Sooch knew and respected co-founder Charles Bisgaier, who preceded her as president and CEO of ProNAi and was an early angel investor in the company. 

He, Sooch and co-founder David Lowenschuss, the chief legal officer, say Gemphire is a combination of "gem," for what they think is a gem of a drug, and "sapphire," a reference to the career that Bisgaier's father, Abraham, had as a jewelry maker in New York, arriving here from a concentration camp after World War II. 

The risk was reduced by the tens of millions of dollars Pfizer spent between 1999 and 2004 on trials for gemcabene, a drug taken orally once a day. A total of 952 patients with varying levels of LDL — the so-called bad cholesterol — were tested in a total of 17 human trials. Ten were phase-one trials, which found little toxicity, and seven phase-two trials, which showed clinical effectiveness in lowering LDL and triglycerides. 

Before bringing gemcabene to trial, Pfizer decided to focus on another cardiovascular drug, spending $1 billion on Torcetrapib to raise HDL, the so-called good cholesterol. During phase-three trials, patients began dying and the trials halted. Soon after, in 2008, Pfizer ended all R&D on cardiovascular drugs. 

Bisgaier was on the original patent for gemcabene when it was developed by Parke-Davis in 1995. He and Lowenschuss, veterans of Ann Arbor-based Esperion Therapeutics Inc. before it was bought by Pfizer in 2003 and then veterans of Pfizer, tried to license the drug.

After three years of lobbying, in 2011, Pfizer agreed. 

The two then spent three years going through reams of data from the 17 human trials to decide on a first market application, filing for more patents and applying for orphan status from the FDA to treat homozygous familial hypercholesterolemia, a genetic disorder that causes levels of LDL to soar to about 500 milligrams per deciliter of blood. Any level above 129 is considered high. There are estimated to be only 2,000 patients in the U.S. and 45,000 worldwide with the condition, which often results in heart attacks, strokes and death before the age of 20. 

With orphan status approved in February and one patent approved so far, it was time to recruit Sooch and time for her to start raising money again. 

"You cannot find an asset with this much data. The data package is compelling," said Sooch, a native of India who in June was named one of Crain's American Dreamers for her successes here. 

This month, the funding round she raised for ProNAi was honored at the annual awards dinner of the Michigan Venture Capital Association as the financing deal of the year.

Because orphan drugs treat patients with severe or deadly diseases that are rare, they present small markets. Without help, drug companies wouldn't develop therapies, so the FDA provides a streamlined path to market. 

In Gemphire's case, that could mean as little as three years to market instead of nine or 10. And because of all the human trials already conducted, Sooch thinks it will mean a cost of getting to market of $25 million instead of hundreds of millions. 

The company hopes to get FDA approval early next year for trials that will start in the summer. 

Gemphire plans to conduct a small phase-two trial on 10 patients to determine dosing levels, then a phase-three trial of 50 patients worldwide. There are pockets of patients with the condition in the Netherlands, South Africa, Lebanon and Quebec. Because patients are diagnosed early and require lifelong treatment, they are easy to find and test. 

The company has hired six veterans of the pharmaceutical industry who will start work in January and expects to have a staff of 10-12. 

Most development work and the ramping up of production will be done by area contract research organizations and contract manufacturers. If phase-two and -three tests go as planned, market-scale manufacturing would be done by a large pharmaceutical company, Sooch said. 

Only two drugs have been approved for homozygous familial hypercholesterolemia, and both are extremely toxic to the liver, according to the FDA. 

An eventual exit for investors could include a sale to big pharmaceutical company or, like ProNAi, through an initial public offering. 


[Read article online.]

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