***see below = “We believe that sometime in the first half of 2016 we should have an IND filed on our small molecule and companies with an IND filed tend to be worth north of half a billion dollars.”
Regen BioPharma’s new drug therapy clears FDA hurdle
La Mesa is not the typical area to start a biotech company –– and Dr. David Koos, CEO of Regen BioPharma, Inc. is not your typical biotech CEO.
“For me, what you see is what you get, I’m pretty basic. I’m interested in the science, but not the way a scientist is necessarily. I’m interested in it as a fan, someone who is excited about breakthroughs.”
Koos founded Regen “through the course of good luck” with partner Dr. Tom Ichim and in 2012 took the company public. Ichim was the one with the scientific know-how and Koos, whose degrees are in finance and behavioral science, brought experience from the business world, although the field of medicine was already in his blood.
~~~ Koos (left) and Dr. Harry Lander, president and chief scientific officer of Regen BioPharma (Photo by Jeff Clemetson)~~~
“I came out of a medical family,”Koos said. “My dad was a doctor; brother’s a doctor; my mom and aunts were all nurses so I had a natural interest in what was going on in biotechnology.”
Before diving into a biotech startup, Koos worked as an investment banker in Palm Springs then Beverly Hills, but grew tired of the traffic and “fast-paced lifestyle” of Los Angeles and moved back to La Mesa with the intention of starting something new.
“I got back here and got somewhat introspective about what I wanted to do; if I wanted to continue to be someone who raised money in finance companies or if I wanted to be somebody that actually built something.”
That something Koos built is starting to pay off.
Regen recently cleared an Investigational New Drug (IND) application through the FDA for HemaXellerate, a drug therapy that treats aplastic anemia. The drug now can move to clinical trials involving patients. Aplastic anemia is a potentially fatal bone marrow disease that prevents the body from producing enough blood cells, leading to bleeding, infection and fever.
“We’ve gone from ideas to actually having substance in the company. So that’s huge,” Koos said. “There (are) lots of biotech companies out there that say, ‘this is what I want to be when I grow up,’ but we’re actually starting to put some meat on the plate.”
HemaXellerate is a biologic drug therapy that involves “taking your own body cells, concentrating a specific type of them and reinjecting them,” said Dr. Harry Lander, president and chief scientific officer of Regen Biopharma. “Typically, (a doctor) would take about 200 cubic centimeters of fat cells and put in a proprietary and patented cocktail of enzymes to dissolve the fat cells and isolate the stem cells from the fat and those are what gets injected back into the bloodstream and they find their way right to the bone marrow.”
Naturally occurring aplastic anemia is very rare –– only around 600 cases a year in the U.S. It is much more common for patients to contract the disease after undergoing chemotherapy or other radiation treatments, Koos said.
When Regen was first being developed, Koos and Ichim went through a list of thousands of pieces of intellectual property that were available but weren’t being developed. They picked therapies they felt they could develop, HemaXellerate being one of them.
“From our standpoint we took this (intellectual property) and moved it forward because it was an area that we felt was way underserved and aplastic anemia seems to be an issue with patients that are treated with chemotherapy and radiation because those therapies tend to kill off blood cells and make it hard to reproduce them in the bone marrow.”
Besides injectable drugs like HemaXellerate, Regen is also working on “small molecule” (oral pill), stem-cell treatments for cancer.
“What we have going on in cancer therapy is gene-silencing, small molecule and how those interact which will lead to what we believe will be a therapy for treating cancer in a way that is not harmful to the body the way chemotherapy and radiation are,” Koos said.
“These are treatments that are currently –– in the last three years –– are starting to be used,” said Lander. “Jimmy Carter was recently cured of metastasis to his brain. At 91-years-old he’s cured of cancer because of these immunotherapies.”
~~~Dr. David Koos, founder and CEO of Regen BioPharma (Photo by Jeff Clemetson)~~~ The Regen offices at 4700 Spring St. in La Mesa are not what you picture when you think of a biotech firm. There are no labs; no men with white coats peering down microscopes; and no beakers filled with a newly-concocted biochemical. Instead, there are just comfortable offices and a nice view of the city. This is by design.
“We’ve all seen how the typical biotech company works,” Koos said. “Somewhere along the line you go through several rounds of venture capitol; you hire a lot of scientists; you either buy or rent a big building and stuff it full of multimillion dollars of equipment and then if you go through phase one or two or whatever and things fall apart, you’ve got this huge investment and you can’t monetize it. What you spent $10 million on in terms of equipment is maybe worth two, three pennies on the dollar.”
Instead, Regen contracts out the lab work to develop the drugs it has conceptualized and owns or licenses the intellectual property rights for.
“It is a concept that is now being used around the United States and they call it ‘virtual biotech companies,’” said Lander. “Basically, the intellectual property is your main asset, and of course your management team. Doing the science nowadays is essentially a commodity, not always, but it can be a commodity and you can outsource that.”
Research on Regen’s drug therapies were originally done at Oregon Health and Science University. Further research was done at the Torrey Pines Institute and Charles River Laboratories. Other research facilities the company uses are kept secret from competitors.
Financing for the company has come from “a series of private placements,” said Koos. “Up until recently, it’s been friends, family and me.”
Regen is a public company so it can raise money in the capitol markets, a fact that could soon be lucrative for the local biotech firm.
“We believe that sometime in the first half of 2016 we should have an IND filed on our small molecule and companies with an IND filed tend to be worth north of half a billion dollars.”
Koos and Lander stressed that that money is not the only motivating factor for Regen, and even joked that their business model is not like so-called ‘Pharma Bro’ Martin Shkreli’s, who made headlines for purchasing a patent on a lifesaving drug and raising the price over 4,000 percent.
“Ideally, designing some of these new immuno-oncology drugs that are actually small molecules would be sort of a Holy Grail for the insurance companies; for biopharma; and for the patients,” said Lander. “If we can develop a drug that is as effective or more effective than the current biologics –– that is small molecule and therefore much cheaper –– that would be wonderful. People would have access to it all over the world and not just the United States.”
So will Regen relocate to the more typical biotech areas of San Diego County once it makes the big time with a life-saving cancer drug? No, said Koos.
“Every time I bump into somebody at one of these biotech functions they’re like, ‘How come your office is out in La Mesa instead of Sorrento Valley or La Jolla?’ I feel like those areas are so over-penetrated and over-served by biotech –– that and I live about five minutes up the street in Mt. Helix.”
––Write to Jeff Clemetson at jeff@sdcnn.com.
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