(Marin Independent Journal (CA) Via Acquire Media NewsEdge) Aug. 18--A new company spun off from Novato's Buck Institute for Research on Aging will focus on bringing promising new compounds for treating lupus and other autoimmune diseases to market.
The new company, Mount Tam Biotechnologies, has licensed worldwide rights to the compounds from the Buck Institute.
"These are some of the most promising, late-stage commercial assets in the Institute," said Chester Aldridge, who will serve as chairman of the new company's board of directors.
Aldridge said Mount Tam Biotechnologies has been formed to take these assets, which include 45 patents and patent applications, through the Food and Drug Administration's approval process. Mount Tam Biotech will focus initially on TAM-01, a treatment for lupus. Aldridge said a great deal of preliminary work has been done on TAM-01, and an application will be filed with the FDA soon to begin the trials necessary for regulatory approval for sale.
The compounds that the Buck Institute is licensing to Mount Tam Biotech weren't developed by the Buck Institute. They were acquired more than a year ago from Biotica Technology Ltd., itself a spin-off from Cambridge University.
The Buck Institute began a three-year collaboration with Biotica in September 2011 to study the potential of rapamycin for treating age-related diseases. Rapamycin, an mTOR inhibitor, is an immunosuppressant drug approved for use by the U.S. Food and Drug Administration to help prevent organ rejection after transplants.
In a prepared statement, Buck Institute CEO Brian Kennedy said, "At the Buck, we are working to understand how normal aging contributes to the development of conditions specifically associated with getting older. mTOR is a keystone in this scientific journey as we work on understanding how chronic diseases, like the autoimmune diseases Mount Tam is working on, make it harder to live healthier as we age."
Stelio Tzannis, who will serve as Mount Tam Biotech's CEO, says there is little doubt that rapamycin can be an effective weapon against lupus, a chronic, autoimmune disease that can damage various parts of the body, including internal organs.
"There were a couple of studies published within the last three years in which they exposed lupus patients to very low doses of rapamycin," Tzannis said, "and they were able to see significant reductions of all the biomarkers of the disease."
The problem with using rapamycin in its natural form has been that it can cause severe and sometimes fatal side-effects, Tzannis said. He said, however, the rapamycin analog developed by Biotica appears to have eliminated these side-effects.
Dr. Andras Perl, a professor of rheumatology at SUNY Upstate Medical University, said clinical research has shown that mTOR is a validated pathway for the treatment of lupus.
Dr. Joan Merrill, medical director for the Lupus Foundation of America, however, said it is too soon to say with certainty that rapamycin will be effective in battling lupus.
"That is not something that anyone should be claiming," Merrill said. "Really, there isn't a lot of data."
The FDA approved the first treatment for lupus, Benlysta, in 2011, but it is expensive and has proven to be only marginally effective. If TAM-01 does ultimately prove effective, it could be a very lucrative drug.
Aldridge said drugs developed for lupus qualify for protections afforded by the Orphan Drug Act, passed by Congress in 1983. That legislation, gives orphan drug developers exclusive sales rights for seven years plus tax incentives for conducting clinical trials. The law was designed for drugs that affect fewer than 200,000 people.
But Aldridge said the market for a drug to treat lupus would be much larger than for typical orphan drugs, since lupus affects 1.5 million people in the United States and at some 5 million people worldwide.
Mount Tam Biotechnologies is the latest venture of US Equity Holdings, a corporate incubator created by Aldridge. Through US Equity Holdings, Aldridge manages numerous companies in the fields of entertainment, the Internet, clean energy and biotechnology.
"I'm really a serial entrepreneur," Aldridge said. "My expertise is licensing very strong intellectual property and then bringing in the right management team, and going through value-creation milestones."
While serving as the CEO of the now defunct Red Mile Entertainment, a Sausalito-based video game publisher, Aldridge licensed and published MTV's JackAss and Frank Miller's Sin City.
Tzannis, who will serve as Mount Tam's CEO, currently oversees Delos Pharmaceuticals Inc., another Buck Institute spinoff created in 2012 to develop other compounds acquired from Biotica.
Tzannis said Mount Tam Biotechnologies will operate out of offices at the Buck Institute, and Buck Institute researchers will work collaboratively with the company. He said, however, that Mount Tam's clinical, regulatory and manufacturing work will be outsourced. The company will be comprised of Tzannis, Ben Zadik, who will serve as the chief financial and operating officer, and Mohammad Modarres, vice president of operations.
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