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U of Miami, Seed-One Launch Heat Biologics To Develop Lung Cancer Vaccine, Asthma Rx

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This article has been updated from a previous version, which incorrectly said that UM Innovation, rather than the university, sometimes takes an equity stake in UM spinouts.
 
The University of Miami Miller School of Medicine and venture capital firm Seed-One Ventures last week said that they have created a startup company called Heat Biologics to further develop a potential lung cancer vaccine and asthma therapy discovered at the school.
 
The vaccine, based on the heat shock protein gp-96, is intended as a treatment for non-small cell lung cancer patients, for whom current treatment options are essentially limited to surgery or chemotherapy.
 
Heat Biologics is currently enrolling patients in a Phase I clinical trial of the vaccine at UM’s Sylvester Comprehensive Care Center, and said that it hopes to receive fast-track designation by the US Food and Drug Administration based on the current dearth of treatment options for NSCLC.
 
Meantime, the asthma therapy, based on agonists and antagonists of tumor necrosis factor receptor 25, is being considered as an adjunct therapy to increase the efficacy of the NSCLC vaccine, but may also have potential as a standalone treatment for asthma and other autoimmune diseases.
 
Heat Biologics is a product of UM Innovation, an organization created by the university last year to provide traditional technology-transfer services, technology development, and incubation under one roof to attract private investment in promising UM research discoveries, according to Bin Yan, director of marketing and business development for UM Innovation.
 
UM Innovation comprises the university’s technology-transfer office, the Wallace H. Coulter Center for Translational Research, and an under-construction Life Science Park. The school formed UM Innovation late last year to revamp its tech-transfer program, which had been providing less-than-stellar returns for the school in previous years.
 
According to statistics compiled by the Association of University Technology Managers, in 2006 UM was issued a single US patent compared with four in 2005; it applied for 26 US patents compared with 30 the previous year; and it executed 10 licenses or options, compared with 17 such deals the previous year. Despite the declines, licensing income rose to $930,000 in 2006 from $635,000 in 2005.
 
The school also failed to spin out a single company in 2005 or 2006, a fact that Yan blamed both on the lack of VC presence in the area and on a lack of sophistication on the part of the UM tech-transfer office.
 
“In the past, I think it’s fair to say that Miami had not been on the radar of many big-money VCs, partly because of our location, and partly because we had not structured attractive deals,” Yan told BTW this week.
 
“Now we are working harder and smarter to try and understand what investors are looking for, and doing our best to deliver it,” she said, adding that UM Innovation will go a long way toward fulfilling that goal by acting as “a one-stop shop” to address all technology-development needs at UM.
 

“In the past, I think it’s fair to say that Miami had not been on the radar of many big-money VCs; partly because of our location, and partly because we had not structured attractive deals.”

Specifically, the university’s tech-transfer office still does traditional tasks such as reviewing faculty research, coaxing invention disclosures from them, and filing patent applications.
 
However, UM Innovation’s second leg — the Coulter Center for Translational Research — functions as a tech-development center that helps mature technologies to the point where they can attract outside investment. The Coulter Center, which was formed about three years ago, does this by acting like an “in-house venture capital” firm, but with lab space, Yan said.
 
“As part of UM Innovation, we review a portfolio of investments, select the best ones, and focus our resources to help those,” she said. “We provide not only funding, but also facilities and services.”
 
She said the center has a cGMP facility, wet-lab space, and regulatory consultants, “so when needed, we can bring a promising project to a stage to attract a commercial licensee or to attract an investor to build a company around it.”
 
The last leg of UM Innovation is a 1.4-million-square-foot life sciences park currently under construction adjacent to the Miller School of Medicine campus, which will house primarily university startup companies, including Heat Biologics.
 
So far, the new umbrella strategy has produced positive results, according to Yan. Although she could not disclose specific numbers — the school is currently preparing tech-transfer statistics to disclose to AUTM — Yan said that UM Innovation has spawned “a few” startup companies and is in the process of finalizing “a few more” this month. In addition, she said, the number of licensing deals executed by the school is on the rise.
 
Miami Heat
 
In the case of Heat Biologics, Yan said that UM Innovation has inked a “typical” licensing deal with an up-front payment, milestones, and royalties; and also is exploring an ongoing research collaboration with the laboratory of Eckhard Podack, a professor of medicine and chairman of microbiology and immunology at the Miller Medical School, and primary inventor of the gp-96 and TNFR25 technologies.
 
UM often takes an equity stake in its spinout companies, but Yan declined to disclose whether it has taken an equity position in Heat Biologics, citing the fact that the university is currently working through internal conflict-of-interest procedures that could arise because the Phase I clinical trials are being conducted at a UM medical facility.
 
In any case, Seed-One Ventures, a VC firm with offices in the Miami area, has invested an undisclosed amount in the company. Seed-One “evaluates hundreds of technologies every year, and the treatments developed by Dr. Podack are among the best we’ve seen,” Jeffrey Wolf, managing partner at Seed-One, said last week in a statement.
 
“His approach represents … a non-traditional view of certain prevailing ideas about immunology,” Wolf added. “The decision to form Heat Biologics around [this] breakthrough work was an easy one.”
 
Wolf will serve as CEO of Heat Biologics and oversee development and commercialization of the company’s initial products, according to the company.
 
Podack’s technology is not a vaccine in the traditional sense in that it stimulates the immune system after the diagnosis of NSCLC, which accounts for some 85 percent of all lung cancers.
 
On its own, the body’s immune system can recognize NSCLC as dangerous, but typically will not attack those cells. The immune system will react to the gp-96 heat shock protein produced by NSCLC cells, but that protein typically remains protected inside the cells.
 
To overcome this, Podack genetically engineered NSCLC cells to secrete gp-96, which subsequently “induces tumor-antigen specific cytotoxic T-cells and natural killer cells,” Podack said in a statement.
 
Furthermore, the TNFR agonists that Podack has developed can block the production of regulatory T-cells, which in turn enables the immune system to work “uninhibited” against the cancer and increase the efficacy of the vaccine, he said. The TNFR antagonists, meantime, are being explored as a treatment for asthma and other auto-immune diseases, he added.
 
Phase I clinical trials of gp-96 are currently ongoing under the direction of Luis Raez, associate professor of medicine and co-leader of the Lung Cancer Site Disease Group at the Sylvester Comprehensive Cancer Center. Podack said that he believes the vaccine could win fast-track designation from the FDA, which would mean a six-month review followed immediately by a Phase III trial in hundreds of patients.

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