Heat Biologics Launch (Miami Herald)

Cancer Vaccine Deal Reached

The University of Miami Medical School and a venture capital firm have started a company to develop a lung cancer vaccine

August 2, 2008

After a decade of research, the University of Miami has announced it’s teaming up with a venture capital firm to start a company to develop a lung cancer vaccine that could have huge benefits for those suffering from the deadly disease – if the vaccine makes it through a lengthy series of tests.

The UM medical school and Seed-One Ventures, a Miami Beach firm, have formed Heat Biologics to work on technologies developed by Eckhard Podack, a doctor who is head of the Department of Microbiology and Immunology. Details of the deal were not revealed.

Over the past few years, several universities, including Harvard, have announced attempts to develop a lung cancer vaccine and so far they have led to nothing.

Podack’s work is based on injecting genetically altered cancer cells into patients who already have the disease. According to his theory and research, the injected cells would activate killer cells that would attack the lung cancer. The altered cells release a substance called heat shock protein, which is normally locked inside cells. Podack has developed a way to release the protein, allowing it to do its work.

”I’m cautiously optimistic,” said Bart Chernow, the school’s vice provost for technology advancement, but you never know until you get through the clinical trials.

Because the vaccine, called gp-96, involves injecting cancer cells, Podack said the tests will be conducted only on those who already have cancer.

Heat Biologics and the university already are enrolling patients for a Phase I test, to show that it can be safely injected into humans. If that works out, researchers then will start a Phase II trial, in which it will test on late-stage lung cancer patients.
Because such patients tend to die quickly, any positive results in prolonging life or diminishing cancers could also be seen quickly, Podack said. If the vaccine showed good results, the U.S. Food and Drug Administration would likely rush to approve it, perhaps in two or three years.

Podack said he has been working on several variations of a lung cancer vaccine. Another one is already through a Phase I trial. That concept is licensed to another company, Pique Therapeutics.

“I’m not a businessman,” Podack said. I’m a scientist. I want to see what works and how it works.

It’s taken quite a while to get to this point. In 2000, The Miami Herald published an article – ”A Magic Bullet for Lung Cancer?” discussing the vaccine work of Podack, Kasi Sridhar and others at UM.

Podack said he has made several attempts at a vaccine, but their development has been slowed by regulatory issues. The gp-96 vaccine was licensed by UM to a slow-moving company for six or seven years without any visible effort.

NEW COMPANY

The University regained control of the license and now is working with Seed-One, which focuses on developing start-ups in their earliest stages, according to managing partner Jeffrey Wolf.

Seed-One’s model is to start a company from scratch from a research project, with Wolf being chief executive for a while before finding another manager.

Among Seed-One’s efforts are GenerationOne, focused on gathering fast information for disease management projects, and Elusys Therapeutics, which develops treatments for life-threatening infectious diseases.

It’s a really exciting technology, Wolf said of the new UM project. It’s ”much broader than a lung cancer vaccine. There are two technologies we’re pursuing first – the vaccine and something for asthma – but there are many other possible applications,” based on treating immune systems with antibodies or genetically altered cells.

The second technology can ”speed up and slow down” the immune system, Wolf said. In conjunction with the gp-96 protein, it can assist the immune system to work with the vaccine, rather than fight it.
With asthma and other inflammatory diseases, it can work as an anti-inflammatory agent.
The Heat Biologics deal marks an important step for the University, Chernow said. ”We’re going to be doing a lot of things like this,” he said.

OWNS PATENTS

The University owns the patents of its employees’ work, including that of Podack, but Heat Biologics will likely need the researcher to continue developing the technology. Podack said he and the new company had not yet agreed on a contract.
Chernow didn’t reveal specifics of the deal with Seed-One, but said, ”Normally, universities never take more than a 19 or 20 percent equity position in a company” using its patents.

The private company usually reimburses the research institution for some of its previous expenses in developing the product and funds research going forward, with the University getting royalties when the product gets to market, Chernow said.

 

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