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PsiOxus Starts Human Tests of Cancer Vaccine

PsiOxus Therapeutics Ltd. began human testing of an experimental treatment that uses viruses to attack cancer cells while sparing healthy ones.

PsiOxus, a closely held company whose investors include Imperial Innovations Group Plc (IVO) and a GlaxoSmithKline Plc (GSK) venture-capital fund, tested the product, known as ColoAd1, Sept. 24 in a patient in Belgium who has late-stage head and neck cancer, Chief Executive Officer John Beadle said in an interview. PsiOxus also gained permission to enroll patients in the U.K. and Spain in the early- and mid-stage trial called Evolve, the company said in a statement today.

With the start of human testing, PsiOxus joins a competition with companies including Amgen Inc. (AMGN), Jennerex Inc. and Transgene SA (TNG) to develop vaccines using oncolytic tumor viruses, pathogens that infect and destroy cancer cells. The approach may enhance the tumor-fighting effects of standard treatments such as chemotherapy and radiation.

“ColoAd1 is much more potent as a cancer-killing virus but it doesn’t kill any of the normal cells,” Beadle said.

If either the cancer treatment or a medicine the Abingdon, England-based company is developing for cachexia, a muscle- wasting and weight-loss condition, progress toward regulatory approval they could help PsiOxus generate revenue to fund other treatments still in the laboratory or lead to its sale. The company’s shareholders include Glaxo’s SR One, Imperial Innovations, Invesco Perpetual, Lundbeckfond Ventures and Mercia Fund Management Ltd.

‘Chimeric’ Viruses

The cancer treatment was developed by scientists who began work at the University of Birmingham in 2001 and moved to the University of Oxford the next year. They chose it from a library of “chimeric” viruses that combine elements of multiple viruses. The injection uses oncolytic adenoviruses that thrive and replicate in tumor cells’ environment. It belongs to a group of therapies known as cancer vaccines that stimulate the body’s own defenses.

The product may also be effective against solid tumors that occur in the epithelial tissue of major abdominal organs such as the colon, breast, kidney, lung and liver and in tumors that resist existing treatments, Beadle said.

Some cancer specialists are skeptical. There is “very little concrete evidence” that oncolytic viruses are effective in people, said Christian Ottensmeier, a professor of experimental cancer medicine at the University of Southampton in Southampton, England, who has worked on other cancer vaccines. That may stem from the wrong choice of virus or the fact that most people have antibodies which might impair adenoviruses, a common source of infections, Ottensmeier said.

Skeptical View

“My personal view is one of skepticism, that this won’t do anything effective in people, but this is cancer immunotherapy,” he said in a telephone interview. “It may be that the field of oncolytic tumor viruses is too young.”

Amgen, based in Thousand Oaks, California, last year bought BioVex Group Inc. for $425 million in cash and as much as $575 million in additional payments for the oncolytic vaccine for melanoma T-VEC. The results of final-stage tests on the product are due to be published in 2013. Illkirch, France-based Transgene last week reported positive interim results from mid- stage human tests of JX594, the liver cancer therapy it’s developing with Jennerex.

“It’s an area that’s generating more excitement in the pharmaceutical industry,” says Robin Davison, an analyst at Edison Investment Research in London.

Dendreon’s Provenge

Dendreon Inc. got U.S. approval for the first medicine to train the body’s immune system to attack tumor cells like a virus two years ago. The product, Provenge, costs $93,000 per treatment cycle. The therapy involves extracting white blood cells from a patient, mixing them with vaccine components and injecting the combination back into the person.

“With Provenge, you’re harvesting the cells and putting them back in the body,” Beadle said. “We’re doing that, but inside your body.”

PsiOxus has raised 33 million pounds ($53.5 million), including 22 million pounds in a financing completed in July, Beadle said. It has enough money to complete early- and mid- stage trials of ColoAd1’s safety and efficacy in 126 patients with late-stage cancers, he said. The first phase will be completed next year and the second phase by 2015.

Cachexia Treatment

PsiOxus is already testing another medicine, MT-102, in a mid-stage trial of 132 patients with cachexia and sarcopenia that it expects to conclude next year. Cachexia is the immediate cause of death in 20 percent to 40 percent of cancer patients, according to the U.S. National Cancer Institute. Sarcopenia is a related syndrome associated with aging.

PsiOxus doesn’t plan to become a full-scale developer and marketer of medicines, Beadle said. It wants to focus on cancer- vaccine discovery through mid-stage tests and may hand off what it finds to partners by licensing or selling treatments or may eventually attract an acquirer, he said. An initial public offering is probably not realistic in the current market, Beadle said.

“The most likely outcome is a trade sale” of PsiOxus, Davison of Edison Research says. “It’s likely someone says, ‘Let’s just buy the company outright.’”

To contact the reporter on this story: Andrea Gerlin in London at agerlin@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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