October 2, 2014

Florida Biotech

Pet project: Morphogenesis' cancer vaccine for dogs gives pet owners hope

Making Morphogenesis' vaccine available to human patients will take more time and effort.

Amy Keller | 2/28/2012

Patricia & Michael Lawman

[Photo: Mark Wemple]


Morphogenesis

Employees: 9

CEO: Patricia Lawman, Ph.D. in molecular and cellular biology from the University of Florida

President/chairman: Michael Lawman, Ph.D., University of Surrey in England

Startup capital: Grants and angel investors

Budget: "Our burn rate last year was less than $400,000 ... pretty shoestring," says Patricia Lawman.

Products: In addition to ImmuneFx and the PACS Cell Separator, company researchers are working on creating banks of stem cells for use in preventing rejection of transplanted organs. They're also exploring certain marine organisms for potential use in biotechnology products and services. A subsidiary called Veterinary Oncology Services has created custom-tailored vaccines to treat dogs with cancer. The company also developed a vaccine to treat a horse suffering from melanoma. "The vet said the tumors are shrinking," says Lawman. "That's our first horse."
In a basement lab of a Tampa hospital, a scientist at Morphogenesis injects genetic material from a common streptococcal bacterium into a cluster of tumor cells taken from a dog with cancer. Within a couple of days, a protein that's specific to the bacteria shows up on the surface of the tumor cells.

The company then irradiates the protein-tagged cancer cells, turning them into a vaccine it calls ImmuneFx that can be injected into dogs suffering from lymphoma and other cancers.

Morphogenesis CEO Patricia Lawman explains how the vaccine works: Cancer cells, she says, grow unchecked because they produce so many mutations that the body's immune system stops recognizing them as intruders. The vaccine, once it's injected into the animal, tags the cancer cells with the protein, essentially planting "a red flag on top of the cancer cell that says 'I'm foreign.' "

The body's natural defenses recognize and pounce on the bacterial protein. In the process, they uncloak the cancer cells and attack them as well, in what Lawman calls an "immune cascade."

Lawman says her company's vaccine provides an effective, non-toxic alternative to chemotherapy and radiation for dogs. Some animals, which typically die within two to eight weeks of a lymphoma diagnosis, have lived two to six times longer than expected, with one complete regression in a dog with a less aggressive tumor.

Lawman says survival periods could be improved further by combining early diagnosis with vaccination and other therapies. Currently, the company's Veterinary Oncology Services subsidiary sells the cell-processing treatment to 14 vets in Florida at $3,200 per eight-dose regimen.

The development of the vaccine reflects both the promise of biotechnology and the length of time it can take to deliver on that promise. ImmuneFx has its roots in research that Lawman and her husband, researcher Michael Lawman, began more than 20 years ago at the Walt Disney Memorial Cancer Institute at Florida Hospital in Orlando. Their initial research involved using genetically altered cells in therapeutic ways — helping the body to accept transplanted organs, for example.

In 1995, the Lawmans decided to commercialize their discoveries. The Disney cancer institute gave the Lawmans the rights to all the technology they'd developed there, along with some startup cash. With additional funding from grants and angel investors, the Lawmans narrowed their focus and — after 16 years — translated their research into two products.

In addition to ImmuneFX, Morphogenesis has created a device called the PACS Cell Separator with a range of uses, from stem cell transplants to early cancer diagnoses and patient monitoring. Lawman says the company expects to move forward with the cell separator in the second quarter of this year.

The company expects to get its first significant revenue from the huge veterinary market, however. In 2010, Morphogenesis signed an agreement with Novartis Animal Health to develop a vaccine grown from Morphogenesis' stock cell lines rather than a canine's own tumor. If successful, the development of an off-the-shelf vaccine for mass-production could give Morphogenesis — which is not yet profitable — a strong foothold in the veterinary oncology market.

Meanwhile, the company is pushing for human trials of ImmuneFX. The company always intended to develop a human cancer vaccine, but bringing a human drug to the market requires many years and many more regulatory hurdles than for veterinary applications.

"It's a long process," says Lawman, who has been putting together an investigational new drug application and interviewing potential sites for a clinical trial. "Hopefully, we'll get that going this year."

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