A Tampa Company has received approval to start clinical trials on a new form of gene therapy to treat cancerous tumors.
Morphogenesis, Inc. will begin the trials on six patients with an aggressive form of skin cancer at Moffitt Cancer Center this summer.
The therapeutic vaccine is injected into a cancerous tumor and triggers a patient’s immune system to destroy it.
A protein in the vaccine acts as a beacon for the immune system, which destroys the tumor cells that are expressing the beacon, said Morphogenesis CEO Pat Lawman. The immune cells then go throughout the body and kill other similar tumor cells, she said.
“So we have seen very few side effects because this programs the immune system to target only the cancer cells and not the healthy cells,” Lawman said. “It’s personalized because it invokes an immune response against that person’s tumor cells.”
Other gene therapies that use the body’s immune system have had success treating cancer but they have setbacks, she said. Other therapies may miss some tumor cells found in a person’s body and may come with damaging side effects, she said.
“The beacon that we place on a person’s tumor cells … alerts the immune system to all the things that are relevant about that person’s tumor so it becomes highly personalized” Lawman said. “We’ve seen very few side effects – mostly injection site reactions.”
And unlike cancer treatments that cost between $150,000 and $500,000, she said the treatment, known as ImmuneFX, would be more affordable.
“We think that this could be widely available to many different people around the word,” Lawman said. “So that is something internally that we're very excited about.”
The Phase 1b study will be conducted at Moffitt for patients with a type of stage three melanoma that is not amenable to surgery.
Morphogenesis will start enrolling patients in June and the trial is expected to last about six months. The company is already planning phase 2 trials.
If the trials go as planned and the treatment qualifies for an expedited review from the Food and Drug Administration, it could be available to the public in less than five years, Lawman said.
Morphogenesis’ initial round of investment raised $16 million and was led by Dr. Kiran Patel, a Tampa entrepreneur and philanthropist.
“It’s extremely rewarding to reach this point with the Morphogenesis team who have been pursuing such formidable endeavors in biotechnology that will put Tampa on the map,” Patel said in a release.