TAMPA, Fla. (WFLA) – The Tampa company that developed a cancer vaccine that targets a specific part of the disease in a patient is expanding its human clinical trials into late-stage cancers and enrolling new patients.
CEO Patricia Lawman explained how the vaccine, known as ImmuneFx, worked.
“So basically we’re taking all of the smarts of the immune system, of the body, and bringing it to bear on a person’s tumor. So what we do is basically put a bacterial gene – it’s not a bacteria, it’s not a live bacteria – it’s a single gene that we put into a patient’s tumor cells. This is expressed as a protein on the surface of the tumor cells, like a beacon, if you will, and it brings in the immune system,” she said. “And once the immune system sees our bacterial beacon it can then expose all of the patient’s tumor antigens that are in that person’s tumor.”
Now Morphogenesis is expanding its human clinical trials into two more types of cancer, including advanced Merkel cell carcinoma and cutaneous squamous cell carcinoma.
Twenty adult patients of any sex, ethnicity and race with confirmed, accessible legions will be eligible for the study.
Lawman said the study will be relatively easy for these patients.
“As a direct injectable, we wanted something that was easy in the clinic. So what happens in the clinic, this is administered with a tuberculin syringe, just like you would get a normal vaccine,” she explained. “And it’s injected right into the tumor, so it’s one injection and then it sort of fans out to spread the genes through the tumor bed. But really, it takes about 30 seconds.”
That’s 30 seconds compared to a patient sitting in a chemo infusion bed for hours. And the injection doesn’t require local anesthesia.
The clinical trial will span over five different sites, including the Tampa Bay area location that opened at Moffitt Cancer Center two weeks ago.
Lawman confirmed her team is scouting a site at the University of Southern California.
The company hopes to have a site there, a site in the middle of the country and others in the northeast.
The 20 patient clinical trial is just the beginning of the study.
“All of these phase one studies that we’re doing with the skin cancers are leading up to our big phase two study. That will be 160 patients. And there will be melanoma, Merkel cell and cutaneous squamous cell patients. So those patients then can just feed right into the phase two study,” Lawman said.
The trial is slated to last for a year to 18 months and is focused on primarily making sure the vaccine is safe in humans.
“Because patient recruitment is always an issue. So if anybody knows anybody that has those types of skin cancers and want to give this a try, it’s just a one or two or three injection study. So the maximum time that somebody would be on this study will be like seven weeks,” Lawman explained.
If the data regarding the vaccine in skin cancer is good, Morphogenesis is hopeful for the feature.
“If the data turns out to be really good, we’re hoping – and this is just a hope – that, that will be what’s called a pivotal trial. And if the data is good, the FDA may be able to say, ‘you can now commercialize this,’’’ she said. “So maybe three years from now for skin cancers, but then we have to test it in other cancers as well.”
To be eligible for the clinical trial, patients must have at least one injectable lesion and have progressed despite standard therapies, or are intolerant to or refused standard therapies.
Lawman confirmed participating in the clinical trial does not preclude a patient from moving on to receive other therapies for skin cancer.
It is too early for Morphogenesis to guess how much this treatment would cost if it becomes commercialized.
Individuals interested in participating in the clinical trial can visit this website.