The first human clinical trial is underway at Moffitt Cancer Center with what researchers are calling a "cancer vaccine."
Health News Florida's Daylina Miller spoke with Patricia Lawman, the co-founder of Tampa-based Morphogenesis. The immunotherapy company developed the vaccine, which is injected into cancer patients to help their immune systems identify and destroy tumors.
The Phase I clinical trial for the vaccine, called ImmuneFX, is being tested on patients with severe cutaneous melanoma.
What does a cancer vaccine mean exactly?
“It's kind of an odd term that has been handed down for a number of years. But really a vaccine is to potentially create an immune response against something.
So we usually think about getting a flu shot. So a flu shot has live or attenuated virus particles that we give to a person and then you mount an immune response to all of those elements of that virus. And then when you're exposed to the virus, then you're prevented from getting the flu. So that is a preventative or prophylactic vaccine.
Our vaccine, on the other hand, is the therapeutic vaccine. So we're evoking an immune response. But it's a therapeutic response after someone already has cancer.
Can you talk a little bit more about the clinical trial over at Moffitt?
“This is the first time our vaccine has been tested in humans. We have provided vaccines for veterinarians for a number of years for treating naturally occurring cancers in dogs, cats and horses.
It's a small trial - six patients. But basically, we're looking to see that the safety we saw in animals is now safe in humans, which we totally believe that it is. And then it's sort of like the jumping off part for expanding this to different types of cancer and larger numbers of patients."
This first clinical trial is dealing with melanoma?
“Yes. So this is the way it's termed , it’s stage three, four. So it's late stage disease that has a cutaneous lesion so that we can inject that. And then the other qualification of that is it’s unresectable. So it's in a place where surgery can't be used, or it's near some vital organ where you can't or there's metastatic spreads so that even if you resect it, and you basically removed it surgically, it wouldn't make a difference for the patient.
But it's a fairly quick protocol. I mean, they're injected one lesion, two, or three, depending on how many they have, and then watch them. And theoretically, if they're doing well, then they could have another series of injections up to three rounds.
So far, three patients have completed the study completely. So we're looking for three more to finish that up. And then we're starting another sort of expansion of this melanoma study to include Merkel cell and squamous cell carcinomas. We're looking to enroll 20 patients, and this will be at Moffitt. But it'll also be at two other sites that we're qualifying at the moment."
What do these trials mean for the feature of cancer treatment?
“We believe that it's going to form the foundation of cancer therapy; we know that it can be used in combination with other types of therapy.
Through our veterinary work, it was used in combination with chemotherapy, with surgery, with radiation. And in our laboratory models, we also put it in combination with checkpoint inhibitors. And checkpoint inhibitors are becoming a mainstay in immunotherapy.
But for checkpoint inhibitors to work, you have to have activated T cells. And that's what our vaccine does. It creates this army of activated T cells against multiple tumor antigens. So we think the combination will be very powerful.”
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