TAMPA, Fla. (WFLA) – A skin cancer vaccine developed by a Tampa company is entering “phase one” of clinical trials.
Morphogenesis, Inc. completed its first-in-human phase one trial in cutaneous melanoma at Moffitt Cancer Center within the past year and has now moved into studying patients in earlier stages of skin cancers.
The company will initiative phase one of the trial of “IFx-Hu2.0” for treating these stages.
The vaccine contains a bacterial protein that has the unique ability to attach itself to cancer cells, allowing the immune system to target those dangerous cells and destroy them.
“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,” Dr. Patricia Lawman previously explained to 8 On Your Side’s Daisy Ruth. “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.”
Morphogenesis’ prospective, multi-site trial of the phase one trial of “IFx-Hu2.0” is designed to assess how safe and tolerable the vaccine would be in patients with early-stage basal cell carcinoma, squamous cell carcinoma or cutaneous melanoma, where the standard procedure of care is removal by surgery.
The company’s director of regulatory affairs, Ashraf Dehlawi, explained how the phase one trial in early-stage cancers will work.
“This is a very simple study. We are engaging local dermatology clinics, we are trying to keep it local and regional as much as we can. We have five sites slated to conduct this study. It’ll be in 100 patients and it’s a very simple process in which patients come in and get a single injection in one of their lesions and they come back for a follow-up visit four weeks later and standard of care procedures would be followed,” Dehlawi said.
Dehlawi explained these patients are usually typical candidates for wide local excisions or total tumor lesion excisions from their skin, which he said are procedures that happen.
“Very easily and readily in dermatology clinics, all the time, pre-operation and post-operation tissue of the patient would be studied,” Dehlawi said.
The primary purpose of the study is to assess the safety, tolerability and feasible treatment with the vaccine as a monotherapy in patients with skin cancer. The trial of the vaccine will include 100 men and/or women of any ethnicity and race, who suffer from at least one lesion of the qualifying skin cancers.
Morphogenesis is also looking forward to the future and developing vaccines for other types of cancers.
“We do have a pipeline in terms of our clinical development strategy, in which we are targeting various types of cancers moving forward. GI cancers, colorectal, pancreatic, multiple myeloma, those are all things we’re looking at in the future to be able to move in to,” Dehlawi said.