The first-in-human Phase I clinical trial will test an immunotherapeutic vaccine for unresectable stage III/IV metastatic melanoma.
The trial will be on an outpatient basis, with the vaccine administered directly into a participant’s melanoma lesion. Patients will be assessed over a four-week period to inform researchers of the safety and feasibility of the vaccine’s use.
Morphogenesis will provide the immunotherapeutic vaccine and sponsor the study but the product will be tested by Moffitt at their center. Moffitt is not acting as a CRO within this trial but is the primary site and is recruiting patients and working on some of the results within the lab.
The immunotherapeutic vaccine has a specific mechanism of action that works around a single bacterial gene. Patricia Lawman, CEO of Morphogenesis told us that a single bacterial gene is introduced into the patient’s tumor cells. “Once it’s injected into a person’s tumor cells the tumor cells themselves make the response very personalized to that patient,” Lawman said.
She further explained, “What it does is creates an immune response against multiple tumor antigen, whatever tumor antigens are present on the patient’s tumors.”
Morphogenesis pathway has involved testing immunotherapy in companion animals with naturally occurring cancers. It is believed by the company, that in-human clinical trials have failed despite positive lab mouse models because the results did not translate to results in humans. Thus, preclinical testing in companion animals provides more accuracy as the results translate to humans.
“It’s really given us confidence going into our in-human trials where we won’t know what will happen until we do the study and I think certainly we feel like there will be no serious adverse effects,” Lawman said in response to positive animal study outcomes.
According to Joseph Markowitz of Moffitt and the principal investigator of the trial, the trial may be extended depending upon the results seen.
Upon completion of the Phase I trial, the company will move into broader clinical protocols for clinical investigations in which the vaccine will be combined with other immunotherapies, particularly checkpoint inhibitors.