TAMPA, FF, USA I August 29, 2018 I Morphogenesis, Inc., a Tampa, FL-based immunotherapy company celebrates the launch of its first human clinical study in a strategic collaboration with the Cutaneous Oncology Program at Moffitt Cancer Center.

After the successful completion of a preclinical research collaboration with Moffitt’s Shari Pilon-Thomas, Ph.D., and Joseph Markowitz, M.D., Ph.D., and subsequent FDA approval for Morphogenesis to move forward with its clinical studies, the Company has embarked on its first-in-human Phase 1 clinical trial.

During this phase, patients with unresectable stage III/IV metastatic melanoma will receive Morphogenesis’ novel cancer immunotherapeutic vaccine during one outpatient visit. The vaccine is injected directly into a melanoma lesion with some patients receiving the therapeutic vaccine in up to three melanoma lesions, as a single-agent. Patients will be assessed over a four-week period to establish the product’s safety and feasibility of use.

“Regardless of the degree of complexity of an individual’s case, this truly patient-specific approach capitalizes on the antigenic differences between tumors and normal cells to create the broadest immune response possible,” said Morphogenesis CEO Patricia Lawman. “We’re hopeful for positive outcomes.”

One of the hallmarks of Morphogenesis’ pathway to human trials has been the Company’s extensive history of testing its immunotherapy in companion animals with naturally occurring cancers. Many human clinical trials have failed on the backs of positive outcomes in laboratory mouse models because the results do not necessarily translate to results in humans. Morphogenesis’ wide-ranging studies in dogs, cats and horses provide a solid springboard for human studies.

Upon the successful completion of this Phase 1 trial, the Company will transition into broader clinical protocols for subsequent phases of its clinical investigations. These later studies will combine the vaccine with other immunotherapies, such as checkpoint inhibitors. Combining the Company’s innovative, cancer immunotherapeutic vaccine with other therapies is part of a long-term clinical development plan that will be studied under subsequent protocols.

“I am excited to provide this novel agent to our melanoma patients and to continue our research to understand the mechanism of action within patient-derived samples. Our goal is to enhance the ability of the immune system to recognize and eliminate tumors leading to improved outcomes in melanoma patients,” said Dr. Markowitz, the principal investigator of the Phase 1 trial.

These trials are coming to fruition after Morphogenesis closed a $16 million Series A investment round in May led by Dr. Kiran Patel and KP Biotech Group.

SOURCE: Morphogenesis