Morphogenesis, Inc Celebrates Advancement into Human Clinical Trials

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Morphogenesis, Inc Celebrates Advancement into Human Clinical Trials

TAMPA, Fla. – (August 27, 2018) – Morphogenesis, Inc., a Tampa, FL-based immunotherapy company, celebrated the launch of its first human clinical study in a strategic collabration with the Cutaneous Oncology Program at Moffitt Cancer Center during a private event held over the weekend.    

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 the 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. These 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 really 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 stage 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, a company managed by Dr. Patel.

About Morphogenesis, Inc. - Morphogenesis, located in Tampa, FL, is developing targeted immunotherapies for the treatment of cancer. The Company’s patented immunotherapy is based on a single bacterial gene that when expressed on the surface of a patient’s tumor cells, educates the immune system to target that patient’s unique set of tumor antigens (neoantigens) without toxic-effects. For more information visit www.morphogenesis-inc.com.

About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 49 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt is a Top 10 cancer hospital and has been nationally ranked by U.S. News & World Report since 1999. Moffitt devotes more than 2 million square feet to research and patient care. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet^® status, its highest distinction. With more than 6,000 team members, Moffitt has an economic impact in the state of $2.1 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the momentum on Facebook, Twitter and YouTube. 

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