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Morphogenesis, Inc Celebrates Advancement into Human Clinical Trials

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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.

Visit: morphogenesis-inc.com
or moffitt.org

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