Sept. 11, 2008 | Merrimack Pharmaceuticals says it has advanced the first systems biology product to human clinical development. Merrimack announced the first patient has received an initial dose in a Phase 1 clinical study of its first oncology product, MM-121, a human monoclonal antibody and a first-in-class therapeutic designed to block signaling of the ErbB3 receptor.
“We used a combination of high-throughput biology and computer simulation to discern the importance of targeting ErbB3 signaling in tumor cells,” said Dr. Ulrik B. Nielsen, senior vice president of research. “We believe this is the first systems-designed therapeutic in clinical development. Until now, computer simulation has not been widely applied toward understanding optimal therapeutic strategies for treating cancers driven by complex signaling pathways.”
ErbB3 is a receptor in the ErbB family, a pathway that plays a critical role in cancer signaling. With the initiation of the Phase 1 trial, MM-121 becomes the first systems biology product as well as the first selective ErbB3 antagonist to enter human clinical development.
Preclinical data demonstrating the impact of MM-121 in multiple cancer models were presented at the annual meeting of the American Association for Cancer Research in April. The Phase 1 dose escalation study will evaluate the safety and pharmacokinetics (PK) of MM-121. Enrollment is underway at Fox Chase Cancer Center and two additional leading oncology sites are expected to participate in the trial later this year.