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Merrimack Pharmaceuticals Initiates Enrollment in a Phase 1 Study of MM-121, an ErbB3 Antagonist

Monday, August 11, 2008 General News
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CAMBRIDGE, Mass., Aug. 11 Merrimack Pharmaceuticals, Inc.today announced that the first patient has received an initial dose in a Phase1 clinical study of the Company's first oncology product, MM-121, a fullyhuman monoclonal antibody and a first-in-class therapeutic designed to blocksignaling of the ErbB3 receptor.
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ErbB3 is a receptor in the ErbB family, a pathway that plays a criticalrole in cancer signaling. With the initiation of the Phase 1 trial, MM-121becomes the first systems biology product as well as the first selective ErbB3antagonist to enter human clinical development.
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"We used a combination of high-throughput biology and computer simulationto discern the importance of targeting ErbB3 signaling in tumor cells," saidDr. Ulrik B. Nielsen, Senior Vice President of Research. "We believe this isthe first systems-designed therapeutic in clinical development. Until now,computer simulation has not been widely applied toward understanding optimaltherapeutic strategies for treating cancers driven by complex signalingpathways."

Preclinical data demonstrating the impact of MM-121 in multiple cancermodels were presented at the annual meeting of the American Association forCancer Research in April. The Phase 1 dose escalation study will evaluate thesafety and pharmacokinetics (PK) of MM-121. Enrollment is underway at FoxChase Cancer Center and two additional leading oncology sites are expected toparticipate in the trial later this year.

"ErbB3 is now recognized as a potentially important target in many typesof cancer including lung, breast, colorectal, ovarian and others," said Dr.William J. Slichenmyer, Senior Vice President and Chief Medical Officer atMerrimack. "Preclinical studies of MM-121 have demonstrated antitumor activityin a wide range of tumor types and a very favorable safety profile. We areoptimistic that these findings may translate into clinical benefit forpatients who participate in the clinical trials. In addition, we are verypleased to be working with leading clinical investigators at outstandingacademic cancer research centers."

Merrimack has developed a broad intellectual property position around itsoncology therapeutic portfolio, including MM121. This portfolio includes U.S.and international patent filings relating to compositions of matter andmethods of use as well as licensed patents and pending patent applications,trade secrets and proprietary know-how.

About MM-121

MM-121 is a monoclonal antibody designed to block signaling of the ErbB3receptor, a receptor in the ErbB family, a pathway that plays a critical rolein cancer signaling. Upon initiation of the Phase 1 trial, MM-121 becomes thefirst systems biology product as well as the first selective ErbB3 antagonistto enter human clinical development. Preclinical data exhibiting MM-121'simpact on multiple cancer models (including lung, ovarian, breast, prostateand renal) were presented at the annual meeting of the American Associationfor Cancer Research in April 2008. The Phase 1 trial is being conducted at 3centers in the United States.

About Merrimack

Merrimack Pharmaceuticals, Inc., is a biotechnology company focused on thediscovery, design and development of novel treatments for diseases in theareas of autoimmunity and cancer. Its autoimmune candidate, MM-093, iscurrently in Phase 2 clinical development. Its first oncology product, MM-121is currently in Phase 1 clinical development. MM-093 and MM-121 areinvestigational drugs and have not been approved by the U.S. Food and DrugAdministration or any international regulatory agency. The company'sproprietary Network Biology discovery platform, developed with the help ofleading scientists from MIT and Harvard, enables the high throughput profilingof protein networks as a basis for improved validation, lead identificationand speed in the development of innovative therapeut
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