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US FDA accepts Morphotek's IND application for next-generation Farletuzumab ADC MORAb-202

Exton, Pennsylvania
Friday, January 12, 2018, 11:00 Hrs  [IST]

Morphotek, a subsidiary of Eisai has announced that the US Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) Application for MORAb-202, an antibody-drug conjugate (ADC), to treat solid tumors that express folate receptor alpha (FRA). A phase 1 dose-escalation study will be conducted in the US to evaluate the safety and preliminary efficacy of MORAb-202 in patients with solid tumors that express FRA.  The solid tumors to be studied include advanced or metastatic endometrial, non-small cell lung, ovarian and triple-negative breast cancer.

MORAb-202 is a novel investigational ADC that uses a cathepsin-cleavable linker to combine investigational farletuzumab with the microtubule inhibitor payload, eribulin. Farletuzumab is a humanized antibody targeting FRA and has been studied in clinical trials in patients with FRA-expressing tumors. FRA expression is observed in a large number of cancers, including endometrial, gastric, non-small cell lung, ovarian and triple-negative breast, but is largely absent from normal tissue.  Eribulin mesylate (Halaven) is approved in the US for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease, including an anthracycline and a taxane in either the adjuvant or metastatic setting.

"We are pleased that the FDA has accepted our IND application to study MORAb-202, an antibody-drug conjugate that combines farletuzumab with the regulatory-approved eribulin, in solid tumors that express folate receptor alpha," said Nicholas Nicolaides, president and chief executive officer of Morphotek. "This investigational agent has shown robust antitumor effects in a number of preclinical FRA-expressing tumor models, making it a potential promising candidate for the treatment of cancers that express this biomarker."


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