M2 PHARMA-January 11, 2018-Morphotek submits Farletuzumab
Antibody-Drug Conjugate MORAb-202 NDA with US FDA for solid tumors
(C)2018 M2 COMMUNICATIONS
Morphotek Inc said on Wednesday that the US Food and Drug
Administration (FDA) has filed its Investigational New Drug (IND)
Application for MORAb-202, an antibody-drug conjugate (ADC), with the US
Food and Drug Administration (FDA) for the treatment solid tumors that
express folate receptor alpha (FRA).
Following the successful filing of its Investigational NDA with the
US FDA, the company will now conduct a Phase 1 dose-escalation study in
the US to evaluate the safety and preliminary efficacy of MORAb-202 in
patients with solid tumors that express FRA.
Under the study, the solid tumors to be included are advanced or
metastatic endometrial, non-small cell lung, ovarian and triple-negative
breast cancer, added the company.
The company said 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
humanised antibody targeting FRA and has been studied in clinical trials
in patients with FRA-expressing tumors, which 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
Morphotek Inc is a clinical-stage biotechnology company focused on
developing novel classes of biological-based products and a subsidiary
of Eisai Inc.
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