Research & Development
Morphotek submits Farletuzumab Antibody-Drug Conjugate MORAb-202 NDA with US FDA for solid tumors
11 January 2018 -

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 tissue.

Morphotek Inc is a clinical-stage biotechnology company focused on developing novel classes of biological-based products and a subsidiary of Eisai Inc.