Morphotek has enrolled the first patient in a Phase l study of MORAb-202 for the treatment of solid tumours that express folate receptor alpha (FRA).

Known as MORAb-202-J081-101, the first-in-human, dose-escalation study is currently being carried out in Japan to evaluate the safety and preliminary efficacy of MORAb-202 in affected patients.

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After completing the dose-escalation phase that seeks to establish initial safety and optimal dosing, additional subjects will be enrolled to further study the safety and preliminary efficacy of MORAb-202 in select tumour types such as triple-negative breast and endometrial cancers.

Currently under development by Morphotek, MORAb-202 is a new investigational antibody-drug conjugate (ADC) that uses a cathepsin-cleavable linker to combine investigational farletuzumab with the microtubule inhibitor payload, eribulin.

“This experimental agent is a potential promising ADC candidate for FRA-positive cancers.”

Farletuzumab is a humanised antibody designed to target FRA and has been investigated in clinical trials in patients with FRA-expressing tumours.

FRA expression is primarily observed in a large number of cancers, including endometrial, gastric, non-small cell lung, ovarian and triple-negative breast, but is mostlyabsent from normal tissue.

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Morphotek president and CEO Nicholas Nicolaides said: “The combination of farletuzumab linked to the regulatory-approved eribulin has shown robust antitumor effects in a number of preclinical FRA-expressing tumour models, which makes this experimental agent a potential promising ADC candidate for FRA-positive cancers.”

Eribulinmesylate (Halaven) is currently approved in the US to treat patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease such as an anthracycline and a taxane in either the adjuvant or metastatic setting.