9MW2821 is intended for patients with locally advanced or metastatic Nectin-4 positive TNBC. Credit: lovelyday12/Shutterstock.

The US Food and Drug Administration (FDA) has granted fast track designation to biopharmaceutical company Mabwell’s antibody-drug conjugate (ADC) 9MW2821 for the treatment of triple-negative breast cancer (TNBC).

Mabwell’s 9MW2821 is intended for treating patients with locally advanced or metastatic Nectin-4 positive TNBC.

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The regulatory milestone could expedite the development and review of 9MW2821, which has received multiple FDA regulatory designations within six months.

9MW2821 previously secured fast track designation for advanced, recurrent or metastatic oesophageal squamous cell carcinoma (ESCC) and recurrent or metastatic cervical cancer (CC) after platinum-based chemotherapy, along with orphan drug designation for oesophageal cancer.

Developed using Mabwell’s ADC platform and automated hybridoma antibody molecular discovery platform, 9MW2821 is the first site-specific conjugated Nectin-4-targeting ADC.

It is also the first Nectin-4-targeting ADC from a Chinese company to enter clinical study.

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9MW2821’s conjugate technology linkers and optimised ADC conjugation process enable site-specific modification of the antibody.

The ADC specifically targets Nectin-4 on tumour cell membranes, facilitating internalisation and cytotoxic drug release, ultimately inducing apoptosis [molecular steps within a cell leading to its death] in cancer cells.

In May 2024, Mabwell announced the progress of the trial of its 9MW2821 for TNBC.

9MW2821’s monotherapy data from 20 participants with locally advanced or metastatic TNBC treated with the dose of 1.25 mg/kg and evaluable for tumour assessment showed a 50% objective response rate and an 80% disease control rate.

One subject had been in complete response for 20 months.

The company has 14 pipeline products – 10 new drug candidates and four biosimilars.