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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

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.

See Also:

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

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.