BioNTech Embarks on Breast Cancer Precision Drug Late-Stage Trial, Challenging AstraZeneca

By Jace Dela Cruz

Jan 23, 2024 05:20 AM EST

BioNTech and its partner Duality Biologics have launched a late-stage trial to test their precision drug against a specific type of breast cancer, challenging a rival partnership between AstraZeneca and Daiichi Sankyo. 

(Photo : ANDRE PAIN/AFP via Getty Images)
The company logo is seen on screens at the BioNTeCH research institute in Mainz, Rhineland-Palatinate, western Germany, on October 5, 2022.

BioNTech Drug Trial for Women With Advanced Breast Cancer 

As the company renewed its focus on its traditional roots in oncology, Reuters reported that BioNTech's drug would be tested on women with a specific type of advanced breast cancer that has low levels of a cell surface receptor known as HER2.

HER2, a common mechanism of tumor growth, is also targeted by known drugs such as Roche's Herceptin. AstraZeneca and Daiichi Sankyo have advanced the concept with their drug Enhertu, based on the antibody-drug conjugate technology, a variety of high-precision chemotherapy.

BioNTech and Duality's new Phase III trial will reportedly focus on patients with tumors that grow in reaction to the hormones progesterone or oestrogen and have low levels of HER2. BioNTech and Duality said around 40% to 45% of all patients who have metastatic breast cancer meet those criteria. 

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More Than 500 Patients to Be Enrolled in BioNTech and Duality's Drug Trial

The new trial would test BioNTech and Duality's drug on HER2-type breast cancer patients. Analysts expect this drug to generate billions of dollars in annual revenue since it has been approved to treat a larger population of HER2-type breast cancer patients, including women with low levels of the receptor.

In a joint statement, BioNTech and Duality said the trial is expected to enroll at least 532 patients at 223 clinical sites worldwide, initially in China, followed by the United States, Europe, and additional regions.

"The initiation of the Phase 3 trial marks an important step in the development of our next-generation ADC candidate with the first indication progressing into pivotal evaluation," Vivian Gu, MD, Chief Medical Officer at DualityBio, said in a statement.

 "Results from our Phase 1/2 clinical study indicate a robust mechanism of action of BNT323/DB-1303 (drug) and have demonstrated preliminary efficacy and a manageable safety profile. We look forward to further advancing this differentiated ADC candidate," she added.

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