Revolutionary Milestone: BioNTech and DualityBio Forge Ahead to Phase III with ADC for HER2-Low Breast Cancer

BioNTech’s Bold Move: ADC Gears Up for Phase III Battle in Breast Cancer Arena

In a strategic move to challenge industry giants like AstraZeneca and Daiichi Sankyo, BioNTech is pushing forward with its licensed antibody-drug conjugate (ADC), DB-1303, entering Phase III trials. Teaming up with DualityBio, the creator of this potent ADC, BioNTech is gearing up to take on the heavyweight Enhertu in the realm of heavily treated breast cancer.

This game-changing addition to BioNTech’s portfolio was acquired in April 2023, with a jaw-dropping upfront payment of $170 million to China’s DualityBio. But that’s just the beginning; the deal includes a potential $1.5 billion in milestone payments, not to mention tiered royalties.

DB-1303 is set to go head-to-head with chemotherapy in a Phase III open-label trial, targeting patients with HER2-low, HR+ metastatic breast cancer that has stubbornly persisted despite prior endocrine therapy.

Imagine ADC therapy as a precision-guided missile for cancer, with an antibody pinpointing the delivery of a potent cancer-killing payload. DB-1303, armed with its topoisomerase-1 inhibitor, has already shown promise in Phase I/II trials, demonstrating both excellent tolerability and encouraging antitumor activity, even in a population that’s undergone extensive prior treatments.

Should BioNTech and DualityBio’s ADC receive approval, it could emerge as a formidable competitor to the HER2-directed antibody and topoisomerase inhibitor conjugate, Enhertu. This blockbuster drug is already a major player in the market, with projected annual sales of $2.4 billion by the end of March 2024.

The ADC arena is red-hot, with BioNTech’s partner Pfizer making a splash with its $43 billion acquisition of Seagen in March 2023, securing four FDA-approved cancer ADCs.

And there’s more to the story. In August, BioNTech and DualityBio expanded their collaboration to include another ADC, this time a Trop2 antibody-drug conjugate, which has shown promising results in non-small cell lung cancer and other solid tumors. These deals grant BioNTech global marketing rights for the three drugs, except in mainland China, Hong Kong, and Macau, where DualityBio retains commercial control.

In this dynamic landscape, Gilead’s Trodelvy currently stands as the sole FDA-approved Trop-2 directed ADC across multiple indications, with soaring sales primarily driven by breast cancer, reaching $260 million in the second quarter of 2023, and projections soaring to $2.8 billion by 2028.

For BioNTech, this expansion into the ADC realm marks a strategic shift to diversify revenue streams. The move comes in the wake of sharp declines in COVID-related product sales, with revenue for the first half of 2023 plummeting to $1.5 billion compared to $10.4 billion during the same period last year.

As DB-1303 embarks on its Phase III journey, the biotech world eagerly watches, with primary completion expected by the promising date of August 2025.

Leave a Comment