BioNTech and DualityBio Advance Novel HER2-low Breast Cancer Drug to Phase III Trial

BioNTech, DualityBio, Breast Cancer, DB-1303, HER2-low breast cancer, Clinical trial initiation, Antibody-drug conjugate

BioNTech, the renowned name behind the COVID-19 vaccine breakthrough, is venturing into uncharted territory with its licensed antibody-drug conjugate (ADC), DB-1303. Teaming up with DualityBio, the creators of this ADC, BioNTech is set to challenge the dominance of AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu in a specific, heavily treated breast cancer population.

This ambitious move unfolded after BioNTech acquired DB-1303 in April 2023, shelling out an upfront payment of $170 million to China’s DualityBio. However, the stakes are higher than ever, with potential milestone payments totaling a staggering $1.5 billion, not to mention tiered royalties.

DB-1303 is gearing up for a Phase III showdown against chemotherapy. The battleground? Patients with HER2-low, HR+ metastatic breast cancer, a group for whom standard treatments have fallen short.

So, what makes ADC therapy special? Think of it as a precision missile for cancer. It combines an antibody designed to target cancer cells with a potent payload for destruction. In the case of DB-1303, it carries a topoisomerase-1 inhibitor.

Early results from the Phase I/II trials have raised hopes. The treatment proved well-tolerated and showcased promising antitumor activity, even in patients who had undergone extensive prior treatments.

If DB-1303 earns its stripes with FDA approval, it could pose a substantial challenge to AstraZeneca and Daiichi Sankyo’s HER2-directed antibody and topoisomerase inhibitor conjugate, Enhertu. This juggernaut has already achieved blockbuster status, with projected annual sales of $2.4 billion for the fiscal year ending March 2024.

The ADC market is ablaze with activity. BioNTech’s partner, Pfizer, made headlines with its monumental $43 billion acquisition of Seagen, securing four FDA-approved cancer ADCs in the process. Clearly, the potential in this field is immense.

In August, BioNTech and DualityBio expanded their collaboration to include yet another ADC, this time a Trop2 antibody-drug conjugate. This third-generation ADC has demonstrated efficacy against non-small cell lung cancer (NSCLC) and various solid tumors.

These strategic moves grant BioNTech global marketing rights for these three drugs, except in mainland China, Hong Kong, and Macau, where DualityBio retains commercial rights.

Gilead’s Trodelvy is the sole Trop-2 directed ADC approved by the FDA for multiple indications. Its sales are on a steady rise, primarily driven by breast cancer, with analysts projecting a staggering $2.8 billion in sales by 2028.

For BioNTech, these ventures signal a return to its roots in cancer therapeutics, especially as COVID-related product sales have seen a significant decline. In the first half of 2023, revenue dropped to $1.5 billion, compared to an astonishing $10.4 billion during the same period the previous year.

As for DB-1303, it’s slated to complete its Phase III journey by August 2025. BioNTech’s foray into the world of cancer therapeutics is a testament to its enduring commitment to innovation and addressing unmet medical needs, even beyond the realm of pandemics.

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