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BioNTech, Duality score initial trial win with breast cancer precision drug

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By Ludwig Burger

FRANKFURT (Reuters) -BioNTech and its partner Duality Biologics said on Friday that a late-stage trial testing their precision drug against a certain type of breast cancer reached its main goal of slowing down disease progression.

For COVID-19 vaccine maker BioNTech, the news marks the first success in a cancer trial that could potentially lead to market approval amid a renewed focus on its traditional roots in oncology.

In a joint statement, the partners said that a Phase 3 trial testing experimental drug BNT323 in China in comparison with Roche’s Kadcyla in certain cases of breast cancer met the primary endpoint of progression-free survival at a pre-specified interim analysis.

The patients taking part in the trial suffered from HER2-positive breast cancer that could no longer be removed surgically and who had undergone prior established drug treatment.

HER2 is a common mechanism of tumour growth that has been targeted by established drugs such as Roche’s Herceptin.

BioNTech’s drug, also known as trastuzumab pamirtecan, is based on the antibody-drug conjugate technology, a type of high-precision chemotherapy.

Rivals AstraZeneca and Daiichi Sankyo have invested heavily in the same concept with their leading HER2 drug Enhertu.

That drug is expected by analysts to generate several billions of dollars in annual revenue, mainly because it has been approved to treat a larger population of HER2-type breast cancer patients that include women with low levels of the receptor.

BioNTech and Duality are also testing their drug on patients with low levels of HER2.

(Reporting by Ludwig Burger, editing by Rachel More, Kirsti Knolle)

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