By Ludwig Burger FRANKFURT (Reuters) -Germany’s 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 […]
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BioNTech, Duality score initial trial win with breast cancer precision drug
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By Ludwig Burger
FRANKFURT (Reuters) -Germany’s 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 in a renewed focus on its traditional roots in oncology.
Shares in BioNTech jumped almost 10% after the announcement.
In a joint statement, the partners said that a Phase IIItrial testing experimental drug BNT323 in China against Roche’s Kadcyla in certain cases of breast cancer met the primary endpoint of progression-free survival at a pre-specified interim analysis. The trial compared the effect of the drugs given to participants in two groups.
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.
“It is exciting that this is BioNTech’s first late-stage oncology programme that meets the primary endpoint of a pivotal Phase III trial,” Van Lanschot Kempen analyst Sushila Hernandez told Reuters.
Hernandez said that she looked forward to the full dataset and the readout of the global Phase III trial in breast cancer that could support potential approvals in the United States and the European Union.
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 Chinese biotech firm Duality are also testing their drug on patients with low levels of HER2.
(Reporting by Ludwig Burger, additional reporting by Paolo Laudani; Editing by Rachel More, Kirsti Knolle and Emelia Sithole-Matarise)