BioNTech is flush with Covid-19 vaccine revenue and it’s putting some of that money to work by acquiring rights to a therapy in the hot area of antibody drug conjugates, or ADCs. It’s the second such deal BioNTech has made this year, and like the first one, it puts the German company in potential competition with Daiichi Sankyo.
Under deal terms announced Thursday, BioNTech is paying MediLink Therapeutics $70 million up front for rights to an ADC that targets human epidermal growth factor receptor 3, or HER3. This receptor is overexpressed by several types of cancer, including non-small cell lung cancer and breast cancer. The expression of HER3 is associated with the spread and progression of the disease.
Suzhou, China-based MediLink specializes in ADCs, a type of cancer drug that chemically links a tumor-targeting antibody to a toxic drug payload. The company aims to improve on current approaches to ADC drug development with technology that broadens the selection of antibodies and also offers better safety and efficacy. In lab and animal testing, the company says that compared to currently available ADCs, its drugs show a wider therapeutic window, the dose range in which a therapy is effective without causing unacceptable toxic effects. The company’s ADC technology platform is called Tumor Microenvironment Activable LINker-payload, or TMALIN.
Daiichi Sankyo is going after HER3 with an ADC called patritumab deruxtecan. A Phase 1 study showed the therapy demonstrated tolerability and a manageable safety profile. The drug has proceeded to a Phase 2 test in patients whose non-small cell lung cancer is characterized by EGFR mutations. Study participants were previously treated with a tyrosine kinase inhibitor that targets EGFR as well as platinum-based chemotherapy.
Patritumab deruxtecan is wholly owned by Daiichi Sankyo. The company’s HER2-targeting ADC, Enhertu, was developed in partnership with AstraZeneca. This ADC initially won FDA approval in 2019 for treating HER2-positive breast cancer and in 2021 for gastric cancer. Last year, Enhertu notched additional FDA approvals for treating breast cancer that expresses low levels of HER2 and for non-small lung cancer characterized by the HER2 mutation.
BioNTech’s initial work oncology centered on applying its messenger RNA technology to cancer vaccines. The company has since expanded its scope to other modalities. BioNTech entered the ADC field in April, striking a deal with Shanghai-based Duality Bio for global rights, except China, for two ADCs. The more advanced of the pair has reached Phase 2 testing and it targets HER2, making it a potential competitor to AstraZeneca and Daiichi Sankyo’s Enhertu. The target of the second ADC included in the deal has not been disclosed.
BioNTech’s collaboration agreement with MediLink grants it rights to develop, manufacture, and commercialize an HER3-targeting ADC. Those rights span the globe, except for mainland China, Hong Kong, and Macau, where MediLink retains rights. Development, regulatory, and commercialization milestones could bring the payout to more than $1 billion.
Public domain image by the National Cancer Institute