BioNTech eyes next-gen ADCs for cancer via MediLink pact

12 Oct 2023
License out/inADCPhase 1Phase 2Clinical Result
BioNTech has struck a research and licensing agreement with Chinese biotech MediLink Therapeutics centred on developing a next-generation antibody-drug conjugate (ADC) directed against HER3. The biomarker is overexpressed in various cancer types such as non-small-cell lung cancer (NSCLC) and breast cancer, is closely tied to metastasis, and has upregulated expression after front-line drug therapy, which makes it "an adequate target for cancer treatment," according to the companies.
The German mRNA drug developer first entered the ADC space earlier this year when it paid DualityBio $170 million upfront, plus agreed to another $1.5 billion in potential milestones, for two ADC products outside the Chinese market. The latest deal, announced Thursday, includes an upfront payment of $70 million to MediLink, plus the possibility of over $1 billion more in development, regulatory and commercial milestones. In return, BioNTech has been granted exclusive global rights to one of MediLink's ADC assets, excluding in China, Hong Kong and Macau.
The press release announcing the deal does not specify a particular ADC candidate, but MediLink refers to one that has demonstrated "encouraging efficacy and safety" in various preclinical tumour models, while preliminary clinical data "further supports the conceptual validation of this candidate."
According to the company's website, one of its most advanced compounds, YL201, is currently in Phase I as a potential treatment for solid tumours. It consists of a recombinant IgG1 monoclonal antibody and camptothecin derivate as the cytotoxic payload, the website says. Its pipeline includes another Phase I candidate, dubbed YL202, also for solid tumours, as well as multiple pre-clinical assets.
Catch-up with Daiichi
Medilink claims its TMALIN technology is able to sidestep the shortcomings of traditional ADC drugs, touting "unique enzyme digestion characteristics" and "special structure [that] enables ADC to enrich the tumour microenvironment, [increasing] the ratio of payload in the tumor and blood concentration." Advantages of ADCs formed by TMALIN include fewer instances of payload falling off in non-target tissues, resulting in less "off-target" toxicity, as well as chemical stability and high coupling efficiency, it says.
Last month, Daiichi Sankyo reported that its HER3-directed ADC patritumab deruxtecan demonstrated clinically meaningful and durable responses in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression with an EGFR TKI and platinum-based chemotherapy. Findings from the Phase II HERTHENA-Lung01 trial were presented at the World Conference on Lung Cancer (WCLC).
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