MediLink Therapeutics (Suzhou) Co., Ltd.. (10/12/23). "Press Release: MediLink Therapeutics Announces Strategic Collaboration and Worldwide License Agreement with BioNTech to develop next-generation anti-cancer antibody-drug conjugate". Suzhou.

	Region	ww excl China
	Organisation	MediLink Therapeutics (Suzhou) Co., Ltd.
	Group	MediLink Therapeutics (Group)
	Organisation 2	BioNTech SE (Nasdaq: BNTX)
	Group	BioNTech (Group)
	Product	anti-HER3 ADC (MediLink / BioNTech)
	Product 2	TMALIN® ADC platform technology (Tumor Microenvironment Activable LINker-payload )
	Index term	BioNTech–MediLink Therapeutics: antibody-drug conjugates, 202310– collab + ww license excl China $70m upfront + $>1b milestones for anti-HER3 ADC

MediLink Therapeutics ("MediLink"), announced today that it has entered into a strategic research collaboration and worldwide license agreement with BioNTech SE (Nasdaq: BNTX, "BioNTech"), a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, on the development of a next-generation antibody-drug conjugate candidate ("ADC"), against Human Epidermal Growth Factor Receptor 3 (HER3).

Under the terms of the agreement, MediLink will grant BioNTech exclusive global rights for the development, manufacturing, and commercialization of one of MediLink's ADC assets excluding Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region. In exchange, BioNTech will provide MediLink with an upfront payment totaling of $70 million and additional development, regulatory and commercial milestone payments potentially totaling over $1 billion. The completion of the agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino ("HSR") Antitrust Improvements Act.

HER3 is a target that is overexpressed in various cancer types, such as non-small cell lung cancer and breast cancer and is closely associated with tumor metastasis and disease progression. Furthermore, HER3 expression is upregulated after frontline drug therapy, making it an adequate target for cancer treatment. MediLink's ADC candidate has demonstrated encouraging efficacy and safety in various preclinical tumor models through the utilization of MediLink's TMALIN® technology, and preliminary clinical data further supports the conceptual validation of this candidate.

About MediLink Therapeutics

MediLink Therapeutics founded in 2020, is a clinical stage biotech company focused on developing globally competitive conjugated drugs. MediLink has built a differentiated proprietary Tumor Microenviroment Activable LINker-payload (TMALIN®) ADC technology platform. It can generate homogeneous ADC, and further improve the therapeutic window in treatment of solid tumors. We focus clinical drug development on unmet medical needs and will continuously expand into new disease areas to serve the global patients.

Our headquarter is located in Suzhou and has established R&D subsidiaries in Shanghai and Boston.

About TMALIN® Platform

The Tumor Microenvironment Activable LINker-payload (TMALIN®) is a novel ADC platform technology developed by MediLink Therapeutics with independent intellectual property rights. It utilizes a dual cleavage mechanism both intracellularly and extracellularly, taking advantage of the tumor microenvironment and traditional lysosomes. TMALIN® offers high hydrophilicity, high homogeneity DAR value, high in vitro & in vivo stability, and tumor accumulation characteristics. In multiple CDX and PDX models, as well as tox studies, it has demonstrated a wider therapeutic window compared to existing ADC technologies. Currently, several ADC products based on this platform have entered into clinical trial stage.

Record changed: 2024-01-06