It looks like Shanghai Miracogen Inc.’s antibody-drug conjugate (ADC) partnership with Synaffix BV is paying off as MRG-004A, an ADC designed to treat solid tumors, has entered a U.S. phase I/II trial to treat solid tumors.

Astellas Pharma Inc. and Seagen Inc. received approval through a priority review from Japan's Ministry of Health, Labour and Welfare for Padcev (enfortumab vedotin) to treat radically unresectable urothelial carcinoma that has progressed after chemotherapy. The green light for the antibody-drug conjugate is based on the global phase III EV-301 clinical trial, which included sites in Japan.

Monoclonal antibodies are already a pillar of cancer therapy, and cancer makes up the largest indication of FDA-approved antibodies, with almost 40% of the total. At the 2021 European Society of Medical Oncology (ESMO) Congress, Elena Garralda predicted that engineered versions of classical antibodies will soon join them on their pedestal.

Bristol Myers Squibb Co. and Eisai Co. Ltd. inked a potential $3.1 billion agreement to co-develop and co-commercialize the antibody-drug conjugate MORAb-202 for advanced solid tumors.

Bristol Myers Squibb Co. (BMS) and Eisai Co. Ltd. inked a potential $3.1 billion agreement to co-develop and co-commercialize the antibody-drug conjugate (ADC) MORAb-202 for advanced solid tumors. Eisai’s first ADC, MORAb-202 pairs the company’s anti-folate receptor alpha (FRα) antibody with the Tokyo-based firm’s anticancer agent eribulin using an enzyme cleavable linker. It is characterized as a potential best-in-class candidate and is under investigation for tumors that include endometrial, ovarian, lung and breast cancers in two studies: a phase I effort in Japan and a phase I/II experiment in the U.S. The companies plan to enter the registrational stage of development as early as 2022.

Remegen Ltd.’s HER2-targeted disitamab vedotin became the first domestic antibody-drug conjugate (ADC) to win marketing approval in China, just three months after the company scored its first NDA approval in China for its lupus drug Tai’ai (telitacicept).

Remegen Ltd.’s HER2-targeted disitamab vedotin became the first domestic antibody-drug conjugate (ADC) to win marketing approval in China, just three months after the company scored its first NDA approval in China for its lupus drug Tai’ai (telitacicept). The news sent Remegen’s share price (HKEX:9995) up 12.8% in Hong Kong on June 9.

Byondis BV is gearing up for a U.S. filing of an antibody-drug conjugate (ADCs) in advanced HER2-positive breast cancer, but CEO Marco Timmers has grand plans to partner up with big pharma and expand into other diseases.