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.
Cell therapy developer Cellular Biomedicine Group Inc. (CBMG) completed a $120 million series A financing, its first since becoming a private company. The funds will benefit the U.S. and China-based firm’s CAR T pipeline.
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.
Cstone Pharmaceuticals Co. Ltd. released positive data from the phase III trial, Gemstone-302, of sugemalimab plus chemotherapy for the first-line treatment of patients with stage IV squamous and non-squamous non-small cell lung cancer.
Imugene Ltd.’s recent win with a patent granted in Japan with its HER-Vaxx immunotherapy, in development for HER2-positive gastric cancer, represented a smallish but significant win in the HER2/neu space, where plenty of other players are busy, with Greenwich Life Sciences Inc. a strong emerging name.
Despite Beyondspring Pharmaceuticals Inc.’s phase III study meeting its primary and key secondary endpoints of a plinabulin/docetaxel combination in treating non-small-cell lung cancer (NSCLC), the company stock (NADAQ:BYSI) took a pounding. Shares sunk 32.9% on Sept. 20 to close at $15.36 each.
Takeda Pharmaceutical Co. Ltd. has grabbed a slice of the non-small-cell lung cancer (NSCLC) market, becoming the first company to gain FDA approval for an oral drug targeted against a rare form of the disease.
Abion Inc., which focuses on precision oncology, raised ₩38.76 billion (US$33.36 million) in its debut on the Korean Stock Exchange’s Kosdaq board on Sept. 8.
Innovent Biologics Inc. has inked a $312 million licensing deal for the development and commercialization of Genfleet Therapeutics Inc.’s KRAS G12C inhibitor, GFH-925, in mainland China, Hong Kong, Macau and Taiwan. Innovent also has additional option-in rights for global development and commercialization.