Amgen shelled out $400 million upfront for ex-Japan rights to Kyowa Kirin's anti-OX40 atopic dermatitis candidate. Johnson & Johnson and Legend Biotech's anti-BCMA CAR-T therapy turned up more multiple myeloma data and secured an FDA priority review. CStone Pharmaceuticals' PD-L1 inhibitor, partnered with Pfizer and EQRx in different territories, reported a phase 3 win in stage 3 non-small cell lung cancer. And more.
Amgen is paying Kyowa Kirin $400 million upfront to partner up on KHK4083, an OX40 antibody the Japanese drugmaker is developing for moderate to severe atopic dermatitis. Early phase 2 data showed the drug beat placebo at reducing the area and severity of eczema. If all goes according to plan, Amgen has promised up to $850 million in milestones and will lead commercialization outside of Japan.
Johnson & Johnson and Legend Biotech’s anti-BCMA CAR-T therapy, cilta-cel, a potential rival to Bristol Myers Squibb and bluebird bio’s Abecma, scored an FDA priority review with a decision set by Nov. 29. An update of data at ASCO from the phase 2 part of the Cartitute-1 study showed that a year and a half after cilta-cel treatment, 80% of heavily pretreated multiple myeloma patients enjoyed a stringent complete response, up from 67% reported at the one-year point.
CStone Pharmaceuticals claimed a phase 3 win for its PD-L1 inhibitor sugemalimab, which is licensed to Pfizer in China and to EQRx in the U.S. The Gemstone-301 trial enrolled Chinese patients with stage 3 non-small cell lung cancer without disease progression after chemoradiotherapy. The drug beat placebo at stalling cancer progression or death at an interim analysis.
Merck & Co. has officially spun off Organon with its women’s health, legacy products and biosimilars franchises. China is the newco’s second largest market. According to CEO Kevin Ali, about 60% of Organon’s established portfolio products in the country have gone through the volume-based procurement program, with another 20% being exposed in the coming year.
Samsung Biologics is adding an mRNA vaccine substance manufacturing capability at its site near Incheon, South Korea. It’s expected to be operational early next year. The CDMO is already tasked to help Moderna with fill-finish duties of its mRNA COVID-19 vaccine.
Junshi Biosciences and U.S. partner Coherus BioSciences reported a phase 3 win for their PD-1 inhibitor toripalimab at ASCO. In the Jupiter-02 trial conducted in Asia, adding tori to chemo slashed the risk of disease progression or death by 48% among patients with newly diagnosed metastatic nasopharyngeal carcinoma. While life extension data were not mature at the moment, a 40% reduction in risk of death was observed for tori.
LianBio paid $12 million upfront to license Lyra Therapeutics’ chronic rhinosinusitis candidate LRY-210 in greater China, South Korea, Singapore and Thailand. It’s a miniaturized device that’s implanted deep in the nasal passages, where it delivers the steroid mometasone for up to six months. Lyra stands to receive up to $135 million in milestones.