Researchers at Inserm have developed a method to direct pre-existing antibodies toward new targets. Their bimodular fusion proteins could be a broadly useful method for expanding access to antibody therapy. In a study that appeared in the Feb. 11, 2022, issue of Science Advances, the teams showed that antibodies to Epstein-Barr virus (EBV), which are present in 95% of the global population, could be redirected to a target cell of their choosing by fusing an EBV antigen to a cellular targeting ligand.
Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 on Feb. 10 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
Cstone Pharmaceuticals Co. Ltd.’s orally administered Tibsovo (ivosidenib tablets) received the green light from China’s NMPA for use in adult patients with relapsed/refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation. It is the first IDH1 inhibitor to reach market in China.
SCG Cell Therapy Pte. Ltd. has acquired rights to human induced pluripotent stem cell technology from Singapore’s Agency for Science, Technology and Research (A*STAR)’s Accelerate Technologies Pte. Ltd. to support the development of natural killer (NK) cell therapies for leukemia, liver cancer, gastric cancer and other solid tumors.
3Sbio Inc.’s subsidiary, Sunshine Guojian Pharmaceutical Co. Ltd., has licensed out the global rights of its anti-PD-1 antibody candidate, 609-A, to Florida-based Syncromune Inc. in a deal the company said is worth up to “hundreds of millions of U.S. dollars.”
Sihuan Pharmaceutical Holdings Group Ltd.’s subsidiary Xuanzhu Biopharmaceutical Co. Ltd. has raised ¥610.5 million ($96 million) in a series B round led by Sunshine Life Insurance Corp. Ltd.
Antengene Corp. Ltd. received marketing approval from China’s NMPA for ATG-010 (selinexor), a drug that was in-licensed from Karyopharm Therapeutics Inc. It was approved for use in combination with dexamethasone to treat adults with relapsed or refractory multiple myeloma.
China’s NMPA has given thumbs up to Cstone Pharmaceuticals Co. Ltd.’s Cejemly (sugemalimab), an anti-PD-L1 monoclonal antibody. It was approved for use in treatment-naïve metastatic (stage IV) non-small-cell lung cancer (NSCLC) patients in combination with chemotherapy.
DUBLIN – ITM Isotope Technologies Munich (ITM) SE has secured its first radiopharmaceutical licensing deal in China, a pact with Grand Pharmaceutical Group Ltd. involving two radiopharmaceutical candidates, as well as a companion diagnostic for one of them.
Legochem Biosciences Inc. has licensed out its antibody-drug conjugate (ADC) LCB-14 to Iksuda Therapeutics Ltd. in the duo’s latest deal that is worth $1 billion. Daejeon, South Korea-based Legochem will receive $50 million in an up-front payment and near-term milestones, and up to $950 million in developments, regulatory and commercial milestones.
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