Astellas Pharma Inc.’s claudin (CLDN) 18.2-targeted monoclonal antibody, zolbetuximab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and could be the first CLDN18.2 molecule to be approved in Europe if it receives final approval.
Succeeding where others have failed in an indication with high unmet need, Celldex Therapeutics Inc. disclosed top-line data from the phase II trial with barzolvolimab (barzo) against two common forms of chronic inducible urticaria (CIndU): cold urticaria (ColdU) and symptomatic dermographism (SD).
Astellas Pharma Inc.’s claudin (CLDN) 18.2-targeted monoclonal antibody, zolbetuximab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and could be the first CLDN18.2 molecule to be approved in Europe if it receives final approval.
Biogen Inc. and partner Eisai Co. Ltd. said the EMA’s Committee for Medicinal Products for Human Use has adopted a negative opinion on the marketing bid for lecanemab in early Alzheimer’s disease (AD) and mild AD. The humanized anti-soluble aggregated amyloid-beta monoclonal antibody is approved in the U.S., Japan, China, South Korea, Hong Kong and Israel, and is being sold in the U.S., where it’s branded Leqembi, as well as Japan and China. Eisai, of Tokyo, will ask the CHMP to re-examine the matter.
Medannex Ltd. has been awarded an Innovate UK grant to fund a £313,000 (US$403,000) project developing a new treatment for pediatric osteosarcoma. Innovate UK will fund £231,000 (US$297,000) of the project costs, with the remainder financed by Medannex.
Iaso Biotechnology Co. Ltd. has announced that China’s National Medical Products Administration (NMPA) has approved the IND application for IASO-782 injection for a new indication – systemic lupus erythematosus.
Zyversa Therapeutics Inc. has selected obesity and its related metabolic complications as the lead indication for its inflammasome ASC inhibitor IC-100.
Many respiratory syncytial virus (RSV) disease vaccines are for older adults but Merck & Co. Inc.’s monoclonal antibody, MK-1654 (clesrovimab), which just produced positive top-line phase IIb/III data, aims at a far smaller and younger market. Data for protecting healthy preterm and full-term infants from RSV disease show the double-blind, randomized, placebo-controlled clinical trial hit all its primary efficacy and safety endpoints, including the incidence of RSV-associated medically attended lower respiratory infection for 150 days compared to placebo.
BK polyomavirus (BKV) reactivation in immunocompromised renal transplant patients may result in BKV-associated nephropathy and hemorrhagic cystitis. There are no suitable animal models of BKV to date, and although there are several treatment options under development, none have reached regulatory approval so far.
Catalym GmbH has closed a $150 million series D to take its first in class immune potentiator visugromab into phase IIb development in a number of solid tumors. The round follows on the heels of data from a phase I/IIa trial which showed visugromab in combination with the PD-1 inhibitor antibody Opdivo (nivolumab, Bristol Myers Squibb) increased T-cell infiltration and generated durable antitumor responses in patients who had exhausted all other treatment options.
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