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.
Ligand Pharmaceuticals Inc. is adding one more income stream to its portfolio, with the $100 million acquisition of Apeiron Biologics AG, owner of royalty rights to Qarziba, a treatment for high risk neuroblastoma that is currently marketed in 35 countries and is en route to approval in the U.S.
Autoimmune disease specialist Scirhom GmbH has raised €63 million (US$68 million) in a series A to take an antibody against iRhom2, an enzyme that regulates TNF-alpha secretion, into the clinic. The company has approval for a phase I trial in healthy volunteers that will start later this year, with plans for proof-of-concept trials in rheumatoid arthritis and inflammatory bowel disease to follow.
Researchers from Columbia University and collaborators described the mechanism used by mAb 77, a single-chain variable fragment (scFv) derived from monoclonal antibody (mAb 77.4) targeting MeV F peptide, to neutralize viral infection.
Less than a month after the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee handed down a unanimous vote in favor of Eli Lilly and Co.’s Alzheimer’s disease candidate (AD), donanemab, the agency approved the drug as a once-monthly injection for adults with early symptomatic disease. Branded Kisunla, the beta-amyloid antagonist marks the second approved AD drug that has demonstrated in clinical trials an ability to slow cognitive decline, going up against Leqembi (lecanemab) from Biogen Inc. and Eisai Co. Ltd., which won full approval in July 2023, only six months after nabbing an accelerated nod.
At the Congress of the European Academy of Neurology, researchers from Dianthus Therapeutics Inc. presented preclinical data on DNTH-103, a monoclonal antibody engineered to selectively target the active form of complement C1s.
Kbio Inc. has obtained IND clearance from the FDA for EV68-228-N, a human monoclonal IgG1 against the capsid of enterovirus D68 (EV-D68) designed as an intravenous therapeutic for the treatment of acute flaccid myelitis.
Transmembrane serine protease 6 (TMPRSS6) is a negative regulator of hepcidin, which is the main iron homeostasis-regulating hormone. Regeneron Pharmaceuticals Inc. has recently presented preclinical data for the monoclonal antibody targeting TMPRSS6, REGN-7999, which is being developed for the treatment of iron overload.
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