Immunofoco Biotechnology Co. Ltd. reported encouraging early clinical data for its CLDN18.2-targeted CAR T therapy, IMC-002, in heavily pretreated gastric and gastroesophageal junction cancer, adding momentum to the push to extend cellular immunotherapy into solid tumors. The study met its primary safety objectives, with no dose-limiting toxicities observed during escalation. Cytokine release syndrome occurred in all treated patients but was limited to grade 1 or 2 events, and no immune effector cell-associated neurotoxicity syndrome or treatment-related deaths were reported. IMC-002 showed notable early efficacy signals. The objective response rate reached 66.7%, and although survival follow-up remains immature, median progression-free survival was 7 months, while median overall survival reached 10.3 months.

Lexeo on the march in phase I/II with PKP2-ACM therapy

Lexeo Therapeutics Inc. this week rolled out preliminary phase I/II data with LX-2020 in PKP2-associated arrhythmogenic cardiomyopathy (PKP2-ACM). The results are from the Heroic-PKP2 experiment, where gene therapy LX-2020 proved generally well-tolerated across dose cohorts and led to robust transduction, increased PKP2 protein expression, and clinically meaningful improvement or stabilization in measures of arrhythmia burden in the majority of subjects. PKP2-ACM is a hereditary heart condition caused by mutations in the PKP2 gene, which encodes the protein plakophilin-2. Mutations in the gene are the most common genetic cause of the disease, accounting for about 40% of all cases. Along with New York-based Lexeo, other developers are busy in the space.

Enterobiotix seeks new funds to advance microbiome pill in IBS

Microbiome specialist Enterobiotix Ltd. is in the throes of raising a new round of funding for a phase IIb trial after reporting positive results from the phase IIa study of EBX-102-02, an oral therapy for irritable bowel syndrome (IBS). In the 122-patient U.K. phase IIa trial there were clinically meaningful improvements in IBS symptom severity score, with separation from placebo seen as early as week one and maintained in the six-week follow-up. The improvements were seen in both IBS with constipation and IBS with diarrhea. Enterobiotix is laying plans to start the phase IIb in 2026 and has received advice from the U.S. FDA on the trial design and the endpoints.

GLP-1 obesity drugs cleared of suicide warning

The good news seems to keep rolling in for glucagon-like peptide-1 (GLP-1) receptor agonists used to treat obesity. Citing its evaluation of the drugs that found no increased risk of suicidal ideation or behavior, the U.S. FDA is requesting that the risk be removed from the warnings and precautions section of labeling for the GLP-1 obesity drugs. The warning, which has been part of the labeling of Novo Nordisk A/S’ Wegovy (semaglutide) and Eli Lilly and Co.’s Zepbound (tirzepatide) since their respective approvals in 2021 and 2023, was tied to the indication, not the drugs themselves.

Sea anemone venom acts as a senolytic tool against cancer

The sea anemone Stichodactyla helianthus, which carpets the Caribbean seafloor, may hold the key to eliminating the senescent cells that survive cancer therapy. A collaboration led by Spanish scientists across several international research centers has discovered a new type of toxin that selectively eliminates senescent cancer cells. Sea anemone venom not only acts as a senolytic but also promotes tumor removal and helps prevent its reappearance. “There is a lot of interest right now in the industry worldwide to find compounds that are targeting these senescent cells,” senior author Maria Ikonomopoulou told BioWorld. “If you have a compound that can kill these senescent cells as well as the cancer cells, or in combination with other chemotherapy approaches, then you have a better success rate potentially in the patients.”

Also in the news

Aktis, Aligos, Anavex, Applied Cells, Argenx, Basilea, Bio Usawa, Biogen, Biomarin, Biomedx, Cassava, CombinableAI, Converge, Creative Medical Technology, Curasight, Disc, Eisai, Esteve, Fortress, Immuneel, Immunity, Immunofoco, Infinitusbio AI, Insitro, Integrated DNA Technologies, Juvena, Kincell, LG Chem, Lobe, Magnet, Marea, Moleculin, Neuronos, Nuclera, Nuvation, Oncovita, Outsee, Pacira, Pelthos, Pharmaessentia, Proxima, Recludix, Sentynl, Solid, Tersera, XTL

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