Gracell Biotechnologies Inc. is initiating two clinical trials in China in refractory systemic lupus erythematosus for lead candidate GC-012F, a CD19/B-cell maturation antigen dual-targeting CAR T.
Creo Medical Group plc says it is poised to address the mismatch between the advances in screening technology, which are making it possible to detect early-stage lung cancer, and the current invasive and inappropriate methods of treating it, following the first-in-human use of its Microblate Flex microwave ablation device.
Impressive data continue to roll out for Day One Biopharmaceuticals Inc.’s tovorafenib in pediatric low-grade glioma, with results from 69 evaluable patients with relapsed or progressive disease showing a 67% overall response rate, as measured by Response Assessment for Neuro-Oncology High-Grade Glioma, in the phase II Firefly-1 trial.
Positive data from two studies treating early breast cancer with CDK4/6 inhibitors presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago showed progress is helping patients live longer. The two treatments and companies, Novartis AG and Eli Lilly and Co., are nearly head-to-head competitors in the niche indication.
HER2-targeting bispecific antibody zanidatamab, in development by Jazz Pharmaceuticals plc and Zymeworks Inc., produced better antitumor responses than current standard of care when used as a second-line treatment for biliary tract cancer (BTC) in a pivotal phase IIb study, bringing it closer to becoming the first therapy to target HER2-expressing BTC.
Additional data from a phase II trial of S1P modulator icanbelimod (CBP-307) reinforced earlier positive results in ulcerative colitis (UC), potentially putting Connect Biopharma Holdings Ltd. in a better negotiating position as it seeks a partner to take the program forward, while in-house activities remain focused on an early 2024 regulatory filing for atopic dermatitis candidate CBP-201.
The coming months represent a crucial phase in the development of Selection Inc., a U.S.-German firm that is tackling a target in autoimmune disease that has evaded the best efforts of many other drug developers.
Wesper Inc., a longitudinal and wireless clinical-grade sleep testing platform, showed ‘exceptional accuracy’ in a head-to-head comparison with polysomnography in a study published in The Journal of Clinical Sleep Medicine. The wireless, longitudinal sleep testing platform had a breathtaking 95% correlation with the cumbersome gold standard test for sleep apnea.
Hookipa Pharma Inc. is looking to raise about $50 million in a public offering to further advance its lead immunotherapy candidate, HB-200, into a pivotal phase III trial in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) for the first-line treatment of recurrent or metastatic head and neck cancer associated with human papillomavirus (HPV) 16.
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