Clinical Trial News

Ivonescimab shows promising anti-tumor activity and safety in CRC, TNBC, and HNSCC, with encouraging Phase II data supporting its clinical development expansion beyond metastatic NSCLC, as presented at ESMO 2024.

Antennova presented ATN-037 data at ESMO Congress 2024, showing ORR of 21.1% and DCR of 89.5% in NSCLC/melanoma patients resistant to CPIs. Phase I data indicated ATN-037's potential to reverse anti-PD-1 resistance.

Regeneron's melanoma combo therapy, fianlimab plus Libtayo, shows 25% complete response and 57% objective response rates after 23 months in a Phase I trial, with ongoing Phase III studies.

Zynyz (retifanlimab) plus chemotherapy significantly improved progression-free survival in advanced anal cancer patients, according to a Phase III trial presented at ESMO 2024, suggesting it may become a new standard of care. The trial included people with HIV and showed a 37% reduction in disease progression risk, with Zynyz recipients experiencing longer progression-free survival and response duration compared to placebo recipients. Incyte plans to seek FDA approval for Zynyz in anal cancer by year-end.

Epitomee Medical received FDA approval for its weight management pill, causing a 152% share price surge. Despite Nestlé's withdrawal from marketing, CEO Dan Hashimshony plans to sign distribution agreements for a 2025 launch. The pill targets low to medium obesity and avoids injection-based treatments.

Perioperative durvalumab plus neoadjuvant chemotherapy followed by radical cystectomy and adjuvant chemotherapy demonstrated significant event-free survival and overall survival benefits in cisplatin-eligible muscle-invasive bladder cancer patients, according to the NIAGARA study presented at the 2024 ESMO Congress.

Apple's latest AirPods Pro can function as hearing aids with FDA-approved software, reducing the need for additional devices. The FDA's approval marks the first over-the-counter hearing aid software, aiming to improve accessibility for those with mild to moderate hearing loss.

Gene therapy tools enabling in vivo CAR T generation offer potential to make CAR T therapies faster, better, and cheaper, bypassing ex vivo limitations. Companies like Interius and Umoja are pioneering this approach with engineered lentiviral vectors and lipid nanoparticles, targeting immune cells directly in the body. This shift could blur the lines between cell and gene therapies, with initial trials in cancer and autoimmune diseases expected to yield significant insights by 2026.

C4XD discovers genetic signature distinguishing a4b7 integrin therapy responders and non-responders in IBD, using PatientSeek platform for precision medicine.

Certa Therapeutics announces WHO grants INN 'asengeprast' to its lead candidate FT011, a novel GPR68 antagonist for chronic fibrosis. Asengeprast shows promising efficacy in Phase I and IIa SSc studies, with plans for Phase IIb trials. Certa aims to develop precision therapies for fibrotic diseases.