Clinical Trial News

A vaccine, BNT116 by BioNTech, targeting non-small cell lung cancer (NSCLC) is being tested in Maryland and Virginia, aiming to eliminate cancer cells and prevent recurrence through a global clinical trial. Using mRNA technology, it trains the immune system to recognize and attack NSCLC-specific tumor markers. The trial, recruiting participants in the D.C. region, will test BNT116's efficacy alone and with chemotherapy/immunotherapy, aiming to prevent lung cancer recurrence.

Astellas Pharma Inc. announced the first patient dosing in the HIGHLIGHT 1™ Phase 3 study for fezolinetant, an oral, nonhormonal treatment for moderate to severe vasomotor symptoms in breast cancer patients on adjuvant endocrine therapy.

Mabwell Therapeutics received NMPA approval for a Phase III trial of 9MW2821 plus Toripalimab vs. chemotherapy for urothelial carcinoma. The trial is currently enrolling patients previously treated with PD-(L)1 inhibitor and platinum-containing chemotherapy. 9MW2821, a Nectin-4-targeting ADC, is the first of its kind in China, with over 400 subjects enrolled across multiple indications. It has received FDA Fast Track, Orphan Drug, and Breakthrough Therapy designations for various indications.

The FDA approves Insulet's Omnipod 5, the first automated insulin delivery system for people with type 2 diabetes, offering a simpler alternative to traditional insulin management methods.

Diakonos Oncology secures $11.4m in seed financing to advance its dendritic cell vaccine candidate, DOC1021, into a Phase II clinical trial for glioblastoma treatment.

GI Innovation and Merck & Co (MSD) collaborate on a Phase II trial to assess GI-102 combined with Keytruda for metastatic liver cancer, melanoma, and renal cell carcinoma. The trial, conducted in South Korea and the US, aims to provide treatment options for patients resistant to immuno-oncology treatments.

Merck initiates Shorespan-007, a Phase 3 trial evaluating bomedemstat for essential thrombocythemia (ET) patients not previously treated with cytoreductive therapy, aiming to address unmet needs in myeloproliferative neoplasms (MPNs).

Opna Bio has dosed the first subject in a Phase I trial of OPN-6602, an EP300/CBP bromodomain inhibitor for multiple myeloma. The open-label study aims to enroll up to 130 subjects to evaluate safety, tolerability, pharmacokinetics, and early anti-tumor activity. The trial includes a dose-escalation phase with 90 patients and a dose-expansion phase with 40 patients, expected to complete in H2 2026.

Biosense Webster completes enrolment of Omny-IRE trial, evaluating Omnypulse platform for mapping and treating paroxysmal atrial fibrillation. The platform combines pulsed field ablation therapy with mapping via Carto 3 system, aiming to provide electrophysiologists with new tools for optimal patient procedures.

Vaderis announces positive results from its HHT clinical trial with VAD044, showing favorable safety, tolerability, and efficacy in key disease manifestations. Ongoing OLE data at 6 months confirm consistent safety and improvements in bleeding parameters.