Clinical Trial News

Laboratory mice with Alzheimer’s-like cognitive issues showed improved memory after treatment with a new drug targeting neuroinflammation-related brain proteins, potentially offering a breakthrough in Alzheimer’s treatment.

Daiichi Sankyo and Merck's ifinatamab deruxtecan shows 54.8% ORR at 12 mg/kg in pretreated ES-SCLC patients, selected as optimal dose for IDeate-Lung01 phase 2 trial extension and IDeate-Lung02 phase 3 study.

Cannabidiol (CBD) extends lifespan and alleviates symptoms in Leigh syndrome animal models, improving mitochondrial function and neurological health.

OncLive’s weekly roundup highlights FDA approvals, including afamitresgene autoleucel for synovial sarcoma, vorasidenib for astrocytoma/oligodendroglioma, CB-012 for AML, and companion diagnostics for olaparib/abiraterone in BRCA+ mCRPC. Interviews discuss targeted therapies in mCRC and ASCO’s health equity recommendations.

Elevidys, an AAV-based gene therapy for Duchenne muscular dystrophy, received FDA approval in 2023 for ambulatory patients aged 4-5 with specific DMD gene mutations, and expanded approval in 2024 for broader patient groups. While not curative, it offers a functional gene version, but faces challenges like insurance coverage and long-term data needs. Experts highlight the importance of patient education and choice amidst expanding treatment options.

Two biotechs, Bicara Therapeutics and Zenas BioPharma, plan to raise $200 million each in IPOs. Bicara's ficerafusp alfa targets EGFR and TGF-b for potent anti-tumor activity, while Zenas' obexelimab targets CD19 and FcγRIIb to treat autoimmune diseases. Both companies expect pivotal trial data in 2025.

A new bowel cancer trial using immunotherapy (pembrolizumab) before surgery showed 59% of patients cancer-free post-treatment, with all patients remaining cancer-free months later, potentially reducing the need for post-operative chemotherapy.

Reid Merryman, MD, discussed the evolution of minimal residual disease (MRD) testing in lymphoma, focusing on the use of circulating tumor DNA (ctDNA) assays at the SOHO 2024 Annual Meeting. He highlighted the increased sensitivity of next-generation sequencing and the potential for MRD-guided therapy in clinical trials, emphasizing the need for standardized assays to integrate MRD into treatment decisions.

The FDA granted breakthrough therapy designation to edaravone and dexborneol sublingual tablets (Sanbexin; Simcere Pharmaceuticals) for acute ischemic stroke. The phase 3 trial showed significant neurological recovery and independent living ability improvement compared to placebo. The sublingual formulation allows rapid absorption, with 64.4% achieving mRS score of 1 or less on day 90 in the study drug group versus 54.7% in the placebo group. Adverse events were similar between groups.

BVI to launch SERENITY and SERENITY Toric IOLs in 2025; modeling life after blue zones for longevity; hyperopia linked to depression risk; saline-powered ultra-thin battery for smart contact lenses; Ocuphire Pharma starts phase 3 VEGA-3 trial for presbyopia treatment.