Clinical Trial News

HYD LLC announces review papers on Deuterium-Depleted Water (DDW) in cancer therapy, showing DDW inhibits tumor cell proliferation and migration, promotes autophagy, apoptosis, and senescence, and can reduce cancer recurrence. DDW's mechanism involves different isotopic properties of Hydrogen and Deuterium, leading to altered cell division and metabolism. A Phase 2 trial demonstrated DDW's efficacy in reducing prostate cancer size and improving survival rates. HYD seeks partners for Phase II/III studies to potentially approve DDW as a cancer treatment.

Twice-yearly azithromycin distribution reduced all-cause childhood mortality in children aged 1-59 months in Niger, but not in infants aged 1-11 months.

The FDA approved resmetirom, a drug for metabolic dysfunction-associated steatohepatitis (MASH), developed by Duke professor Paul Yen. Resmetirom targets MASH, a liver disease linked to obesity, affecting 115 million globally. Yen's research, focusing on thyroid hormones, led to the drug's development, aiming to prevent severe complications like cirrhosis and cardiovascular disease.

Laurence Albiges discussed effective treatments for various non–clear cell renal cell carcinoma (nccRCC) subtypes at the 2024 Kidney Cancer Research Summit. Treatments include combinations like cabozantinib/nivolumab for papillary RCC, lenvatinib/pembrolizumab for chromophobe RCC, and immuno-oncology plus tyrosine kinase inhibitor for translocation RCC. Challenges include small patient numbers and the need for more data on adjuvant strategies.

Cytonics completes enrollment for Phase 1 study of CYT-108, a recombinant protease inhibitor for knee osteoarthritis, with no drug-related adverse events reported. Top-line results expected in Q2 2025.

Akeso, Inc. to present results from 13 clinical studies on cadonilimab, ivonescimab, ligufalimab, and penpulimab at ESMO Congress 2024, covering advanced colorectal cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, hepatocellular carcinoma, nasopharyngeal carcinoma, gynecological malignancies, gastric cancer, esophageal squamous cell carcinoma, and biliary tract malignancies. Key findings include ivonescimab's efficacy in mCRC and TNBC, and a Phase III study comparing anlotinib plus penpulimab versus sorafenib for HCC.

Advancements in MRD detection, particularly through high-throughput sequencing, have expanded ctDNA assays' utility across all lymphoma subtypes. IgHTS, panel-based assays like CAPP-Seq, and emerging assays such as PhasED-seq and MAESTRO offer varying sensitivities, with newer assays aiming to maximize tumor reporters for improved ctDNA detection. These improvements are driving clinical trials adapting therapy based on ctDNA results.

First patient dosed in ONSEMBLE Phase 2 trial of Onvansertib for KRAS/NRAS-mutated mCRC. SAB full membership introduced. Fairooz Kabbinavar appointed as CMO. $97 million in cash, equivalents, and short-term investments as of March 31, 2023, with runway into 2025.

Vor Bio's Phase 1/2 VBP101 study shows trem-cel + Mylotarg reliable engraftment, shielding, broadened therapeutic window, and patient benefit in relapsed/refractory AML. VCAR33ALLO and new asset VADC45 show potential in oncology, gene therapy, and autoimmune disorders.

Psyence Biomed to acquire Clairvoyant Therapeutics, executing a Phase IIb clinical trial for a synthetic psilocybin candidate as a potential AUD treatment. Topline data expected in early 2025.