Clinical Trial News

CSL and Arcturus Therapeutics received approval from Japan's MHLW for their updated sa-mRNA Covid-19 vaccine, Kostaive, targeting the JN.1 Omicron subvariants for adults 18 and older. Meiji Seika Pharma will distribute the vaccine in time for the October Covid-19 vaccination campaign, marking the world's first commercially available sa-mRNA Covid-19 vaccine for adults. The approval is based on clinical evidence supporting the vaccine's safety and effectiveness, with data showing superior immunogenicity to Omicron BA 4/5 and duration of immunity up to one year.

Combining Astragalus Polysaccharides (PG2) with standard chemoradiotherapy (CCRT) significantly improves survival rates for advanced esophageal cancer patients, according to a study by PhytoHealth Corporation. The study found that PG2, a proprietary extract of Astragalus membranaceus roots, enhances immune system modulation and tumor suppression, offering new hope for esophageal cancer treatment.

Acrivon Therapeutics reports 62.5% response rate for ACR-368 in endometrial cancer patients, with no median duration reached at 6 months. FDA clears ACR-2316 for Phase 1 trials, starting Q4 2024. Company has funds until H2 2026, driven by AP3 Interactome platform.

Ascendis Pharma announced positive topline data from the pivotal ApproaCH Trial of TransCon CNP (navepegritide) for children with achondroplasia, demonstrating superior annualized growth velocity (AGV) compared to placebo: 1.49 cm/year overall (p<0.0001), 1.78 cm/year for ages 5-11 (p<0.0001), and 1.02 cm/year for ages 2-<5 (p=0.0084). TransCon CNP also improved height Z-scores and quality of life measures, with a safety profile comparable to placebo. Ascendis plans to submit an NDA to the FDA in Q1 2025 and an MAA to the EMA in Q3 2025.

PDS Biotech announces updated VERSATILE-002 Phase 2 trial results: Median Overall Survival of 30 months, Objective Response Rate of 36%, and Disease Control Rate of 77% for Versamune® HPV + KEYTRUDA® in HPV16-positive recurrent/metastatic HNSCC. Plans to initiate VERSATILE-003 Phase 3 trial this year.

PDS Biotechnology presented updated VERSATILE-002 trial data on Versamune HPV + KEYTRUDA for HPV16+ recurrent/metastatic HNSCC at ESMO 2024. Median Overall Survival was 30 months (95% CI 19.7), compared to 12-18 months for pembrolizumab. Objective Response Rate was 36% vs. 19-25%, Disease Control Rate was 77%, and 21% had deep tumor responses. 9% had complete responses, and 9 patients experienced Grade ≥3 treatment-related adverse events.

Dose 1 of PBFT02 in upliFT-D trial achieved robust CSF progranulin levels in FTD-GRN patients, sustained for up to 12 months, and was well-tolerated with no serious adverse events.

Researchers at UBC Okanagan developed the iValve, a mechanical heart valve combining tissue valve performance with mechanical durability, potentially eliminating the need for daily anticoagulants. Designed for high-heart-rate applications, it aims to improve patient quality of life and is set for animal and clinical trials within two years.

Kisqal added to endocrine therapy in NATALEE trial reduces recurrence risk by 28.5% beyond three years in stage II/III HR+/HER2- early breast cancer, with consistent benefits across subgroups and secondary endpoints, including distant disease-free survival and a trend for improved overall survival.

The STRIDE regimen's safety profile aligns with known medicine profiles, with no new safety signals. IMFINZI and IMJUDO are approved for advanced or unresectable HCC in multiple countries. Immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, and endocrinopathies, are noted, necessitating close monitoring and prompt management. Infusion-related reactions and complications post-HSCT are also highlighted. IMFINZI and IMJUDO are not recommended for pregnant or breastfeeding women.