Clinical Trial News

OSE Immunotherapeutics launches Artemia Phase 3 trial for Tedopi® cancer vaccine in second-line NSCLC, authorized in 14 countries. The trial aims to confirm Tedopi®'s therapeutic benefit in metastatic cancer patients, with presentations at the 2024 World Conference on Lung Cancer and the European Society for Medical Oncology congress.

FDA approved Casgevy and Lyfgenia, gene therapies for Sickle Cell Disease, in December 2023. Casgevy uses CRISPR/Cas 9 to reactivate fetal haemoglobin, while Lyfgenia inserts a new gene for haemoglobin A. Clinical trials showed reduced sickle cell crises, with minor side effects.

DelveInsight's 'Non-Small-Cell Lung Cancer Pipeline Insight 2024' covers 135+ companies and 150+ pipeline drugs, highlighting key players like BridgeBio Pharma, Daiichi Sankyo, and Merck. Prominent therapies include Trastuzumab deruxtecan, DS-1062a, and Pembrolizumab. Recent studies by Merck, AstraZeneca, and Gilead focus on Phase 3 trials for V940, Durvalumab, and Zimberelimab, respectively.

HS-20093, a B7-H3–targeted ADC, showed promising efficacy in ES-SCLC patients with ORR of 61.3% at 8 mg/kg and 50.0% at 10 mg/kg in the ARTEMIS-001 trial. The 8 mg/kg dose had a better safety profile with no new safety signals identified. B7-H3 expression had a low correlation with tumor response.

Daye's diagnostic tampon, designed for self-collection of vaginal and cervical fluids to detect STIs and HPV, outperformed conventional swabs in a trial with 250 participants. The tampon, approved in the UK and US, is expected to increase STI and HPV screening participation. The trial's success relied on efficient patient recruitment strategies, including digital marketing and pre-consenting.

Biotron's BIT225-012 Phase 2 trial met safety and tolerability endpoints but failed to meet primary efficacy endpoint in reducing SARS-CoV-2 nasal viral load. Four participants had unquantifiable nasal virus levels on Day 1. Biotron remains optimistic about its viroporin antagonist platform.

Zongertinib showed significant efficacy in pretreated NSCLC patients with HER2 TKD mutations, including those with brain metastases, with a 66.7% ORR and 94% tumor shrinkage. The drug was well-tolerated, with no treatment-related deaths and low incidence of dose reductions.

UAB startup TIXiMED Inc. gains FDA clearance for TIX100, an oral Type 1 diabetes drug, to proceed to clinical trials, potentially easing the burden of daily insulin injections.

Innovent Biologics presents updated Phase 2 trial results of Dupert® (fulzerasib), a KRAS G12C inhibitor for advanced NSCLC at WCLC 2024. Fulzerasib showed 49.1% ORR and 90.5% DCR, with a median PFS of 9.7 months. It was well-tolerated, with no additional safety signals. Dupert® was approved by NMPA in August 2024 for KRAS G12C mutated NSCLC patients.

Sacituzumab govitecan (Trodelvy) demonstrated antitumor activity in extensive-stage small cell lung cancer (ES-SCLC) patients, with an overall response rate of 41.9% and a disease control rate of 83.7%. The treatment showed efficacy in both platinum-resistant and -sensitive disease subgroups, with a safety profile consistent with previous studies. These findings support further investigation in a randomized phase 3 trial.