Merck provides update on phase 3 KEYNOTE-867 and KEYNOTE-630 trials
- Merck is discontinuing the Phase 3 KEYNOTE-867 trial evaluating KEYTRUDA in combination with SBRT for stage I or II NSCLC due to lack of improvement in event-free survival (EFS) or overall survival (OS).
- The decision follows a recommendation from an independent Data Monitoring Committee (DMC) after a planned interim analysis showed no significant benefit and higher adverse events.
- Merck is also discontinuing the Phase 3 KEYNOTE-630 trial evaluating KEYTRUDA for high-risk locally advanced cSCC post-surgery and radiation, based on DMC's recommendation for futility.
- Data analyses for both trials are ongoing, and results will be shared with the scientific community and regulatory agencies.
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Repare Therapeutics announces strategic reprioritization to focus on broad clinical portfolio
- Repare Therapeutics is streamlining operations to focus on its clinical-stage oncology programs: lunresertib, camonsertib, RP-1664, and RP-3467.
- The company plans to reduce its workforce by approximately 25%, primarily affecting the preclinical group, to save around $15 million annually.
- Key upcoming milestones include data from the MYTHIC dose expansion trial in Q4 2024 and potential registrational trials in 2025.
- Repare expects to report initial data from the TRESR trial of camonsertib in 2025 and initiate a Phase 1 trial of RP-3467 in Q4 2024.
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Azitra announces first patient dosed in phase 1b trial of ATR-12 for Netherton syndrome
- Azitra has initiated dosing the first patient in its Phase 1b clinical trial evaluating ATR-12 for Netherton syndrome.
- The trial will enroll approximately 12 adult patients, with twice-daily treatment for 14 days.
- Primary endpoints focus on safety and tolerability, while secondary and exploratory endpoints assess efficacy signals and biomarkers.
- Interim safety data is expected in early 2025, with full results anticipated in the second half of 2025.
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Vaxart publishes preclinical data on mucosal vaccine for HPV-related cervical dysplasia
- Vaxart's HPV vaccine constructs stimulate specific T cell immune responses, reduce tumor size, and increase survival in an animal model.
- The mucosal vaccine platform shows promise for a non-invasive treatment for HPV-related cervical dysplasia.
- Preclinical data indicate that the vaccine generates a specific T cell response to HPV16 E6 and E7 proteins.
- Concurrent administration of anti-PD-1 with vaccination further increased survival in animal models.
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Aclarion launches second clinical utility and economic trial site with first surgeon in New Jersey
- Aclarion expands its multi-center CLUE trial to New Jersey, with Dr. Justin Kubeck at Ocean Pain and Spine in Toms River.
- CLUE aims to assess how often Nociscan’s AI data changes the initial treatment plan for chronic low back pain patients.
- Dr. Kubeck joins Dr. John Keller, a neurosurgical spine surgeon in Michigan, in the trial.
- The trial seeks to provide compelling data to payers on the impact of Nociscan during the treatment planning stage.
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