相关临床试验
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- Rigel Pharmaceuticals named Alison L. Hannah, M.D., as Executive Vice President and Chief Medical Officer, effective July 1, 2026, succeeding Lisa Rojkjaer, M.D. - Dr. Hannah brings decades of oncology drug development experience, including prior roles at CytomX Therapeutics and SUGEN, and has served on Rigel's Board of Directors since May 2021. - Her appointment comes as Rigel advances its lead pipeline asset R289, a dual IRAK1/4 inhibitor, through a Phase 1b study in relapsed or refractory lower-risk myelodysplastic syndrome. - The company expects to complete enrollment and select a recommended Phase 2 dose for R289 in the second half of 2026, with preliminary data anticipated by year-end.
- CytomX Therapeutics announced key 2026 milestones for varsetatug masetecan, a masked antibody-drug conjugate targeting EpCAM in colorectal cancer patients. - The company plans to release Phase 1 expansion data in Q1 2026 from approximately 100 patients and initiate a combination study with bevacizumab. - CytomX aims to align with FDA on registrational study design for the potential first-in-class ADC in advanced colorectal cancer. - The company is also advancing CX-801, a masked interferon alpha-2b, in combination with pembrolizumab for advanced melanoma treatment.
- DelveInsight's latest pipeline report reveals over 70 companies are actively developing more than 75 therapeutic candidates for HER2-negative breast cancer treatment. - Recent clinical trials include Washington University's Phase II study of PD 0332991 combined with anastrozole for early-stage ER+ breast cancer and MedSIR's Phase II trial investigating improved tolerance of sacituzumab govitecan. - Leading pipeline candidates include Genentech's Giredestrant (Phase III SERD), Inavolisib (Phase III PI3Kα inhibitor), and CytomX's conditionally activated antibody-drug conjugate CX-2009. - Merck Sharp & Dohme initiated a Phase III study evaluating Sac-TMT followed by carboplatin/paclitaxel versus chemotherapy in combination with pembrolizumab for high-risk triple-negative breast cancer.
- CytomX Therapeutics announced initial Phase 1 biomarker data for CX-801, a masked interferon alpha-2b PROBODY cytokine, demonstrating tumor-selective interferon signaling activation in advanced melanoma patients. - The data show CX-801 induces tumor-localized activation of immune cell populations and interferon-stimulated genes including PD-1 and PD-L1 in paired tumor biopsies. - CX-801 appears generally well tolerated and can modulate the immune tumor microenvironment in metastatic melanoma patients refractory to prior immune checkpoint inhibitor therapy. - The findings support the ongoing Phase 1 combination study of CX-801 with KEYTRUDA in melanoma, with clinical data expected in 2026.
- CytomX Therapeutics has appointed Rachael Lester as Senior Vice President and Chief Business Officer to lead strategy and business development functions for the company's masked biologics platform. - Lester brings over two decades of experience in biopharmaceutical business development, including previous roles at Replicate Bioscience, Harpoon Therapeutics, and Onyx Pharmaceuticals. - The appointment comes as CytomX advances its clinical pipeline including CX-2051 for colorectal cancer and CX-801 for melanoma, both utilizing the company's PROBODY therapeutic platform. - CytomX's multi-modality platform has produced therapeutic candidates across antibody-drug conjugates, T-cell engagers, and immune modulators with strategic partnerships including Amgen, Bristol Myers Squibb, and Regeneron.
- CytomX Therapeutics has dosed the first patient in a Phase 1 trial combining its masked interferon alpha-2b (CX-801) with Merck's Keytruda in patients with metastatic melanoma. - The novel combination aims to address the high unmet need in PD-1 refractory melanoma by localizing interferon's potent immune-stimulating effects to tumors while minimizing systemic toxicities. - Initial Phase 1a translational and biomarker data from this study are expected in the second half of 2025, potentially advancing a new approach in combination immuno-oncology therapy.
- CytomX's EpCAM-targeting antibody-drug conjugate CX-2051 demonstrated a 28% confirmed response rate in late-line colorectal cancer patients, significantly outperforming current standard therapies with single-digit response rates. - The novel PROBODY® masking technology appears to successfully target EpCAM, a previously "undruggable" tumor antigen, with manageable safety profile and no dose-limiting toxicities observed in the Phase 1 study. - Median progression-free survival reached 5.8 months with 43% response rate at the highest dose level (10 mg/kg), supporting plans to advance to Phase 2 trials in first half of 2026.
- Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. - Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. - These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. - The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.
- CytomX Therapeutics has dosed the first patient in a combination arm studying CX-801 with Keytruda (pembrolizumab) for patients with metastatic melanoma. - The Phase 1 trial aims to evaluate safety, tolerability, and preliminary efficacy of this novel combination approach targeting advanced melanoma patients. - This study represents a significant step in exploring how CX-801's mechanism may potentially enhance the effectiveness of established immunotherapy treatments.
