相关临床试验
3
1 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
1
33.3%
招募中
1
33.3%
终止
1
33.3%
暂无批准数据
- The checkpoint inhibitor refractory cancer market is expected to grow significantly by 2036, driven by rising resistance to immune checkpoint inhibitors and demand for next-generation therapies. - Approximately 40–60% of patients with melanoma, NSCLC, renal cell carcinoma, urothelial carcinoma, and head and neck cancers experience primary resistance to PD-1/PD-L1 inhibitor therapy. - Promising investigational therapies include Sitravatinib + Nivolumab, TAVO + Pembrolizumab, Botensilimab + Balstilimab, and ICT01, which aim to overcome resistance and restore antitumor immunity. - The United States accounted for the largest checkpoint inhibitor refractory cancer treatment market size in the 7MM in 2025.
- HEPHAISTOS-Pharma has appointed Stephan Braun, former Chief Medical Officer of ImCheck Therapeutics, as its new Chief Medical Officer to lead clinical development strategy. - The appointment comes as the company prepares to advance its lead candidate HEPHA440, a third-generation TLR4 agonist small molecule, into first-in-human studies. - HEPHA440 is designed to activate the innate immune system by targeting myeloid cells within the tumor microenvironment and has demonstrated compelling anti-tumor activity in preclinical cancer models. - The drug candidate is scheduled to enter clinical trials in 2027, with Braun leading the preparation of clinical trial design and translational development strategy.
- ImCheck Therapeutics will present data from the EVICTION Phase I/II study at ASH 2025, highlighting high remission rates and overall survival for ICT01 combined with azacitidine and venetoclax in newly diagnosed AML patients. - ICT01 is a first-in-class humanized monoclonal antibody that selectively activates γ9δ2 T cells by targeting BTN3A, demonstrating a unique mechanism of action that modulates both innate and adaptive immunity. - The EVICTION study is evaluating ICT01 across multiple cancer types, with the AML cohort focusing on older or unfit patients with newly diagnosed acute myeloid leukemia. - Ipsen has entered into an agreement to acquire ImCheck Therapeutics, with the transaction expected to close by the end of Q1 2026.
- Ipsen announced the acquisition of ImCheck Therapeutics for €350 million upfront plus milestone payments totaling up to €1 billion, focused on the lead immunotherapy ICT01 for acute myeloid leukemia. - ICT01 demonstrated promising efficacy in the Phase I/II EVICTION trial, with treatment responses nearly doubling compared to historical standard of care data in newly diagnosed AML patients ineligible for intensive chemotherapy. - The first-in-class monoclonal antibody targets BTN3A and activates γδ T cells, representing a novel immunotherapy mechanism that received Orphan Drug Designations from FDA and EMA in July 2025. - Ipsen plans to initiate Phase IIb/III registrational studies for ICT01 in 2026, targeting the high unmet medical need in older AML patients who cannot tolerate intensive chemotherapy.
- ImCheck Therapeutics will present updated Phase I/II EVICTION trial data showing high complete remission rates when ICT01 is combined with azacitidine and venetoclax in newly diagnosed AML patients. - ICT01, a novel γ9δ2 T-cell activator targeting BTN3A (CD277), demonstrates promising efficacy without compromising safety in older or unfit adults with acute myeloid leukemia. - The data will be presented at the AACR Annual Meeting 2025 in Chicago on April 28, building on previous findings shared at ASH 2024 that showed the combination's potential as a new treatment approach.
• ImCheck Therapeutics' ICT01, combined with azacitidine and venetoclax, demonstrates high complete remission rates in newly diagnosed AML patients. • The EVICTION trial's interim results highlight ICT01's safety and tolerability in older or unfit AML patients, including those with TP53 mutations. • ICT01, a novel γ9δ2 T-cell activator, targets butyrophilin 3A, enhancing anti-tumor immune responses in hematologic malignancies. • The Phase I/II study's findings will be presented at the 66th American Society of Hematology Annual Meeting, offering insights into ICT01's potential.
- The FDA granted Fast Track designation to ICT01 plus azacitidine and venetoclax for acute myeloid leukemia (AML) treatment in patients unfit for standard induction chemotherapy. - ICT01, a humanized anti-BTN3A monoclonal antibody, selectively activates gamma-delta T cells and is under evaluation in the phase 1/2a EVICTION trial. - Interim phase 1 data showed a strong safety profile and a 30% disease control rate, leading to a randomized dose-optimization cohort in October 2023. - The Fast Track designation may allow ImCheck Therapeutics more frequent FDA meetings, priority review, and accelerated approval.
