相关临床试验
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- Veloxis Pharmaceuticals has dosed the first participant in its Phase 2 RENGEVITY-201 trial (NCT07290777) evaluating pegrizeprument (VEL-101) in kidney transplant recipients. - The randomized, multicenter, partially blinded, active-control study will compare pegrizeprument against tacrolimus in up to 120 de novo kidney transplant recipients. - Pegrizeprument is a pegylated monoclonal antibody fragment that blocks CD28-mediated effector-T cell costimulation while preserving CTLA-4-mediated immunosuppression. - The FDA has granted pegrizeprument Orphan Drug Designation for liver transplant rejection prevention (December 2025) and heart allograft rejection prophylaxis (March 2026).
- Veloxis Pharmaceuticals' pegrizeprument (VEL-101) received FDA Orphan Drug Designation for preventing heart allograft rejection in transplant patients. - The pegylated monoclonal antibody fragment blocks CD28-mediated T cell activation while preserving CTLA-4 immunosuppressive functions through a dual mechanism. - This designation follows a previous orphan status for liver transplant rejection prevention, addressing unmet needs in solid organ transplantation. - Heart transplant recipients face lifelong immunosuppression with complex dosing regimens and toxicities that can negatively impact graft survival.
- OSE Immunotherapeutics announced that the Independent Data Monitoring Committee issued a second positive recommendation for the ongoing pivotal Phase 3 ARTEMIA trial evaluating Tedopi® in advanced non-small cell lung cancer. - The trial has randomized 163 patients and compares Tedopi® monotherapy with standard docetaxel in HLA-A2-positive patients with metastatic NSCLC who developed secondary resistance to immune checkpoint inhibitors. - Study enrollment is expected to conclude by year-end 2026, with interim futility analysis anticipated in Q3 2026 and overall survival primary endpoint results expected in Q1 2028.
- The FDA has granted Orphan Drug Designation to pegrizeprument (VEL-101), a novel pegylated monoclonal antibody fragment being developed to prevent organ rejection in liver transplant patients. - Pegrizeprument works through a dual mechanism by blocking CD28-mediated T cell activation while preserving CTLA-4 immunosuppressive functions, offering a potentially innovative approach to transplant immunosuppression. - The designation highlights the significant unmet medical need for liver transplant recipients who require lifelong immunosuppression with current therapies often associated with complex dosing and toxicities. - Veloxis Pharmaceuticals licensed the drug from OSE Immunotherapeutics in 2021 and holds worldwide development and commercialization rights for all transplant indications.
- OSE Immunotherapeutics announced expansion of lusvertikimab into chronic pouchitis and hidradenitis suppurativa as part of its 2026-2028 strategic plan targeting autoimmune diseases. - The company plans to initiate a Phase 2 clinical trial in the second half of 2026, subject to funding, while transitioning ulcerative colitis indication to subcutaneous formulation. - Strategic approach includes developing lusvertikimab IV in rare/specialty indications requiring modest financial investment compared to further UC development. - The plan aims to validate a potentially predictive biomarker from the Phase 2 CoTikiS study that showed strong clinical response in approximately 25% of patients.
- OSE Immunotherapeutics announced a strategic amendment to its AbbVie partnership, regaining control of ABBV-230's preclinical and Phase 1 development while AbbVie retains rights for later-stage development and commercialization. - ABBV-230 is a monoclonal antibody targeting ChemR23, a dual-function receptor involved in inflammation initiation and resolution, representing a potential first-in-class therapy for chronic inflammatory diseases. - The restructured agreement maintains unchanged commercial terms including royalties and milestone payments, with OSE assuming full financial responsibility for early-stage development contingent on securing adequate funding. - Under the revised terms, OSE will no longer receive the Phase 1 initiation milestone payment but becomes eligible for subsequent development milestone payments if AbbVie advances the candidate beyond Phase 1.
- OSE Immunotherapeutics and the FoRT Foundation completed enrollment of 105 HLA-A2 positive patients in the Combi-TED Phase 2 trial evaluating Tedopi cancer vaccine combinations for metastatic non-small cell lung cancer. - The three-arm study compares Tedopi plus nivolumab, Tedopi plus docetaxel, or docetaxel alone as second-line treatment following first-line chemo-immunotherapy. - The trial's primary endpoint is 1-year survival rate, with top-line results expected in the second half of 2026. - This study expands Tedopi's clinical development beyond the ongoing ARTEMIA pivotal trial, targeting a broader NSCLC patient population including those with more aggressive disease.
- Boehringer Ingelheim's SIRP inhibitor BI 765063, when combined with PD-1 inhibitor ezabenlimab and cetuximab, showed manageable safety and promising antitumor activity in patients with recurrent/metastatic head and neck cancer. - The company's next-generation SIRP inhibitor, BI 770371, demonstrated good tolerability both alone and in combination with ezabenlimab in patients with advanced solid tumors, with no dose-limiting toxicities observed. - Both antibodies work by blocking the "don't eat me" signal cancer cells use to evade immune detection, potentially enabling immune cells like macrophages to better recognize and destroy tumor cells.
- OSE Immunotherapeutics has secured €1.3 million in non-dilutive funding to lead the 36-month "HexARN" program focused on advancing mRNA therapeutics delivered via lipid nanoparticles. - The strategic collaboration brings together OSE Immunotherapeutics, Inside Therapeutics, and MiNT Laboratory to overcome challenges in RNA therapy selectivity, safety, target expansion, and manufacturing scalability. - The consortium aims to develop novel RNA therapeutics for inflammatory disorders and autoimmune diseases, leveraging advantages over conventional antibody approaches while improving delivery methods.
- Researchers from OSE Immunotherapeutics and Léon Bérard Cancer Center have developed a tumor-agnostic composite gene expression signature that predicts survival in patients treated with immune checkpoint inhibitors. - The new biomarker could overcome limitations of current predictive markers like PD-L1 expression and tumor mutational burden, potentially improving patient stratification regardless of cancer type. - Findings presented at the 2025 AACR Annual Meeting demonstrate the signature's ability to identify three distinct patient groups with different clinical outcomes following immunotherapy treatment.
