Galapagos announces FDA clearance of IND application for Phase 1/2 ATALANTA-1 study of CD19 CAR-T, GLPG5101, in relapsed/refractory non-Hodgkin lymphoma
- The FDA has cleared Galapagos' IND application for the ATALANTA-1 Phase 1/2 study of GLPG5101 in relapsed/refractory non-Hodgkin lymphoma (R/R NHL).
- GLPG5101 is an autologous CD19 CAR-T cell therapy produced using a decentralized manufacturing platform, with a median vein-to-vein time of seven days.
- The Phase 1 study aims to evaluate the safety and preliminary efficacy of GLPG5101, while Phase 2 will focus on the objective response rate and other secondary objectives.
- The study is ongoing in Europe, showing encouraging early results, and each patient will be followed for 24 months.
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GI Innovation announces new clinical trial collaboration and supply agreement to evaluate GI-102 in combination with Keytruda in patients with immunotherapy-resistant liver cancer, melanoma, and renal cell carcinoma
- GI Innovation has signed a clinical trial collaboration and supply agreement with MSD to evaluate GI-102 combined with Keytruda.
- The Phase 2 trial will enroll patients with immunotherapy-resistant liver cancer, melanoma, and renal cell carcinoma.
- Previous trials showed a 42.9% overall response rate for GI-102 in melanoma patients and 60% tumor regression in a preclinical liver cancer model.
- The trial will be conducted at 14 hospitals in South Korea and renowned sites in the U.S., including the Mayo Clinic and Cleveland Clinic.
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Opna Bio doses first patient in phase 1 study in multiple myeloma with OPN-6602
- Opna Bio has initiated a Phase 1 clinical study for OPN-6602, an EP300/CBP bromodomain inhibitor, in multiple myeloma.
- The trial aims to enroll up to 130 patients with relapsed or refractory multiple myeloma at U.S. sites.
- Objectives include assessing safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of OPN-6602.
- Completion of the study is expected in the second half of 2026.
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CytoDyn engages leading CRO for Phase II inflammation trial
- CytoDyn Inc. has partnered with Syneos Health for its upcoming Phase II study on leronlimab's effects on chronic inflammation.
- Syneos Health is a top biopharmaceutical solutions organization, involved in the development or commercialization of 92% of novel new drugs approved by the FDA from 2019-2023.
- The study aims to generate clinical data to support leronlimab's utility in addressing various medical concerns.
- Leronlimab is a humanized IgG4 monoclonal antibody targeting CCR5, being studied for oncology, inflammation, HIV, and MASH.
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