Evaluation of the safety and efficacy of triple 바카라사이트 굿모닝 therapy in Korea and the U.S.
[by Ji, Yong Jun] ABL Bio announced on June 4 that it has received approval from the Ministry of Food and Drug Safety for the clinical phase 1b/2 trial (IND) plan. The trial will evaluate the triple combination therapy of ABL Bio’s dual antibody candidate, 'ABL103 (development code),' MSD (Merck, USA)'s anti-PD-1 immunotherapy 'KEYTRUDA (pembrolizumab)' and 'Taxane.'
ABL103 is a dual antibody that simultaneously targets 'B7-H4' and '4-1BB,' representing one of the pipelines utilizing ABL Bio's 4-1BB-based dual antibody platform, 'Grabody-T.' This platform is engineered to mitigate the 'liver toxicity' associated with existing 4-1BB monoclonal antibodies and to improve antitumor activity by selectively activating immune T cells in the tumor microenvironment. Currently, Phase 1 바카라사이트 굿모닝 trials for ABL103 monotherapy are ongoing in the United States and Korea. Additionally, with the recent IND approval, Phase 1b and 2 바카라사이트 굿모닝 trials investigating the triple combination therapy are scheduled to be conducted in Korea and the U.S.
This Phase 1b and 2 바카라사이트 굿모닝 trial is structured in two parts focused on safety (Safety Lead-in Part) to identify the optimal dosing for the triple combination therapy, as well as one part for dose expansion (Dose Expansion Part). Through this design, ABL Bio intends to assess the safety and the therapeutic efficacy of the ABL103 triple combination therapy.
“We have secured approval from the Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA) to initiate 바카라사이트 굿모닝 trials assessing the safety and efficacy of ABL103 triple combination therapy,” said Lee Sang-hoon, CEO of ABL Bio. “We expect that the combination therapy of ABL103, Keytruda, and Taxane will offer new treatment options for patients with refractory solid tumors.”
"The 바카라사이트 굿모닝 trials of 4-1BB-based dual antibodies, including ABL103, are proceeding smoothly," Lee further added. "We will do our utmost in research and development (R&D) to bring encouraging updates, such as the recent IND approval for the phase 1b and 2 바카라사이트 굿모닝 trials of ABL103."