ABL Bio

- ABL111/givastomig is a bispecific antibody targeting Claudin 18.2 (CLDN 18.2)-positive tumor cells that conditionally activates T cells via 4-1BB in the tumor microenvironment, with potential CLDN 18.2 specificity even in tumors with low levels of CLDN 18.2 expression- Poster highlights Phase 1 pharmacokinetic modeling data for dose optimization of givastomig- The optimal dose of ABL111/givastomig is identified as 8-12 mg/kg dosed every two weeks (Q2W) ABL Bio (CEO Sang Hoon Lee, “ABL”), a company specializing in bispecific antibodies, today announced that its partner I-Mab presented the Phase I pharmacokinetic modeling clinical of ABL111/givastomig (TJ033721), at the 39th Annual Meeting for the Society for Immunotherapy of Cancer (SITC 2024) 2024, held in Houston, Texas from November 8th through 10th. Givastomig is a bispecific antibody targeting Claudin 18.2 and 4-1BB. It is being evaluated in ongoing Phase 1b dose expansion and combination studies in treatment-naive metastatic gastric cancers. The poster highlighted the dose optimization analysis for givastomig monotherapy using data from three clinical studies and non-clinical experiments. The poster entitled “Optimal dose estimation using an integrated approach from Phase I data of givastomig, a novel Claudin18.2×4-1BB bispecific antibody” was presented on November 9, 2024, in the Poster Hall of the George R. Brown Convention Center. The studies demonstrated a dose-response relationship for givastomig and identified 8-12 mg/kg Q2W as the optimal monotherapy dose range for gastric cancer patients. ABL Bio and I-Mab are currently conducting a Phase 1b study evaluating givastomig in combination with nivolumab plus chemotherapy in patients with treatment-naïve Claudin18.2-positive metastatic gastric cancers. “ABL111/givastomig is an investigational agent that was developed based on the company’s Grabody-T platform. Our Grabody-T platform has led to promising product candidates, enhanced by our efforts to advance and optimize the 4-1BB technology in our bispecific antibodies,” said Sang Hoon Lee, CEO of ABL Bio. “Givastomig appears to maintain strong tumor binding and anti-tumor activity, while minimizing liver toxicity and systemic immunotoxicity commonly seen with other emerging 4-1BB-based product candidates. Top line data are expected in H2 2025 from the Phase 1b dose escalation clinical trial evaluating the combination of givastomig plus nivolumab and chemotherapy.” About ABL111/givastomig Givastomig (TJ033721/ABL111) is a bispecific antibody targeting Claudin (CLDN) 18.2-positive tumor cells. It conditionally activates T cells in the tumor microenvironment where CLDN18.2 is expressed using 4-1BB. Activated T cells attack Claudin 18.2-positive tumor cells while preserving normal cells, potentially avoiding potential for serious liver toxicity. . In March 2022, ABL111/givastomig received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) as a treatment for gastric cancer (including gastroesophageal junction cancer). Givastomig, is being jointly developed through a global partnership with I-Mab. ABL shares worldwide rights with I-Mab equally, excluding China and South Korea, where ABL retains full rights. About ABL Bio ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. More than 15 clinical projects for over 7 programs, including ABL001, ABL111/givastomig, ABL503/ragistomig, ABL105, ABL202, ABL301, and ABL103, are directed at important cancer targets such as PD-L1, Claudin 18.2, B7-H4 and HER-2, and are underway for different indications in various countries, including the United States, China, Australia, and Korea. ABL’s lead program, ABL001, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. The program recently completed patient enrollment in a Phase 2/3 clinical trial for biliary tract cancer, and the top-line data will be disclosed in 2025. In addition, encouraging Phase 1 data were just presented at the European Society of Medical Oncology (ESMO2024) for ABL111/givastomig, in development with I-Mab for gastric cancers (including gastroesophageal junction, GEJ). Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). Note: this is a translated version of the original Korean language document, prepared and provided solely for readers’ convenience. In case of any discrepancy or dispute, the Korean language document prevails.

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