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- Expanded Phase 1 study showed promising single-agent, ABL111 monotherapy activity in heavily pre-treated patients with gastric cancers expressing Claudin 18.2 at low and high levels
- Confirming 7 partial responses and 14 stable diseases in phase 1 clinical trial for ABL111 monotherapy
- A Phase 1b study, evaluating ABL111 in combination with standard-of-care treatment (nivolumab + chemotherapy (FOLFOX)) in front-line gastric cancers, is ongoing
ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its global partner I-Mab presented a poster presentation highlighting encouraging top-line results from the ongoing Phase 1 clinical trial of ABL111 (Givastomig / TJ033721) in patients with advanced solid tumors, especially gastric cancers (including gastroesophageal carcinoma) at the European Society for Medical Oncology 2024 (ESMO 2024) held in Barcelona, Spain from September 13 to 17.
ABL111 is a bispecific antibody developed using the Company’s Grabody-T platform. This antibody targets Claudin18.2-positive tumor cells that conditionally activates T cells via 4-1BB in the tumor microenvironment, where Clauin18.2 is expressed. It is being jointly developed by ABL Bio and I-Mab. The interim results of the Phase 1 trial for ABL111were first disclosed at ESMO 2023, and a Phase 1b clinical trial a combining ABL111 plus nivolumab plus chemotherapy (FOLFOX) is currently underway in the U.S. and China.
The poster focused on 43 patients enrolled in the dose expansion study (doses ranging from 5 mg/kg to 18 mg/kg) with gastric cancers, including advanced gastroesophageal carcinoma (GEC). Study data indicates that ABL111 has a strong overall safety profile.
No dose-limiting toxicity was reported up to 15 mg/kg Q2W and 18 mg/kg Q3W, and a maximum tolerated dose (MTD) was not identified. The most common treatment-related adverse events were nausea (25.6%), anemia (23.3%), and were mainly Grade 1 or Grade 2.
In terms of efficacy, among 43 patients with Claudin18.2-positive gastric and esophageal cancer, seven patients reported partial responses (one at 5 mg/kg, one at 8 mg/kg, four at 12 mg/kg, and one at 18 mg/kg), and 14 patients confirmed as stable diseases. Five of the seven patients who had achieved a partial response (71%) had previously received a checkpoint inhibitor.
Sang Hoon Lee, CEO of ABL Bio said “We are pleased by the promising monotherapy efficacy results of the Phase 1 clinical trial for ABL111 presented at ESMO 2024. These data build on positive results from last year’s ESMO congress and provide encouraging data, with a strong overall safety profile. Based on the encouraging initial efficacy signals and overall safety profile for ABL 111, we believe ABL111 has the potential to be a front-line treatment option for patients with gastric cancers. We are enthusiastic about the ongoing combination clinical trial of ABL111 plus nivolumab plus chemotherapy and will do our best to accelerate clinical development through close cooperation with I-Mab.”
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 pipelines, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, 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 1b data were just presented at ESMO2024 for ABL111, 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 document prevails.