ABL Bio Announces Interim Data from Phase 1 Clinical Trial of 'ABL111'

4-1BB Based Bispecific Antibody
"Safety Met... Simultaneous Development of 1st and 3rd Line Therapies"

ABL Bio announced on the 26th that it presented interim data from the Phase 1 clinical trial of the 4-1BB-based bispecific antibody pipeline 'ABL111' and its future clinical development strategy at an analyst meeting and an online briefing held on the 25th.

ABL Bio CI. [Image provided by ABL Bio]

ABL111 is a bispecific antibody co-developed by ABL Bio and Nasdaq-listed company iMab. It is one of the pipelines applying ABL Bio's 4-1BB bispecific antibody platform 'Grabody-T' and targets Claudin18.2, which is mainly expressed in gastric and esophageal cancers.

According to the briefing, among the 12 treatment-related adverse events (TRAE) occurring in more than 5% of the 55 patients participating in the Phase 1 trial of ABL111, no life-threatening Grade 4 or higher adverse events were observed, indicating a high safety profile. Regarding liver toxicity, a known side effect of 4-1BB, only one Grade 3 event was reported, with no Grade 4 or higher adverse events confirmed. For the three most common adverse events (nausea, vomiting, fatigue) observed in zolbetuximab monotherapy, no Grade 3 or higher side effects were reported in the ABL111 Phase 1 trial.

In the key efficacy indicator, objective response rate (ORR), ABL111 showed superior results compared to clinical outcomes of zolbetuximab monotherapy. In an interim analysis of 17 patients in the Phase 1 trial, ABL111 demonstrated a 24% ORR, and in the patient group receiving the optimal dose of 12 mg/kg for subsequent trials, the ORR reached 40%.

Furthermore, efficacy according to expression levels was also superior for ABL111 compared to zolbetuximab. While zolbetuximab showed efficacy only in patients with Claudin18.2 expression of 70% or higher, ABL111 demonstrated efficacy across a broad range of expression levels, including partial response (PR) cases reported in patients with Claudin18.2 expression as low as 11%.

Currently, the Phase 1 trial of ABL111 is being conducted in the United States and China. The dose escalation and expansion parts of the trial involved 55 patients with advanced or recurrent refractory solid tumors expressing Claudin18.2 at 1% or higher. Among them, 17 patients with gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma who received doses of 5, 8, 12, and 15 mg/kg and were evaluable for efficacy were included in the interim data analysis.

Lee Sang-hoon, CEO of ABL Bio, stated, "ABL111 will be developed simultaneously as a first-line and third-line treatment. ABL Bio and iMab plan to initiate new clinical trials for the triple combination therapy of ABL111 aimed at first-line treatment approval, while continuing monotherapy trials of ABL111 to prepare for approval as a third-line treatment. ABL111 is just the beginning of the Grabody-T series, and we will accelerate the development of other pipelines such as ABL503 and ABL103 to achieve noteworthy results."

This content was produced with the assistance of AI translation services.