ABL Bio reports 18% ORR for dual antibody ‘피망 바카라’ targeting Claudin18.2 and 4-1BB in esophageal cancer

[by Kang, In Hyo] ABL Bio, a company specializing in dual antibody therapeutics, announced on July 2 that its partner company I-Mab has published clinical data on the monotherapy of ‘피망 바카라 (givastomic),’ a bispecific antibody targeting Claudin18.2 and 4-1BB, in the international academic journal Clinical Cancer Research (CCR).

CCR is a leading peer-reviewed journal in the field of clinical oncology, published by the American Association for Cancer Research (AACR). The recently published article presents encouraging efficacy and safety data from a Phase 1 clinical trial of 피망 바카라 monotherapy in patients with Claudin18.2-positive gastric cancer.

The Phase 1 clinical data for 피망 바카라 monotherapy had previously been presented in poster format at the European Society for Medical Oncology (ESMO) annual meetings in 2023 and 2024. The clinical trial enrolled a total of 75 patients with solid tumors, including gastric cancer, among whom 43 had advanced or metastatic gastroesophageal cancer expressing Claudin18.2.

Data analysis revealed that 7 out of the 43 patients with Claudin18.2-positive achieved a partial response (PR), with an objective response rate (ORR) of 16% (7/43) for 피망 바카라 monotherapy. Following the data cutoff presented at ESMO 2024, 2 additional patients were enrolled, with 1 achieving PR, thereby increasing the ORR to 18% (8/45).

The disease control rate (DCR) was 49% (21 out of 43 patients), including 14 patients who achieved stable disease (SD). Most adverse reactions were reported as mild, classified as grade 1 to 2. Notably, the Claudin18.2 expression levels in patients who responded to 피망 바카라 monotherapy ranged from 11% to 100%, indicating that the treatment may demonstrate therapeutic efficacy even in patients with relatively low Claudin18.2 expression, according to the company.

“We are pleased to publish the clinical data of 피망 바카라 monotherapy as the first paper in the prestigious international academic journal CCR,” said Lee Sang-hoon, CEO of ABL Bio. “Moving forward, we will make every effort to successfully advance global clinical trials of 피망 바카라 through close collaboration with I-Mab, and to produce meaningful results in combination therapy clinical trials that may offer new treatment options for patients with gastric cancer,” he added.

피망 바카라 is a bispecific antibody targeting Claudin18.2-positive tumors, with a mechanism of action that enables selective activation of T cells via the 4-1BB pathway specifically in the tumor microenvironment where Claudin18.2 is expressed. The treatment is currently in Phase 1b clinical trial as part of a triple combination therapy with the immune checkpoint inhibitor nivolumab and chemotherapy, with the goal of developing it as a ‘first-line treatment’ for patients with gastric cancer. In the previous Phase 1 clinical trial, 피망 바카라 monotherapy demonstrated strong antitumor activity driven by the close interaction between Claudin18.2 and 4-1BB, while mitigating the toxicity commonly seen in conventional 4-1BB-targeting antibodies.