Givastomig dose confirmed at 8 mg/kg with 79% ORR, Phase 3 talks under way with FDA; lazistomig shows improved safety on 6-week dosing, targeting patients unresponsive to immunotherapy
ABL Bio, a bispecific antibody-focused biotech, unveiled clinical data from two of its immuno-oncology pipeline candidates at Europe's largest oncology conference, moving the company closer to global Phase 3 trials.
The company said Monday it had presented clinical data for givastomig (ABL111) and lazistomig (ABL503) — both 4-1BB-based bispecific antibody cancer treatments co-developed with US-based NovaBridge Biosciences — at the European Society for Medical Oncology (ESMO 2026). Both candidates are built on ABL Bio's proprietary Grabody-T platform technology.
Givastomig targets Claudin18.2, a protein overexpressed in gastric and pancreatic cancers. Updated analyses from 71 patients enrolled in its Phase 1b trial — 31 in the 8 mg/kg cohort and 40 in the 12 mg/kg cohort — were presented. After weighing efficacy, safety and long-term follow-up data, the companies confirmed 8 mg/kg as the dose for further clinical development.
In the 8 mg/kg cohort, the objective response rate was 79 percent (23 of 29 patients) and the disease control rate reached 97 percent (28 of 29). Patients with high Claudin18.2 expression of 75 percent or above achieved an ORR of 82 percent, while those with expression levels between 1 and 74 percent still recorded 75 percent, demonstrating strong antitumor activity regardless of expression level. No grade 4 or 5 severe treatment-related adverse events were reported.
ABL Bio and NovaBridge have completed key design discussions with the US Food and Drug Administration for a global Phase 3 trial. Givastomig has already received both orphan drug and fast track designations from the FDA, which is expected to accelerate its development timeline.
Lazistomig, which targets the immune checkpoint protein PD-L1, also showed improved safety in its Phase 1 monotherapy trial when the dosing interval was extended from every two weeks to every six weeks, with a reduction in grade 3 or higher adverse events. Despite the longer interval, key CD8+ T-cell activation was maintained, while immunosuppressive regulatory T cells remained at baseline levels.
Particularly notable was that 84.6 percent of patients who responded to lazistomig (11 of 13) had previously failed or relapsed after treatment with existing PD-(L)1 immune checkpoint inhibitors, underscoring the drug's potential as a new option for patients who do not respond to standard immunotherapy.
"Givastomig has built confidence in its durability and safety through long-term follow-up data, and we have made progress in Phase 3 discussions with the FDA," said Lee Sang-hoon, chief executive of ABL Bio. "We will work with NovaBridge to accelerate Phase 3 preparations, while also actively advancing combination clinical development of lazistomig with PD-1 inhibitors based on the optimized dosing schedule."
ABL Bio develops next-generation treatments for neurodegenerative diseases and cancer, drawing on its proprietary blood-brain barrier shuttle platform Grabody-B and its immuno-oncology bispecific antibody platform Grabody-T.
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