givastomig (TJ-CD4B)

In addition, givastomig-mediated T cell activation and tumor-killing was enhanced in combination with chemotherapies used in 1L or 2L treatment for gastric cancer, including 5-fluorouracil plus oxaliplatin (FOLFOX) and paclitaxel...2 expression (25–50% of 2+), a triple-combination of givastomig, nivolumab and FOLFOX resulted in better tumor growth inhibition (TGI=40%), accompanied by an increase in tumor-infiltrating T cells, compared to nivolumab plus FOLFOX (TGI=8%)...2 expression. The synergistic anti-tumor activity by givastomig in combination with current therapeutics in 1L/2L treatment for gastric cancer, as demonstrated in preclinical studies, warrants further investigation of these combinations in clinics.

The PK profile, s4-1BB induction, and efficacy signal support 12 mg/kg as an optimal dose. Further development of givastomig mono- and combo- therapy in GEC and other cancers is planned.

Givastomig/ABL111 is a novel CLDN18.2×4-1BB bispecific antibody which has the potential to treat patients with gastric cancer with a wide range of CLDN18.2 expression level through the restricted activation of 4-1BB T cells in tumor microenvironment to avoid the risk of liver toxicity and systemic immune response.

P1, N=102, Recruiting, I-Mab Biopharma Co. Ltd. | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Sep 2024

TJ-CD4B did not induce systemic immune response nor hepatic toxicity due to the CLDN18.2 dependent 4-1BB stimulation. These data warrant the current clinical development in phase I trial to validate the safety properties and tumor specific responses.

P1, N=108, Recruiting, I-Mab Biopharma Co. Ltd. | Not yet recruiting --> Recruiting

P1, N=108, Not yet recruiting, I-Mab Biopharma Co. Ltd.