OBI-999

P1/2, N=44, Terminated, OBI Pharma, Inc | N=185 --> 44 | Trial completion date: Dec 2025 --> Oct 2023 | Recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Oct 2023; Has not shown its expected therapeutic potential for the enrolled patients in this trial

P1/2, N=185, Recruiting, OBI Pharma, Inc | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Nov 2023 --> Nov 2025

We demonstrated significant synergistic effects of OBI-999 and pembrolizumab in several animal models. These synergistic effects may be attributed to the ability of OBI-999 to induce ICD, as demonstrated by the release of DAMPs in vitro and tumor-specific immunity in vivo, suggesting that OBI-999 can create a tumor microenvironment that enhances the function of pembrolizumab. The results suggest that combination therapy with OBI-999 and immune checkpoint inhibitors is warranted in human clinical studies.

In addition, GH-targeting antibody-drug conjugate (ADC) OBI-999 has been demonstrated an excellent tumor growth inhibition potency in animal models across multiple cancer types including gastric cancer (GC)... GH level was associated with the survival of GC patients and positively correlated with cell surface PD-L1 expression in vitro. Therefore, GH-targeting therapy has a potential application for the treatment of GC patients.

P1/2, N=185, Recruiting, OBI Pharma, Inc | Active, not recruiting --> Recruiting

P1/2, N=185, Active, not recruiting, OBI Pharma, Inc | Recruiting --> Active, not recruiting

An attractive therapeutic target, Globo H-targeted agents are being tested in early clinical trials (e.g., OBI-833, a Globo H antigen conjugated to a mutated diphtheria toxin with potential antineoplastic activities, and OBI-999, an antibody-drug conjugate (ADC) consisting of a Globo H monoclonal antibody with a synthetic antineoplastic agent) . The association with TMB-H, MSI-H, and PD-L1 status suggests that in some tumors Globo H may be a promising target for combination therapy with immune checkpoint inhibition . The association with different cell populations suggests manipulating the cellular balance in the TME as an approach to improve the efficacy of treatment . NK cell checkpoint inhibitors are in clinical trials and might be utilized in high Globo H cancers; treatments inducing DCs in tumors have been shown to enhance responses to BRAF and PD-L1 blockade and might be applicable in the context of Globo H immunotherapy to overcome Treg immune suppression .