KVA12123 Advances in VISTA-101 Trial with Promising Early Clinical Results

Kineta, Inc., a biotech firm specializing in innovative oncology immunotherapies, has shared updates on its VISTA-101 Phase 1/2 clinical trial. The trial is assessing the efficacy of KVA12123, a VISTA-blocking immunotherapy, both as a standalone treatment and in conjunction with Merck’s KEYTRUDA® (pembrolizumab), for patients with advanced solid tumors. KVA12123 has successfully passed the fifth monotherapy dose level and the second combination dose level without encountering any dose limiting toxicities or cytokine-related adverse events, indicating a positive safety profile.
In the monotherapy group, 12 out of 21 patients showed stable disease as the best overall response, with an average duration of 15 weeks. Notably, a patient with non-small cell lung cancer, who had failed previous treatments, maintained stable disease for 28 weeks. In the combination therapy group, out of 9 patients, 2 showed stable disease and 1 exhibited a partial response with a significant reduction in target lesions. Eight patients in this group continue to receive treatment.
Biomarker analysis revealed a dose-dependent increase in pro-inflammatory cytokines, chemokines, non-classical monocytes, and T cells, suggesting KVA12123's potential to enhance the immune response against tumors. The company's Chief Scientific Officer, Thierry Guillaudeux, Ph.D., expressed optimism about the drug's potential to address immunosuppression in the tumor microenvironment.
However, due to funding issues, Kineta has halted new patient enrollment in the VISTA-101 trial and is exploring strategic alternatives to maximize value for stakeholders. The company's restructuring and pursuit of strategic options are in response to certain investors' refusal to meet their funding commitments. Despite this, existing patients in the trial are allowed to continue their participation.
Kineta is committed to developing next-generation immunotherapies and has a pipeline that includes KVA12123 and a preclinical monoclonal antibody targeting CD27. The company's focus is on overcoming the challenges associated with current cancer therapies by leveraging its expertise in innate immunity. KVA12123, in particular, is being developed to target immune suppression in the tumor microenvironment, potentially offering a new approach to managing solid tumor cancers. The drug's mechanism of action is seen as complementary to T cell-focused therapies, and it may be effective against various types of cancer, including non-small cell lung cancer, colorectal, renal cell carcinoma, head and neck, and ovarian cancer.
VISTA is a negative immune checkpoint that can suppress T cell function in solid tumors, and high expression levels are linked to poor survival rates in patients. Blocking VISTA can stimulate a robust immune response to counteract immunosuppression and promote anti-tumor activity.

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