Apexigen, Inc. announced the presentation of new data from Phase 2 multicenter clinical trials evaluating sotigalimab (sotiga), Apexigen's agonist antibody targeting CD40, in two poster presentations at the ASCO Gastrointestinal Cancers Symposium, being held both virtually and in San Francisco, California from January 19-21, 2023. Takeaways: -- Sine-agagent sotiga induced infiltration and activation of myeloid cells, including dendriticells and macrorophages in the TME. Sotiga also induced infiltration of CD8+ T cells while decreasing the frequency of CD4+ regulatory T cells in the TME.

-- T cell composition and density in the TME at baseline is associated with tumor response, potentially identifying patients more likely to respond to treatment. The ability to modify the immune microenvironment from "cold" to "hot" further validates sotiga's mechanism of action. Presentation Highlights Key Takeaways: Sotiginin combination with SCRT induces immune activation in the TME, with the potential to improve clinical reresponses and avoid the need for surgery.

Single-cell RNA sequencing performed on tumor biopsies taken pre- and post- sotiga in combination with SCRT demonstrated induction of robust immune responses. The addition of sotiga to SCRT induced greater antigen presenting cells and CD8+ T cell activation compared to SCRT alone. Immune changes were observed with SCRT alone but were more robust with the addition of sotiga.

In the SCRT with sotiga group there was a greater induction of genes associated with M1-like macrophages, with no change in M2 genes. In lymphocytes, sotiga treatment led to an induction of genes related to Th1 and B cell response. These emerging data highlight the potential of combining sotiga, an agent that induces robust immune responses, with SCRT to treat rectal cancer patients.