Kairos Pharma (KAPA) Maxim Group’s 2024 Healthcare Virtual Summit summary

Company overview and focus

• Developing therapeutics to reverse cancer drug resistance and immune suppression, with a focus on CD105 and monoclonal antibody ENV105 targeting multiple cancers.

• Clinical-stage programs include phase 2 in prostate cancer and phase 1 in EGFR-dependent non-small cell lung cancer.

• Target indications include prostate, lung, head and neck, breast, and colon cancers, prioritizing based on available data and market size.

Mechanism of action and scientific rationale

• CD105 is a cell surface protein involved in drug resistance via BMP4 signaling and dedifferentiation, impacting several resistance mechanisms in prostate and lung cancer.

• ENV105 blocks CD105, resensitizing tumors to previously failed therapies and potentially reversing resistance to checkpoint inhibitors.

• CD105 also influences PD-L1 expression on T-cells, suggesting a role in immunotherapy resistance.

Clinical trial design and progress

• Prostate cancer phase 2 trial: randomized, 90 patients, comparing apalutamide alone vs. apalutamide plus ENV105, with a primary endpoint of progression-free survival and a 30% improvement target.

• Safety readout expected in the next month, interim efficacy data in 2025, and final readouts several months later.

• Lung cancer phase 1 trial: 50 patients, with arms for Tagrisso-resistant and incompletely treated patients, focusing on safety, dose-finding, and biomarker identification.