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, aiming to restore effectiveness of existing cancer drugs.

• Lead program targets CD105, a cell surface protein central to drug resistance in multiple cancers, using a monoclonal antibody (ENV105).

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

• Additional targets include head and neck, breast, and colon cancers, with a focus on large market indications.

• Immunotherapy pipeline includes novel GITR ligand modulators for cancer and autoimmune diseases, currently at pre-IND stage.

Mechanism of action and scientific rationale

• CD105 is upregulated in response to therapy and drives resistance via survival signaling and dedifferentiation.

• Blocking CD105 with ENV105 reverses resistance to anti-androgens, Tagrisso, and potentially checkpoint inhibitors.

• ENV105 may resensitize tumors to PD-1 antibodies and impacts PD-L1 expression on T-cells.

• GITR ligand modulators expand T-effector cells and reduce T-regs, enhancing anti-tumor immunity.

• Small molecule GITR ligand inhibitors may have applications in autoimmune diseases and transplantation.

Clinical trial design and progress

• Prostate cancer phase 2 trial: randomized, 90 patients, comparing apalutamide alone vs. apalutamide plus ENV105, with crossover for non-responders.

• Primary endpoint is progression-free survival, aiming for a 30% improvement over control.

• Safety readout expected in the next month, interim efficacy in 2025, and final data later that year.

• Lung cancer phase 1 trial: 50 patients, includes those with recurrence on Tagrisso and those with residual disease, focusing on safety, dose, and biomarker identification.

• Biomarker development supported by a $3.2M NIH grant, with a three-gene panel identified to predict responders.