Kairos Pharma (KAPA) Lytham Partners 2025 Investor Healthcare Summit summary

Strategic focus and clinical programs

• Developing therapeutics to reverse cancer drug resistance, targeting key moments of resistance or immune suppression.

• Lead drug ENV105 in phase II trial for prostate cancer and phase I trial for non-small cell lung cancer resistant to TAGRISSO.

• KROS201, a cell therapy for glioblastoma, has IND clearance and benefits from a strategic relationship with Cedars-Sinai Medical Center.

• Pipeline includes agents targeting immune suppression and drug resistance across multiple cancer types.

• Intellectual property portfolio extends through 2040, covering composition, use, and development methods.

Mechanism of action and clinical data

• ENV105 is a neutralizing antibody targeting CD105, restoring sensitivity to hormone and EGFR therapies in resistant tumors.

• Phase II trial in prostate cancer showed a 62% clinical benefit in patients previously resistant to standard hormone therapies, with no grade 3 or 4 toxicities.

• Identified three predictive biomarkers to optimize patient selection for future trials, enabling smaller, more efficient phase III studies.

• Ongoing randomized phase II trial compares apalutamide alone versus in combination with ENV105, with progression-free survival as the primary endpoint.

• Phase I trial in lung cancer focuses on patients with partial or complete resistance to TAGRISSO, with safety and biomarker identification as key endpoints.

Immunotherapy and pipeline expansion

• Immunotherapy assets target the GITR receptor to increase killer T cells and reduce immunosuppressive Treg cells, addressing low response rates in current immunotherapies.

• KROS201 (T cell therapy for glioblastoma), KROS101 (small molecule to increase T cell growth), and KROS102 (reduces T cell growth for autoimmune diseases) are in development.

• KROS301 and KROS401 target triple-negative breast cancer and tumor-associated macrophages, respectively.

• ENV-205 is an antibody targeting mitochondrial DNA to reverse chemotherapy resistance.

• Pipeline addresses large and fast-growing markets in prostate, lung, head and neck, and immuno-oncology.