Kairos Pharma (KAPA) investor relations material

Study background and rationale

• ENV105 (carotuximab) is a neutralizing antibody targeting CD105, combined with apalutamide for metastatic castration-resistant prostate cancer (mCRPC).

• The trial addresses resistance to hormone therapies, a major unmet need in advanced prostate cancer.

• Preclinical studies showed ENV105 can resensitize tumors to hormone therapy by blocking CD105.

• The phase II trial is randomized, aiming to enroll 100 patients across multiple centers and is currently accruing at major cancer centers.

• The study includes a safety arm and a randomized comparison of apalutamide alone versus the combination.

Interim efficacy results

• Median progression-free survival (PFS) was 13.7 months, with ENV105 plus apalutamide exceeding the trial's target PFS improvement and surpassing standard care benchmarks.

• Seven of nine patients experienced a decrease in PSA from baseline, though early decreases were mainly attributed to apalutamide.

• Five patients surpassed one year on treatment, and five of eight continued without disease progression at analysis.

• The trial is powered to show a 45% improvement in PFS, with ENV105 achieving results above this threshold.

• ENV105 is also being studied in a Phase 1 trial for lung cancer.

Safety and tolerability

• ENV105 plus apalutamide was well tolerated, with no dose-limiting toxicities, no Grade 3 or 4 toxicities, and no unexpected adverse events.

• Most common side effect was manageable nosebleeds; only one grade 3 anemia/epistaxis event occurred.

• No serious or unexpected toxicities were observed; side effects were manageable with supportive care.