Kairos Pharma Ltd. (NYSE American: KAPA) has announced a strategic collaboration with Bayer to evaluate its lead antibody candidate, ENV-105 (carotuximab), in combination with Bayer’s XOFIGO (radium-223 dichloride) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) involving bone. ENV-105 is a first-in-class CD105/BMP signaling inhibitor designed to overcome cancer drug resistance and is currently being evaluated in Phase 1 and Phase 2 clinical trials. The company previously reported interim Phase 2 data showing median progression-free survival of more than 13 months in prostate cancer patients, while XOFIGO is the only FDA-approved alpha-emitting radiopharmaceutical for symptomatic bone metastases in this patient population.
The collaboration will evaluate whether ENV-105 can enhance and extend responses to XOFIGO by targeting CD105, a protein associated with treatment resistance following androgen receptor inhibition and radiation therapy. Preclinical studies have demonstrated ENV-105’s ability to re-sensitize tumors to radiation, and management believes combining the therapy with XOFIGO could provide a more durable treatment option for patients with advanced prostate cancer.
ENV-105 targets CD105, a protein identified as a key driver of resistance and disease relapse in response to standard therapy. By reversing drug resistance, ENV-105 aims to restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV-105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer and a Phase 1 trial for non-small cell lung cancer. As of the date of this press release, ENV-105 has not been approved as safe or effective by the United States Food and Drug Administration or any other comparable foreign regulator.
This collaboration is significant as it combines a novel immunotherapy with an established radiopharmaceutical to address a major unmet medical need in advanced prostate cancer. Prostate cancer is the second most common cancer in men worldwide, and metastatic castration-resistant prostate cancer with bone metastases has limited treatment options. The synergy between ENV-105 and XOFIGO could potentially improve patient outcomes by tackling resistance mechanisms.
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