Kairos Pharma Ltd. (NYSE American: KAPA) has entered into 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 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. Kairos said 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. This partnership is significant because it addresses a critical unmet need in prostate cancer treatment: overcoming resistance to standard therapies. For patients with metastatic castration-resistant prostate cancer that has spread to the bone, treatment options are limited. If successful, the combination could extend survival and improve quality of life.
Kairos Pharma is at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. Its lead candidate, ENV-105, targets CD105—a protein identified as a key driver of resistance and disease relapse in response to standard therapy. ENV-105 aims to reverse drug resistance by targeting CD105 and 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 aimed at addressing significant unmet medical needs. 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 could have broad implications for the oncology field. If the combination proves effective, it may set a new standard of care for advanced prostate cancer patients with bone metastases. It also highlights the potential of targeting CD105 to overcome resistance to radiation and hormonal therapies, which could be applicable to other cancers. The partnership between a small biotech and a large pharmaceutical company like Bayer underscores the industry’s interest in innovative approaches to drug resistance. For investors, this collaboration adds credibility to Kairos Pharma’s pipeline and could accelerate development of ENV-105. The latest news and updates relating to KAPA are available in the company’s newsroom at https://ibn.fm/KAPA.

