Kairos Pharma Ltd. (NYSE American: KAPA) reported favorable interim safety results from its ongoing Phase 1 trial evaluating ENV-105 (carotuximab) in combination with osimertinib (Tagrisso) for patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) who have developed resistance to osimertinib. The company announced that no Grade 3 or higher treatment-related adverse events have been observed among the 13 patients treated with ENV-105 to date, supporting continued advancement of the program toward an early efficacy readout.
ENV-105 is designed to inhibit CD105, a protein associated with acquired drug resistance, with the goal of restoring sensitivity to osimertinib. The Phase 1 study is evaluating the safety, tolerability and recommended Phase 2 dose of the combination therapy. All reported side effects have been manageable through standard supportive care. The company believes ENV-105 has the potential to extend the clinical utility of osimertinib, the current standard of care for EGFR-mutated NSCLC, by addressing acquired resistance after disease progression.
According to the press release, the full details can be accessed at https://ibn.fm/SmdwW. Kairos Pharma, based in Los Angeles, California, is focused on oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. ENV-105 is also in a Phase 2 clinical trial for castrate-resistant prostate 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 announcement is significant because it provides early evidence that the combination of ENV-105 and osimertinib may be well-tolerated, which is a critical step toward addressing a major unmet need in EGFR-mutated NSCLC: acquired resistance to osimertinib. If subsequent efficacy data are positive, ENV-105 could potentially extend the duration of effective treatment for patients who currently have limited options after progression on osimertinib. The favorable safety profile also de-risks the program, allowing the company to move forward with dose escalation and eventually into a Phase 2 trial designed to measure clinical benefit.
Investors and stakeholders can find the latest news and updates relating to KAPA in the company’s newsroom at https://ibn.fm/KAPA. The ongoing trial results will be closely watched by the oncology community, as they could potentially reshape treatment paradigms for a patient population with high unmet need.
