Kairos Pharma Ltd. (NYSE American: KAPA) has reported favorable interim safety data from its ongoing Phase 1 clinical 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 among 13 patients treated with ENV-105 to date, no Grade 3 or higher treatment-related adverse events were observed, and all side effects were manageable through standard supportive care. These results support the 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. Osimertinib is the current standard of care for EGFR-mutated NSCLC, but patients often develop resistance, limiting its long-term effectiveness. Kairos Pharma believes that ENV-105 has the potential to extend the clinical utility of osimertinib by addressing this acquired resistance after disease progression. The Phase 1 study is evaluating the safety, tolerability, and recommended Phase 2 dose of the combination therapy.
The favorable safety profile is a critical milestone, as it allows the trial to proceed without dose-limiting toxicities. The company stated that all reported side effects were mild to moderate and manageable, which is encouraging for patients who have limited treatment options after progressing on osimertinib. The next step involves moving toward an efficacy readout to determine if ENV-105 can indeed reverse resistance and improve outcomes.
ENV-105 is also being investigated in a Phase 2 clinical trial for castrate-resistant prostate cancer. The drug has not yet been approved by the U.S. Food and Drug Administration or any other foreign regulator. For more details, the full press release is available at https://ibn.fm/SmdwW.
Kairos Pharma, based in Los Angeles, California, focuses on oncology therapeutics using structural biology to overcome drug resistance and immune suppression. The company’s lead candidate, ENV-105, targets CD105, a key driver of resistance and relapse in response to standard therapy. By targeting CD105, ENV-105 aims to reverse drug resistance and restore the effectiveness of standard therapies across multiple cancer types. The company’s stock is traded on the NYSE American under the symbol KAPA, and the latest news and updates are available in the company’s newsroom at https://ibn.fm/KAPA.
