KAPA News & Events

Kairos Pharma announces that it has entered into binding terms to acquire CL-273 from Celyn Therapeutics, a company backed by OrbiMed and Torrey Pines Investment. John Yu, M.D., Kairos Pharma CEO, commented: "The signing of binding terms to acquire CL-273 represents a pivotal step in building Kairos Pharma's next generation of targeted therapies for EGFR-mutant lung cancer. This transaction is expected to be value-accretive. CL-273's AI-designed, wild-type-sparing pan-EGFR profile positions it as a potentially best-in-class asset in a large, fast-growing $16.2 billion lung cancer market with significant unmet needs due to the development of resistance. Given its prestigious backing, we believe partnering with Celyn Therapeutics offers additional high-quality science to our existing pipeline. We believe in the rigor of the data package supporting CL-273. We further believe that together with an OrbiMed-backed innovator, Kairos Pharma is strongly positioned to deliver a highly differentiated, potentially best-in-class, EGFR inhibitor to patients worldwide."

Kairos Pharma announced the signing of a term sheet for a strategic asset acquisition with Celyn Therapeutics. Under the proposed terms of the agreement, Kairos Pharma will acquire worldwide rights to two clinical-stage oncology assets targeting non-small cell lung cancer: CL-273, a pre-IND, reversible, wild-type-sparing pan-EGFR inhibitor, and CL-741, a Phase 1-ready, orally available type IIb c-MET kinase inhibitor. John Yu, Kairos Pharma CEO, commented: "We anticipate this acquisition will significantly expand our oncology pipeline with late-preclinical and Phase 1-ready assets in a multi-billion dollar market with substantial unmet medical needs. With this acquisition, if completed, we will strengthen our armamentarium to reverse oncology drug resistance - by implementing therapeutics that specifically target resistance mutations that arise from targeting the EGFR receptor. Importantly, our established clinical consortia on the West Coast, anchored at Cedars-Sinai Medical Center in Los Angeles, provides us with the clinical infrastructure and expertise to rapidly initiate and execute Phase 1 and Phase 2 studies for both compounds."

Kairos Pharma files $75M mixed securities shelf

Kairos Pharma announced efficacy data from its ongoing Phase 2 clinical trial of ENV105 in patients with metastatic castration-resistant prostate cancer. Kairos Pharma is hosting a virtual KOL event to provide perspectives on this data at 5 p.m. ET / 2 p.m. PT. All patients enrolled in the trial had already failed at least one other hormone therapy modality. This predetermined interim analysis covers the same 10 patients from the safety-arm of the trial, with all patients having failed at least one androgen receptor inhibitor hormone therapy prior to acceptance. Two of the ten patients withdrew from the trial for unrelated events. Of the eight remaining patients, the median progression-free survival was more than 13 months, with five of the eight patients continuing treatment without progression. Seven of nine patients demonstrated a decrease of their prostate-specific antigen from baseline. The interim efficacy analysis of the trial demonstrated that ENV105, a CD105 antagonist, in combination with standard of care hormone therapy apalutamide demonstrated a progression-free survival of 13 months. Notably, the trial is powered to show a 45% improvement in the PFS. This translates to an increase in PFS from 3.7 to 6.7 months. This mark was far exceeded by the ENV105/ Apalutamide combination. The four-month timeframe is significant as 2nd or 3rd line standard of care hormone therapy has a 3.7-month median efficacy, as reported by the CARD trial. The same study also showed the use of chemotherapy provided eight months' PFS, by imaging, accompanied with greater toxicity. The randomized Phase 2 trial aims to enroll 100 patients in total and is presently accruing patients at Cedars-Sinai Medical Center, City of Hope, and Huntsman Cancer Center. The study is designed to evaluate the safety, tolerability, and early signs of efficacy of ENV105, a CD105 antagonist, in men whose disease has progressed following standard hormone-based therapies. The interim safety analysis of the same trial, announced in July of this year, demonstrated that ENV105 was well tolerated when combined with standard of care hormone therapy, apalutamide, from the first 10 enrolled patients. Thus far, there have been no dose-limiting toxicities or unexpected adverse events reported to date. In addition, the treatment-related side effects were manageable with standard supportive care. Notably, no Grade 3 or Grade 4 toxicities were observed.