Kairos Pharma Ltd. Announces Completed Enrollment of the Safety Arm of Its Phase 2 Clinical Trial of ENV105 in Metastatic, Castration-Resistant Prostate Cancer
Kairos Pharma (NYSE: KAPA) has completed the safety lead-in phase of its Phase 2 clinical trial for ENV105 in treating metastatic, castration-resistant prostate cancer. The trial combines ENV105 with apalutamide, a standard prostate cancer treatment.
The study consists of two parts: the completed safety lead-in and an ongoing randomized portion comparing apalutamide alone versus apalutamide with ENV105. The company expects to release safety and efficacy data from the safety arm in the first half of 2025.
Patient enrollment continues for the randomization arm at cancer centers in Los Angeles and Salt Lake City. The trial includes biomarker validation to identify patients most likely to benefit from the combination therapy. The study is supported by Kairos Pharma and a National Cancer Institute grant.
Kairos Pharma (NYSE: KAPA) ha completato la fase di introduzione alla sicurezza del suo studio clinico di Fase 2 per ENV105 nel trattamento del cancro prostatico metastatico resistente alla castrazione. Lo studio combina ENV105 con apalutamide, un trattamento standard per il cancro alla prostata.
La ricerca è composta da due parti: la fase di introduzione alla sicurezza completata e una parte randomizzata in corso che confronta apalutamide da sola contro apalutamide con ENV105. L'azienda prevede di rilasciare dati sulla sicurezza e sull'efficacia dalla fase di sicurezza nella prima metà del 2025.
L'arruolamento dei pazienti continua per la fase di randomizzazione presso i centri oncologici di Los Angeles e Salt Lake City. Lo studio include la validazione dei biomarcatori per identificare i pazienti più propensi a beneficiare della terapia combinata. La ricerca è supportata da Kairos Pharma e da un finanziamento del National Cancer Institute.
Kairos Pharma (NYSE: KAPA) ha completado la fase de introducción a la seguridad de su ensayo clínico de Fase 2 para ENV105 en el tratamiento del cáncer de próstata metastásico resistente a la castración. El ensayo combina ENV105 con apalutamida, un tratamiento estándar para el cáncer de próstata.
El estudio consta de dos partes: la fase de introducción a la seguridad completada y una parte aleatorizada en curso que compara apalutamida sola frente a apalutamida con ENV105. La empresa espera publicar datos de seguridad y eficacia de la fase de seguridad en la primera mitad de 2025.
La inscripción de pacientes continúa para la fase de aleatorización en los centros oncológicos de Los Ángeles y Salt Lake City. El ensayo incluye la validación de biomarcadores para identificar a los pacientes que tienen más probabilidades de beneficiarse de la terapia combinada. El estudio cuenta con el apoyo de Kairos Pharma y una subvención del National Cancer Institute.
카이로스 제약 (NYSE: KAPA)은 전이성, 호르몬 저항성 전립선암 치료를 위한 ENV105의 2상 임상 시험에서 안전성 도입 단계를 완료했습니다. 이 시험은 ENV105와 전립선암의 표준 치료제인 아팔루타미드를 결합합니다.
연구는 완료된 안전성 도입 단계와 아팔루타미드 단독 요법과 ENV105와 함께하는 아팔루타미드를 비교하는 진행 중인 무작위 부분으로 구성됩니다. 회사는 2025년 상반기에 안전성 부분의 안전성 및 효능 데이터를 발표할 예정입니다.
환자 등록은 로스앤젤레스와 솔트레이크시티의 암 센터에서 무작위화 부분을 위해 계속되고 있습니다. 이 시험은 조합 치료의 혜택을 받을 가능성이 가장 높은 환자를 식별하기 위한 바이오마커 검증을 포함합니다. 이 연구는 카이로스 제약과 국립암연구소의 지원을 받습니다.
Kairos Pharma (NYSE: KAPA) a terminé la phase d'introduction à la sécurité de son essai clinique de Phase 2 pour ENV105 dans le traitement du cancer de la prostate métastatique résistant à la castration. L'essai combine ENV105 avec l'apalutamide, un traitement standard pour le cancer de la prostate.
L'étude se compose de deux parties : la phase d'introduction à la sécurité achevée et une partie randomisée en cours comparant l'apalutamide seul à l'apalutamide avec ENV105. La société prévoit de publier des données sur la sécurité et l'efficacité de la phase de sécurité au cours du premier semestre 2025.
L'inscription des patients se poursuit pour la partie randomisée dans des centres de cancérologie à Los Angeles et Salt Lake City. L'essai comprend la validation des biomarqueurs pour identifier les patients les plus susceptibles de bénéficier de la thérapie combinée. L'étude est soutenue par Kairos Pharma et un financement du National Cancer Institute.
Kairos Pharma (NYSE: KAPA) hat die Sicherheitsleitphase seiner Phase-2-Studie für ENV105 zur Behandlung von metastasierendem, kastrationsresistentem Prostatakrebs abgeschlossen. Die Studie kombiniert ENV105 mit Apalutamid, einer Standardbehandlung für Prostatakrebs.
Die Studie besteht aus zwei Teilen: der abgeschlossenen Sicherheitsleitphase und einem laufenden randomisierten Teil, der Apalutamid allein mit Apalutamid in Kombination mit ENV105 vergleicht. Das Unternehmen plant, in der ersten Hälfte von 2025 Sicherheits- und Wirksamkeitsdaten aus dem Sicherheitsarm zu veröffentlichen.
Die Patientenrekrutierung für den Randomisierungsarm läuft weiterhin in Krebszentren in Los Angeles und Salt Lake City. Die Studie umfasst die Validierung von Biomarkern, um Patienten zu identifizieren, die am ehesten von der Kombinationstherapie profitieren. Die Studie wird von Kairos Pharma und einem Zuschuss des National Cancer Institute unterstützt.
- Completion of safety lead-in phase for Phase 2 trial
- Trial progress on schedule with continued enrollment
- Additional funding support from National Cancer Institute grant
- Final safety data not available until 2025
- Trial still in early phases with no efficacy data yet
Insights
The completion of the safety lead-in arm of Kairos Pharma's Phase 2 trial for ENV105 represents a procedural milestone in their clinical development pathway. This indicates that the combination of ENV105 with apalutamide (an established androgen receptor antagonist) demonstrated sufficient safety to advance to the randomized portion of the study. For metastatic castration-resistant prostate cancer (mCRPC) patients, this represents a potential new combination approach targeting an area with significant unmet medical need.
The trial design is methodologically sound - starting with a safety cohort before proceeding to the randomized efficacy comparison. Notably, they're incorporating biomarker validation throughout the study to identify optimal responders, which aligns with modern precision medicine approaches in oncology. The expected safety data readout in first half of 2025 provides a clear timeline for initial results.
It's important to understand that this milestone, while positive, is preliminary. Safety lead-ins typically involve smaller patient numbers and while they can rule out obvious toxicity concerns, they don't guarantee efficacy or commercial viability. The continuation of enrollment at major cancer centers in Los Angeles and Salt Lake City suggests institutional support, and the NCI grant backing adds credibility to the scientific approach. The focus remains on the randomized comparison data, which will ultimately determine ENV105's potential value in mCRPC treatment.
Kairos Pharma's announcement represents a standard clinical development milestone that keeps their lead program on track but offers new information. Completing the safety lead-in suggests that ENV105's combination with apalutamide didn't reveal prohibitive toxicity issues, allowing continuation to the randomized portion where efficacy will be more rigorously tested.
The first half of 2025 data readout timeline gives investors a clear catalyst to monitor. For a small-cap company (
The biomarker strategy is noteworthy from an investment perspective - developing companion diagnostics to identify high-responding patient subsets could create a more efficient path to market even if the drug doesn't show benefit across all patients. This approach has proven successful for other oncology therapies.
However, investors should recognize that this remains a relatively early-stage clinical program with significant development hurdles ahead. The metastatic castration-resistant prostate cancer space is competitive with multiple established therapies and pipeline candidates. Without preliminary efficacy signals or safety data details in this announcement, the true value proposition of ENV105 remains to be determined through future data readouts. The continued enrollment at major cancer centers indicates institutional confidence in the trial design, which is incrementally positive.
Company expects safety data readout in 2025 as Randomized Arm continues enrollment at key medical centers
The second part of the study, which randomizes patients to receive either apalutamide alone or in combination with ENV105 is ongoing. The Company expects to announce the safety and efficacy data readout from the safety arm of the trial beginning in the first half of 2025.
“This is an important milestone in this trial as it helps to establish the safety and preliminary efficacy of the combination therapy with ENV105, which is essential in order to proceed with the randomized portion of the trial. We are very pleased with the rate of our progress thus far and are grateful to our participating centers for their continued dedication to the trial,” said John Yu, M.D., Kairos CEO.
The Company is also validating biomarkers throughout the study to best identify those patients believed to have the most benefit for the combination therapy. In the meantime, the Company continues to enroll patients for the randomization arm of the study at key cancer centers in
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CORE IR
Louie Toma
investors@kairospharma.com
Source: Kairos Pharma, Ltd
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