Kairos Pharma Adds Huntsman Cancer Institute for Phase 2 ENV105 Clinical Trial
Kairos Pharma (NYSE American: KAPA) announces the addition of Huntsman Cancer Institute in Salt Lake City, Utah as a new site for its Phase 2 clinical trial of ENV105 in castrate-resistant prostate cancer patients. The randomized trial compares apalutamide alone versus apalutamide+ENV105 combination therapy. The study, supported by Kairos and the National Cancer Institute, aims to identify blood markers that could help select patients who would benefit most from ENV105 treatment.
ENV105 is being developed to address resistance in various cancers as they become resistant to standard treatments. The addition of Huntsman, a renowned cancer center, is expected to enable testing ENV105 in a broader patient population while adding credibility to the study within the medical community.
Kairos Pharma (NYSE American: KAPA) annuncia l'aggiunta del Huntsman Cancer Institute di Salt Lake City, Utah, come nuovo sito per il suo studio clinico di fase 2 su ENV105 in pazienti con cancro alla prostata resistente alla castrazione. Lo studio randomizzato confronta l'apalutamide da sola contro la terapia combinata apalutamide+ENV105. La ricerca, supportata da Kairos e dal National Cancer Institute, mira a identificare marcatori ematici che potrebbero aiutare a selezionare i pazienti che trarrebbero maggior beneficio dal trattamento con ENV105.
ENV105 viene sviluppato per affrontare la resistenza in vari tipi di cancro man mano che diventano resistenti ai trattamenti standard. L'aggiunta del Huntsman, un rinomato centro oncologico, dovrebbe consentire di testare ENV105 su una popolazione di pazienti più ampia, aumentando anche la credibilità dello studio all'interno della comunità medica.
Kairos Pharma (NYSE American: KAPA) anuncia la incorporación del Huntsman Cancer Institute en Salt Lake City, Utah, como un nuevo sitio para su ensayo clínico de fase 2 de ENV105 en pacientes con cáncer de próstata resistente a la castración. El ensayo aleatorizado compara apalutamida sola con la terapia combinada de apalutamida+ENV105. El estudio, apoyado por Kairos y el Instituto Nacional del Cáncer, tiene como objetivo identificar marcadores en sangre que puedan ayudar a seleccionar a los pacientes que más se beneficiarían del tratamiento con ENV105.
ENV105 se está desarrollando para abordar la resistencia en varios tipos de cáncer a medida que se vuelven resistentes a los tratamientos estándar. La inclusión de Huntsman, un reconocido centro oncológico, se espera que permita probar ENV105 en una población de pacientes más amplia, al mismo tiempo que aumenta la credibilidad del estudio dentro de la comunidad médica.
카이로스 파마 (NYSE American: KAPA)가 헌츠맨 암 연구소를 유타주 솔트 레이크 시티의 새로운 ENV105 임상 시험 2단계 연구 장소로 추가한다고 발표했습니다. 무작위로 배정된 이 시험은 아팔루타미드 단독 요법과 아팔루타미드+ENV105 조합 요법을 비교합니다. 카이로스와 국립암연구소의 지원을 받는 이번 연구는 ENV105 치료의 최대 혜택을 볼 수 있는 환자를 선별하는 데 도움이 될 수 있는 혈액 마커를 식별하는 것을 목표로 하고 있습니다.
ENV105는 여러 유형의 암이 표준 치료에 대해 저항성을 가지게 될 때 이를 해결하기 위해 개발되고 있습니다. 저명한 암 센터인 헌츠맨의 추가는 더 넓은 환자 집단에서 ENV105를 시험할 수 있게 할 것으로 기대되며, 의료 커뮤니티 내에서 연구의 신뢰성을 높입니다.
Kairos Pharma (NYSE American: KAPA) annonce l'ajout du Huntsman Cancer Institute à Salt Lake City, Utah, comme nouveau site pour son essai clinique de phase 2 sur ENV105 chez des patients atteints de cancer de la prostate résistant à la castration. L'essai randomisé compare l'apalutamide seul à la thérapie combinée apalutamide+ENV105. L'étude, soutenue par Kairos et le National Cancer Institute, vise à identifier des marqueurs sanguins pouvant aider à sélectionner les patients qui bénéficieraient le plus du traitement par ENV105.
ENV105 est en cours de développement pour traiter la résistance dans divers cancers lorsqu'ils deviennent résistants aux traitements standards. L'ajout du Huntsman, un centre de cancérologie de renom, devrait permettre de tester ENV105 sur une population de patients plus large tout en ajoutant de la crédibilité à l'étude au sein de la communauté médicale.
Kairos Pharma (NYSE American: KAPA) gibt die Hinzufügung des Huntsman Cancer Institute in Salt Lake City, Utah, als neuen Standort für seine Phase-2-Studie zu ENV105 bei Patienten mit kastrationsresistentem Prostatakrebs bekannt. Die randomisierte Studie vergleicht Apalutamid allein mit der Kombinationstherapie Apalutamid+ENV105. Die Studie, die von Kairos und dem National Cancer Institute unterstützt wird, zielt darauf ab, Blutmarker zu identifizieren, die helfen könnten, Patienten auszuwählen, die am meisten von der ENV105-Behandlung profitieren würden.
ENV105 wird entwickelt, um der Resistenz gegen verschiedene Krebsarten zu begegnen, wenn sie gegenüber Standardbehandlungen resistent werden. Die Hinzufügung von Huntsman, einem renommierten Krebszentrum, wird erwartet, dass es die Testung von ENV105 in einer breiteren Patientengruppe ermöglicht und gleichzeitig die Glaubwürdigkeit der Studie innerhalb der medizinischen Gemeinschaft erhöht.
- Addition of prestigious Huntsman Cancer Institute expands clinical trial reach
- Study receives National Cancer Institute (NCI) grant support
- Trial aims to identify blood markers for patient selection optimization
- None.
Insights
The expansion of Kairos Pharma's Phase 2 trial for ENV105 to include Huntsman Cancer Institute marks a strategic advancement in their clinical development program. This expansion carries several significant implications:
The multi-center approach, particularly including a prestigious institution like Huntsman, enhances the trial's statistical power and credibility. The focus on identifying blood-based biomarkers is particularly noteworthy, as it could lead to a companion diagnostic that would enable precise patient selection - a important factor for both regulatory approval and commercial success in the competitive oncology market.
The trial's design targeting castrate-resistant prostate cancer (CRPC) addresses a critical unmet need. Current hormone therapies like apalutamide eventually face resistance, leading to treatment failure. If ENV105 successfully demonstrates the ability to overcome this resistance, it could potentially:
- Extend the therapeutic window of existing treatments
- Reduce healthcare costs associated with switching therapies
- Improve patient outcomes in a market segment valued at several billion dollars
The NCI grant support provides external validation of the scientific merit and adds non-dilutive funding. The expansion to multiple sites also accelerates patient recruitment, potentially shortening the time to market while providing diverse patient data essential for regulatory submissions.
While early in Phase 2, the strategic execution of this trial positions Kairos to potentially address a significant market opportunity in oncology, where resistance mechanisms remain a primary challenge in treatment efficacy.
ENV105 can potentially address resistance in a wide range of cancers as they become resistant to standard treatments.
Huntsman Cancer Center is another renowned center to be added to support the Company’s randomized trial for patients receiving either apalutamide or apalutamide+ENV105 combination therapy. The trial is supported by Kairos Pharma Ltd. and a grant from the National Cancer Institute (NCI).
Kairos Pharma Chief Scientific Officer Dr. Neil Bhowmick said, “Huntsman is an excellent addition to our roster of investigational sites. Multiple sites allow Kairos Pharma to test ENV105 in a broader patient population to identify blood markers that could help select patients expected to benefit most from ENV105 treatment, and the reputation of Huntsman only serves to elevate the study among the medical community.”
Kairos CEO Dr. John Yu added, “This is another important milestone in our mission to develop first-in-class approaches to address the inevitable resistance that develops in prostate cancer patients receiving hormone therapy, as it provides continued validation for the science behind ENV105. Huntsman Cancer Center is a first-class research institution, and we look forward to our continued collaboration with them.”
About Kairos Pharma Ltd.
Based in
Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements as those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential” or “hopes” or the negative of these or similar terms. The reader is cautioned not to rely on these forward-looking statements. If underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Kairos Pharma. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance. In evaluating these forward-looking statements, you should consider various factors, including: our expectations regarding the success and/or completion of our Phase 1 and Phase 2 clinical trials; our success in completing newly initiated clinical trials, commence new trials, and obtain regulatory approval following the conclusion of such trials; challenges and uncertainties inherent in product research and development; and the uncertainty regarding future commercial success. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking statements discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us, including those described in Kairos Pharma’s prospectus and other filings made with the SEC. We are not obligated to publicly update or revise any forward-looking statement, and Kairos Pharma is not required to update any forward-looking statement as a result of new information or future events or developments, except as required by
View source version on businesswire.com: https://www.businesswire.com/news/home/20250211925173/en/
Contact:
CORE IR
Louie Toma
investors@kairospharma.com
Source: Kairos Pharma, Ltd
FAQ
What is the purpose of Kairos Pharma's Phase 2 ENV105 clinical trial?
How is KAPA's ENV105 Phase 2 trial being funded?
What is the significance of adding Huntsman Cancer Institute to KAPA's ENV105 trial?