Kairos Pharma Enters Agreement with PreCheck Health Services to Develop Biomarkers to Identify Patients Responsive to ENV105 to Target Cancer Drug Resistance in Prostate and Lung Cancer Patients
Kairos Pharma (NYSE American: KAPA) has entered a collaboration with PreCheck Health Services Inc. to develop companion biomarkers for its cancer therapy, ENV105, targeting prostate and lung cancers. The partnership aims to enhance patient screening and therapy monitoring for Kairos Pharma's Phase 1 and Phase 2 clinical trials.
PreCheck will analyze biopsy tissues and circulating tumor cells from patients in ongoing trials, including a Phase 2 randomized trial in prostate cancer and a Phase 1 trial in lung cancer. The collaboration will use PreCheck's SolidTumorCheck+ platform for gene expression profiling of tumor biopsies.
The partnership focuses on developing an FDA-approved companion diagnostic for ENV105, which will help identify suitable patients for treatment in Phase 3 clinical trials. This collaboration is expected to advance personalized cancer treatment and improve patient outcomes.
Kairos Pharma (NYSE American: KAPA) ha avviato una collaborazione con PreCheck Health Services Inc. per sviluppare biomarcatori accompagnatori per la sua terapia oncologica, ENV105, mirata ai tumori della prostata e del polmone. L'obiettivo della partnership è migliorare lo screening dei pazienti e il monitoraggio della terapia per i trial clinici di Fase 1 e Fase 2 di Kairos Pharma.
PreCheck analizzerà tessuti bioptici e cellule tumorali circolanti dai pazienti nei trial in corso, inclusi un trial randomizzato di Fase 2 per il cancro alla prostata e un trial di Fase 1 per il cancro ai polmoni. La collaborazione utilizzerà la piattaforma SolidTumorCheck+ di PreCheck per il profiling dell'espressione genica delle biopsie tumorali.
La partnership si concentra sullo sviluppo di un diagnostico accompagnatorio approvato dalla FDA per ENV105, che aiuterà a identificare i pazienti idonei per il trattamento nei trial clinici di Fase 3. Questa collaborazione è destinata a promuovere il trattamento personalizzato del cancro e migliorare gli esiti per i pazienti.
Kairos Pharma (NYSE American: KAPA) ha entrado en una colaboración con PreCheck Health Services Inc. para desarrollar biomarcadores complementarios para su terapia contra el cáncer, ENV105, que se dirige a los cánceres de próstata y pulmón. El objetivo de la asociación es mejorar el cribado de pacientes y el monitoreo de la terapia para los ensayos clínicos de Fase 1 y Fase 2 de Kairos Pharma.
PreCheck analizará tejidos de biopsia y células tumorales circulantes de pacientes en ensayos en curso, incluyendo un ensayo aleatorizado de Fase 2 en cáncer de próstata y un ensayo de Fase 1 en cáncer de pulmón. La colaboración utilizará la plataforma SolidTumorCheck+ de PreCheck para el perfilado de expresión génica de biopsias tumorales.
La asociación se centra en desarrollar un diagnóstico complementario aprobado por la FDA para ENV105, que ayudará a identificar a los pacientes adecuados para el tratamiento en ensayos clínicos de Fase 3. Se espera que esta colaboración avance en el tratamiento personalizado del cáncer y mejore los resultados en los pacientes.
Kairos Pharma (NYSE American: KAPA)는 전립선 및 폐암을 대상으로 하는 암 치료제 ENV105에 대한 동반 바이오마커 개발을 위해 PreCheck Health Services Inc.와 협력하게 되었습니다. 이 파트너십의 목표는 Kairos Pharma의 1상 및 2상 임상 시험을 위한 환자 선별 및 치료 모니터링을 개선하는 것입니다.
PreCheck는 진행 중인 시험에 참여하는 환자의 생검 조직과 순환 종양 세포를 분석합니다. 여기에는 전립선암에 대한 2상 무작위 시험 및 폐암에 대한 1상 시험이 포함됩니다. 이 협력에서는 PreCheck의 SolidTumorCheck+ 플랫폼을 사용하여 종양 생검의 유전자 발현 프로파일링을 수행합니다.
파트너십은 ENV105에 대한 FDA 승인 동반 진단 개발에 초점을 맞추고 있으며, 이는 3상 임상 시험에서 치료를 받을 적합한 환자를 식별하는 데 도움이 될 것입니다. 이 협력은 개인 맞춤형 암 치료를 발전시키고 환자 결과를 개선하는 데 기여할 것으로 기대됩니다.
Kairos Pharma (NYSE American: KAPA) a engagé une collaboration avec PreCheck Health Services Inc. pour développer des biomarqueurs accompagnateurs pour sa thérapie contre le cancer, ENV105, ciblant les cancers de la prostate et du poumon. L'objectif de ce partenariat est d'améliorer le dépistage des patients et le suivi des thérapies dans les essais cliniques de phase 1 et de phase 2 de Kairos Pharma.
PreCheck analysera les tissus de biopsie et les cellules tumorales circulantes des patients participant aux essais en cours, y compris un essai randomisé de phase 2 pour le cancer de la prostate et un essai de phase 1 pour le cancer du poumon. La collaboration utilisera la plateforme SolidTumorCheck+ de PreCheck pour le profilage de l'expression génique des biopsies tumorales.
Le partenariat se concentre sur le développement d'un diagnostic accompagnateur approuvé par la FDA pour ENV105, qui aidera à identifier les patients appropriés pour le traitement lors des essais cliniques de phase 3. Cette collaboration devrait faire progresser le traitement personnalisé du cancer et améliorer les résultats pour les patients.
Kairos Pharma (NYSE American: KAPA) hat eine Kooperation mit PreCheck Health Services Inc. geschlossen, um Begleitbiomarker für die Krebstherapie ENV105 zu entwickeln, die auf Prostata- und Lungenkrebs abzielt. Ziel der Partnerschaft ist es, das Screening von Patienten und das Monitoring der Therapie in den Phase 1 und Phase 2 klinischen Studien von Kairos Pharma zu verbessern.
PreCheck wird Gewebeproben und zirkulierende Tumorzellen von Patienten in laufenden Studien analysieren, einschließlich einer randomisierten Phase-2-Studie bei Prostatakrebs sowie einer Phase-1-Studie bei Lungenkrebs. Die Zusammenarbeit wird die SolidTumorCheck+-Plattform von PreCheck verwenden, um die Genexpressionsprofilierung von Tumorgeweben zu ermöglichen.
Die Partnerschaft konzentriert sich auf die Entwicklung eines von der FDA genehmigten Begleitdiagnosetests für ENV105, der dabei helfen wird, geeignete Patienten für die Behandlung in Phase-3-Studien zu identifizieren. Diese Kooperation soll die personalisierte Krebsbehandlung vorantreiben und die Patientenversorgung verbessern.
- Partnership with PreCheck Health Services to develop companion biomarkers for ENV105
- Potential for more precise patient screening and therapy monitoring in clinical trials
- Development of a companion diagnostic for ENV105 to guide patient selection in Phase 3 trials
- Utilization of advanced molecular diagnostics and gene expression profiling technology
- None.
Insights
This collaboration between Kairos Pharma and PreCheck Health Services represents a significant advancement in personalized cancer treatment. The development of companion biomarkers for ENV105 could revolutionize patient selection for clinical trials and eventual treatment in prostate and lung cancers.
Key points:
- The partnership aims to identify biomarkers predictive of ENV105 response, potentially increasing treatment efficacy.
- Utilization of PreCheck's SolidTumorCheck+ platform for gene expression profiling enhances the precision of patient screening.
- The focus on circulating tumor cells may lead to non-invasive liquid biopsy tests, a major advancement in cancer diagnostics.
- The development of a companion diagnostic could streamline patient selection for Phase 3 trials and beyond.
This approach aligns with the growing trend of precision medicine in oncology. If successful, it could significantly improve treatment outcomes and reduce unnecessary treatments for non-responsive patients. However, investors should note that biomarker development and companion diagnostic approval processes can be lengthy and complex, potentially affecting the timeline for ENV105's broader market adoption.
This partnership has several potential financial implications for Kairos Pharma:
- Market Differentiation: Developing companion biomarkers could give ENV105 a competitive edge in the crowded cancer therapeutics market.
- Increased Efficacy: Better patient selection may lead to improved trial outcomes, potentially accelerating the drug approval process.
- Cost Efficiency: Precise patient targeting could reduce the overall cost of clinical trials and future treatments.
- Expanded Market Opportunity: Success in both prostate and lung cancer trials could open up significant market potential, given the high incidence rates of these cancers.
- Future Revenue Streams: The companion diagnostic itself could become a valuable asset if approved by the FDA.
While the immediate financial impact may be , this collaboration positions Kairos Pharma for potentially stronger long-term growth. Investors should monitor the progress of the clinical trials and biomarker development as key indicators of future value. The company's relatively small market cap of
LOS ANGELES, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company, announces a groundbreaking collaboration with PreCheck Health Services Inc., a CLIA-certified and CAP-accredited clinical laboratory specializing in genetic sequencing. The partnership focuses on the development of companion biomarkers for Kairos Pharma’s cancer therapy, ENV105, which targets prostate and lung cancers. This strategic agreement aims to advance the precision of patient screening and therapy monitoring for Kairos Pharma’s Phase 1 and Phase 2 clinical trials, with the aim of advancing cancer treatment by identifying patients who will benefit most from ENV105.
Kairos Pharma and PreCheck Health Services will utilize advanced molecular diagnostics to corroborate and further develop biomarkers previously identified in a Phase 2 clinical trial. These biomarkers are designed to predict patient responses to ENV105 prior to treatment, offering a more personalized approach to cancer care. Under the agreement, PreCheck will analyze biopsy tissues and circulating tumor cells from patients enrolled in Kairos Pharma’s ongoing clinical trials, including a Phase 2 randomized, multi-institutional trial in prostate cancer and a Phase 1 trial in lung cancer. The goal is to confirm the predictive capabilities of these biomarkers and to discover new biomarkers that can identify suitable candidates for the novel therapy.
The collaboration will rely on PreCheck’s proprietary SolidTumorCheck+ platform, which allows for gene expression profiling of tumor biopsies. This technology will be employed to examine samples from patients with both lung and prostate cancer. Furthermore, the analysis of circulating tumor cells aims to offer non-invasive insights, potentially leading to the development of liquid biopsy tests for future patient screening and therapy monitoring.
Clinical Trials at the Forefront of Oncology Research
The biomarkers will be tested in two key clinical trials:
- NCT05401110: A Phase 1 trial targeting patients with EGFR-driven lung cancer who have developed resistance to osimertinib. Pre-treatment biopsies will undergo somatic gene expression profiling using the SolidTumorCheck+ platform to identify biomarkers that can predict a favorable response to ENV105.
- NCT05534646: A phase 2 trial for patients with castrate-resistant prostate cancer (CRPC) who have shown resistance to multiple androgen receptor signaling inhibitors. Here, the focus will be on the somatic profiling of circulating tumor cells and tumor biopsies to confirm previously identified biomarkers and identify any new ones tied to ENV105’s efficacy.
Both trials aim to integrate cutting-edge biomarker analysis into treatment plans, ensuring that patients most likely to benefit from ENV105 are accurately identified.
Development of Companion Diagnostics
A companion diagnostic is an FDA-approved test which can identify patients that are most likely to benefit from a therapeutic product. One of the key outcomes of this partnership is the creation of a companion diagnostic for ENV105. PreCheck will develop a three-gene PCR analysis or other genetic tools to predict patient response to the therapy. This diagnostic will seek FDA approval as a critical tool for the identification of suitable patients with prostate or lung cancer, guiding inclusion for treatment in Phase 3 clinical trials.
Dr. Neil Bhowmick, Kairos Pharma’s Chief Scientific Officer, expressed optimism about the collaboration, stating, “Leveraging PreCheck’s vast experience in genetic testing provides a considerable advance in the development of our therapies. The integration of their expertise will significantly enhance our ability to identify patients who will benefit from ENV105 and guide the development of non-invasive liquid biopsy tests.”
A Step Forward in Cancer Treatment
The development of these companion biomarkers is poised to transform how cancer patients, particularly those with resistant forms of prostate and lung cancer, are treated. The integration of biomarkers and liquid biopsy technologies will allow for more precise targeting of therapies, reducing the likelihood of ineffective treatments and increasing the probability of positive outcomes.
Dr. John Yu, Kairos Pharma’s CEO, commented, “This collaboration is an exciting step forward for Kairos Pharma. By working with PreCheck Health Services, we are advancing our mission to provide personalized cancer treatment solutions. The biomarkers we develop will enable us to tailor therapies to individual patients, improving their chances of a successful response to ENV105.”
About Kairos Pharma Ltd.
Based in Los Angeles, California, Kairos Pharma Ltd. (NYSE American: KAPA) is at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. With a diverse pipeline of investigational therapies, the company is committed to reversing the harmful effects of cancer on the body’s immune system and improving patient outcomes through innovative treatment options. For more information, visit kairospharma.com.
About PreCheck Health Services Inc.
PreCheck Health Services Inc. is a CLIA-certified and CAP-accredited clinical laboratory known for its expertise in genetic sequencing. PreCheck provides advanced diagnostic services to support precision medicine, particularly in the field of oncology. To learn more about their offerings, visit precheckhealth.com.
This strategic agreement marks a significant step in the development of personalized cancer therapies, offering hope to patients with prostate and lung cancer who have few remaining treatment options. Through the power of biomarkers and genetic analysis, Kairos Pharma and PreCheck Health Services are working together to shape the future of oncology treatment, with ENV105 leading the way.
CAUTIONARY STATEMENT CONCERNING 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 filed 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 U.S. federal securities laws.
Contact:
CORE IR
Louie Toma
investors@kairospharma.com
FAQ
What is the purpose of Kairos Pharma's collaboration with PreCheck Health Services?
Which clinical trials will utilize the biomarkers developed by Kairos Pharma and PreCheck Health Services?
What technology will PreCheck Health Services use to analyze patient samples for Kairos Pharma (KAPA)?
What is the ultimate goal of the companion diagnostic being developed for ENV105?
