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Kairos Pharma Adds City of Hope Cancer Center for Phase 2 ENV105 Clinical Trial

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Kairos Pharma (NYSE American: KAPA) announces the addition of City of Hope Cancer Center in Duarte, California to its Phase 2 clinical trial for ENV105 in castrate-resistant prostate cancer patients. The trial will compare apalutamide alone versus apalutamide+ENV105 combination therapy. This is the first of several planned new centers to be added. The expansion aims to test ENV105 in a broader patient population and identify blood markers for patient selection. The trial is supported by Kairos Pharma and a National Cancer Institute grant. Preclinical findings indicate ENV105 blocks hormone therapy resistance mechanisms.

Kairos Pharma (NYSE American: KAPA) annuncia l'aggiunta del City of Hope Cancer Center a Duarte, California, al suo studio clinico di fase 2 per ENV105 in pazienti con cancro alla prostata resistente alla castrazione. Lo studio confronterà l'apalutamide da solo con la terapia di combinazione apalutamide+ENV105. Questo è il primo di diversi centri nuovi pianificati da aggiungere. L'espansione mira a testare ENV105 in una popolazione di pazienti più ampia e identificare marcatori ematici per la selezione dei pazienti. Lo studio è sostenuto da Kairos Pharma e da un finanziamento del National Cancer Institute. I risultati preclinici indicano che ENV105 blocca i meccanismi di resistenza alla terapia ormonale.

Kairos Pharma (NYSE American: KAPA) anuncia la incorporación del City of Hope Cancer Center en Duarte, California, a su ensayo clínico de fase 2 para ENV105 en pacientes con cáncer de próstata resistente a la castración. El ensayo comparará apalutamida sola frente a la terapia combinada apalutamida+ENV105. Este es el primero de varios nuevos centros que se planean agregar. La expansión tiene como objetivo probar ENV105 en una población de pacientes más amplia e identificar marcadores en sangre para la selección de pacientes. El ensayo cuenta con el apoyo de Kairos Pharma y una subvención del National Cancer Institute. Los hallazgos preclínicos indican que ENV105 bloquea los mecanismos de resistencia a la terapia hormonal.

카이로스 제약(Kairos Pharma)(NYSE American: KAPA)이 캘리포니아 듀아르트에 있는 City of Hope Cancer Center를 호르몬 저항성 전립선암 환자를 대상으로 하는 ENV105의 2상 임상시험에 추가한다고 발표했습니다. 이 시험은 단독으로 사용한 아팔루타미드와 아팔루타미드+ENV105의 조합 요법을 비교합니다. 이는 추가될 여러 계획된 새로운 센터 중 첫 번째입니다. 이 확장은 ENV105를 더 넓은 환자 집단에서 테스트하고 환자 선정을 위한 혈액 마커를 식별하는 것을 목표로 합니다. 이 시험은 카이로스 제약과 국립 암 연구소(National Cancer Institute)의 지원을 받습니다. 전임상 결과는 ENV105가 호르몬 치료 저항 메커니즘을 차단한다는 것을 나타냅니다.

Kairos Pharma (NYSE American: KAPA) annonce l'ajout du City of Hope Cancer Center à Duarte, Californie, à son essai clinique de phase 2 pour ENV105 chez des patients atteints de cancer de la prostate résistant à la castration. L'essai comparera l'apalutamide seul à la thérapie combinée apalutamide+ENV105. Il s'agit du premier de plusieurs nouveaux centres prévus à ajouter. L'expansion vise à tester ENV105 dans une population de patients plus large et à identifier des marqueurs sanguins pour la sélection des patients. L'essai est soutenu par Kairos Pharma et une subvention du National Cancer Institute. Des découvertes précliniques indiquent qu'ENV105 bloque les mécanismes de résistance à la thérapie hormonale.

Kairos Pharma (NYSE American: KAPA) gibt die Aufnahme des City of Hope Cancer Center in Duarte, Kalifornien, in seine Phase-2-Studie für ENV105 bei Patienten mit kastrationsresistentem Prostatakrebs bekannt. Die Studie wird Apalutamid allein mit der Kombinationsbehandlung Apalutamid+ENV105 vergleichen. Dies ist das erste von mehreren geplanten neuen Zentren, die hinzugefügt werden sollen. Die Ausweitung zielt darauf ab, ENV105 in einer breiteren Patientengruppe zu testen und Blutmarker zur Auswahl von Patienten zu identifizieren. Die Studie wird von Kairos Pharma und einem Zuschuss des National Cancer Institute unterstützt. Präklinische Ergebnisse deuten darauf hin, dass ENV105 Mechanismen der Resistenz gegen die Hormontherapie blockiert.

Positive
  • Received National Cancer Institute (NCI) grant funding for the trial
  • Expansion of trial sites with addition of major cancer center
  • Multiple peer-reviewed articles supporting the science
  • Preclinical data shows potential to block hormone therapy resistance
Negative
  • Still in early clinical development phase (Phase 2)
  • Efficacy in humans yet to be proven

Insights

The addition of City of Hope Cancer Center to Kairos Pharma's Phase 2 clinical trial for ENV105 represents an incremental step in the company's clinical development program. While expanding trial sites is important for patient recruitment and data collection, this specific news is primarily operational in nature and doesn't materially impact the company's immediate market prospects.

The trial's focus on castrate-resistant prostate cancer and potential biomarker identification could be significant long-term, but current news lacks concrete data or milestone achievements. The NCI grant support adds credibility but was previously known. For a micro-cap company ($19.7M), investors should focus more on actual trial results and cash runway rather than site additions.

ENV105 can potentially address resistance in a wide range of cancers as they become resistant to standard treatments.

LOS ANGELES--(BUSINESS WIRE)-- Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company developing therapies to surmount current cancer drug resistance and immune suppression, today announces the addition of City of Hope Cancer Center in Duarte, California to the Phase 2 clinical trial for ENV105 for castrate-resistant prostate cancer patients.

City of Hope Cancer Center is the first of several planned new centers to be added in the coming weeks to support the Company’s randomized trial for patients receiving either apalutamide or apalutamide+ENV105 combination therapy. The additional centers 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. 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, “The preclinical findings suggest that ENV105 blocks a central mechanism of hormone therapy resistance. We are encouraged that we have multiple peer-reviewed articles in addition to receiving an NCI grant that supports the solid science behind this trial. We are fortunate to be working with the talented and experienced oncologists at City of Hope, who will be key participants in a trial that may provide patients with a new alternative to the current standard of care.”

Kairos CEO Dr. John Yu added, “This is an 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 additional validation for the science behind ENV105. City of Hope is a first-class research institution, and we look forward to our continued collaboration with them.”

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. Our lead candidate, ENV105, is an antibody that targets CD105—a protein identified as a key driver of resistance to various cancer treatments. Elevation of CD105 in response to standard therapy results in resistance and disease relapse. ENV105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer and a Phase 1 trial for lung cancer aimed at addressing significant unmet medical needs. For more information, visit kairospharma.com.

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 U.S. federal securities laws.

CORE IR

Louie Toma

investors@kairospharma.com

Source: Kairos Pharma, Ltd

FAQ

What is the purpose of Kairos Pharma's (KAPA) Phase 2 ENV105 trial?

The trial aims to evaluate ENV105 in combination with apalutamide versus apalutamide alone in castrate-resistant prostate cancer patients, focusing on addressing hormone therapy resistance.

Which new cancer center joined Kairos Pharma's (KAPA) ENV105 Phase 2 trial?

City of Hope Cancer Center in Duarte, California joined as the first of several planned new centers for the Phase 2 ENV105 trial.

How is Kairos Pharma's (KAPA) ENV105 Phase 2 trial being funded?

The trial is funded by both Kairos Pharma and a grant from the National Cancer Institute (NCI).

What is the mechanism of action for Kairos Pharma's (KAPA) ENV105?

According to preclinical findings, ENV105 blocks a central mechanism of hormone therapy resistance in cancer treatment.

Kairos Pharma, Ltd.

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