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OnKure to Present Clinical and Preclinical Data for OKI-219 at the 2024 San Antonio Breast Cancer Symposium

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OnKure Therapeutics (NASDAQ: OKUR) announced the presentation of two abstracts featuring preliminary clinical and preclinical data for OKI-219, their mutant-selective PI3KαH1047R inhibitor, at the 2024 San Antonio Breast Cancer Symposium (SABCS). The presentations will cover results from the PIKture-01 first-in-human study and preclinical data on OKI-219's enhanced activity in breast cancer models. The symposium will be held both virtually and in-person from December 10-13, 2024. OnKure will host a conference call on December 13 to discuss the preliminary data and provide a corporate update.

OnKure Therapeutics (NASDAQ: OKUR) ha annunciato la presentazione di due abstract contenenti dati clinici e preclinici preliminari per OKI-219, il loro inibitore selettivo PI3KαH1047R per mutazioni, al Simposio sul Cancro alla Mammella di San Antonio 2024 (SABCS). Le presentazioni riguarderanno i risultati dello studio PIKture-01, il primo studio clinico sull'uomo, e dati preclinici sull'attività potenziata di OKI-219 in modelli di cancro al seno. Il simposio si terrà sia virtualmente che di persona dal 10 al 13 dicembre 2024. OnKure ospiterà una conference call il 13 dicembre per discutere i dati preliminari e fornire aggiornamenti aziendali.

OnKure Therapeutics (NASDAQ: OKUR) anunció la presentación de dos resúmenes que incluyen datos clínicos y preclínicos preliminares sobre OKI-219, su inhibidor selectivo de PI3KαH1047R para mutaciones, en el Simposio sobre Cáncer de Mama de San Antonio 2024 (SABCS). Las presentaciones cubrirán los resultados del estudio PIKture-01, el primer estudio en humanos, y datos preclínicos sobre la actividad mejorada de OKI-219 en modelos de cáncer de mama. El simposio se llevará a cabo tanto de forma virtual como presencial del 10 al 13 de diciembre de 2024. OnKure realizará una llamada de conferencia el 13 de diciembre para discutir los datos preliminares y proporcionar una actualización corporativa.

온큐어 테라퓨틱스 (NASDAQ: OKUR)는 2024년 샌안토니오유방암심포지엄(SABCS)에서 변이 선택적 PI3KαH1047R 억제제인 OKI-219에 대한 초기 임상 및 전임상 데이터가 포함된 두 개의 초록을 발표한다고 발표했습니다. 발표에서는 PIKture-01 연구의 결과와 유방암 모델에서 OKI-219의 향상된 활기에 대한 전임상 데이터가 다뤄질 것입니다. 심포지엄은 2024년 12월 10일부터 13일까지 온라인과 오프라인 모두에서 열립니다. 온큐어는 12월 13일에 초기 데이터를 논의하고 기업 업데이트를 제공하기 위해 컨퍼런스 콜을 개최할 예정입니다.

OnKure Therapeutics (NASDAQ: OKUR) a annoncé la présentation de deux résumés contenant des données cliniques et précliniques préliminaires sur OKI-219, leur inhibiteur sélectif PI3KαH1047R pour les mutations, lors du Symposium sur le Cancer du Sein de San Antonio 2024 (SABCS). Les présentations couvriront les résultats de l'étude PIKture-01, la première étude sur l'homme, et des données précliniques sur l'activité améliorée d'OKI-219 dans des modèles de cancer du sein. Le symposium se tiendra à la fois virtuellement et en personne du 10 au 13 décembre 2024. OnKure organisera une conférence téléphonique le 13 décembre pour discuter des données préliminaires et fournir une mise à jour sur l'entreprise.

OnKure Therapeutics (NASDAQ: OKUR) hat die Präsentation von zwei Abstracts angekündigt, die vorläufige klinische und präklinische Daten für OKI-219, ihren mutantenselektiven PI3KαH1047R-Inhibitor, auf dem 2024 San Antonio Breast Cancer Symposium (SABCS) vorstellen. Die Präsentationen werden Ergebnisse der PIKture-01-Studie, der ersten Studie am Menschen, und präklinische Daten zur verbesserten Aktivität von OKI-219 in Brustkrebsmodellen abdecken. Das Symposium findet sowohl virtuell als auch persönlich vom 10. bis 13. Dezember 2024 statt. OnKure wird am 13. Dezember eine Telefonkonferenz abhalten, um die vorläufigen Daten zu erörtern und ein Unternehmensupdate zu geben.

Positive
  • Drug candidate OKI-219 selected for presentation at major cancer symposium
  • Ongoing first-in-human clinical trial (PIKture-01) with preliminary results to be presented
  • Multiple presentation formats including clinical and preclinical data
Negative
  • None.

OnKure to host a conference call to review key data presented at SABCS and provide a general corporate update on Friday, December 13, 2024 at 8:00 a.m. ET

BOULDER, Colo., Nov. 01, 2024 (GLOBE NEWSWIRE) -- OnKure Therapeutics, Inc. (NASDAQ: OKUR), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines in oncology, today announced that two abstracts discussing preliminary clinical data and preclinical data for OKI-219, a potential best-in-class, mutant-selective PI3KαH1047R inhibitor, have been selected for presentation during poster sessions at the 2024 San Antonio Breast Cancer Symposium (SABCS), which is being held virtually and in person from December 10–13, 2024.

Poster presentation details:
Poster Title: Preliminary results from PIKture-01, a First-in-Human Study of OKI-219, a mutant
selective inhibitor of PI3KαH1047R, in mutant selected solid tumors including breast cancer
Author: Alexander Spira, MD, PhD, et al.
Presentation ID: P3-08-19
Poster Session: Poster Session 3
Session Location: Halls 2-3
Presentation Date/Time: Thursday, December 12, 2024 12:30 PM to 2:00 PM CST
Abstract Number: SESS-3634

Poster Title: OKI-219 enhances activity of SOC therapies in double and triple combinations in pre-clinical PI3KαH1047R mutant breast cancer models
Author: Molly Taylor, PhD, et al.
Presentation ID: P4-12-20
Poster Session: Poster Session 4
Session Location: Halls 2-3
Presentation Date/Time: Thursday, December 12, 2024 05:30 PM to 7:00 PM CST
Abstract Number: SESS-2240

On November 25th, SABCS will publish the full text from all regular abstracts on its website (click here). OnKure plans to include additional data in the posters being presented at SABCS, which will be made available on the Company’s website after the poster is presented. For more details about SABCS please visit: https://www.sabcs.org/.

OKI-219 is being investigated in the PIKture-01 clinical trial. PIKture-01 is a first-in-human study of the PI3KαH1047R Mutant-Selective Inhibitor OKI-219 as monotherapy in participants with advanced solid tumors and in combination with endocrine therapy or HER2-Targeted Therapy in participants with advanced breast cancer. Additional information about PIKture-01 may be found at www.ClinicalTrials.gov, using Identifier: NCT06239467.

Data Review Conference Call

OnKure will host a conference call and live webcast Friday, December 13, 2024 at 7:00 a.m. CT (8:00 a.m. ET) to discuss the preliminary data from its first-in-human PIKture-01 trial of OKI-219, which were presented at SABCS. To participate, please dial 877-407-0789 (domestic), 201-689-8562 (international) and refer to conference ID 13750009. To access the webcast, click here. Following the live event, a replay will be also available on the Events page of the Investors section of the Company’s website.

About OnKure

OnKure is a clinical-stage biopharmaceutical company focused on the discovery and development of best-in-class precision medicines that target biologically validated drivers of cancers that are underserved by available therapies. Using structure-based drug design platform, OnKure is building a robust pipeline of tumor-agnostic candidates that are designed to achieve optimal efficacy and tolerability. OnKure is currently developing OKI-219, a selective PI3KαH1047R inhibitor, as its lead program. OnKure aims to become a leader in targeting oncogenic PI3Kα and has multiple programs designed to enable best-in-class targeting of this key oncogene.

For more information about OnKure, visit us at www.onkure.com and follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding, OnKure’s product candidates and programs, including OKI-219; OnKure’s ability to advance additional programs; the expected milestones and timing of such milestones, including for OKI-219 and its discovery programs; and statements regarding OnKure’s financial position, including its liquidity, cash runway and the sufficiency of its cash resources. In some cases, you can identify forward-looking statements by terminology such as “estimate,” “intend,” “may,” “plan,” “potentially” “will” or the negative of these terms or other similar expressions.

The company based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things, those risks described in the section entitled “Risk Factors” in documents that OnKure files from time to time with the Securities and Exchange Commission (“SEC”), including the final 424B3 proxy statement/prospectus filed with the SEC on August 26, 2024. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this press release.

Contact:

Dan Ferry
LifeSci Advisors
daniel@lifesciadvisors.com


FAQ

What will OnKure (OKUR) present at the 2024 San Antonio Breast Cancer Symposium?

OnKure will present preliminary clinical data from the PIKture-01 trial and preclinical data for OKI-219, their mutant-selective PI3KαH1047R inhibitor, in two poster sessions on December 12, 2024.

When is OnKure's (OKUR) conference call to discuss the SABCS data?

OnKure will host a conference call on Friday, December 13, 2024, at 8:00 a.m. ET to discuss the preliminary data from the PIKture-01 trial and provide a corporate update.

What is the PIKture-01 trial investigating for OnKure (OKUR)?

PIKture-01 is a first-in-human study investigating OKI-219 as monotherapy in advanced solid tumors and in combination with endocrine therapy or HER2-Targeted Therapy in advanced breast cancer patients.

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