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OnKure Therapeutics (NASDAQ: OKUR) has rescheduled its investor call to review preliminary data from the PIKture-01 trial of OKI-219 to Tuesday, December 10, 2024, at 7:00 a.m. CT, moved from the previously announced December 13 date. The call will coincide with the publication of posters at the 2024 San Antonio Breast Cancer Symposium (SABCS).
Two posters will be presented at SABCS: one showing preliminary results from the PIKture-01 first-in-human study of OKI-219, and another demonstrating OKI-219’s enhanced activity in pre-clinical PI3KαH1047R mutant breast cancer models. The PIKture-01 trial investigates OKI-219 as monotherapy in advanced solid tumors and in combination with endocrine or HER2-Targeted therapy for advanced breast cancer.
OnKure Therapeutics (NASDAQ: OKUR) ha riprogrammato la sua chiamata con gli investitori per esaminare i dati preliminari dello studio PIKture-01 su OKI-219 a martedì 10 dicembre 2024, alle 7:00 CT, spostata dalla data precedentemente annunciata del 13 dicembre. La chiamata coinciderà con la pubblicazione dei poster al 2024 San Antonio Breast Cancer Symposium (SABCS).
Due poster saranno presentati al SABCS: uno che mostra i risultati preliminari dello studio PIKture-01, il primo sull’uomo per OKI-219, e un altro che dimostra l’attività potenziata di OKI-219 nei modelli preclinici di cancro al seno mutante PI3KαH1047R. Lo studio PIKture-01 indaga OKI-219 come monoterapia in tumori solidi avanzati e in combinazione con terapia endocrina o terapia mirata HER2 per il cancro al seno avanzato.
OnKure Therapeutics (NASDAQ: OKUR) ha reprogramado su conferencia con inversionistas para revisar los datos preliminares del ensayo PIKture-01 de OKI-219 para el martes 10 de diciembre de 2024, a las 7:00 a.m. CT, movido de la fecha previamente anunciada del 13 de diciembre. La conferencia coincidirá con la publicación de pósters en el 2024 San Antonio Breast Cancer Symposium (SABCS).
Se presentarán dos pósters en el SABCS: uno mostrando resultados preliminares del estudio PIKture-01, el primero en humanos de OKI-219, y otro que demuestra la actividad mejorada de OKI-219 en modelos de cáncer de mama mutante PI3KαH1047R en preclínica. El ensayo PIKture-01 investiga OKI-219 como monoterapia en tumores sólidos avanzados y en combinación con terapia endocrina o terapia dirigida HER2 para el cáncer de mama avanzado.
OnKure Therapeutics (NASDAQ: OKUR)는 OKI-219의 PIKture-01 시험의 초기 데이터를 검토하기 위한 투자자 전화 회의를 2024년 12월 10일 화요일 오전 7시 CT로 재조정하였으며, 이전에 발표된 12월 13일에서 변경되었습니다. 이번 전화 회의는 2024 San Antonio Breast Cancer Symposium (SABCS)에서 포스터 발표와 동시에 진행될 예정입니다.
SABCS에서 두 개의 포스터가 발표됩니다: 하나는 OKI-219에 대한 첫 번째 인체 연구인 PIKture-01의 초기 결과를 보여주고, 다른 하나는 PI3KαH1047R 변이 유방암 모델에서 OKI-219의 향상된 활성을 입증합니다. PIKture-01 시험은 고급 고형 종양에서 OKI-219의 단독 요법을 조사하며, 고급 유방암에 대해 내분비 요법 또는 HER2 표적 치료와의 병용 요법을 연구합니다.
OnKure Therapeutics (NASDAQ: OKUR) a reprogrammé son appel aux investisseurs pour examiner les données préliminaires de l’essai PIKture-01 sur OKI-219 au mardi 10 décembre 2024, à 7h00 CT, déplacé de la date précédemment annoncée du 13 décembre. L’appel coïncidera avec la publication d’affiches lors du 2024 San Antonio Breast Cancer Symposium (SABCS).
Deux affiches seront présentées au SABCS : l’une montrant les résultats préliminaires de l’étude PIKture-01, la première sur l’humain pour OKI-219, et l’autre démontrant l’activité améliorée d’OKI-219 dans des modèles de cancer du sein précliniques mutés PI3KαH1047R. L’essai PIKture-01 étudie OKI-219 en tant que monothérapie dans les tumeurs solides avancées et en combinaison avec une thérapie endocrinienne ou une thérapie ciblée HER2 pour le cancer du sein avancé.
OnKure Therapeutics (NASDAQ: OKUR) hat seinen Anruf mit Investoren zur Überprüfung vorläufiger Daten der PIKture-01-Studie zu OKI-219 auf Dienstag, den 10. Dezember 2024, um 7:00 Uhr CT verschoben, nach vorheriger Ankündigung am 13. Dezember. Der Anruf wird zeitgleich mit der Veröffentlichung von Postern auf dem 2024 San Antonio Breast Cancer Symposium (SABCS) stattfinden.
Auf dem SABCS werden zwei Poster präsentiert: eines zeigt erste Ergebnisse aus der PIKture-01-Studie, die erste Studie am Menschen zu OKI-219, und ein weiteres demonstriert die verbesserte Aktivität von OKI-219 in präklinischen Modellen von PI3KαH1047R-mutiertem Brustkrebs. Die PIKture-01-Studie untersucht OKI-219 als Monotherapie bei fortgeschrittenen soliden Tumoren und in Kombination mit endokriner oder HER2-zielgerichteter Therapie bei fortgeschrittenem Brustkrebs.
Investor call to review preliminary data from the PIKture-01 trial is now planned for Tuesday, December 10th, at 7 a.m. CT
BOULDER, Colo., Nov. 25, 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 posters selected for presentation at the 2024 San Antonio Breast Cancer Symposium (SABCS), including the poster presenting the preliminary data from the Company’s first-in-human PIKture-01 trial of OKI-219, will be published to the symposium’s virtual meeting platform for registered attendees on December 10th.
OnKure will now hold its investor call to review preliminary data from the PIKture-01 study of OKI-219 on Tuesday, December 10, 2024 at 7:00 a.m. CT (8:00 a.m. ET). The Company had previously announced the investor call would be held on Friday, December 13, 2024. To join the call, please dial 877-407-0789 (domestic), 201-689-8562 (international) and refer to conference ID 13750009. The call may also be accessed via webcast (click here) or from the Events page of the Investors section of the Company’s website at www.onkure.com. A replay of the webcast will be available on OnKure’s website for at least 30 days following the call.
In addition, today, SABCS published 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.
There are no changes to the planned in-person poster presentations at SABCS, which is taking place in San Antonio, Texas.
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
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.
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 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
When is OnKure’s (OKUR) investor call for PIKture-01 trial data in December 2024?
OnKure’s investor call is scheduled for Tuesday, December 10, 2024, at 7:00 a.m. CT (8:00 a.m. ET).
What will OnKure (OKUR) present at the 2024 SABCS conference?
OnKure will present two posters at SABCS: preliminary results from the PIKture-01 study of OKI-219, and data on OKI-219’s activity in pre-clinical breast cancer models.
What is the purpose of OnKure’s (OKUR) PIKture-01 clinical trial?
PIKture-01 is a first-in-human study testing OKI-219 as monotherapy in advanced solid tumors and in combination with endocrine or HER2-Targeted therapy in advanced breast cancer patients.
How can investors join OnKure’s (OKUR) December 10 conference call?
Investors can join by dialing 877-407-0789 (domestic) or 201-689-8562 (international) with conference ID 13750009, or access the webcast through OnKure’s website.
