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

Key Takeaway: OnKure Therapeutics announced that two abstracts for OKI-219 have been selected for presentation at the 2024 San Antonio Breast Cancer Symposium. This includes preliminary clinical data from the PIKture-01 study, which targets specific mutant solid tumors. A conference call will be held following the symposium to further discuss the findings. OnKure is focused on developing precision oncology therapies, with OKI-219 as a lead program in their promising pipeline.

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POSITIVE FACTORS

  • OnKure's OKI-219 is selected for presentation at a major oncology conference.
  • The preliminary data from the PIKture-01 study shows promise in treating mutant-selective tumors.
  • OnKure aims to advance its innovative pipeline targeting challenging cancer therapies.

Full Press Release Details

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.
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.
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.

Frequently Asked Questions

What is the focus of OnKure Therapeutics?

OnKure Therapeutics specializes in developing precision medicines in oncology.

When is the SABCS being held?

The 2024 San Antonio Breast Cancer Symposium will take place from December 10–13.

What is OKI-219?

OKI-219 is a mutant-selective PI3KαH1047R inhibitor under investigation.

When will OnKure's data review call occur?

The data review conference call is scheduled for December 13, 2024, at 8:00 a.m. ET.

Where can I find more information about the PIKture-01 trial?

Additional details on the PIKture-01 trial are available at ClinicalTrials.gov.

Last updated: Nov 1, 2024