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

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 PI3Kα^H1047R 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 PI3Kα^H1047R, 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 PI3Kα^H1047R 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 25^th, 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 PI3Kα^H1047R 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 PI3Kα^H1047R 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