Press Release

BOSTON, March 07, 2023 (GLOBE NEWSWIRE) -- Ikena Oncology, Inc. (Nasdaq: IKNA, “Ikena”), a targeted oncology company forging new territory in patient-directed cancer treatment, today announced that the Company is presenting preclinical data on its newest program in next-generation MEK-RAF inhibition, IK-595, at the American Association for Cancer Research (AACR) Special Conference: Targeting RAS, taking place this week in both a poster presentation and a plenary session talk.

Ikena’s Chief Scientific Officer, Michelle Zhang, Ph.D., will give an oral presentation at the conference which is taking place in Philadelphia, Pennsylvania, from March 5-8, 2023. The poster will be presented in Session B today, Tuesday, March 7. Dr. Zhang will present at a plenary session on Wednesday, March 8.

The RAS pathway is implicated in at least half of a million new cancer diagnoses each year in the United States alone. Ikena’s MEK-RAF inhibitor, IK-595, the Company’s lead candidate in the RAS pathway, is designed to achieve more comprehensive inhibition of MAPK signaling than existing inhibitors by trapping MEK-RAF in an inactive complex, including ARAF, BRAF, and CRAF. Specifically, the stabilization of the inactive MEK-CRAF complex by IK-595 potentially provides two key advantages: First, it relieves the well-recognized CRAF-mediated bypass that leads to the reactivation of MAPK signaling and resistance to first-generation MEK inhibitors in RAS mutant cancer cells. Second, sequestering CRAF in a complex with MEK also blocks the kinase-independent anti-apoptotic function of CRAF in RAS and RAF mutated cancers, which is not addressable with first generation MEK or pan-RAF inhibitors.

Highlights of the poster and Dr. Zhang’s oral presentation include:

• IK-595 stabilizes the MEK-RAF complex in an inactive conformation to stop CRAF bypass
• IK-595 potently blocks MEK phosphorylation in RAS mutant cancer cells
• IK-595 achieves deeper and more durable inhibition of MAPK signaling and ERK phosphorylation across multiple KRAS mutant, NRAS mutant, and CRAF altered cancer cell lines, compared to existing MEK inhibitors
• IK-595 drives robust anti-tumor efficacy and tumor regression in mouse models of KRAS mutant, NRAS mutant, and CRAF amplified cancers, across pancreatic, lung, bladder, and AML
• Strong synergy of IK-595 in combination with therapies targeting multiple key mechanisms in vitro, including in combination with KRAS G12C, EGFR, PI3K, mTOR, SHP2, and SOS1 inhibitors
• IK-595 is designed to have a shorter projected half-life in humans that allows a differentiated dosing strategy potentially achieving a greater therapeutic window than existing MEK inhibitors

“IK-595 has incredible potential as a best-in-class, next-gen MEK-RAF inhibitor and I am thrilled to be able to share these data with the field showing some of the important chemical and biological considerations we have integrated into the design of IK-595,” said Michelle Zhang, Ph.D., Chief Scientific Officer of Ikena. “We believe the CRAF bypass and kinase independent activity have been holding the MEK inhibitor class back from being able to address patient needs. These data demonstrate the strength of IK-595’s ability in trapping CRAF in an inactive complex – preventing that crucial therapeutic resistance mechanism in RAS and RAF mutant cancers that cannot be addressed with first-generation MEK inhibitors or pan-RAF inhibitors. We look forward to continuing to advance IK-595 as a potentially transformative therapeutic option for multiple cancers in the RAS space.”

Ikena plans to submit an Investigational New Drug application (IND) for IK-595 in the second half of 2023. First-in-human studies will target selected subsets of RAS mutant cancers, potentially including CRAF dependent, NRAS mutant, and KRAS mutant tumors with significant unmet medical need.

Presentation and poster details are as follows:

Poster Presentation
Abstract Title: IK-595, a MEK-RAF complex inhibitor, obviates CRAF mediated resistance resulting in superior RAS/MAPK pathway inhibition and anti-tumor activity in RAS/RAF altered cancers
Poster: Session B
Date: Tuesday, March 7, 2023
Time: 1:00 p.m. ET

Plenary Session Presentation
Presentation Title: IK-595, a MEK-RAF complex inhibitor, obviates CRAF mediated resistance resulting in superior RAS/MAPK pathway inhibition and anti-tumor activity in RAS/RAF altered cancers
Session: Plenary Session 7: Targeting RAS
Date: Wednesday, March 8, 2023
Time: 8:00 a.m. ET - 9:40 a.m. ET

More details on the conference program can be found on the conference website. Ikena’s poster presentation will be available on the Resources section of the company’s website following the conference.

About Ikena Oncology
Ikena Oncology^TM  is focused on developing differentiated therapies for patients in need that target nodes of cancer growth, spread, and therapeutic resistance in the Hippo and RAS onco-signaling network. The Company’s lead targeted oncology program, IK-930, is a paralog-selective TEAD inhibitor addressing the Hippo signaling pathway, a known tumor suppressor pathway that also drives resistance to multiple targeted therapies. The Company’s additional research spans other targets in the Hippo pathway as well as the RAS signaling pathway, including developing IK-595, a novel MEK-RAF inhibitor. Additionally, IK-175, an AHR antagonist, is being developed in collaboration with Bristol Myers Squibb. Ikena aims to utilize their depth of institutional knowledge and breadth of tools to efficiently develop the right drug using the right modality for the right patient. To learn more, visit www.ikenaoncology.com or follow us on Twitter and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding: the timing and advancement of our targeted oncology programs, including the timing of updates; our expectations regarding the therapeutic benefit of our targeted oncology programs; our ability to efficiently discover and develop product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the implementation of our business model, and strategic plans for our business and product candidates. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of our targeted oncology programs; our expectations regarding the therapeutic benefit of our targeted oncology programs; expectations regarding our new executive officer; our ability to efficiently discover and develop product candidates; the implementation of our business model, and strategic plans for our business and product candidates, and other factors discussed in the “Risk Factors” section of Ikena’s Form 10-Q for the quarter ended September 30, 2022, which is on file with the SEC, as updated by any subsequent SEC filings. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

Investor Contact:
Rebecca Cohen
Ikena Oncology
rcohen@ikenaoncology.com  

Media Contact:
Luke Shiplo
LifeSci Communications
lshiplo@lifescicomms.com