IK-595 / ImageneBio - LARVOL DELTA

Study of IK-595 in RAS- or RAF-altered Advanced Tumors (clinicaltrials.gov) - P1 | N=75 | Terminated | Sponsor: Ikena Oncology | N=150 ➔ 75 | Trial completion date: Jul 2027 ➔ Sep 2025 | Recruiting ➔ Terminated | Trial primary completion date: Jul 2027 ➔ Sep 2025; Limited resources and strategic priorities

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Trial termination • Brain Cancer • Colorectal Cancer • Glioma • High Grade Glioma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Thyroid Gland Carcinoma • BRAF

Preliminary results from a first-in-human study of IK-595, an oral MEK/RAF molecular glue, in patients with RAS- or RAF-altered advanced solid tumors (AACR 2025) - P1 | "IK-595 is well tolerated in pts with low-grade skin and GI toxicities as the most frequently observed adverse events. Encouraging target inhibition and early antitumor activity in RAS- and RAF-altered solid tumors was observed. Clinical trial information: NCT06270082"

Clinical • Metastases • P1 data • Genito-urinary Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Urothelial Cancer • BRAF • KRAS • NF1

A first-in-human study of IK-595, an oral MEK/RAF molecular glue, in patients with RAS- or RAF-altered advanced solid tumors. (ASCO 2024) - "Key exploratory endpoints include changes in pERK in peripheral blood cells, changes in pERK target genes in tumor biopsies, and assessment of candidate baseline response biomarkers. The study began in December 2023 and enrollment in Cohort 1 was completed with no DLTs; dose escalation continues to enroll."

Clinical • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Neurofibromatosis • Oncology • Pancreatic Cancer • Solid Tumor • Targeted Protein Degradation • BRAF • KRAS • NF1 • NRAS

Ikena Oncology Announces Strategic Update (GlobeNewswire) - P1 | N=150 | NCT06270082 | Sponsor: Ikena Oncology | "IK-595: MEK-RAF Molecular Glue: The first two cohorts in the Phase 1 study of IK-595 in patients with RAS and RAF mutant cancers have cleared; backfilling in select cohorts is planned for the second half of 2024. Promising early pharmacokinetics (PK) and pharmacodynamics (PD) activity has been observed, with dose dependent exposure and target modulation measured in the blood. Reached above 80% pERK inhibition at 4 hours post dosing to date, with above 60% inhibition sustained through 24 hours; dose escalation continues."

PK/PD data • Trial status • Solid Tumor

Ikena Oncology Reports First Quarter 2024 Financial Results and Corporate Update (GlobeNewswire) - "IK-595: MEK-RAF Molecular Glue: Dose escalation in the Phase 1 study of IK-595 in patients with RAS and RAF mutant cancers continues, with backfilling in select cohorts planned for the second half of 2024."

Trial status • Colorectal Cancer • Glioma • Melanoma • Non Small Cell Lung Cancer • Pancreatic Cancer • Thyroid Gland Carcinoma

IK-595, a best-in-class MEK-RAF molecular glue, drives broad and potent anti-tumor activity across RAS-MAPK pathway-altered cancers as a monotherapy and in combination (AACR 2024) - "Preclinical pharmacology studies provide clear guidance to the clinical development plan of IK-595, where flexible dosing schedules, multiple expansion cohorts in RAS/RAF altered patient populations, and combination therapies with mediators of resistance will be explored. IK-595 is a novel MEK-RAF molecular glue that prolongs pathway inhibition, minimizing the potential for resistance, while providing an optimal therapeutic window for patients with RAS/RAF-driven cancer."

Monotherapy • Oncology • Solid Tumor • BRAF • KRAS • NF1 • NRAS

Study of IK-595 in RAS- or RAF-altered Advanced Tumors (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Ikena Oncology

New P1 trial • Brain Cancer • CNS Tumor • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Glioma • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Thyroid Gland Carcinoma • BRAF

Ikena Oncology Outlines Key Priorities and Provides Corporate Updates (GlobeNewswire) - "IK-595: MEK-RAF Molecular Glue: The initial cohort was dosed with IK-595 in December 2023 and has subsequently cleared the safety evaluation window. Enrollment of targeted RAS and RAF mutant cancer patients in dose escalation continues, where multiple dosing schedules are being explored."

Trial status • Solid Tumor

IK-595, a best-in-class MEK-RAF complex inhibitor, drives broad and potent anti-tumor activity in RAS/RAF-driven tumors. (AACR-NCI-EORTC 2023) - No abstract available

Oncology

Ikena Oncology Reports Second Quarter 2023 Financial Results and Corporate Update (GlobeNewswire) - "IK-595: IND application submission for IK-595 planned by year end 2023; Additional preclinical updates and indication selection data for IK-595 will be presented in 2023 at the 5th Annual RAS-Targeted Drug Discovery Development Conference in September and AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October."

IND • Preclinical • Oncology

Ikena Oncology Acquires Pionyr Immunotherapeutics in All-Stock Transaction (GlobeNewswire) - "Ikena Oncology, Inc...and Pionyr Immunotherapeutics, Inc...announced the closing of Ikena’s acquisition of Pionyr in an all-stock transaction. Ikena acquired all of Pionyr’s assets, including approximately $43 million in net cash, in exchange for shares of IKNA stock, in a combination of common stock and non-voting convertible preferred stock priced at $7.15 per share....The transaction further strengthens Ikena’s financial position as the Company advances development of its targeted oncology programs. The new capital will enable Ikena to expand and accelerate its targeted oncology programs, including both IK-930, Ikena’s clinical program targeting the Hippo pathway with initial clinical data expected this year, and IK-595, a MEK-RAF complexing inhibitor expected to have an IND submitted this year."

IND • M&A • Oncology

Ikena Oncology Reports First Quarter 2023 Financial Results and Highlights Advancements Across Targeted Oncology Pipeline (GlobeNewswire) - "Initial clinical data from the monotherapy portion of the ongoing Phase 1 clinical trial of IK-930, including patients from the dose escalation cohorts and backfilling, is planned for the fourth quarter of 2023....Investigational new drug (IND) application submission for IK-595 planned for the second half of 2023....IK-175: AHR Inhibitor in Collaboration with Bristol Myers Squibb...The Phase 1 clinical trial in urothelial carcinoma has completed enrollment; treatment is ongoing and the program is eligible for opt-in from Bristol Myers Squibb through early 2024."

Enrollment closed • IND • P1 data • Genito-urinary Cancer • Mesothelioma • Oncology • Solid Tumor • Urothelial Cancer

Ikena Oncology Announces $40 Million Underwritten Offering (GlobeNewswire) - "Ikena Oncology, Inc...announced today the pricing of an underwritten offering of 6,110,000 shares of common stock (the “Shares”) at an offering price of $6.55 per share....The offering is expected to close on or about May 17, 2023, subject to satisfaction of customary closing conditions. The Company anticipates the net proceeds of the offering, together with existing cash, cash equivalents and investments, to further its ongoing clinical development of targeted oncology programs and advance them to clinical data read outs beyond the initial data for the monotherapy portion of the ongoing IK-930 Phase 1 clinical trial in the fourth quarter of 2023 and initial clinical data for IK-595, in addition to working capital, capital expenditures and other general corporate purposes."

Financing • P1 data • Mesothelioma • Oncology • Solid Tumor

Ikena Oncology Reports Fourth Quarter and Full Year 2022 Financial Results (GlobeNewswire) - "Phase 1 trial of IK-930 in Hippo altered cancers (NCT05228015) continues to advance as expected, with multiple dose escalation cohorts cleared....Initial clinical data from the monotherapy portion of the Phase 1 study is expected in the second half of 2023....Investigational new drug application (IND) submission for IK-595 to the U.S. Food & Drug Administration (FDA) planned for the second half of 2023. IK-175: AHR Inhibitor in Collaboration with Bristol Myers Squibb....The program is eligible for opt-in from Bristol Myers Squibb through early 2024."

IND • P1 data • Genito-urinary Cancer • Mesothelioma • Oncology • Solid Tumor • Urothelial Cancer

Ikena Oncology Presents Preclinical Data on IK-595, Best-in-Class Next-Generation MEK-RAF Complex Inhibitor, in Plenary Session at AACR Special Conference on RAS Targeting (GlobeNewswire) - "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 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."

Preclinical • Acute Myelogenous Leukemia • Bladder Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Malignancies • Leukemia • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor