APL-122 / Edison Oncology, Apollomics - LARVOL DELTA

Phase 1 dose escalation of EO1001, an oral brain-penetrating pan-ErbB inhibitor, in advanced cancer: Preliminary results from an ongoing Phase 1–2a clinical trial (SNO 2025) - "EO1001 demonstrates early evidence of clinical activity at dose and exposure levels predicted to be therapeutically relevant based on preclinical data. Enrollment is ongoing in a Phase 2 expansion cohort to further assess safety and CNS-targeted efficacy at or below the MTD."

Clinical • Metastases • P1/2 data • Oncology • Solid Tumor • EGFR • ERBB4

EO1001: Encouraging Early Clinical Activity and Durable Disease Control in ErbB-Driven Tumors (ACCESS Newswire) - "Edison Oncology Presents New...Data...at SNO 2025....Interim results from the Phase 1 dose-escalation portion of the ongoing Phase 1-2a trial demonstrated that EO1001 was generally well tolerated across dose levels from 2.5 mg to 90 mg once daily....Notably, patients with recurrent glioblastoma harboring EGFR extracellular domain mutations-including EGFRvIII and A289 hotspot variants-experienced prolonged stable disease, consistent with preclinical models showing rapid and efficient brain penetration with brain-to-plasma ratios exceeding 4:1 and durable tumor retention."

P1 data • Glioblastoma

Phase 1 dose escalation of EO1001, an oral brain-penetrating pan-ErbB inhibitor, in advanced cancer: Preliminary results from an ongoing Phase 1–2a clinical trial (WFNOS 2025) - "EO1001 demonstrates early evidence of clinical activity at dose and exposure levels predicted to be therapeutically relevant based on preclinical data. Enrollment is ongoing in a Phase 2 expansion cohort to further assess safety and CNS-targeted efficacy at or below the MTD."

Clinical • Metastases • P1/2 data • Oncology • EGFR • ERBB4

Apollomics Reports Full Year 2024 Financial Results and Highlights Clinical Updates and Business Progress (GlobeNewswire) - "Other pipeline programs : (i) APL-122:...Edison has completed six dose escalation cohorts in the Phase 1 trial, including two within the expected therapeutic window, and expects to provide a data update in 2025; (ii) APL-102:...The Phase 1 clinical trial in China has been closed and Apollomics expects to provide topline results in 2025."

P1 data • Trial status • Solid Tumor

A Phase 1-2 clinical trial of EO1001, a novel irreversible pan-ErbB inhibitor with promising brain penetration (LCC 2023) - "Biomarker evaluations are conducted if medically feasible at the discretion of the investigator. Results of the study will inform design of future clinical trials with EO1001,"

Clinical • P1/2 data • CNS Disorders • Oncology • EGFR • ERBB4 • HER-2

A Phase 1-2 clinical trial of EO1001 (APL-122), a novel irreversible pan-ErbB inhibitor with promising brain penetration (SNO 2021) - "Toxicity is assessed based on NCI CTCAEv5 and tumor response is assessed by RECIST 1.1. CNS exposure is evaluated in patients via CSF collection with confirmed CNS disease involvement."

Clinical • P1/2 data • CNS Disorders • Oncology • EGFR • ERBB4 • HER-2

Edison Oncology and Apollomics Inc. Announce Treatment of First Patient For EO1001 (APL-122) in a Phase I/IIa Clinical Trial (GlobeNewswire) - "Edison Oncology Holding Corp...and Apollomics Inc...reported that the first patient was dosed with EO1001 (APL-122) in a Phase I/IIa clinical trial in patients with advanced solid tumors...The Phase I/IIa clinical trial will enroll up to 50 patients and is being conducted in Australia under contract service provided by Senz Oncology Pty Ltd."

Trial status • Oncology • Solid Tumor

Apollomics, Inc. and Edison Oncology Announce Licensing Agreement for Novel Protein Tyrosine Kinase Inhibitor Targeting Solid Tumors (GlobeNewswire) - “Apollomics, Inc…and Edison Oncology Holding Corp., today announced that Apollomics has been granted worldwide rights, excluding China, Hong Kong and Taiwan, for the development and commercialization of EO1001.…‘Looking ahead, a Clinical Trial Notification (CTN) Application in Australia will be submitted to initiate a clinical trial in the second quarter of this year’…Under the terms of the agreement, Apollomics has the exclusive rights to develop and commercialize EO1001 globally, except in China, Hong Kong and Taiwan. Edison Oncology will receive an upfront cash payment and will be eligible to receive potential development and sales milestone payments, as well as tiered royalties on net sales.”

Licensing / partnership • New trial • Oncology • Solid Tumor