On September 30, 2021 Edison Oncology Holding Corp. ("Edison Oncology"), a company established to develop new therapies targeting the fight against cancer, and Apollomics Inc. ("Apollomics"), an innovative biopharmaceutical company committed to the discovery and development of mono- and combination oncology therapies, reported that the first patient was dosed with EO1001 (APL-122) in a Phase I/IIa clinical trial in patients with advanced solid tumors (Press release, Apollomics, SEP 30, 2021, View Source [SID1234590534]). EO1001 is a potent irreversible tyrosine kinase inhibitor (TKI) that has demonstrated inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent in laboratory studies.
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"We are thrilled to see our first patient treated with EO1001 and hope that the potential safety and efficacy suggested by our preclinical data has the potential to translate into clinical benefits for patients suffering from cancer," said Jeffrey Bacha, B.Sc., MBA, Co-Founder and Chief Executive Officer of Edison Oncology. "Our preclinical studies have shown that EO1001 is potent against multiple activating mutations in the intracellular domain of EGFR. We look forward to the results from this first clinical trial as we believe EO1001 has the potential to address unmet medical needs in many types of cancer including non-small cell lung cancer, breast cancer and glioblastoma."
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. The objective of this first-in-human clinical trial is to examine the safety and tolerability of EO1001 in patients with metastatic or advanced stage ErbB-1(EGFR), ErbB-2(HER2) and/or ERbB-4 (HER4) positive cancer. Patients with relapsed ErbB-positive cancers in solid tumors, including patients with central nervous system (CNS) involvement, will be enrolled at several clinical sites in Australia.
Sanjeev Redkar, PhD, Co-Founder and President of Apollomics, added, "We are pleased to achieve this important milestone in the development of EO1001 which we refer to as APL-122. In preclinical models, APL-122 demonstrated activity in ErbB positive tumors and the ability to penetrate and treat cancers in the CNS. Therefore, this Phase I/IIa study is inclusive of patients with brain metastases. Advancing into human clinical trials marks a pivotal step in our development of this promising cancer therapy."
Dr. Sophia Frentzas, medical oncologist and clinical researcher at Monash Cancer Center in Melbourne, Australia and Principal Investigator for the clinical trial said, "ErbB positive tumors represent a significant patient population with unmet clinical needs. These include patients with HER2 (ErbB2) positive breast cancer and EGFR (ErbB1) mutant lung cancer who have acquired resistance, or are refractory, to frontline targeted therapy. They also include those patients with other tumour types where the ErbB pathway has been increasingly shown to be a clinically significant oncogenic driver (e.g. GBM, endometrial, ovarian, bladder cancer and others). Cross-talk between ErbB family members is implicated in resistance to treatment and the growing incidence of central nervous system metastases plays a significant role in patient morbidity and mortality. In particular, the latter presents a significant limitation with currently available targeted therapies. EO1001 is an oral, brain-penetrating, uniquely potent, pan-ErbB inhibitor. We look forward to exploring its safety and efficacy in this first-in-human trial."
On February 9, 2021, Edison Oncology and Apollomics announced an exclusive licensing agreement whereby Apollomics will develop and commercialize EO1001 (APL-122) globally, except in Mainland China, Hong Kong and Taiwan.
About EO1001
EO1001 is an irreversible tyrosine kinase inhibitor (TKI) that has demonstrated inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent in laboratory studies. EO1001 is potent against mutations in the intracellular domain of EGFR that are typically found in diseases such as Non-Small Cell Lung Cancer (NSCLC) including T790M, L858R and d746-750, HER2 (ErbB2) which is prominent in breast cancer, and against the EGFR-variant III (EGFRvIII) that is characteristic of glioblastoma. In preclinical trials, EO1001 has been well-tolerated and demonstrated the ability to enter the central nervous system (CNS) following oral dosing and activity against treatment-resistant EGFRvIII-driven tumors, including malignancies in CNS, in vivo. EO1001 is referred to as APL-122 by Apollomics.