PANGYO, South Korea I September 14, 2023 I Oscotec Inc. and ADEL Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application of ADEL-Y01 for the treatment of Alzheimer’s disease (AD).

Oscotec and ADEL are jointly developing a novel disease-modifying immunotherapy agent (ADEL-Y01) targeting tau protein accumulation in the AD brain. ADEL-Y01 is a recombinant IgG1 class type monoclonal humanized antibody that recognizes and binds to tau protein acetylated at lysine-280 (acK280) thus inhibiting aggregation and propagation of tau seeds and enhancing microglial tau clearance. Administration of ADEL-Y01 has ameliorated memory impairment, behavioral deficits, and tau pathology in preclinical models, which was published early this year (“Monoclonal antibody Y01 prevents tauopathy progression induced by lysine 280-acetylated tau in cell and mouse models” in The Journal of Clinical Investigation)

This phase 1a/1b study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ADEL-Y01 in healthy volunteers as well as in participants with Mild Cognitive Impairment due to Alzheimer’s disease or mild Alzheimer’s disease.

“We are convinced that ADEL-Y01 has the strong potential to be a much needed treatment option for patients with Alzheimer’s disease based on its novel mechanism of action and the strength of preclinical data,” said Dr. Taeyoung Yoon, CEO/CSO of Oscotec. “Initiating the first-in-human study of ADEL-Y01 is a significant milestone to the Oscotec-Adel partnership, which also serves as a vehicle for Oscotec in expanding its R&D horizon beyond small molecule.”

“The IND clearance by the FDA represents a major achievement for us, especially in light of our first candidate entering into clinical trials,” said Seung-Yong Yoon, M.D., CEO of ADEL. “We are enthusiastic about commencing the clinical trial, as it brings us closer to providing therapeutic solutions for the patients grappling with tauopathies including AD.”

About Oscotec Inc.

Oscotec is a clinical stage drug discovery and development company pursuing translation of  rigorous science into innovative medicine for clinically unmet needs.. The Company’s clinical pipeline consists of targeted therapeutics in immunology and oncology. Oscotec is developing cevidoplenib (SYK inhibitor) for ITP (Phase 2, completed) and FLT3/AXL inhibitor for AML (Phase 1) as well as solid tumors (Phase 1). The company is also the originator of Lazertinib (LECLAZA®), a 3rd generation EGFR inhibitor being developed by Janssen Pharma and Yuhan Corp. for lung cancers.

About ADEL Inc.

ADEL is a leading company of cutting-edge technologies for the treatment and diagnosis of neurological diseases including Alzheimer’s disease. Founded by scientists who have investigated Alzheimer’s disease at Asan Medical Center, University of Ulsan College of Medicine, Korea, ADEL is developing smart, innovative drug candidates for the patients worldwide.

SOURCE: Oscotec