ADEL, Inc.

PANGYO, South Korea, Feb. 23, 2024 /PRNewswire/ -- Oscotec Inc. and ADEL Inc. announced the dosing of the first healthy participant in its first-in-human study 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 uniquely designed to target tau protein acetylated at lysine-280 (acK280), inhibiting aggregation and propagation of toxic tau and thus may slow the course of the disease. This phase 1a/1b study in the U.S. is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ADEL-Y01 in 40 healthy volunteers as well as in 33 participants with Mild Cognitive Impairment due to Alzheimer's disease or mild Alzheimer's disease. "Given that tau is strongly correlated with AD progression and clinical severity, targeting of tau is anticipated to effectively slow the disease progress. As our understanding of the pivotal role of the tau mid-region MTBR increases, selecting the right epitope becomes crucial in developing tau-targeting therapeutics to attain clinical benefits", explained SeungYong Yoon, MD/PhD, CEO of ADEL. "Oscotec is pleased to reach a significant milestone leading the clinical study as a co-developer with ADEL, and we will continue to bring innovative medicines in neurogenerative diseases", said Taeyoung Yoon, CEO of Oscotec. The preclinical results of ADEL-Y01 in animal models were published last year, demonstrating improvement in memory impairment, behavioral deficits through the inhibition of Tau seeding and propagation.("Monoclonal antibody Y01 prevents tauopathy progression induced by lysine 280–acetylated tau in cell and mouse models" in The Journal of Clinical Investigation 2023) 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. Contacts Jihyun Park, IR/PR [email protected] Kyung Hoon Hwang, Research Director/COO [email protected] SOURCE Oscotec Inc.

PANGYO, South Korea, Sept. 14, 2023 /PRNewswire/ -- 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. Contacts Jihyun Park, IR/PR [email protected] June Hahn, BD [email protected] Kyung Hoon Hwang, Research Director/COO [email protected] SOURCE Oscotec Inc.

HELM Audio and ASIUS TECH are honored with this award and to announce the first step in truly impacting hearing health with our upcoming launch of Ear-Defense AirTips™. DALLAS, Nov. 16, 2022 /PRNewswire/ -- HELM Audio INC., the award-winning audio innovation company today announces Ear-Defense AirTips, a revolutionary hearing protection and listening enhancement device. Ear-Defense AirTips represent a completely new concept in the hearing protection industry, and the design is a total rethinking of HEARABLE products. Continue Reading In partnership with ASIUS Technologies and their multi-patented ADEL™ (Ambrose Diaphonic Ear Lens) technology demonstrates a shift in how hearing can be protected, enhanced, and restored. ADEL creates a "Second Ear Drum" creating a natural way to protect against noise and pressure induced hearing loss that doesn't sacrifice audio fidelity. Users of ADEL equipped products can safely hear in a variety of environments without exposure to damaging sound pressure levels. HELM AUDIO™ WINS A 6th CES INNOVATION AWARD THAT WILL CHANGE HOW THE WORLD HEARS Tweet this Over 1.5 Billion people live with hearing loss or hearing issues worldwide, that worsen with age. ELM and ASIUS are positioned to provide solutions that represent a paradigm shift in hearing health and protection. The ADEL AirTips tech represents a giant leap forward by the pioneer of in-ear monitor headphones, Stephen Ambrose. Ambrose's expertise and research led to the development of ADEL™ for not only audio professionals, but everyone with an interest in preserving their hearing. Proven in case studies and funded by the National Institutes of Health, the National Science Foundation and supported by leading US Universities, the results are dramatic. Brian Johnson of AC/DC in a variety of interviews and the recently published new book "The Lives of Brian: A Memoir," talks about how the ADEL Technology gave him hope by allowing him to hear again and ultimately rejoin the band. " With hearing loss affecting Billions of people worldwide, everyone should consider what can be done to protect one of our most important senses. HELM is proud to introduce products which provide this protection." Eric Johnson, CEO HELM Audio "Because conventional hearing protection is so fundamentally flawed, and widespread, we chose to join forces with Helm to deliver the new standard that will eliminate noise induced hearing loss – worldwide." Steve Lebischak, CEO, Asius Technologies. The Ear-Defense AirTips hearing protection products will launch in early Q1 and we look forward to announcing the AirTips Hearable in the coming months. Learn more about our mission and Ear-Defense AirTips at helmaudio.com. For more information and to get on the media reviewer list please email [email protected] ABOUT HELM HELM Audio™ Inc. is an award-winning audio innovation company crafted on a foundation of disruptive audio technologies and products. We are disruptive innovators introducing products that will redefine hearing protection, enhancing how we hear, and ultimately working to restore hearing abilities. Our mission is to change how the world hears by delivering transformational audio products that change lives and makes life better. ABOUT ASIUS Asius Technologies is the leading developer of highly engineered audio products that enhance sound while mitigating hearing damage caused by harmful pressures created by an earbud or hearing aid speaker. Our products are used and enjoyed the world over by sound engineers, musicians, audiophiles, and anyone who wants to continue enjoying music and preserve their hearing. SOURCE HELM Audio Inc.