Cevidoplenib

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.

With the efficacy comparable to rival drugs, Oscotec plans to advance to the next step, leaving the door open for partnership PANGYO, South Korea, Feb. 24, 2023 /PRNewswire/ -- Oscotec Inc. announced topline results for Phase 2 trial evaluating the efficacy, safety and tolerability of cevidoplenib (SYK inhibitor) in immune thrombocytopenia (ITP) patients who have failed to respond or relapsed after prior therapy. Cevidoplenib was evaluated in a 61-participant randomized, placebo-controlled trial to access its efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of select (200 mg BID and 400 mg BID) doses in ITP patients with a platelet count <30,000/µL. The study duration was 20 weeks per subject, which consists of up to 4 weeks of screening period, 12 weeks of treatment period, and 4 weeks of follow-up period. Primary endpoint of this study is the platelet response rate defined as platelet counts (PLTs) ≥30,000/µL and doubling the baseline. The response rate for the participants who were treated with cevidoplenib at the higher dose (400 mg) was 63.6% compared to 33.3% on placebo with p-value of 0.151. In the secondary endpoints, 50.0% of the participants on the higher dose (400 mg) achieved 2 or more consecutive PLTs of ≥30,000/µL compared to 8.3% on placebo (p = 0.015) and 40.9% achieved PLT ≥50,000/µL vs. 8.3% on placebo (p = 0.055). It should be noted that these secondary endpoints were more comparable to the ones used as the primary endpoints in the clinical trials of the competitors. Oscotec is planning to present detailed results at European Hematology Association in June. "We are elated to see the data that confirms the potential of cevidoplenib becoming a safe and effective medicine for ITP patients who are not responding to the current standard therapies." said Dr. Taeyoung Yoon, CEO/CSO of Oscotec. "Not only that, the data indicate that our SYK inhibitor will be at least as efficacious as the competitors in late stage development. With the proven, exceptional safety profile and the convenience of oral dosing, we believe that cevidoplenib could one day become a genuinely competitive drug of choice for patients with ITP. We will explore every available option including partnership to deliver our drug as quickly as we can to those who suffers from the potentially crippling disease." About Immune Thrombocytopenia (ITP) Immune thrombocytopenia (ITP) is a disorder that can lead to easy or excessive bruising and bleeding. The bleeding results from unusually low levels of platelets. Formerly known as idiopathic thrombocytopenic purpura, ITP can cause purple bruises, as well as tiny reddish-purple dots that look like a rash. The prevalence (how many have ITP at any time) is 9.5 per 100,000. ITP patients experience chronic fatigue. The most concerning, but rare, form of bleeding due to ITP is an intracranial hemorrhage (bleeding in the brain). ITP treatment consists of the administration of corticosteroids, immunoglobulins, thrombopoietin receptor agonists, etc. However, sustained remission in the absence of treatment suggests the optimization of ITP management is necessary. About Oscotec Inc. Oscotec is a clinical stage drug discovery and development company and focus on discovering small molecules with a novel mechanism of action and validating the drug-target-disease hypothesis through rigorous science into clinical proof-of-concept. The Company's clinical pipeline consists of targeted therapeutics in immunology and oncology. Oscotec is developing cevidoplenib (SYK inhibitor) for ITP (Phase 2) and FLT3/AXL inhibitor for AML (Phase 1) as well as solid tumors (Phase 1). The company is also a originator of lazertinib, a 3rd generation EGFR inhibitor being developed by Janssen Pharma and Yuhan Corp. for lung cancers. Contacts Jihyun Park, IR/PR [email protected] June Hahn, BD [email protected] SOURCE Oscotec Inc.