Tanfanercept

HL192 (ATH-399A) was well tolerated with no major safety issues in any of the 76 participants. No serious treatment related adverse events were reported and such findings were proportional between placebo and dosed groups. PK results support once a day dosing. ROCKVILLE, Md. and SEOUL, South Korea, Nov. 25, 2024 /PRNewswire/ -- HanAll Biopharma, Daewoong Pharmaceutical and NurrOn Pharmaceuticals successfully completed their Phase 1 study of HL192 (ATH-399A), which is being developed as a disease-modifying therapy for Parkinson's disease. The study met its primary endpoints of safety and tolerability in 5 different ascending dose groups, demonstrating significant progress in the treatment of this debilitating neurological disorder. This first-in-human study included single ascending dose (SAD), multiple ascending dose (MAD), and food effect components. "We are extremely pleased to announce the completion of the first-in-human study," said Sean Jeong, MD, MBA, CEO of HanAll Biopharma. "Successfully demonstrating the safety and tolerability in healthy volunteers, including older adults, is a key step in our mission to develop a disease-modifying therapy for Parkinson's disease. These findings bring hope to millions of patients and their families who are affected by this challenging condition." "We are excited to report positive results for our Phase 1 trial, confirming the well-tolerated safety profile of HL192 (ATH-399A) in healthy participants and expect to launch the next clinical trial in people with Parkinson's disease," said Deog Joong Kim, PhD., CEO of NurrOn Pharmaceuticals. NurrOn was awarded a $1.7 million grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) in support of the Phase 1 clinical trial of HL192 (ATH-399A), that initiated in the second half of 2023. "The Michael J. Fox Foundation remains steadfast in our commitment to accelerate the development of better treatments for the more than 6 million people living with Parkinson's disease around the world," said Katharina Klapper, principal of clinical research at MJFF. "The successful completion of the study's Phase 1 HL192 (ATH-399A) trial marks a meaningful step forward in advancing today's therapeutic pipeline." Parkinson's disease is a progressive neurological disorder that affects millions of people worldwide. Current treatments primarily focus on managing symptoms, but there is an urgent need for therapies that can alter the disease's progression. HL192 (ATH-399A) represents a promising approach, targeting the underlying mechanisms of Parkinson's disease to provide a more effective and long-lasting treatment. The study enrolled 76 healthy participants. Participants in the SAD and food effect arms received HL192 (ATH-399A) once, while participants in the MAD arm received a single dose once a day for twelve days, with careful monitoring and assessment of safety and tolerability. The results demonstrated a favorable safety profile. Key findings include equivalent percentages of treatment emergent adverse events (TEAEs) between those who received treatment compared to those who received placebo, with no clear dose dependent trends. Additionally, all tested dose levels were well below the pre-determined NOAEL (no observed adverse effect level) concentrations, further confirming the safety and tolerability of the chosen dose levels. HanAll and Daewoong plan to initiate the next clinical trial in people with Parkinson's disease in collaboration with NurrOn. The study will further evaluate the safety of HL192 (ATH-399A). The companies remain dedicated to developing this important asset with the goal to improve patient lives in an area of great unmet need. About HanAll Biopharma HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with presence in Korea, the USA, Japan, and Indonesia with the mission of making meaningful contributions to patients' lives by introducing innovative, impactful medicines to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in the therapeutic areas of endocrine, circulatory, and urologic diseases for over 50 years. HanAll has also expanded its focus to immunology, oncology, neurology, and ophthalmology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. One of its lead pipeline assets, HL161 (INN: batoclimab), an anti-FcRn antibody, is being developed in Phase 3 and Phase 2 trials across the world for the treatment of autoimmune diseases including generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP). HL161ANS (IMVT-1402), another anti-FcRn antibody from HanAll, is planned to begin registrational studies in GD and Rheumatoid Arthritis (RA). Another lead asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, has commenced a Phase 3 clinical study in the US and is also being evaluated in China for the treatment of dry eye disease. HL192 (ATH-399A), a Nurr1 activator targeting Parkinson's Disease, has completed a Phase 1 study in healthy volunteers. For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR ([email protected], [email protected]). About Daewoong Pharmaceutical. Co., Ltd. Daewoong Pharmaceutical (KRX: 069620.KS), established in 1945, is a global pharmaceutical company based in South Korea. The company is committed to the development, manufacturing, and commercialization of pharmaceutical products, with a mission to provide the most beneficial total solutions, including pharmaceuticals and services, which contribute to improving the quality of life of valued consumers. Operating with a keen focus on both domestic and international markets, Daewoong Pharmaceutical specializes in developing treatments for intractable and rare diseases. The company's diverse portfolio encompasses novel drugs, biologics, new products, and C&D, all supported by in-house research and development, open collaboration, and advanced manufacturing facilities. Marking significant achievements in drug development, Daewoong Pharmaceutical has successfully developed novel drugs for GERD, featuring the active ingredient Fexuprazan, and for Type 2 diabetes, with the active ingredient Enavogliflozin, in two consecutive years. The company is currently advancing in the development of First-in-Class Oral Anti-Fibrotic Agent for Idiopathic Pulmonary Fibrosis, utilizing Bersiporocin as a PRS Inhibitor. Notably, Bersiporocin has been designated by the U.S. FDA as an orphan drug and a Fast Track development product. Daewoong is dedicated to completing the Phase 2 clinical study of this drug by 2025. For more information, visit Daewoong Pharmaceutical's website and LinkedIn page. Media inquiries can be directed to Daewoong's PR at [email protected]. About NurrOn Pharmaceuticals NurrOn Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing novel, targeted therapeutics for the treatment of Parkinson's disease (PD) and other Nurr1-related incurable human disorders. Through targeting Nurr1, the master regulator for dopaminergic neuron development and maintenance, we aim to develop a paradigm changing PD treatment to improve patients' quality of life. While currently there are only symptomatic treatment options for patients with PD, there have not been any successful therapies to slow or prevent the progression of the disease. We believe that disease-modifying therapies will be achieved through targeting Nurr1, which has generated supportive data as a new druggable PD target. NurrOn was awarded a substantial grant from Michael J. Fox Foundation in support of the Phase 1 clinical trial of HL192 (ATH-399A), that initiated in the second half of 2023. For further information on NurrOn Pharmaceuticals, please visit our official website or contact [email protected]. Disclaimer Statement The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "may," "will," or "should," and include statements HANALL (the company, we) makes concerning its 2024 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners', advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. These may include various significant factors, such as our expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities, and regulatory approval requirements. In addition, performance may be affected by our reliance on collaborations with third parties, estimating the commercial potential of our product candidates, our ability to obtain and maintain protection of intellectual property of technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of product candidates. A further list and description of these risks, uncertainties, and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations. SOURCE HanAll Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HanAll records revenue of 36.8 billion KRW in the third quarter, with an operating profit of 430 million KRW. Results for the Phase 1 study in healthy subjects for HL192 (ATH-399A), a novel compound targeting Parkinson's Disease, are expected in November 2024. ROCKVILLE, Md. and SEOUL, South Korea, Nov. 1, 2024 /PRNewswire/ -- HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for the third quarter of 2024 and provided business updates. HanAll ended the third quarter with total revenue of 36.8 billion KRW, reflecting an 11.7% increase from the same period in 2023 and an operating profit of 430 million KRW. Pharmaceutical sales reached 34 billion KRW from robust sales of key products. In the third quarter, HanAll's anti-FcRn assets demonstrated potential as best-in-class treatments for a range of autoimmune diseases, particularly Graves' Disease. Ongoing studies include a Phase 2b trial in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) as well Phase 3 studies in generalized Myasthenia Gravis (gMG) and Thyroid Eye Disease (TED), with topline results expected in the first quarter of 2025 and first half of 2025, respectively. Additionally, HanAll, in collaboration with NurrOn Pharmaceuticals and Daewoong Pharmaceutical, completed the Phase 1 study of HL192 in healthy subjects. Results for the HL192 Phase 1 study are anticipated in November of this year. "This past quarter, HanAll's focus and agile execution have positioned us for significant growth while allowing us to continue our R&D efforts through strategic, value enhancing cost optimization. Looking ahead, we are committed to expanding our competitive advantage by specializing in key products and strengthening our R&D capabilities as we strive to realize our highest potential as a global company," said Sean Jeong, MD, MBA, CEO of HanAll Biopharma. Third Quarter 2024 BUSINESS UPDATE Pipeline Development Highlights A comprehensive update of HanAll's public pipeline development below includes an overview of research along with lists of compounds, targeted indications and developmental phases. AUTOIMMUNE DISEASES PROGRAMS Batoclimab (HL161BKN) A novel, fully human, subcutaneously administered antibody targeting FcRn with the potential to address multiple IgG-mediated autoimmune diseases, batoclimab is designed to selectively bind to FcRn, which plays a role in recycling IgG, thereby reducing levels of harmful IgG antibodies Immunovant, a member of the Roivant group of companies, as well as HanAll's licensed partner in the United States and Europe, is making progress across four autoimmune indications. Phase 3 studies in gMG and TED are advancing, with topline results expected in the first quarter of 2025 and first half of 2025, respectively. Immunovant reported positive results from the Phase 2a study of batoclimab in Graves' Disease. The study demonstrated that a higher dose of batoclimab achieved a 76% response rate in patients who were not adequately controlled on antithyroid drugs (ATDs) by 12 weeks of treatment. The ATD-free response rate for these patients at the same time point was 56%. Immunovant is progressing with subject enrollment in the ongoing Phase 2b study for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The data obtained from this study will also be utilized to refine the study design for a potential registrational program for IMVT-1402 in CIDP. Initial results from the first period of the Phase 2b study are anticipated in the first quarter of 2025. Harbour BioMed, another licensed partner which transferred exclusive rights to develop, manufacture, and commercialize batoclimab in the Greater China region to CSPC NBP Pharmaceuticals Co., Ltd. (NBP Pharma), resubmitted the Biologics License Application (BLA) for batoclimab to the National Medical Products Administration (NMPA) in June 2024, which was accepted by the NMPA in July 2024. The BLA incorporated additional long-term safety data from the Phase 3 study in gMG which concluded in June 2023. HL161ANS (IMVT-1402) Another novel, fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG is designed to deliver maximum lgG reductions, while minimizing interference with albumin recycling Immunovant plans to initiate a pivotal study in Graves' Disease (GD) leveraging findings from the batoclimab Phase 2a study in GD data. The results from the previous study indicate a significant correlation between the reduction of IgG levels and clinical outcomes, underscoring the potential of HL161ANS/IMVT-1402 as a best-in-class treatment option for patients with GD. Immunovant intends to initiate 4 to 5 potentially registrational studies for IMVT-1402 (HL161ANS) before the conclusion of the first quarter of 2025. Additionally, the company plans to commence studies for IMVT-1402 across a total of up to 10 indications (in the aggregate) by the end of the first quarter of 2026. The company is also exploring initiating a registrational development in gMG with IMVT-1402. Immunovant will work to optimize the HL161ANS/IMVT-1402 CIDP trial design, drawing insights from the ongoing CIDP Phase 2b trial for batoclimab. OPHTHALMIC DISEASE PROGRAM Tanfanercept (HL036) A novel topical protein therapy for ophthalmic diseases, including dry eye disease (DED), which inhibits TNF, a key mediator of ocular inflammation HanAll Biopharma and Daewoong Pharmaceutical are conducting the Phase 3 VELOS-4 study to evaluate the efficacy and safety of tanfanercept in dry eye disease. The topline results for the study are expected in 2026. The Phase 3 VELOS-4 trial builds upon key insights gained from the completed Phase 3 VELOS-3 study. In VELOS-3, tanfanercept demonstrated a statistically significant improvement in the secondary efficacy endpoint of tear volume, as measured by unanesthetized Schirmer testing, in patients treated with tanfanercept compared to those in the vehicle group at week 8 (p=0.002). In addition, a post hoc analysis revealed that a notable proportion of participants in the tanfanercept group (14%) showed significant improvement (p=0.011) in the Schirmer test, with an increase of at least 10mm from baseline at week 8, compared to only 4% in the vehicle group. The 2020 FDA Draft Guidance on Dry Eye Drug Development considers the proportion of participants achieving a minimum 10mm increase in the Schirmer test response rate as an acceptable primary efficacy endpoint for approval. NEUROLOGY PROGRAM HL192 (ATH-399A) A pipeline candidate from NurrOn Pharmaceuticals (originating from Harvard Medical School's Molecular Neurobiology Laboratory) which targets Nurr1, both a master regulator in dopaminergic neuron development and maintenance, as well as an important component in anti-inflammatory functions. HL192 (ATH-399A) is being developed to treat neurodegenerative diseases, including Parkinson's disease (PD). The Phase 1 study of HL192, being developed in collaboration with NurrOn Pharmaceuticals, HanAll Biopharma, and Daewoong Pharmaceutical, has completed dosing with the results expected in November 2024. ONCOLOGY PROGRAMS HL187 is a monoclonal antibody that targets TIGIT (T cell immunoreceptors with Ig and ITIM domains {Immunoreceptor tyrosine-based inhibitory motif domains}). HL186 is a monoclonal antibody that targets TIM-3 (T cell Ig and mucin domain-3). These antibodies are being developed in collaboration with Daewoong Pharmaceutical as potential oncology treatments. HanAll decided to discontinue its monoclonal antibody programs targeting TIM-3 and TIGIT, following the recent data outcomes and decisions from other global companies to cease their programs. HanAll is exploring the potential for developing a new asset for a different oncology target. FINANCIAL HIGHLIGHTS (CONSOLIDATED) Key Highlights About HanAll Biopharma HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with presence in Korea, the USA, Japan, and Indonesia with the mission of making meaningful contributions to patients' lives by introducing innovative, impactful medicines to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in the therapeutic areas of endocrine, circulatory, and urologic diseases for over 50 years. HanAll has also expanded its focus to immunology, oncology, neurology, and ophthalmology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. One of its lead pipeline assets, HL161 (INN: batoclimab), an anti-FcRn antibody, is being developed in Phase 3 and Phase 2 trials across the world for the treatment of autoimmune diseases including generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves' disease (GD). HL161ANS (IMVT-1402), another anti-FcRn antibody from HanAll, is being evaluated in multiple indications including GD. Another lead asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, has commenced a Phase 3 clinical studies in the US and is also being evaluated in China for the treatment of dry eye disease. HL192 (ATH-399A), a Nurr1 activator targeting Parkinson's Disease, has completed a Phase 1 study in healthy volunteers, with results to be announced in November 2024. For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR ([email protected], [email protected]). Disclaimer Statement The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "may," "will," or "should," and include statements HANALL (the company, we) makes concerning its 2024 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners', advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. These may include various significant factors, such as our expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities, and regulatory approval requirements. In addition, performance may be affected by our reliance on collaborations with third parties, estimating the commercial potential of our product candidates, our ability to obtain and maintain protection of intellectual property of technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of product candidates. A further list and description of these risks, uncertainties, and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations. SOURCE HanAll Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED