TDM-105795

HONG KONG, June 12, 2024 /PRNewswire/ -- Even with the ever-changing situation, technological innovation is still the most critical component for biopharmaceutical companies' long-term development. This continuous innovation keeps companies up to date and promotes the evolution of R&D and the success of commercialization. Recently, Viva Biotech's portfolio companies have new updates. Keep reading for more details. VivaVision Forges Strategic Alliance with Renhe Shanliang, and Intitated Their Domestic Phase III Trial for VVN001 On June 6th, World Eye Health Day, a themed event was held in Shanghai. At this grand occasion, guests witnessed the signing of a joint venture agreement between VivaVision, invested and incubated by Viva BioInnovator (VBI), and Jiangxi Shanliang Pharmaceutical Co., Ltd. The two parties will join forces to build a renowned Chinese brand for contact lens care products. Back on March 16th, VivaVision had announced that the initiation meeting for the domestic Phase III clinical trial of VVN001 eye drops - their independently developed dry eye treatment, a LFA-1 antagonist - was successfully convened in Shanghai, marking the official setting sail of the Phase III clinical trial. QurAlis Grants Lilly Exclusive Global License for QRL-204 CAMBRIDGE, Mass., June 3rd, 2024–QurAlis Corporation ("QurAlis"), invested and incubated by Viva BioInnovator (VBI), recently announced that it has entered into an exclusive license agreement with Eli Lilly and Company ("Lilly") in which QurAlis is granting Lilly global rights to develop and commercialize QRL-204, a potentially best-in-class splice-switching antisense oligonucleotide (ASO) designed to restore UNC13A function in amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative diseases. Under the terms of the agreement, QurAlis granted Lilly an exclusive, worldwide license to develop and commercialize QRL-204 and other UNC13A-targeting compounds in exchange for an upfront payment of $45 million to QurAlis, plus an additional equity investment. QurAlis is also eligible for future milestone payments of up to $577 million and tiered royalties on net sales. Arthrosi Announces Multiple Presentations at the European League Against Rheumatism (EULAR) Congress 2024 SAN DIEGO, May 30th, 2024 /PRNewswire/ -- Arthrosi Therapeutics, Inc., invested and incubated by Viva BioInnovator (VBI), is a late-stage biotechnology company developing a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and Tophi in patients with gout. Recently they announced the acceptance of two presentations, including one poster tour at the European League Against Rheumatism (EULAR) Congress 2024 meeting, being held in Vienna, Austria on June 12-15. Lucy Therapeutics Secures New Funding to Advance New Alzheimer's and Parkinson's Treatments WALTHAM, Mass.--(BUSINESS WIRE)--Lucy Therapeutics, Inc. (LucyTx), incubated and invested by Viva BioInnovator (VBI), announced it has raised $12.5 million in additional funding led by existing investors Engine Ventures and Safar Partners with new participation from Bill Gates, Parkinson's UK, and the Michael J. Fox Foundation, which provided a $2 million non-dilutive grant. The fresh capital brings LucyTx's total funding to date to more than $36 million. The investments will further the company's research programs for Alzheimer's and Parkinson's diseases and continue its development of a novel drug target for Rett syndrome. Technoderma Medicines Initiates Phase 2 Clinical Trial for TDM-180935, a Novel Drug for Atopic Dermatitis/Eczema, and Officially Establishes Presence at Chengdu Tianfu International Bio-Town On April 29th, 2024, Technoderma Medicines Inc., ("Technoderma Medicines"), a clinical-stage biotech company developing innovative drugs that is invested and incubated by Viva BioInnovator (VBI), officially announced the initiation of its Phase 2 clinical trial (NCT 06363461) for TDM-180935, a topical ointment for atopic dermatitis/eczema, with patients beginning treatment. Previously, on April 20th, Thyrologics officially established its presence at the Chengdu Tianfu International Bio-Town. Multipeptide Screening Integrated with Biochips, Unveiling New Strategies of XLEMENT and Healthytide On March 27th, 2024, two leading companies in the biopharmaceutical industry - Hangzhou Healthytide Biotechnology Co., LTD. (hereinafter referred to as "Healthytide") and XLEMENT, which is invested incubated by Viva BioInnovator (VBI), announced a strategic cooperation agreement to jointly advance technological innovation and breakthroughs in the field of peptide drug development. Healthytide brings its single-molecule peptide diversity library to the table, while XLEMENT contributes its innovative and industry-leading biochip technology platform to support the collaboration. About VivaVision Biotech VivaVision is a clinical stage pharmaceutical company focused on best-in-class and first-in-class therapies for ocular diseases. VivaVision's current pipeline includes VVN001 for treating dry eye syndrome, VVN539 for the treatment for Glaucoma or Ocular Hypertension, and VVN461 for the treatment of non-infectious ocular inflammation of Uveitis. VivaVision is also engaged in discovery and development of novel therapies for the treatment of other anterior and posterior eye diseases. For more info, visit . About QurAlis Corporation QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets with next-generation precision medicines. QurAlis' proprietary platforms and unique biomarkers enable the design and development of drugs that act directly on disease-causing genetic alterations. Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is advancing a deep pipeline of antisense oligonucleotides and small molecule programs including addressing sub-forms of ALS that account for the majority of ALS patients. For more information, please visit or follow us on Twitter @QurAlisCo. About Arthrosi Arthrosi Therapeutics, Inc. was founded in San Diego, CA, in 2018 with a mission to create a revolutionary treatment option to target uric acid levels and reduce joint damage for people living with gout. With its vast therapeutic and treatment knowledge, Arthrosi has accumulated a comprehensive and robust intellectual property portfolio and impressive Phase 1 and Phase 2b data showing industry-leading efficacy rates and superior safety profiles. About Lucy Therapeutics Lucy Therapeutics is a private biotechnology company in Waltham, MA, founded by Amy Ripka, Ph.D., in 2017, dedicated to unraveling the complex and interrelated biological processes driving mitochondrial dysfunction and addressing them to slow and stop the diseases they cause. Sitting at the center of genetics and metabolism, Lucy Therapeutics is leading the change in how we think about mitochondria and the intersecting pathways that play critical roles in human health and disease, particularly those of the central nervous system, including Parkinson's disease and Rett syndrome. For more information, visit lucytherapeutics.com. About Technoderma Medicines Technoderma Medicines, Inc. is a privately held clinical stage biopharmaceutical company. The Company was originally located in Jiaxing Xiuzhou Biomedicine Guoqian Park, China, and recently relocated to Chengdu Biomed Town, Chengdu, Sichuan Province, China. Its current core programs focus on development of innovative therapies for Androgenetic Alopecia, Atopic Dermatitis, Psoriasis and Lupus Erythematosus. Its "first-in-class" small molecule thyromimetic drug candidate TDM-105795 for Androgenetic Alopecia is currently in Phase 2a clinical testing. Technoderma's novel JAK1/TYK2 inhibitor TDM-180935 for Atopic Dermatitis is now in Phase 1 clinical testing. The pipeline targets dermatologic indications. About XLEMENT As an Innovator in the field of biopharmaceutical R&D and health diagnostics, Liangzhun has independently developed and launched the pioneering next-generation ultra-surface plasmon resonance detection "MetaSPR Biochip Technology". SOURCE Viva Biotech Holdings

2024年4月29日，临床阶段的生物创新药研发公司特科罗生物科技（成都）有限公司（下文简称“特科罗”或“公司”）正式宣布，公司针对特应性皮炎/湿疹TDM-180935外用软膏的2期临床试验(NCT 06363461)已经开始，患者开始用药。据介绍，TDM-180935外用软膏2期临床为期8周，参与试验的患者分为测试软膏的2个浓度组和两个对应对照组，和一个独立药代组。试验采用“随机、制剂溶媒对照、平行组”的研究方法，评估患者用药后，TDM-180935软膏的安全性、疗效、耐受性和药代动力学性能。目前，美国FDA已经批准了该药物的临床试验申请，7个研究中心参加该项试验研究。公司首席医学官Arthur P. Bertolino博士说：“我们期待特应性皮炎/湿疹TDM-180935外用软膏的2期临床试验可以显示药物的初步疗效，即可以′验证概念′（POC），并指导我们确定在下一阶段的临床试验中可以使用药物的浓度。我们相信作为高效的JAK1/Tyk2小分子抑制剂，TDM-180935具有相当的优势。”“TDM-180935外用软膏在1期临床试验中显示出良好的耐受性和极少的系统吸收，我们期待在2期临床试验中可以看到初步疗效。特应性皮炎/湿疹软膏是特科罗第二个进入2期临床试验的产品，这充分证明了公司在治疗各种皮肤病适应症新药研发方面的实力。”公司CEO王增全博士说，“我们会不断将管线产品推到临床试验阶段。”关于TDM-180935 TDM‑180935是治疗特应性皮炎/湿疹的外用候选小分子药物。作为高效的JAK1/Tyk2小分子抑制剂，TDM‑180935在疗效和安全性方面可能会优于市场上的现有药物。临床前研究显示：TDM-180935在多种动物疾病模型的试验中显示出有效性，而且非常适合外用涂抹。功能性细胞测试表明：TDM-180935可以有效抑制与导致特应性皮炎有关的角质细胞以及T细胞介导的致病通路。在大鼠和小型猪试验中，TDM-180935软膏也显示出优异的安全性、极少的系统吸收和毒代特性。已经完成的临床1期结果显示出优异的药物耐受和极少的系统药物暴露。关于特应性皮炎/湿疹 特应性皮炎（AD），也称为特应性湿疹，是一种慢性复发性瘙痒性炎症性皮肤病，通常影响面部、颈部、手脚和四肢屈肌。根据疾病发展阶段（急性、亚急性、慢性），典型的AD皮损包括发红、水肿、皮肤开裂或脱皮、有渗出或无渗出物的鳞状红斑或斑块，以及苔藓化，并伴有严重瘙痒和皮肤干燥。反复搔抓会引发一个持续不断的瘙痒-搔抓循环，严重影响患者的生活质量。世界范围内，AD在儿童中的患病率约为15-20%，在成人中约为1-3%。过去几十年中，工业化国家的发病率增加了2-3倍。AD的发病机制涉及四个主要方面：皮肤屏障功能破坏、暴露于过敏原、微生物感染和免疫功能失调。AD发病与两个主要风险因素相关：一个是编码丝聚蛋白前体的FLG基因的遗传缺陷，丝聚蛋白存在于表皮颗粒层中，它将结构蛋白聚集在一起，形成一个强大的屏障基质；另一个是特应性疾病的家族史，例如食物过敏、过敏性鼻炎和哮喘等。关于特科罗生物科技（成都）有限公司  特科罗生物科技（成都）有限公司是一家临床阶段的生物创新药研发公司。公司总部设在中国四川成都天府国际生物城。公司专注创新药研发，用于治疗雄激素性脱发、特应性皮炎/湿疹、银屑病和红斑狼疮等适应症。全球首创的治疗雄激素性脱发的小分子候选药物TDM-105795已经顺利完成2a阶段临床试验，在向下一阶段临床研究推进；针对特应性皮炎/湿疹的创新型JAK1/TYK2抑制剂TDM-180935已经完成1期临床试验，安全性优异，目前已经开始临床2期POC试验。公司具有多个临床前或临床阶段的候选药物，管线产品都是针对各种皮肤适应症的治疗药物。投资者和媒体联系人特科罗生物科技（成都）有限公司CEO 王增全博士info@tkskin.com●企业发展历程●致药研初心，创健康未来：特科罗生物正式入驻成都天府国际生物城特科罗治疗雄激素性脱发全球首创新药临床二期a试验证实：TDM-105795促进雄激素性脱发患者毛发生长临床阶段生物制药公司特科罗最新进展：雄脱管线步入II期临床