Aprinoia Therapeutics Holdings Ltd.

CAMBRIDGE, Mass., May 20, 2024 (GLOBE NEWSWIRE) -- APRINOIA Therapeutics (“Aprinoia” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics and precision diagnostics for the treatment of neurodegenerative diseases, today announced that on May 8, 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to APN-1607 (florzolotau), a Positron Emission Tomography (PET) tracer for imaging tau protein in patients with suspected progressive supranuclear palsy (PSP). PSP is a rare neurodegenerative disorder caused primarily by the accumulation of a specific form of tau in subcortical brain regions. There are no FDA-approved diagnostic markers for PSP or any other rare tau-related disorder such as frontotemporal dementia, and until now, diagnosis has primarily relied on clinical assessment. APN-1607 may enable more accurate diagnosis at earlier disease stages, potentially improving patient management and resulting in more efficient clinical trial designs for novel therapies. “We are very pleased with the FDA’s decision to grant APN-1607 Fast Track Designation as it underscores the significant unmet medical need for a diagnostic marker for the early diagnosis of PSP and potentially other tau-related disorders, including Alzheimer’s disease. APN1607 is a unique imaging agent as it was designed to detect specific forms of tau implicated in PSP and other related disorders. Sadly, patients with PSP can remain undiagnosed for several years as it is often confused with other Parkinson’s like disorders, especially during the early stages. If approved, APN-1607 would provide physicians with an important diagnostic tool that will allow them to diagnose PSP with greater confidence and differentiate it from other disorders, thereby improving the management of these patients,” stated Dr. Brad Navia, Chief Medical Officer of Aprinoia Therapeutics. “Receiving Fast Track Designation, along with the previously announced “Study May Proceed” letter from the FDA, reinforces the importance of our work related to APN-1607, and specifically, the clinical development plan to advance the asset into the clinic for the early diagnosis of PSP, and potentially other tau-related neurological disorders, including frontotemporal dementia and Alzheimer’s disease. We look forward to our further engagement with the FDA as a part of APN-1607’s Fast Track Designation, as we seek to accelerate the clinical development program for this important diagnostic tracer. We are grateful to our many investigators and partners, including the Alzheimer’s Drug Discovery Foundation and CurePSP for their continued support in our efforts to advance APN-1607 for the diagnosis of PSP and related disorders,” said Dr. Navia. “Providing patients with neurodegenerative disorders, such as Alzheimer’s, and PSP with an early and accurate diagnosis is critical for determining the best course of treatment as well as accelerating drug development via clinical trials. The Fast-Track Designation for Aprinoia’s PET tracer is a milestone for the field that will serve as the first tau imaging agent for PSP and will add to the arsenal of tau imaging tools for Alzheimer’s. This new generation PET Tracer – in addition to other biomarkers – will move us closer to the day when we can treat the right patients with the right drugs at the right time through a precision medicine approach,” said Dr. Howard Fillit, Co-Founder and Chief Science Officer at the Alzheimer’s Drug Discovery Foundation (ADDF). Fast Track Designation is designed to facilitate the development and expedite the review of product candidates that demonstrate the potential to address an unmet medical need, with the goal of advancing important new diagnostic and treatment options to patients more quickly than traditional regulatory routes. Once a drug candidate receives Fast Track Designation, early and frequent communication with the FDA, including discussions around the product candidate’s development plan and regulatory review process are ensured. If the relevant criteria are met, the product candidate may be eligible for Accelerated Approval and Priority Review by the FDA. About APN-1607 APN-1607 is a radioactive fluorinated molecule developed to visualize and quantify 3R and 4R tau aggregates by PET imaging across a number of diverse tau-related disorders, including PSP, frontotemporal dementia and Alzheimer’s disease, among others. APRINOIA is developing APN-1607 as a first-in-class radioactive diagnostic tracer for the detection of 3R and 4R tau aggregates, which contribute to the pathogenesis of various tau-related neurological disorders. APRINOIA previously received an Orphan Drug Designation from the FDA for APN-1607 as a diagnostic agent for PSP. APN-1607 has been clinically utilized in over 3,000 patients through investigator-initiated and sponsor trials, supporting its potential clinical utility as a diagnostic marker for tau-related disorders. In December 2023, enrollment of a Phase 3 trial to evaluate the efficacy and safety of APN-1607 for the diagnosis of Alzheimer’s disease was completed in China and on December 8, 2023, Aprinoia received a “Study May Proceed” letter from the U.S. FDA to conduct a global Phase 3, multicenter, open-label study to evaluate the efficacy and safety of APN-1607 as a diagnostic marker in patients suspected to have PSP. About APRINOIA APRINOIA Therapeutics Inc. is a clinical-stage biotechnology company, headquartered in Cambridge, MA, committed to developing highly sensitive and selective diagnostic and therapeutic agents for a broad range of neurodegenerative diseases. To learn more, please visit and follow us on LinkedIn. Forward-Looking Statement This communication contains forward-looking statements which reflect APRINOIA’s current expectations regarding future events, including its expectations for the future development of the Company. APRINOIA’s actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. No representations or warranties, express or implied are given in, or in respect of, this communication. When APRINOIA uses words such as “may,” “will,” “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements speak only as of the date they are made and factors that may cause actual results to differ materially from current expectations include, but are not limited to: the performance of APRINOIA’s business; the risk that preclinical studies and early-stage clinical trials may not be predictive of future results; the risk that regulatory approvals for APRINOIA’s product development are not obtained or are delayed, and the timing, success and cost of APRINOIA’s pipeline development activities and clinical trials. There may be additional risks that APRINOIA does not presently know, or that APRINOIA currently believes are immaterial, that could cause actual results to differ from those contained in the forward-looking statements. APRINOIA undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date of this communication, except as required by applicable law. Contact: Nick Colangelo IR@aprinoia.com

近日，BioBAY园内企业APRINOIA Therapeutics（新旭生技，以下称Aprinoia）宣布，通过SPAC（海外借壳上市）的方式与Ross Acquisition Corp II（以下称Ross）达成协议，将进行企业合并，预计将于今年上半年完成。根据协议，Aprinoia和Ross将分别成为新成立的实体APRINOIA Therapeutics Holdings Limited（PubCo）的全资子公司。Aprinoia的所有现有股东将把他们在Aprinoia的100%股份转入 PubCo，价值为2.8亿美元。作为企业合并的一部分，Ross首席执行官Wilbur Ross通过可转换票据个人投资750万美元，并承诺在企业合并结束时提供高达1250万美元的注资，这笔资金旨在满足将公司的主要产品18F-APN-1607在中国商业化所需的资金需求。Aprinoia成立于2015年，是一家研究基础深厚的生物技术公司，聚焦两类病态蛋白所导致的神经退行性疾病，分别是：tau蛋白病（包括阿尔茨海默病和进行性核上性麻痹），以及α-突触核蛋白病（包括帕金森病和路易体失智症）。目前，新旭生技已与Biogen和Celgene等全球领先的生物技术公司达成了多项合作，开发用于治疗神经退行性疾病的新型疗法和精确诊断。“经过7年专注于神经退行性变的研发以实现精准神经科学，我们很高兴将我们的公司提升到新的财务和企业发展水平。我们的研发和合作成功证明了我们的产品质量、我们的团队、我们的研究和商业合作伙伴的支持。”Aprinoia首席执行官Ming-Kuei Jang 说，“我们将继续发展公司和产品管线，为医生和有关键医疗需求的患者开发创新产品。”“我们很高兴与Aprinoia合作并支持其解决最重要疾病领域之一的问题。美国目前有超过650万阿尔茨海默病患者，预计到2040年经济负担将超过3500亿美元，这显然是一个值得我们关注的问题。Aprinoia的tau方法可能与Lecanemab等基于β-淀粉样蛋白的产品形成互补。我们对过去两年在这一领域取得的进展感到鼓舞，并相信我们在正确的时间与Aprinoia合作，继续推进这一领域。”Ross首席执行官Wilbur Ross说。▌文章来源：SPAC投资圈责编：赵家帅校对：杜姝审核：任旭推荐阅读资本市场丨易康生物：完成逾亿元A+、A++轮融资资本市场丨和黄医药：超11亿美元！与武田就「呋喹替尼」达成授权合作资本市场丨鼎科医疗：与美敦力再次达成战略合作，携手推动颅内创新产品发展

谁是新药研发公司的“财神爷”？是BD/CBO吗？| 请投票！~~近日，权威生物技术杂志GEN（Genetic Engineering & Biotechnology News）发布了2023年值得关注的七大生物制药趋势。其中一项便是并购交易会有所反弹，普华永道预测，医药和生命科学领域的并购额和数量将在新的一年里反弹，但不会像2021年那样强劲，所有子行业的交易总额将在2250亿美元至2750亿美元之间。近两天便发生了多起并购交易，一起来看下。012023年1月18日，新旭生技（APRINOIA Therapeutics Inc.）与Ross Acquisition Corp II 宣布达成业务合并协议。Ross Acquisition Corp II是美国前商务部长Wilbur Ross创办的一家特殊目的收购公司（SPAC）。Aprinoia 是一家临床阶段生物技术公司，专注于阿尔茨海默病（AD）和进行性核上性麻痹（PSP）等神经退行性疾病诊断工具和疗法开发，将通过与Ross SPAC合并上市。Aprinoia 和Ross SPAC将各自成为新公司Aprinoia Therapeutics Holdings Ltd 的全资子公司，合并后预估企业价值3.196亿美元。作为合并的一部分，APRINOIA的所有现有股东将把他们100%股份转入新公司，预计将持有新公司的42%至74%的股份。Wilbur Ross个人通过可转换票据投资750万美元，并在合并结束时提供1250万美元的资金注入。这笔资金旨在满足公司主导产品18F-APN-1607（APN-1607）在中国实现商业化的资金需求。18F-APN-1607是新一代tau正电子发射断层扫描（PET）影像示踪剂，大幅改善了脱靶性。florzolotau (18F)可通过单次PET扫描，提供分辨率高、可量化的三维成像，将各类tau蛋白病的毒性蛋白聚积物在脑内分布的情形给显示出来，做为临床医生鉴别诊断的重要依据。此独特性使得florzolotau (18F)成为迄今唯一的tau示踪剂，在于不仅能够区分早期与晚期的阿尔茨海默病，还能检测罕见退行性疾病，包括PSP、FTD、PiD（皮克病）。022023年1月17日，Leap Therapeutics, Inc.（纳斯达克股票代码LPTX）和 Flame Biosciences, Inc宣布达成最终合并协议。根据该协议，Leap收购了Flame及其资产，包括FL-301（CLDN 18.2单抗）、FL-302（临床前CLDN18.2/CD137双抗）、FL-501（临床前GDF15单抗）以及截至2022年12月31日的净现金约5000万美元。Flame Biosciences 主要专注于与慢性炎症相关的疾病药物（包括癌症、动脉粥样硬化性心血管疾病和关节炎）的发现、开发与商业化。Leap主要专注于开发靶向和免疫肿瘤疗法，主要候选药物是一款DKK1单抗DKN-01，用于治疗食管胃癌、子宫内膜癌、肺癌、前列腺癌和结直肠癌患者，FDA已授予DKN-01孤儿药资格用于治疗胃和胃食管交界处癌。2020年1月，Leap Therapeutics和百济神州达成协议，百济神州获得在亚洲（日本除外），澳大利亚和新西兰临床开发和推广DKN-01的独家授权许可，预付款和潜在里程碑付款共1.35亿美元。合并后的公司将继续在纳斯达克交易，股票代码为 "LPTX"，将由Leap现有的管理团队领导，并将继续专注于DKN-01临床试验的推进，截至2022年12月31日，合并后的公司总现金余额约为1.15亿美元，预计足以资助Leap计划运营费用和DKN-01、FL-301以及到2025年中期的临床前项目的开发计划。032023年1月17日，tRNA疗法开发公司hC Bioscience宣布已收购4SR Biosciences，4SR的技术将被用于发现和优化能够克服遗传错误的tRNA，推进基于tRNA的疗法开发，以治疗遗传病和癌症。4SR的技术包括一种专有的高通量测序工具MSR-seq，可以测量tRNA的丰度、修饰、充电和对压力、不同的生物条件和基因突变的反应碎片。这可以应用于hC的PTCX（补丁）平台，以纠正蛋白质合成的过早终止，以及增强公司的SWTX（开关）平台，旨在针对遗传病和癌症中的罕见密码子。 042023年1月17日，Elicio Therapeutics 宣布已与Angion（纳斯达克股票代码：ANGN） 达成最终合并协议Angion主要专注于纤维化疾病，自去年几乎停止了所有的开发活动，以保存其剩余的现金，同时寻找可以作为生命线的 "战略替代方案"。Elicio主要开发用于治疗癌症和其他疾病的新型免疫疗法，去年9月放弃IPO，Elicio将与Angion的一家全资子公司进行全股票交易合并。合并后的公司将继续使用Elicio Therapeutics的名称，股票代码为 "ELTX"，合并预计将在2023年第二季度完成。Angion股东预计将拥有新合并公司约34.5%的股份，而Elicio股东将拥有新合并公司65.5%的股份，Angion承诺向Elicio提供1000万美元的过桥贷款，在符合某些条件的情况下将分两期进行。合并后将专注于推进Elicio专有的淋巴结靶向双亲（AMP）技术，开发免疫疗法，重点是ELI-002，一种针对mKRAS驱动肿瘤的治疗性癌症疫苗，由AMP修饰的突变KRAS肽抗原和ELI-004（一种AMP修饰的免疫刺激寡核苷酸佐剂）组成。摘要图：药时代购买的正版图片（123rf）原文题目：本周变动：两天四起并购交易推荐阅读大咖专访 | 别有洞天的兔单克隆抗体世界，且听余国良博士娓娓道来！一个临床试验的失败，为阿斯利康省下14亿美元，Cincor肠子都悔青了制药巨头的2023「首裁」，默克美国分部裁员11%，主要来自「药物发现」团队初三看相声 |《缘满兔儿年！》大年初二 | 「迎婿日」聊一聊那些有价值有温度药味十足的精彩活动——药时代活动回顾与展望！~初一话兔丨祝8家兔年诞生的药企本命年快乐！新春祝福！药时代祝您新春快乐！兔年里大展宏兔！前兔似锦！恩格列净「慢性肾病」适应症获FDA受理，降糖药的「破壁」之路...点击这里，立即报名创新药BD高阶研讨会【上海站】！