NeuroTherapia, Inc.

▎药明康德内容团队报道 根据即刻药数数据库，上周（8月5日~8月11日），全球生物制药领域至少10家致力于创新药研发的公司宣布完成新一轮融资，其中包括2家来自中国的创新生物医药公司。这些获得融资的公司的技术和管线涉及多肽药物、免疫疗法、抗病毒疗法、基因编辑疗法、干细胞疗法等领域。 公司：正序生物 融资轮次：A+轮 融资金额：超亿元人民币 8月8日，正序生物宣布完成超亿元人民币的A+轮融资，由上海国投孚腾资本领投，联新资本、博裕资本、礼来亚洲基金、万物资本、红杉中国等现有股东跟投。融资资金将用于进一步加速CS-101临床研究和商业化推进，并支持体内基因治疗管线的临床转化等。 正序生物专注于开发新型基因编辑疗法，针对遗传疾病、代谢疾病、心血管疾病等疾病，已布局了多条管线。其中CS-101注射液是针对血红蛋白病开发的创新型基因编辑疗法，该产品针对β-地中海贫血症的1期临床试验正在推进。该产品于今年4月在中国获批临床。 公司：IDRx 融资轮次：B轮 融资金额：1.2亿美元 8月7日，致力开发癌症精准疗法的IDRx公司宣布完成1.2亿美元超额B轮融资。此次融资由RA Capital Management、Commodore Capital和Blackstone Multi-Asset Investing领投，其他新投资者包括Rock Springs Capital和一家总部位于美国的专注于医疗保健的基金。现有投资者包括Andreessen Horowitz（a16z）Bio+Health、Casdin Capital、Nextech Invest、Forge Life Science Partners、联合创始人Nick Lydon博士和战略合作伙伴德国默克（Merck KGaA）等也参与了融资。 此轮融资的资金将用于支持IDRx公司主要候选产品IDRx-42的1/1b期胃肠道间质瘤（GIST） 临床研究，以及资助该在研产品在二线GIST患者中第一项关键研究的启动。IDRx-42是一种强效、口服、高度选择性的KIT抑制剂，靶向KIT突变GIST患者的所有主要激活和耐药突变类别。早前，美国FDA曾授予IDRX-42快速通道资格，用于治疗伊马替尼治疗后疾病进展或不耐受后的GIST患者。 公司：Red Queen Therapeutics 融资轮次：A轮 融资金额：5500万美元 8月6日，专注于开发新型抗病毒药物的Red Queen Therapeutics宣布完成Apple Tree Partners（ATP）提供的5500万美元A轮融资，用于其新型抗病毒多肽药物的临床前开发。Red Queen Therapeutics由ATP和医学博士Loren Walensky共同创立，该公司基于一种新型脂肽平台技术开发抗病毒疗法，该技术可阻断病毒-细胞融合，也就是所有包膜病毒进入细胞的方式。该公司正在开发的抗病毒疗法不依赖于免疫系统激活，而是作用于病毒本身，以抑制病毒感染的进展并加速病毒清除。 公司：Shinobi Therapeutics 融资轮次：A轮 融资金额：5900万美元 8月6日，Shinobi Therapeutics宣布获得日本医疗研究开发机构（AMED）5900万美元的投资，用于支持公司针对GPC3+实体肿瘤的iPS-T细胞疗法项目的开发。此外，其他投资者Yosemite和Mitsubishi UFJ Capital也参与了该公司的投资，目前该公司A轮融资已达1.19亿美元。 Shinobi Therapeutics致力于开发一种新型免疫逃逸型iPS细胞疗法，这种干细胞疗法可以与患者的免疫系统形成协同作用，而不是对抗。该公司的开发策略是对iPSCs进行编辑，使其具高度免疫逃逸性，然后再使用其专有技术使iPSCs进行分化以创建CD8αβ iPS-T细胞。Shinobi目前已经建立多个在研管线，适应症涉及实体瘤、自身免疫性疾病和糖尿病等。 公司：NeuroTherapia 融资轮次：B轮 融资金额：1230万美元 8月6日，专注于开发神经退行性疾病疗法的NeuroTherapia宣布完成1230万美元B轮融资。B轮融资由Cleveland Clinic（克利夫兰诊所）领投，先前投资者Brain Trust Accelerator Fund II，Dolby Family Ventures和阿尔茨海默氏症药物发现基金会（ADDF）以及新投资者Foundation for a Better World and CRUINT均参与投资。 该轮融资的资金将主要用于继续推进其CB2受体激动剂NTRX-07治疗阿尔茨海默病（AD）的临床开发。NTRX-07目前处于2期临床研究阶段。公开信息显示，该产品具有中枢神经系统活性，靶向小胶质细胞上的CB2受体，可显著降低炎症因子的表达，从而导致神经元存活和激活。神经炎症被认为在一系列神经系统疾病中起关键作用，如阿尔茨海默病、神经性疼痛、多发性硬化等。 公司：仁远生物 融资轮次：种子轮 融资金额：数百万元 近日业内传来消息，专注于血管修复干细胞治疗的仁远生物完成数百万元种子轮融资，投资方为普禾资本。公开资料显示，仁远生物专注于通过血管修复干细胞技术开发心脑血管疾病治疗产品。该公司采用血管修复干细胞技术，通过参与调节血管新生、损伤血管修复以及疏通血管，有望为心脑血管疾病治疗开辟新途径。仁远生物目前打造了4个在研管线产品，包括VCP01、VCP02、VCP03三款在研药物以及MV3D-01型3D血管芯片在研产品，其中三款在研药物计划于2025年申报IND。 公司：Release Therapeutics 融资轮次：种子轮 融资金额：330万瑞士法郎 8月6日消息，Release Therapeutics完成330万瑞士法郎的种子轮融资。该公司开发了一种细胞大胶囊技术（cell macroencapsulation technology ），旨在将强效治疗性蛋白输送到人类血脑屏障之外。该公司的技术将这种可植入的大胶囊装置与一种永生化成肌细胞系相结合，该细胞系能够产生多种蛋白质，长期输送到中枢神经系统。这种将生物技术和医疗技术相结合的创新，旨在不进行基因治疗的情况下治疗中枢神经系统的遗传性疾病。 Release Therapeutics的主要项目正在临床前开发，用于治疗异染性白质营养不良（MLD），这是一种罕见遗传性疾病，会导致髓磷脂的逐渐丧失，通常影响幼儿。此次融资是在该公司在异染性脑白质营养不良（MLD）动物模型中首次取得临床前结果之后完成。 公司：Amlogenyx 融资轮次：种子轮 融资金额：1400万美元 近日业内消息，Amlogenyx完成了1400万美元的种子轮融资。此次由GordonMD®Global Investments LP和相关投资者以及Ultragenyx Pharmaceutical领投。该公司由Ultragenyx 分拆而来，正在研究和开发阿尔茨海默病和其他淀粉样蛋白疾病的新型基因疗法。Amlogenyx计划用这笔融资资金来推进其第一款蛋白酶候选产品，这款产品旨在有效分解和降解Aβ42。科学界普遍认为Aβ42是导致阿尔茨海默病发生的关键蛋白质。 公司：Nammi Therapeutics 融资轮次：B轮 融资金额：3000万美元 8月6日消息，Nammi Therapeutics获得了骨髓瘤投资基金（MIF）100万美元的投资，该投资是3000万美元B轮融资的一部分。这项投资是在该公司主导项目QXL138AM的第一项人体1期研究计划开始之前进行的，该研究针对的是局部晚期不可切除和/或转移性实体瘤和多发性骨髓瘤患者。 Nammi Therapeutics是一家免疫肿瘤学公司。其QXL138AM是一种掩蔽免疫细胞因子（MIC），由与靶向肿瘤细胞表面CD138蛋白的抗体融合的掩蔽干扰素α（IFNa）组成。临床前数据表明，QXL138AM在10多种肿瘤类型中包括多发性骨髓瘤中具有显著抗肿瘤疗效。基于这些，该产品已获得FDA授予多发性骨髓瘤的孤儿药资格。 公司：MBX Biosciences 融资轮次：C轮 融资金额：6350万美元 8月5日消息，专注于新型肽类药物研发的MBX Biosciences宣布了一项由Deep Track Capital领投的6350万美元的C轮融资，用于支持其正在进行的每周一次MBX-2109治疗甲状旁腺功能减退症的2期临床研究，以及加速推进早期研发管线。新投资者Driehaus Capital Management和T.Rowe Price Associates以及现有投资者Frazier Life Sciences、OrbiMed和Wellington Management等参投。 MBX Biosciences专注于发现和开发新型精确肽疗法，用于内分泌和代谢紊乱治疗。该公司的MBX 2109是一款甲状旁腺激素肽前体药物，已进入甲状旁腺功能减退症的2期临床试验，预计将于2025年三季度获得基线结果。另一款MBX 1416是一款用于减肥后低血糖的候选产品，正在进行1期研究。该公司还拥有肥胖和代谢性疾病的早期候选药物组合，其中长效GLP-1/GIP受体共激动剂前药MBX 4291正在推进IND申报。 希望在投资市场的助力下，这些前沿技术和疗法可以早日造福病患。 参考资料： [1]各公司官网和公开资料 本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权及其他合作需求，请联系wuxi_media@wuxiapptec.com。 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

Investment will allow NeuroTherapia to continue the development of an orally available treatment for Alzheimer's disease. CLEVELAND, Aug. 6, 2024 /PRNewswire/ -- NeuroTherapia, Inc., a clinical-stage company and Cleveland Clinic Innovations portfolio company focused on developing therapies for neurodegenerative diseases, announced today the first closing of its Series B financing with $12.3M in funding. The Series B round, led by Cleveland Clinic, includes all previous investors, Brain Trust Accelerator Fund II, Dolby Family Ventures and the Alzheimer's Drug Discovery Foundation (ADDF) as well as new investors, Foundation for a Better World and CRUINT. NeuroTherapia is using this funding primarily for the continued clinical development of NTRX-07, an orally available cannabinoid receptor agonist, for the treatment of Alzheimer's disease (AD). The company will continue to raise additional funds for its second close in six months, which will enable development of a recently discovered second generation molecule for a separate indication in which neuroinflammation plays a major role. "We were pleased with the Phase 1b trial results that demonstrated a trend toward cognitive benefits in Alzheimer's disease and wanted to continue its development as rapidly as possible," commented Joseph Rich, JD, MBA, Senior Director, Cleveland Clinic Innovations, and lead investor representative in this financing. "We believe that the Company's planned Phase 2a trial has the potential to not only demonstrate the ability of NTRX-07 to inhibit neuroinflammation, but it could also lead to an improvement in biomarkers of cognitive function in patients with Alzheimer's disease." Coincident with the financing, the company welcomes Adam Hoffman to its Board of Directors as an Observer. Mr. Hoffman is an experienced investor and entrepreneur, currently serving as President of Foundation for a Better World. Mr. Hoffman joins Mr. Reher, who will continue to serve as Chairman of the Board, Tony Giordano, Ph.D., NeuroTherapia's President and CEO, and Joseph Rich and Jim Ellis from Cleveland Clinic and Akhil Saklecha, M.D., the CSO at Danaher, on the Board. In addition, Meriel Owen, Ph.D., Director of Search and Evaluation at the ADDF, serves as an Observer. "We are extremely fortunate to have the continued support of our previous investors and to add new investors with significant AD experience," said Dr. Giordano. "The Board has provided invaluable insights over the past 4+ years and I am excited to continue to work with them to advance NTRX-07 for treating AD." In addition to the Phase 2a trial, NeuroTherapia will use funding from this financing to study NTRX-07 in a preclinical model of ARIA (a significant side effect observed with administration of therapeutic monoclonal antibodies) in combination with therapeutic monoclonal antibodies. Based on its mechanism of action, NTRX-07 may reduce or prevent the ARIA side effect associated with monoclonal antibody treatment and/or improve the benefits of these therapies. A demonstration of activity in the preclinical ARIA study could lead to subsequent trials where NTRX-07 is used in combination with the therapeutic monoclonal antibodies to provide additional patient benefits. The company has also identified second-generation molecules that will be advanced for other indications associated with increased neuroinflammation, such as pain, Parkinson's disease or ALS. About NeuroTherapia NeuroTherapia is a clinical-stage, privately held biotechnology company developing oral, small-molecule drugs to address neuro-inflammatory conditions of the central nervous system (CNS), including Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, and other CNS conditions. There is an emerging consensus that neuroinflammation plays a significant role in CNS disease. NeuroTherapia is developing therapeutics that inhibit microglia cells, which are known to express proteins that drive inflammation in the CNS, without affecting the clearance of toxic beta amyloid. We believe this approach will result in improved neuronal function and survival. At NeuroTherapia, our mission is to change the course of the most debilitating and deadly CNS diseases that patients and their families face today. Additional information about NeuroTherapia can be found at . About The Alzheimer's Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $290 million to fund over 750 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 20 countries. To learn more, please visit: . SOURCE NeuroTherapia, Inc.

CLEVELAND, May 8, 2024 /PRNewswire/ -- NeuroTherapia, an early-stage clinical pharmaceutical company, announced today that it has received a grant from the Alzheimer's Association Part the Cloud program for the development of its first-in-class drug, NTRX-07, for the treatment of Alzheimer's disease (AD). The grant from the Alzheimer's Association will help fund the clinical development of NTRX-07, which has shown promising results in preclinical studies and in a small cohort of AD subjects in a Phase 1 study for the treatment of Alzheimer's disease. NTRX-07 is a novel drug that targets neuroinflammation, a key driver of Alzheimer's disease, and has the potential to slow or even halt the progression of the disease. "We're thrilled to receive this grant from Part the Cloud and to have their support in the development of NTRX-07," said Tony Giordano, CEO of NeuroTherapia. "Alzheimer's disease is a devastating illness that affects millions of people worldwide, and we're committed to developing innovative treatments that can make a real difference in the lives of patients and their families." "NTRX-07 represents a new approach to the treatment of AD by addressing the neuroinflammation that plays a role in the damage to the brain. It is an orally administered drug, showing a good safety profile at doses predicted to be efficacious based on modeling of the animal data in the recently completed Phase 1 safety studies in healthy volunteers and a small group of patients with Alzheimer's disease," said Joseph Foss, M.D., Chief Medical Officer for NeuroTherapia. "This Phase 2a study will expand our understanding of the drug in patients with Alzheimer's Disease and may provide early insights into its effects." "Treatments that target Alzheimer's from all angles and all stages of the disease are essential, and that's why strategic research funding that works to diversify the drug pipeline is so important," said Heather Snyder, Ph.D., Alzheimer's Association vice president of medical and scientific relations. "The Alzheimer's Association through Part the Cloud is thrilled to support promising early stage clinical trials, such as this one, by helping accelerate the transition of findings from the laboratory into possible treatments." This is the second grant for the development of NTRX-07 from the Alzheimer's Association. NeuroTherapia has also received venture funding from the Alzheimer's Drug Discovery Foundation, Cleveland Clinic, Brain Trust Accelerator Fund II and Dolby Family Ventures that allowed the Company to complete Phase 1 clinical trials and position itself for the upcoming Phase 2a trial, which is designed not only to show safety and tolerability but also to give an indication of biological activity. For more information about NeuroTherapia and the development of NTRX-07, please visit . SOURCE NeuroTherapia, Inc.