Entos Pharmaceuticals, Inc.

根据公开信息，上周（5月19日~5月25日），全球范围内有至少8家致力于创新药研发的新锐公司宣布完成新一轮融资。通过梳理，这些获得资本青睐的新锐公司正在开发的产品包括小分子药物、基因治疗药物等，针对疾病领域涵盖癌症、杜氏肌营养不良等罕见病、阿尔茨海默病、心脑血管及代谢疾病等。恒瑞医药融资轮次：IPO融资金额：98.9亿港元5月23日，恒瑞医药在香港联合交易所主板正式挂牌上市。恒瑞医药此次全球发售H股总数为224,519,800股（行使超额配售权之前），发行价44.05港元，为发行区间上限定价。基石投资者涵盖新加坡政府投资公司（GIC）、景顺（Invesco）、瑞银全球资产管理集团（UBS-GAM）、高瓴资本、博裕资本等知名机构，参与国际配售的锚定投资者群体亦汇聚国际知名长线基金、主权财富基金等大型投资机构。恒瑞医药创立于1970年，于2000年在上海证券交易所上市，业务覆盖肿瘤、代谢和心血管疾病、免疫和呼吸系统疾病以及神经科学等多个领域。该公司建立了靶向蛋白降解嵌合体（PROTAC）、肽类、单克隆抗体、双特异性抗体、多特异性抗体、ADC及放射性配体疗法等技术平台，已在中国获批上市20款新分子实体药物（1类创新药）和4款其他创新药（2类新药），90多个自主创新产品正在临床开发中，并在国际范围内开展了约400项临床试验。FORE Biotherapeutics融资轮次：D2轮融资金额：3800万美元5月22日，FORE Biotherapeutics宣布完成3800万美元D2轮融资，投资者包括SR One、Medicxi、OrbiMed、HBM Healthcare Investments、Wellington Management、诺华风险基金（Novartis Venture Fund）、Cormorant Asset Management以及3B Future Health Fund。此前D轮及D1轮融资已筹得7500万美元，本轮3800万美元的注入使得D轮融资总额累计达到1.13亿美元。本轮融资将用于持续推进BRAF抑制剂plixorafenib的研发，该产品通过差异化设计规避传统抑制剂耐药性问题。该产品目前正在临床研究中被评估治疗三种不同患者群体，包括BRAF V600复发性原发性中枢神经系统（CNS）肿瘤、罕见BRAF V600突变实体瘤以及BRAF融合实体瘤。Entos Pharmaceuticals融资轮次：未披露融资金额：100万美元5月22日，CureDuchenne Ventures宣布对Entos Pharmaceuticals进行首轮100万美元投资。这家生物技术公司正利用其非病毒、可重复给药的Fusogenix PLV递送平台开发基因治疗药物。Entos将运用这笔资金开发靶向肌肉组织的疗法，递送全长抗肌萎缩蛋白用于治疗杜氏肌营养不良（DMD）。Fusogenix PLV平台结合了病毒与非病毒递送技术的双重优势，采用全新机制实现RNA、DNA及基因编辑疗法的细胞内递送。根据新闻稿，本轮融资将推进开发能突破现有AAV载体疗法局限的基因治疗方案——这种疗法将不排斥具有预存免疫力的个体、允许重复给药，最重要的是能将全长抗肌萎缩蛋白递送至所有目标肌肉组织。ReproNovo融资轮次：A轮融资金额：6500万美元5月21日，Jeito Capital宣布领投ReproNovo的6500万美元（约合5700万欧元）A轮融资。AXA IM Alts与M Ventures作为联合领投方，与Ysios Capital、ALSA Ventures等专业医疗投资基金共同参与本轮融资。ReproNovo致力于开发创新方案解决生殖医学与女性健康领域的未满足需求，涵盖男女不孕不育及子宫健康问题。本轮融资资金将用于推进两款项目进入2期临床研究阶段，包括核心候选药物RPN-001（来曲唑类似物）作为治疗睾酮水平低下所致男性不育的口服疗法；RPN-002（nolasiban，一种口服催产素受体拮抗剂）将探索用于治疗子宫腺肌症（子宫内膜组织侵入子宫肌层的病变，可导致严重经期出血与疼痛），以及提高辅助生殖技术（ART）成功率。Life Molecular Imaging融资轮次：专项投资融资金额：216万美元5月20日，Life Molecular Imaging（LMI）宣布获得Alzheimer's Drug Discovery Foundation (ADDF) 总额216万美元的专项投资，该项投资将支持靶向单胺氧化酶B（MAO-B）的氟-18标记PET显像剂[18F]F-DED的开发。MAO-B作为神经炎症关键生物标志物，与阿尔茨海默病（AD）病理机制密切相关。该项目预计通过[18F]F-DED PET显像技术，揭示散发性与遗传易感型AD患者神经炎症特征，为阐明疾病早晚期神经炎症动态演变提供关键证据。新闻稿表示，神经炎症可能是阿尔茨海默病tau病理向皮层扩散的关键驱动因素。新型神经炎症显像工具有望无创可视化星形胶质细胞活性，结合现有标志物揭示炎症与AD的深层关联。柯君医药融资轮次：B+轮融资金额：超亿元5月20日，柯君医药宣布完成全部超亿元规模B+轮融资。本轮次继2024年9月完成了投资方国信创新股权、谊安集团、英飞尼迪资本、宏海资本联合投资后，本次融资由粤科母基金注资。柯君医药自2018年成立，主要聚焦心脑血管/代谢疾病和抗病毒等治疗领域。其研发的新一代抗血小板药物CG-0255是一款血小板P2Y12受体拮抗剂，采用了全新设计的代谢路径，临床数据显示出其"best-in-class"的潜力。本次融资所得资金将主要用于CG-0255的3期临床开发。在心脑血管/代谢领域，柯君医药自主研发的针对代谢性肝病/减重适应症的肝靶向创新药物CG-0416也已进入临床前研究阶段，这是一款新型水解前药，联合GLP-1/GIP类药物的协同效益，有望带来更好的降脂减重疗效的同时，显著改善肌肉保持水平，并能够强化血脂调节。CellCentric融资轮次：C轮融资金额：1.2亿美元5月19日，CellCentric宣布完成1.2亿美元C轮融资。本轮融资由RA Capital Management与新投资人Forbion共同领投，Avego Bioscience Capital以及美国癌症协会旗下风投机构BrightEdge参与投资。本轮融资所筹资金将加速推进公司口服p300/CBP抑制剂inobrodib治疗多发性骨髓瘤的临床开发，包括启动针对重度经治多发性骨髓瘤患者的2/3期研究，该研究有望支持加速审批。该创新小分子药物通过靶向p300/CBP下调关键癌症驱动因子MYC与IRF4的表达。该产品联合泊马度胺与地塞米松的全口服三联疗法2a期剂量优化研究正在进行中。君合盟融资轮次：战略投资融资金额：数千万元5月19日，君合盟宣布完成数千万元战略融资，由石药国方先导基金独家投资，融资将用于推进公司在研产品管线开发。君合盟成立于2020年11月，是一家专注于重组蛋白创新药物及合成生物学领域创新产品开发的生物科技公司。该公司的研发管线布局围绕严肃医疗、消费医疗、代谢等领域，已实现包括重组I/III型人胶原蛋白原液及制剂、重组A型肉毒毒素等在内的高端重组蛋白产品的规模化放大。其中，核心产品重组人生长激素注射液已完成3期临床；重组A型肉毒毒素已于近日完成成人中重度眉间纹适应症3期临床的首例受试者给药，其用于成人脑卒中后上肢痉挛适应症的2期临床试验也已接近尾声，即将进入到3期临床。期待在资本的助力下，更多前沿疗法和技术能够更快惠及患者。参考资料：[1]各公司官网及公开资料版权说明：本文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。转载授权或其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：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。

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. The Government of Canada is contributing $62 million to Entos Pharmaceuticals to build a 103,000 square-foot manufacturing and R&D facility in Edmonton, Alberta. The build will cost a total of $198.5 million and will hire 90 new employees, according to a Tuesday release. CDMO Vetter is investing over €150 million ($163 million) to expand its warehouse in Ravensburg, Germany. The move will increase its cool storage services, according to a Tuesday release. The European Commission has launched a new regulation called the Critical Medicines Act to improve the continent’s pharma supply chains. The act will increase or improve EU manufacturing capacity for raw materials and drug products, among others. Some member states will or have received financial support to improve manufacturing, according to a Monday release. The Noramco Group is investing $25 million into its factory in Whippany, NJ, to expand manufacturing of sterile injectables, syringes and vials, the company said Monday. Scimplify has secured $40 million in a Series B raise, which will be used to scale up its chemical manufacturing platform, the company announced Wednesday. LGM Pharma is investing over $6 million to expand its Rosenberg, TX, manufacturing site for making liquid, semi-solid and suppository drug products, the company said Wednesday. WuXi XDC has signed a memorandum of understanding with the South Korean biotech AbTis, the company said Tuesday. WuXi will provide its ADC discovery services and manufacturing platform and AbTis will bring its conjugation tech. Emergent BioSolutions and Swiss vaccine company Rocketvax have entered into a new partnership . Emergent will manufacture and commercialize four of Rocketvax’s clinical stage assets, the companies said Wednesday. RoslinCT and Ayrmid Pharma announced their intent to partner on the production of the cell therapy Omisirge for blood cancer, the companies announced Tuesday. RoslinCT will tech transfer and commercially make the drug at its site in Hopkinton, MA.

Entos Pharmaceuticals, a spinout of the University of Alberta, linked up with Eli Lilly in a research collaboration and licensing agreement in 2022. With grant funding from governments at multiple levels in Canada, Entos Pharmaceuticals is looking to plant roots at a CAD $198.5 million ($137.2 million) R&D and manufacturing hub in Edmonton.The 103,000-square-foot R&D center and biomanufacturing plant will be used to develop and produce the company’s Fusogenix proteolipid vehicles (PLVs). The space will support the University of Alberta spin-off's continued evolution, building on its partnership with Eli Lilly centered on the PLV drug delivery technology. In 2022, Lilly shelled out $50 million upfront for exclusive rights to use the tech for nucleic acid-based products targeting the central and peripheral nervous systems.Besides aiding Entos' industry collaborations, the new digs will help to build out Canada’s capacity for domestic drug manufacturing, the company noted in a press release. The Government of Canada agreed to chip in $62 million CAD ($42.8 million) for the site, while the Government of Alberta committed $15.5 million CAD ($10.7 million).Entos was born from the University of Alberta’s Faculty of Medicine & Dentistry and formed as its own entity in 2016.“Our government is protecting the Canadians of tomorrow by making the necessary investments today,” Canada’s Minister of Innovation, Science and Industry, François-Philippe Champagne, said in the release. “By supporting the construction of this state-of-the-art facility in Edmonton, we are strengthening our capacity to produce cutting-edge therapeutics and vaccines, which will better equip Canada in responding to future health emergencies.” Canada has been home to a few new facilities in life sciences lately as the country looks to increase its domestic supply, including a cell and gene manufacturing plant from CDMO OmniaBio and the country’s largest vaccine manufacturing site courtesy of Sanofi.Entos, meanwhile, is “thrilled to receive this investment,” CEO John Lewis said in a statement. “It will help us develop, scale up, produce, and commercialize Fusogenix PLV therapeutics to address critical health needs and fill gaps in Canada’s domestic manufacturing capacity," he added.The company, which also operates in San Diego, California and London, England, uses its proprietary fusogenic fusion associated small transmembrane (FAST) proteins to enable the delivery of mRNA or DNA into target cells. Before Lilly hopped on board, Entos and BioMarin entered into a collaboration in 2021, although that partnership is no longer listed on the company’s website.Separately, Entos is working on drug candidates in cystic fibrosis, Stargardt disease and obesity, including a GLP-1 gene therapy program.