Serabelisib

据创鉴汇不完全统计，上周（10月20日至10月26日）全球大健康领域共披露融资事件28起，总额超7.25亿美元。 潜在最大额融资来自Electra Therapeutics，于10月22日宣布完成1.83亿美元C轮融资。公司计划利用这笔资金推进核心管线ELA026的全球关键2/3期临床试验，主要针对继发性噬血细胞性淋巴组织细胞增多症（sHLH），并扩展其在血液肿瘤方面的适应症研究。ELA026是一种靶向免疫细胞上的信号调节蛋白（SIRP）的单克隆抗体，能够选择性地耗尽病理性髓系细胞和T淋巴细胞。公司同时将推动第二款SIRP靶向疗法ELA822进入临床阶段。 自身免疫性疾病领域，类风湿性关节炎药物研发公司Elevara Medicines完成7000万美元A轮融资，将推进口服CDK4/6抑制剂ELV001的2期临床试验。该药物靶向成纤维样滑膜细胞，已在1期临床中显示初步疗效及安全性。 距离1.3亿美元B轮融资仅五个月，表观遗传重编程公司NewLimit宣布又获得由礼来等机构参投的4500万美元融资，其平台旨在恢复老化细胞的年轻功能，从而延长人类寿命。公司近期在肝代谢、免疫细胞再生领域取得突破，并新启动了针对血管健康的内皮细胞研究项目，进一步拓展其治疗方向。 在新型递送技术领域，星锐医药宣布完成逾3亿元B轮融资，将用于升级肝外靶向递送平台，加速推进体内细胞治疗（in vivo CAR-T）管线的临床开发，进一步夯实RNA治疗领域布局。该公司已建立覆盖脂质纳米颗粒（LNPs）设计与合成的技术平台，其呼吸道合胞病毒疫苗STR-V003获FDA临床试验许可，肿瘤疫苗STR-V005及in vivo CAR-T技术STR-P004先后进入临床阶段。 同期，聚焦疼痛、肿瘤等领域，海博为药业完成超2亿元B轮融资。公司将用于推进第四代BTK抑制剂HBW-3220、Nav1.8抑制剂HBW-004285片及两款KRAS抑制剂的临床开发，其中Nav1.8抑制剂已进入术后急性疼痛2期临床阶段。 其余几家抗肿瘤公司的融资也取得了进展：Faeth Therapeutics完成2500万美元战略融资，其serabelisib + sapanisertib（"PIKTOR"）联合紫杉醇的1b期研究在子宫内膜癌患者中显示出80%的总缓解率；Valink Therapeutics同期完成1180万美元Pre-A轮融资，专注研发双特异性抗体偶联药物，目前正将两个针对实体瘤适应症（包括结直肠癌）的肿瘤学项目推进至临床前开发阶段。 其余融资详见下表。 读者们请星标⭐创鉴汇，第一时间收到推送 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。 版权说明：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发/复制至其他平台。转发授权请在「创鉴汇」微信公众号留言联系我们。 更多数据内容推荐 点击“在看”，分享创鉴汇健康新动态

AUSTIN, Texas--(BUSINESS WIRE)--Faeth Therapeutics, a clinical-stage biotechnology company advancing therapies that systematically target tumor metabolism, today announced the advancement of its lead PIKTOR regimen in endometrial cancer and a $25 million strategic raise, bringing total capital raised to $92 million. The financing was led by S2G Investments with participation from existing investors Khosla Ventures, Future Ventures, Digitalis Ventures, KdT Ventures and Cantos, plus new investors B Capital Group, Avicella and THO Seed Fund. Clinical data from sapanisertib in combination with paclitaxel, one component of the PIKTOR regimen, have been selected for a late-breaking oral presentation at the ESMO 2025 Congress. Faeth's phase 1b study of serabelisib + sapanisertib ("PIKTOR") with paclitaxel demonstrated an 80% overall response rate in endometrial cancer patients, with a median progression-free survival of 11 months versus historical 3-4 months with chemotherapy alone. The strength of these results led the Gynecologic Oncology Group (GOG) Foundation, one of the premier U.S. clinical trial networks, to initiate a phase 2 trial (GOG-3111; NCT06463028), now enrolling patients. The study also includes a predefined substudy testing whether protocolized insulin control under trial conditions through precision nutrition enhances clinical outcomes. Endometrial cancer is one of the highest-need solid tumors and illustrates how Faeth’s approach can change outcomes in diseases where PI3K/AKT/mTOR are implicated. This signaling axis is among the most frequently altered across solid tumors, including endometrial, breast, lung, and ovarian. Current single-node inhibitors often fail due to feedback reactivation and mutations elsewhere in the pathway that limit durability. These inhibitors can only target a small fraction of patients with pathway mutations. Faeth's approach is different: it delivers selective multi-node inhibition at PI3Kα, mTORC1, and mTORC2 while controlling the nutrient supply tumors depend on. Multi-node inhibition of the PI3K/AKT/mTOR pathway has already shown clinical benefit in phase 3 studies, confirming the value of pathway-level control in both mutant and wild-type tumors. Faeth’s selective approach builds on this validation while targeting specific nodes to improve the therapeutic window compared to pan-pathway inhibitors, offering less toxic, more convenient treatment options. In preclinical models, this multi-node approach achieved more complete pathway shutdown than single-agent inhibition. "We've achieved the optimal balance in PI3K pathway inhibition, comprehensive enough to prevent resistance, selective enough to avoid immunosuppression," said Anand Parikh, CEO of Faeth Therapeutics. "The 80% response rate, 11-month progression-free survival, initiation of a trial by the GOG Foundation, and recognition as a late-breaking oral presentation at ESMO show that Faeth is executing as a clinical-stage company positioned to expand across the solid tumors where PI3K alterations drive disease." “I believe recent phase 3 studies are showing validation of multi-node targeting,” said S2G Managing Partner Sanjeev Krishnan. “In my view, insider participation in this financing reflects conviction in Faeth’s progress, while new investors recognize metabolism as a category entering the clinic. Based on emerging evidence, Faeth’s selective multi-node approach appears well suited to capture value as metabolism gains recognition as a potential new pillar of cancer treatment." The $25 million will advance the phase 2 endometrial cancer program through a full data readout in Q3 2026 and expand throughput for the company's MetabOS™ platform. The financing also supports a phase 1 study in locally advanced rectal cancer for Faeth’s non-essential amino acid restricted program and initiation of Faeth's first non-oncology program in Hereditary Tyrosinemia Type 1 (HT1), a rare pediatric metabolic disorder, with IND-enabling studies targeting Q4 2026 clinical entry. Beyond blocking growth signals, Faeth's approach recognizes that tumors have significantly elevated metabolic demands and require specific nutrients to survive. The MetabOS platform integrates genomic, gene expression, and tumor microenvironment data to identify metabolic dependencies and exploit them clinically. Funding will expand MetabOS throughput, enabling Faeth to simulate and validate more regimens designed to address metabolic escape. "If the cell is the unit of life, then metabolism is the first verb in its sentence," said Siddhartha Mukherjee, co-founder of Faeth Therapeutics. "Faeth is intervening where cellular decisions are made fastest: at the metabolic switches tumors rely on to adapt, long before mutations accumulate. That is why metabolism is emerging alongside the genome and immunogenicity as a therapeutic discipline." In addition to its oncology programs, Faeth has initiated translational work to treat HT1, an ultra-rare disorder affecting 1 in 100,000 births, where toxic metabolites accumulate due to an enzyme deficiency. While current treatment prevents liver failure, patients still face unmet medical needs. The company is applying MetabOS to develop metabolic therapeutic approaches for this condition. This program is the first demonstration of MetabOS applied outside of oncology and establishes the platform’s ability to identify and address metabolic dependencies across diseases. About Faeth Therapeutics Faeth Therapeutics is a clinical-stage biotechnology company developing multi-node therapies that block cancer growth signals while controlling tumor fuel supply, leveraging its AI-driven MetabOS™ platform to identify and exploit metabolic dependencies. In addition to advancing multiple solid-tumor studies, Faeth is advancing a translational program in Hereditary Tyrosinemia Type 1 (HT1), the first example of how its approach can extend beyond oncology into rare diseases. Founded in 2019 by leading researchers including Lewis Cantley, PhD, Siddhartha Mukherjee, MD, DPhil, Karen Vousden, PhD, Scott Lowe, PhD, and Greg Hannon, PhD, the company has raised $92 million from S2G Investments, Khosla Ventures, Future Ventures, Digitalis Ventures, KdT Ventures, Cantos, Avicella, THO Seed Fund, and B Capital Group. For more information, visit faeththerapeutics.com.