invIOs

Insight 投融资数据库显示，上周全球药物研发领域发生 17 起投融资事件（截至 10 月 18 日）： 从药物类型来看，小分子新药依旧被资本看好，另外还有细胞和基因疗法、ADC 等新分子持续受追捧； 从地区分布来看，本周获得融资的 Biotech 主要来自中国，占比达到约 37%，包括睿健医药、河络新图、若弋生物、礼新医药、引正基因、丹诺医药等公司； 从金额来看，生成式 AI 新药开发公司 Terray 融资金额最高，获得 1.2 亿美元 B 轮融资。 下面，Insight 数据库将节选部分备受关注的融资案例做介绍，仅供读者参阅。 中国新锐融资   礼新医药完成 3 亿元 C1 轮融资 礼新医药完成由中国生物制药领投的 3 亿元 C1 轮融资，其他投资人包括浦东创投、张江浩珩、启明创投、上海生物医药基金等。同时，该公司近期已启动 C2 轮融资，募集资金将主要用于加速 LM-302、LM-108 等临床管线推进，并支持多个技术平台开发。 礼新医药创立于 2019 年，聚焦于研发肿瘤免疫及肿瘤微环境领域生物创新药。其中，LM-302 是一款抗 CLDN18.2 ADC，已在中国开展 3 期注册临床；LM-108 是一款抗 CCR8 单抗，目前处于临床 2 期阶段；另外还有抗 SIRPα单抗、抗 GPRC5D ADC、抗 PD-1/VEGF 双抗、抗 CEACAM5/4-1BB 双抗等产品，正处于 1 期临床阶段。   丹诺医药完成逾 3 亿元 E 轮融资 丹诺医药完成逾 3 亿元 E 轮融资的首批交割，由中山投控旗下中山创投和 AMR Action Fund 共同领投。本次融资将用于支持该公司核心新药研发管线，包括 TNP-2198 和 TNP-2092 的后期临床和商业化。 丹诺医药专注细菌感染和菌群代谢相关疾病，目前已有多个项目进入后期临床阶段。其中，TNP-2198 对微需氧菌和厌氧菌具有多靶点协同作用机制，目前 3 期临床已接近尾声。TNP-2092 是治疗植入医疗器械感染的三靶点协同作用机制候选药，已在中美完成 Ⅰ 期和 Ⅱ 期试验。   若弋生物完成 Pre-A+轮数融资 若弋生物完成由昆山天使基金投资的数千万元 Pre-A+轮融资，所得资金将主要用于其第三代肉毒素药物管线的中试至商业化生产工艺的技术转移。此外，昆山还将为该公司提供近 1 万平米的商业化生产车间、相应配套政策，以及与上海整形医学产业创新研究院合作等产业环境与产业赋能。 若弋生物核心技术为锌指蛋白药物递送技术平台，核心在研药物管线为重组肉毒素蛋白药物和细胞内抗体。同时，该公司还建立了产业化级昆虫细胞-杆状病毒生产工艺平台，可用于生产复杂蛋白、疫苗、VLP、AAV 病毒载体等产品。   睿健医药完成超亿元 B 轮融资 睿健医药完成由策源资本和国生资本联合领投的超亿元 B 轮融资，所得资金将用于加速推进其帕金森病治疗产品及眼科治疗产品 NouvSight001 的中美临床推进等。同时，该公司 B+轮融资也即将进入收尾阶段，将于近期交割。 睿健医药成立于 2017 年，专注于开发通用型化学诱导细胞治疗药物，管线覆盖神经退行性疾病、眼科等多款 FIC 产品。其中，NouvNeu001 是一种化学诱导的功能型人源多巴胺能神经元前体细胞，已在针对帕金森病的早期临床中表现出运动功能和生活质量的显著改善。   河络新图完成新一轮融资 河络新图宣布完成新一轮融资，募集资金将主要用于推动其在临床级别的再生血小板细胞生产工艺优化及临床试验的开展，并加快其他创新产品研发。 河络新图成立于 2021 年，创业团队由美国麻省理工学院和英国剑桥大学归国学者领衔，致力于将 iPSC 技术转化为临床级别的人造血液细胞产品及国际领先的抗衰服务。该公司计划在 2024 年继续将人工血小板管线作为首发关键点，并尽快完成 IIT 研究。   引正基因完成新一轮战略融资 引正基因（GenEditBio）获得由戈壁大湾区旗下管理的 AEF 大湾区创业基金的战略投资，融资所得将用于开发和提升其基因编辑和递送技术，推进体内研究项目及启动体内临床研究。 引正基因成立于 2021 年，致力于提供潜在治愈性、一次完成且可编程的体内基因组编辑疗法。该公司核心研发领域包括开发新型核酸酶，以及利用 LNP 和 ePDV 作安全高效的药物递送。目前，引正基因以肝脏为靶器官的 GEB-100 和 GEB-200 项目已在非人灵长类动物中完成概念验证研究。 海外新锐融资   Terray 完成 1.2 亿美元 B 轮融资 Terray Therapeutics 完成由 Bedford Ridge Capital 和 NVentures 领投的 1.2 亿美元 B 轮融资，其他投资者包括 Maverick Capital、Goldcrest Capital、Madrona Ventures 等。本次融资将推动该公司基于生成式 AI 开发的内部管线进入临床阶段，并进一步提升其集成 AI 平台 tNova 以支持内部和合作研发项目。 Terray 公司致力于通过大规模整合计算和新型数据，以改善小分子药物开发的速度、成本和成功率，进而改善人类健康。此前，该公司已与与百时美施贵宝和 Calico 公司达成合作。   invIOs GmbH 融资 820 万欧元 invIOs GmbH 宣布已在 A 轮融资中筹集了 820 万欧元，投资人包括现有股东和 Ligand Pharmaceuticals。这笔资金确保了该公司到 2025 年的持续管线进展，以及临床和临床前里程碑的实现。 invIOs 专注于癌症新疗法的发现和开发，正在推进一系列包括小分子和细胞治疗方法的项目。其中，INV501 是一种口服小分子，可以选择性增强 T 细胞介导的抗肿瘤免疫反应，目前正在进行 IND 毒理学研究。另一款 INV441 细胞疗法使用 siRNA 修饰的肿瘤浸润淋巴细胞（TIL），预计将于 2025 年中期启动 1 期试验。   MEDiC Life Sciences 获得 500 万美元战略投资 MEDiC Life Sciences 从 LG 和 Hanmi Pharmaceutical 获得 500 万美元的战略投资，以推动其创新的癌症生物标志物发现技术的采用。此前，MEDiC 公司已在种子轮融资中筹集 800 万美元，投资人包括 Illumina Accelerator、Top Harvest Capital、Primer Sazze 等。 MEDiC 公司成立于 2020 年，主要利用其 MCA 平台发现实体癌的新治疗靶点和生物标志物。除了开发内部的药物项目外，该公司还为其合作伙伴的肿瘤学项目提供新的靶点和生物标志物，并已与百时美施贵宝、Hanmi 等制药公司达成合作。 除了上述案例，本周还有一些其它公司也获得了融资，限于篇幅，此处不再一一介绍。欲了解本周更多融资信息，请点击「阅读原文」前往 Insight 数据库「新药投融资」模块查看。 封面来源：站酷海洛 Plus 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。 编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验 点击阅读原文，立刻解锁！

Funding secures ongoing pipeline progress and achievement of preclinical and clinical milestones Oral small molecule INV501: collaboration with Dana-Farber Cancer Institute (DFCI) making good progress; target validation and details of mechanism of action expected in Q1 2025Cell therapy INV441: pre-IND meeting with US FDA successfully completed; first-in-humans study in glioblastoma to start mid-2025 as part of a new collaboration with DFCI invIOs management to participate in LSX Inv€$tival Showcase™ in London on November 18th VIENNA, Oct. 15, 2024 (GLOBE NEWSWIRE) -- invIOs GmbH (“invIOs”), a privately held biotechnology company developing novel therapies for cancer, today announced that the company has raised €8.2 million in a Series A fundraising that includes strong participation from existing shareholders and Ligand Pharmaceuticals. Ligand recently acquired APEIRON, the former parent company of invIOs. This funding secures ongoing pipeline progress and achievement of clinical and preclinical milestones through 2025. Peter Llewellyn-Davies, CEO & CFO of invIOs, said: “We are pleased to have raised these funds, which enables us to move our programs forward as planned. I am particularly grateful for the strong support of existing shareholders, as well as the commitment of our new shareholder, Ligand Pharmaceuticals.” invIOs also provided an update on recent progress with its two lead anti-cancer programs, INV441 and INV501. The company has collaborations in glioblastoma with the Dana-Farber Cancer Institute (DFCI) for both programs. The collaborations are being led by David Reardon, MD, Clinical Director, Center for Neuro-Oncology at the DFCI and Professor of Medicine at Harvard Medical School. Dr. Reardon is a world-renowned expert in brain cancer, particularly glioblastoma research and treatment. “We are thrilled with the progress of our collaboration with the DFCI for both our oral small molecule candidate, INV501, and now also our cell therapy candidate, INV441. With these two immune-oncological approaches, we are developing cancer therapies that have the potential to address major unmet needs in treating deadly tumors, and we are excited to continue our work to ultimately improve and save patients’ lives,” commented Romana Gugenberger, PhD, Chief Medical and Scientific Officer of invIOs. INV501 first-in-class orally available small molecule. In July 2024, invIOs announced the selection of a lead candidate from its family of compounds. Preclinical testing has shown compelling efficacy and safety results with this candidate in both breast cancer and melanoma models, as well as the ability to cross the blood-brain barrier and initiate anti-tumoral immune reactions. IND-enabling toxicology studies are underway, and manufacturing under GMP conditions is in preparation. Target validation work is planned to be completed and details of the mechanism of action provided in Q1 2025. INV441 cell therapy. INV441 uses tumor-infiltrating lymphocytes (TILs) that are modified via siRNA inhibiting the immune checkpoint Cbl-b and administered directly to the tumor. This approach has demonstrated strong preclinical proof of concept in murine glioma models. In 2024, invIOs filed important IP around this program. invIOs recently held a pre-IND (Investigational New Drug) meeting with the US Food & Drug Administration (FDA). In the meeting, the FDA provided helpful input for the planned Phase 1 study with INV441 which is planned to be conducted by the DFCI and is expected to initiate in mid-2025. Meet invIOs management at LSX Inv€$tival Showcase™ in London on November 18th Peter Llewellyn-Davies, CEO & CFO, and Romana Gugenberger, PhD, Chief Medical and Scientific Officer, will give a company presentation and host 1X1 meetings at this important industry event. To schedule a meeting, please use the conference partnering system or contact: investors@invios.com. About invIOs invIOs is a privately held biotech company based in Vienna, Austria, focusing on the discovery and development of novel therapies for cancer. The invIOs team leverages deep expertise in immune system activation to develop individualized and targeted approaches against solid tumors. invIOs is advancing a pipeline of programs encompassing small molecule and cell therapy approaches. INV501 is a novel small molecule candidate that can selectively enhance T cell mediated anti-tumor immune responses. INV501 is currently in preclinical testing and has demonstrated preclinical proof of concept with strong data in multiple solid tumor indications after oral administration. A lead candidate compound for clinical development has been selected, and IND-enabling studies are ongoing. EPiC, invIOs’ proprietary cell therapy platform, enables rapid treatment of patients in an out-patient setting. EPiC is a technology platform that allows the creation of personalized cell therapies based on localized processing of a patient’s fresh immune cells. Proof of concept has been demonstrated via initial clinical results from the first asset from the EPiC platform, APN401. INV441, also derived from EPiC, is being developed for the treatment of glioblastoma and is in preclinical testing. invIOs has a collaboration with the DFCI for this program. Another EPiC program, INV451, is a novel CAR-T cell approach against lung cancer being developed with the Medical University of Innsbruck. For further information, please visit www.invios.com and connect with us on LinkedIn. Contacts invIOs Peter Llewellyn-DaviesCEO/CFOT +43 1 8656577 0Email: investors@invios.com MC Services AGDr. Cora Kaiser, Dr. Regina LutzT +49 89 210 228 0 US: Laurie DoyleT +1-339-832-0752Email: invios@mc-services.eu

QARZIBA is indicated to treat high-risk neuroblastoma in patients aged 12 months and above. Credit: Kateryna Kon/Shutterstock. Ligand Pharmaceuticals has announced a definitive agreement for the acquisition of the complete outstanding shares of Austria-based biopharmaceutical company APEIRON Biologics in a $100m cash deal. The deal also includes future payments based on commercial and regulatory milestones. The strategic move will grant Ligand royalty rights to QARZIBA (dinutuximab beta), a treatment for high-risk neuroblastoma in patients aged 12 months and above. It is indicated for those who have responded to induction chemotherapy, undergone myeloablative therapy and stem cell transplantation, and with a history of relapsed or refractory neuroblastoma with or without residual disease. APEIRON co-developed QARZIBA, which received the European Medicines Agency approval in 2017. This therapy is currently available in more than 35 countries. See Also: How will a Labour government support the UK clinical trials industry? TLC-2716 by OrsoBio for Familial Hypercholesterolemia (Type II Hyperlipoproteinemia): Likelihood of Approval The company receives royalties on the product’s net sales outside mainland China from Recordati and within mainland China from BeiGene. Ligand will make further payments based on commercial and regulatory milestones, with potential payments up to $28m by either 2030 or 2034 on QARZIBA royalties exceeding preset thresholds. The agreement received unanimous approval from the board of directors of Ligand and the supervisory board of APEIRON. The acquisition will conclude in July 2024. Ligand is also investing $4m in invIOs Holding, an APEIRON spin-off, under a stock purchase agreement. This funding will support the research and development of three early-stage immuno-oncology assets. Ligand CEO Todd Davis stated: “The addition of QARZIBA to our commercial royalty portfolio further supports our growth strategy to invest in high-value medicines that deliver significant clinical value and generate predictable and long-term revenue streams for our investors. “QARZIBA is the only immunotherapy for high-risk neuroblastoma marketed across Europe and in other parts of the world. We believe this drug will be a meaningful contributor to our royalty revenue, which is now driven by a diversified portfolio of 12 key commercial-stage products.”