iOnctura SA

▎药明康德内容团队编辑 欧洲是全球重要医药市场之一，兼具发展成熟、规模庞大、发展稳定及创新驱动等特点。欧洲不仅拥有如拜耳（Bayer）、罗氏（Roche）、阿斯利康（AstraZeneca）等一众知名药企，同时较高的科技创新驱动力使欧洲的新锐创新药企持续获得全球投资者的关注。2024年上半年，至少有101家位于欧洲的创新药公司获得融资，披露融资总额超21亿美元。值得关注的亮点包括： 英国、瑞士、德国占融资主导：英国获融资公司数最多，达38家，瑞士和德国分别有15家和12家公司获得融资。 偶联药物公司势头迅猛：多家偶联药物研发公司获大额融资，如拥有3大技术平台的抗体偶联药物（ADC）研发公司Tubulis获高达1.28亿欧元的B2轮融资、开发下一代ADC的Pheon Therapeutics完成1.2亿美元B轮融资。 癌症疾病领域为关注重点：其中52家获融资公司研发癌症领域新药，值得关注的公司有癌症疫苗研发公司Nouscom、免疫偶联药物研发公司Bright Peak Therapeutics和新型肿瘤免疫抑制剂研发公司iOnctura等。 ITM获1.88亿欧元融资 Isotope Technologies Munich（ITM）是一家放射性药物研发公司，致力于为难治性肿瘤提供新型放射性分子精准治疗和诊断。公司将放射性同位素与能够治疗一系列肿瘤的靶向分子相结合，研发精准肿瘤学产品管线。目前，ITM公司已有多条放射性核素疗法（TRT）进入临床阶段。其中，核心管线ITM-11（edotreotide）是一种肽类药物，能特异性地靶向神经内分泌肿瘤受体，其使用无载体添加 (no carrier added, nca) 的镥-177进行标记。目前ITM-11已经进入临床3期试验阶段，治疗胃肠胰神经内分泌肿瘤（GEP-NETs）。 6月6日，ITM宣布完成1.88亿欧元融资，旨在推动创新放射性药物管线研发，并为公司用于治疗胃肠胰神经内分泌肿瘤的3期候选药物ITM-11做好商业准备。此外，ITM还将利用这笔资金提高其Lutetium-177和Actinium-225的生产能力，扩大其医用放射性同位素的产线，为其全球供应网络提供备受需要的放射性同位素资源。 Tubulis完成1.28亿欧元B2轮融资 Tubulis成立于2019年，致力于通过在抗体偶联药物（ADC）开发的所有方面进行创新，解决该领域的主要瓶颈，以最大化ADCs的整体性能。公司拥有三大技术平台——P5偶联技术平台、Tubutecan（topo-I payload platform）平台以及Tub-tag平台。其技术平台允许使用传统有效载荷之外的载荷类别，并通过新型化学基团，扩展抗体和载荷之间的偶联选择，从而实现稳定的高药物-抗体比（DAR）。基于三大技术平台，Tubulis已经开发出了一系列项目，其中进展最快的是Napi2b ADC药物TUB-040，目前处于临床1期，此外还有两个项目公布了靶点，为5T4 ADC药物TUB-030，CD30 ADC药物TUB-010。 3月14日，Tubulis宣布完成1.28亿欧元B2轮融资，资金将主要支持公司下一代ADC管线临床评估的进展，并帮助实现主要候选药物TUB-040和TUB-030的临床概念验证。 Pheon Therapeutics完成1.2亿美元B轮融资 Pheon Therapeutics专注于开发用于治疗广泛难以治疗的癌症的下一代ADCs。目前公司拥有三款ADC核心项目，这三款ADC所靶向的是一种未公开的新靶点，该靶点在多种实体肿瘤中高度表达。其中一款ADC（PHN-010）使用拓扑异构酶-1抑制剂作为有效载荷，DAR达到8。另外两款ADC则利用其他连接子与有效载荷技术，进一步探索该靶点的治疗潜力。 5月21日，Pheon Therapeutics宣布完成1.2亿美元B轮融资，融资所获得款项将用于开发其三款差异化、潜在“first-in-class”抗体偶联药物以及扩展Pheon的内部技术平台套件以进一步优化其旗下ADC的构成。 Bright Peak Therapeutics完成9000万美元C轮融资 Bright Peak Therapeutics是一家生物技术公司，致力于推进治疗癌症和其他疾病的多功能免疫疗法组合。公司利用蛋白质工程能力和专有的化学蛋白质合成和偶联平台来发现和开发新型蛋白质疗法。其管线主要基于细胞因子IL-2和IL-18开展，药物类型包括增强型细胞因子，抗体-细胞因子偶联物等。以细胞因子为“载荷”，与PD-1单抗偶联，Bright Peak创建了一类新型双靶向生物制剂——Bright Peak Immunoconjugates。其中，核心药物管线BPT567是一种潜在“first-in-class” PD1-IL18免疫偶联物，旨在同时阻断PD（L）-1检查点通路并靶向递送IL-18信号转导。在临床前模型中，BPT567通过阻断PD-1，并特异性靶向IL-18介导的信号，表现出显著的协同抗肿瘤活性。 6月11日，Bright Peak Therapeutics宣布在C轮融资中筹集了9000万美元，所得资金将用于推动该公司的核心管线BPT567进入临床试验，并加速开发该公司一系列下一代免疫疗法。 iOnctura完成8000万欧元B轮融资 iOnctura是一家致力于发展提高癌症免疫疗法疗效的生物制药公司，正在开发一系列口服小分子，目前已将两种候选疗法推进到中期临床开发阶段。其中核心管线roginolisib是一款PI3Kδ别构调节剂，具有独特的化学结构和结合模式。在一项1b期临床试验中，roginolisib在葡萄膜黑色素瘤（UM）中表现出长期安全性和可喜的疗效，且在数月内持续保持临床活性。 6月20日，iOnctura宣布已完成8000万欧元B轮融资，新一轮资金将被用于加速其主导药物roginolisib对罕见眼部癌症——葡萄膜黑色素瘤的治疗研发。 Nouscom完成7580万欧元C轮融资 Nouscom是来自瑞士的一家处于临床阶段的免疫肿瘤学公司，致力于开发以新抗原为靶点、基于病毒载体的现货型和个体化癌症疫苗，旗下主要产品包括针对209个共有新抗原的现货型癌症疫苗NOUS-209以及个体化癌症免疫疗法NOUS-PEV。NOUS-209目前正在随机2期临床试验中进行测试，与帕博利珠单抗联合用于治疗错配修复缺陷/微卫星不稳定（dMMR/MSI）转移性结直肠癌（mCRC）。此外，Nouscom公司已经完成评估NOUS-PEV与检查点抑制剂联合治疗晚期黑色素瘤患者的1b期临床研究，并开展针对具有高度未竟医疗需求适应症的随机2期临床试验。 3月21日，Nouscom公司宣布完成7580万欧元的超额认购的C轮融资，所得资金将用于继续推进和扩大自有临床产品线。 Calluna Pharma完成7500万欧元A轮融资 Calluna Pharma是由Oxitope Pharma和Arxx Therapeutics两家公司合并组成。Oxitope致力于发现和开发治疗氧化应激引起的炎症和心血管疾病药物，主要产品是一款处于临床前阶段的、用于急性冠状动脉综合征（ACS）引起的心肌梗死（MI）再灌注损伤的抗体疗法。Arxx主要开发用于罕见纤维化疾病的疾病修饰疗法，2023年8月，其首款产品抗S100A4单克隆抗体AX-202开始双盲安慰剂对照试验。Calluna将基于损伤相关分子模式（DAMP）的先天免疫领域的专业知识与一系列针对炎症和纤维化适应症的选择性抗体相结合，旨在满足由急性或慢性炎症和非溶解性组织纤维化引起的各种疾病的临床需求。目前公司有四款潜力候选药物管线，包括处于临床1期的靶向S100A4的单克隆抗体CAL101和处于临床前研究的可中和氧化磷脂的单克隆抗体CAL102。 1月23日，合并组成的Calluna Pharma已经于A轮融资中筹募到7500万欧元，此次融资得到了Oxitope和Arxx现有主要投资者Forbion、Sarsia、p53和Investinor的支持。 SynOx Therapeutics完成7500万美元B轮融资 SynOx Therapeutics是一家临床阶段生物制药公司，从Celleron Therapeutics分拆出来。根据与罗氏签订的许可协议，SynOx获得了emactuzumab的全球独家临床开发、生产和商业化的权利。Emactuzumab是一款人源化靶向CSF-1受体（CSF-1R）的潜在“best-in-class”抗体疗法，设计用于靶向和消耗肿瘤组织中的巨噬细胞。Emactuzumab通过抑制CSF-1受体介导的信号通路，促进T细胞浸润和抗癌免疫反应。此前的临床试验数据显示，emactuzumab达到71%的客观缓解率（ORR），可快速缩小肿瘤并且疗效持久，显著改善患者功能性指标。 4月22日，公司宣布完成7500万美元的B轮融资，获得的资金将用于推动emactuzumab的3期临床试验和后续开发，用于治疗腱鞘巨细胞瘤（TGCT）。 读者们请星标⭐创鉴汇，第一时间收到推送 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。 版权说明：本文由药明康德内容团队根据公开资料整理编辑，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

Phase II study in non-small-cell-lung-cancer (NSCLC) to be run in collaboration with the ETOP IBCSG Partners Foundation across sites in Europe Study will investigate dostarlimab + roginolisib +/- docetaxel in patients with NSCLC resistant to first-line checkpoint inhibitor therapy GENEVA and AMSTERDAM, July 9, 2024 /PRNewswire/ -- iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, today announces expansion of the clinical trial program for lead pipeline asset, roginolisib. Via clinical collaboration agreements with the ETOP IBCSG Partners Foundation and GSK, roginolisib will be evaluated in combination with dostarlimab in NSCLC. Roginolisib is an allosteric modulator of PI3Kδ, widely recognized as a 'master switch' of cancer. Inhibition of PI3Kδ unleashes a multi-pronged anti-tumor and immune response to combat the tumor1 . Roginolisib has demonstrated an unprecedented clinical profile in solid and liquid cancers2, with 44 patients treated to date. Emerging clinical and translational biomarker data supports the hypothesis that combining roginolisib with a programmed death receptor-1 (PD-1) targeting agent, with or without docetaxel, may prevent or reverse drug resistance in NSCLC and may show synergistic anti-tumor immune activity without significant addition of toxicity3. Dostarlimab is a PD-1-blocking antibody approved for certain patients with endometrial cancer, which has also demonstrated clinical activity in combination with chemotherapy in NSCLC4. Under the terms of the agreement with iOnctura, GSK will supply dostarlimab for use in a randomized Phase II clinical trial in NSCLC patients resistant to first-line checkpoint inhibitor therapy, with or without docetaxel. iOnctura will retain worldwide rights to roginolisib. The ETOP IBCSG Partners Foundation is a leading organization performing international clinical and translational research in thoracic malignancies and breast cancer. Through the clinical collaboration, iOnctura will be provided access to a network of highly experienced investigators for the Phase II study. Professor Solange Peters, MD, PhD, Chair of Medical Oncology and the Thoracic Malignancies Programme in the Department of Oncology at the University Hospital of Lausanne will be the primary coordinating investigator of the study. Catherine Pickering, Chief Executive Officer of iOnctura, said: "As iOnctura moves into the next phase of clinical development, we are thrilled to be able to assess the effectiveness of roginolisib in combination with dostarlimab for the treatment of NSCLC. The successful uveal melanoma data reported so far, combined with a rich preclinical data package, support the rationale to expand our development program with potentially synergistic combinations in NSCLC." Solange Peters, Professor and Chair of Medical Oncology & Thoracic Malignancies Programme in the Department of Oncology at the University Hospital of Lausanne in Lausanne, Switzerland, commented: "On behalf of the ETOP IBCSG Partners Foundation, we are intrigued by the benefit/risk profile of roginolisib. In patients who no longer respond to current therapies, we wish to investigate whether roginolisib in combination with dostarlimab provides a novel treatment option. ETOP IBCSG Partners Foundation is committed to investigate novel treatment options to help our patients." About iOnctura iOnctura is a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers with precision oral small molecules that target cancers in novel ways. The bold new treatments extend lives and improve healthspans, changing the outlook for patients and their families. Two therapeutic candidates have progressed into mid-stage clinical development: roginolisib is the first allosteric modulator of PI3Kδ and cambritaxestat is the only autotaxin inhibitor in clinical development to treat cancer. iOnctura BV is headquartered in Amsterdam, The Netherlands with its wholly owned Swiss subsidiary, iOnctura SA, located in Geneva, Switzerland. iOnctura is backed by specialist institutional investors including Syncona, EIC Fund, M Ventures, Inkef Capital, VI Partners and Schroders Capital. About roginolisib Roginolisib is the first allosteric modulator of PI3Kδ with a unique chemical structure and binding mode. The PI3K signalling pathway is one of the most commonly dysregulated pathways in cancer and the precise targeting of the PI3Kδ isoform delivers substantial anti-tumor effects with a low-toxicity profile. Clinical data have demonstrated roginolisib's excellent safety profile and sustained clinical activity in uveal melanoma (UM), a rare eye cancer with few available treatments. Randomized Phase II trials are planned to start in late 2024 in UM and other cancers, including non-small cell lung cancer and primary myelofibrosis. About the ETOP IBCSG Partners Foundation The ETOP IBCSG Partners Foundation was established through the merger of the European Thoracic Oncology Platform (ETOP) and the International Breast Cancer Study Group (IBCSG) (ETOP IBCSG Partners Foundation). The foundation, with its legal seat in Bern, Switzerland, has become a leading organization in performing international clinical research in thoracic malignancies and breast cancer. The ETOP IBCSG Partners Foundation is sponsoring and managing an increasing number of clinical trials and translational research projects in Europe and beyond. 1 AACR Volume 3, Issue 4, April 2023, Poster presentation, SITC 2022 2 Poster presentation, ESMO-IO 2023 3 Poster presentation, ESMO-IO 2023, Poster presentation EACR 2023 4 Lim, S.M. et al., Nat Commun 14, 7301 (2023) SOURCE iOnctura

The expansion to roginolisib’s clinical programme is via collaborations with ETOP IBCSG Partners Foundation and GSK. Image credit: Shutterstock/tomertu. Fresh from raising nearly $86m in financing last month, iOnctura will now start evaluating lead asset roginolisib in non-small cell lung cancer (NSCLC). The expansion to roginolisib’s clinical programme is via clinical collaboration agreements with the ETOP IBCSG Partners Foundation and GSK , iOnctura said in a 9 July press release. The Swiss biopharma iOnctura outlined plans for a Phase II study that will investigate roginolisib in combination with GSK’s PD-1 inhibitor Jemperli (dostarlimab). The combo therapy will be evaluated in NSCLC patients resistant to first-line checkpoint inhibitor therapy, with or without docetaxel. Roginolisib is an allosteric modulator of phosphoinositide 3-kinase-δ (PI3Kδ), which iOnctura says is “widely recognised as a ‘master switch’ of cancer.” Inhibition of the protein elicits an anti-tumour effect, which induces immune system activity against cancer cells.  In January this year, roginolisib received an orphan drug designation from the US Food and Drug Administration (FDA). iOnctura is basing the combination with GSK’s programmed death receptor (PD-1) on “emerging clinical and translational biomarker data,” adding that it may prevent or reverse drug resistance in NSCLC. This enhanced anti-tumour immune activity would also be without significant addition of toxicity, according to the biopharma. See Also: Dupixent “addresses current gap” in COPD biologics landscape Peltopepimut-s by ISA Pharmaceuticals for Cervical Cancer: Likelihood of Approval Roginolisib is being evaluated in a Phase I clinical trial (NCT04328844) as a monotherapy and in combination with chemotherapy in patients with advanced or metastatic cancers, including metastatic uveal melanoma . The biopharma reported positive efficacy results at the 80mg dose, with grade 1 and 2 adverse events observed in the continuous daily dosing portion of the trial for patients with solid tumors. iOnctura’s CEO Catherine Pickering said: “The successful uveal melanoma data reported so far, combined with a rich preclinical data package, support the rationale to expand our development program with potentially synergistic combinations in NSCLC.” P13K inhibitors faced a setback in recent years after the FDA’s Oncologic Drugs Advisory Committee (ODAC ) lost confidence in the safety profile of the drugs. The agency recommended that future approvals of PI3K inhibitors for haematologic malignancy indications should require randomised trial data, as per a vote in 2022. The decision was based on high levels of fatal adverse events (AEs) and toxicity observed in patients taking the drug class. Roche made a recent advancement in the space, securing FDA priority review in breast cancer for the PI3K inhibitor inavolisib as a combination therapy with fulvestrant and Pfizer ’s Ibrance (palbociclib). iOnctura raised €80m ($85.8m) in Series B financing earlier this year, helping to fund Phase II activity for roginolisib and its other candidate cambritaxestat, autotaxin inhibitor.