ARGX-119

Argenx is spending $2.2 billion to absorb Forte Biosciences for its phase 2-stage vitiligo and celiac disease drug. The prize for argenx is FB102, an anti-CD122 antibody that demonstrated success in a phase 1b study earlier this month. In that trial, Forte tied FB102 to a 29.6% improvement in a score of facial vitiligo. A readout for phase 2 celiac trial is expected later this year. Argenx, which has previously invested in Forte, said phase 1 studies of FB102 in both indications were “key drivers” of its “decision to move from strategic investment to acquisition.” “Beyond celiac disease and vitiligo, FB102 has the potential to address alopecia areata and additional autoimmune diseases, supporting its profile as a potential pipeline-in-a-product opportunity,” Argenx said in a July 27 release. Argenx added that FB102 “complements argenx’s existing portfolio of antibody-based programs,” which includes the blockbuster autoimmune drug Vyvgart as well as the phase 3-stage C2-targeting antibody empasiprubart for multifocal motor neuropathy and chronic inflammatory demyelinating polyneuropathy, alongside the muscle-specific kinase-targeting adimanebart for neuromuscular disease. “By adding a mechanism focused on pathogenic T-cell and NK-cell activity, [FB102] broaden[s] the company’s ability to pursue diseases driven by different dimensions of the immune system,” argenx explained. The buyout ends Forte’s story on a happy note, following a tough period in 2022 when the company came under pressure from its top shareholder to liquidate in the wake of its lead atopic dermatitis asset failing a phase 2 trial. At the time, the investment firm in question was skeptical of Forte’s plans to sink its remaining cash into FB102, but that bet now seems to have paid off. “We are incredibly proud of what we have achieved in advancing FB102 through clinical development and firmly believe that argenx is the ideal strategic partner to unlock the full potential of this novel anti-CD122 antibody across a broad range of autoimmune diseases,” Forte CEO Paul Wagner, Ph.D., said in this morning’s release. “By combining FB102’s promising clinical profile with argenx’s proven development expertise, global reach and commercial capabilities, we have a unique opportunity to accelerate its development and maximize its impact for patients living with vitiligo, celiac disease, alopecia areata and other autoimmune conditions,” Wagner added. Netherlands-based Argenx is paying $77 per share of Nasdaq-listed Forte, a 40.5% increase on the biotech’s $54.78 closing price on Friday. Argenx CEO Karen Massey put this morning’s acquisition in the context of the biopharma’s “ Vision 2030 ” strategy to transform the treatment of severe autoimmune disease. “The acquisition of Forte Biosciences builds on the strength of that foundation and advances our ambition to be the leading immunology innovator of the future,” Massey said in the release. “The addition of FB102 to our portfolio aligns perfectly with the argenx playbook: compelling biology, strong clinical validation and broad potential to address patient need.” The content above comes from the network. if any infringement, please contact us to modify.

2026年7月27日，全球免疫学创新公司 argenx 和 Forte Biosciences 宣布两家公司已达成最终协议，根据该协议，argenx 将以约为 22 亿美元收购 Forte Biosciences。Forte Biosciences 的主导项目 FB102 是一种首创的抗 CD122 抗体，能够抑制依赖 CD122 的致病性 T 细胞和 NK 细胞，进一步拓展了 argenx 的差异化免疫学药物产品组合。该药物已在白癜风和乳糜泻的临床概念验证中得到证实，并有望用于治疗多种自身免疫性疾病。 argenx 将以约 22 亿美元收购 Forte Biosciences by TiPLab 木桃 核心资产 FB102 是首创靶向CD122的单抗，专为自身免疫性疾病和炎症性疾病而设计，具有差异化的治疗效果。FB102以适当亲和力结合CD122，旨在选择性抑制 IL-2/IL-15 诱导的致病性 NK 细胞和部分 T 细胞亚型的增殖和活化，同时保留Treg细胞中的IL-2信号传导，从而维持免疫调节功能并降低毒性。 其中，CD122（即，IL-2Rβ）是表达于 NK 细胞和部分 T 细胞亚型上的中等亲和力 IL-2/IL-15 受体的亚基，也是表达于 Treg 细胞的高亲和力 IL-2 受体的亚基。 在体外和非人灵长类动物中，已经验证了FB102的这一作用机制。 FB102 在白癜风 Ib 期临床结果显示，第24周面部 FVASI 改善 29.6%，安慰剂为7.9%；乳糜泻 Ib 期已有阳性数据，II期数据预计 2026 年公布。其他适应症还包括斑秃（临床I期）和1型糖尿病。 FB102 补充了 argenx 现有的基于抗体的项目组合，包括 efgartigimod（FcRn拮抗剂）、empasiprubart（抗补体C2抗体）、adimanebart（MuSK激动抗体）和 ARGX-121（抗IgA抗体），以及其他几个早期候选分子，增加了一种抑制致病性 T 细胞和 NK 细胞活性的机制，从而拓宽了其治疗由免疫系统不同环节驱动的疾病的能力。 FB102的核心活性成分家族为PCT/US2023/075600，尚不确定其具体序列，该家族已经进入中美欧（其中美国通过bypass方式进入）、日本、韩国、澳大利亚、加拿大、以色列、墨西哥等国家或地区成员，但是均处于审查状态。 PCT/US2023/075600目前在审状态的权利要求重点在于保护抗体序列，除了权利要求35围绕药物组合物，其他权利要求均从不同角度来限定抗CD122抗体序列： 6 CDR的多个可选序列组合、13组具体6 CDR组合、VH/VL及完整重链、轻链的序列同一性、重链/轻链的信号肽/前导序列、抗体来源及分子形式、CD122结合亲和力等方式。 权利要求并没有涉及核酸/载体/宿主细胞和医药用途等主题，可能会在分案或其他新申请中保护。另外，说明书中仅非常概括提及了治疗用途，比如，治疗“与CD122高表达有关的疾病或症状”，并没有提及具体适应症，可能降低对后续用途专利家族的影响。 实施例中主要验证了本申请抗体对IL-2和IL-15信号的抑制效力优于已知抗CD122抗体；抗体对中等亲和力受体的抑制强于对高亲和力IL-2受体的抑制；抗体结合表位与CD122的IL-2结合界面重叠。 另有一公开家族PCT/US2024/023897涉及GvHD治疗用途，根据其年报披露，还有部分申请应该已经递交但未公开。 在FTO方面，Forte主动发起专利无效挑战，其于PGR2023-00014中挑战了UMass的美国专利 US11,278,505B2，其权利要求广泛涵盖使用IL-15或IL-15受体抑制剂治疗白癜风。2024年6月，PTAB认定被挑战的权利要求1-5因lack of written description和lack of enablement而无效，但UMass已向联邦巡回上诉法院提起上诉，目前还未判决。 * 以上文字仅为促进讨论与交流，不构成法律意见或咨询建议。 © 作为一家专业服务公司，TiPLab坚持原创的系统的研究，注重系统性知识积累与专业影响力。欢迎读者个人分享转发，各专业平台媒体如需转载请联系TiPLab获得授权。  TiPLab提供基于研究的核心知识产权服务 FTO：技术商业化实施的侵权风险防范 TiPLab通过对细分技术领域内核心技术和重要专利的长期研究，结合自身在数据检索和分析方面的专长，致力于帮助客户深入了解、积极应对潜在的专利侵权风险。 Due Diligence：商业活动中的知识产权尽职调查 在企业许可交易、融资、并购、上市等过程中，TiPLab帮助企业和投资方了解目标技术/产品的专利保护强度及产品商业化过程中潜在的专利侵权风险，从而为商业谈判和决策提供支持依据。 Patenting：全球范围内高价值专利资产的创设 TiPLab熟知全球主要国家和地区的法律实践和细分领域内的前沿技术进展情况，通过前瞻性的专利布局策略，帮助客户通过创设有价值的专利资产而获取、保持和巩固独特的竞争优势。