BI-1808

Preclinical manuscript that characterizes the mechanism of action, broad antitumor efficacy, and immune-activating properties of BI-1808 and BI-1910 across diverse tumor microenvironments Data demonstrates the ability of the lead anti-TNFR2 antibody BI-1808 to elicit antitumor immunity in CD8+ T cell poorly infiltrated tumors resistant to immune checkpoint blockade BI-1808 is currently being evaluated in ongoing Phase 2a clinical trials with clinical data showing promising activity across both hematologic and solid tumor settings with the potential to become the next standard of care in ovarian cancer LUND, SE / ACCESS Newswire / August 20, 2026 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a leader in the discovery of novel immune-modulatory antibodies, today announced that a preclinical manuscript characterizing the mechanism of action, broad antitumor efficacy, and ability to elicit antitumor immunity of BI-1808 and BI-1910 has been published in Cancer Research , a peer-reviewed journal of the American Association for Cancer Research. The publication is entitled "Ligand-Blocking and Agonist Antibodies Targeting TNFR2 Employ Distinct Modes of Action to Induce Antitumor Immunity" and is available at . "This publication provides a comprehensive mechanistic understanding of how BI-1808 and BI-1910 modulate the tumor microenvironment to drive antitumor immunity. It also highlights BioInvent's leading role in TNFR2 targeting," said Björn Frendéus, Ph.D., Chief Scientific Officer of BioInvent. "The breadth of activity demonstrated across tumor types, notably including poorly CD8+ T cell infiltrated tumors resistant to immune checkpoint blockade, in these preclinical studies is consistent with the clinical signals we are observing with BI-1808 and reinforces our conviction in TNFR2 as a high-value target in cancer immunotherapy." Both anti-TNFR antibodies show potent anti-tumor efficacy across multiple syngeneic tumor models in vivo, can effectively be combined with anti-PD-1, and trigger CD8+ T cell antitumor immunity, albeit by different mechanisms; BI-1808 is a ligand-blocking FcgR-engaging antibody that depletes immunosuppressive Treg cells and reprograms myeloid cells. BI-1910, currently paused due to priority reasons, is a pure agonist antibody that directly co-stimulates T and NK cells through partially FcgR-independent mechanisms. About BI-1808 BI-1808 is a first-in-class drug candidate targeting TNFR2. TNFR2 is upregulated on both immunosuppressive and inflammatory tumor-infiltrating lymphocytes (TILs) and on myeloid cells in the tumor microenvironment, making it a dynamic, promising new target for cancer immunotherapy. BI-1808 is in clinical development for the treatment of T-cell lymphoma and solid tumors. In an ongoing Phase 1/2a study, it has shown both single-agent activity and excellent tolerability, as well as efficacy and a favorable safety pro combination with pembrolizumab, in solid tumors and T-cell lymphomas About BioInvent BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immunomodulatory antibodies for cancer therapy, with drug candidates in ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary n-CoDeR F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at . For further information, please contact: Cecilia Hofvander, VP Investor Relations Phone: +46 (0)46 286 85 50 Email: cecilia.hofvander@bioinvent.com BioInvent International AB (publ) Co. Reg. No.: 556537-7263 Visiting address: Ideongatan 1 Mailing address: 223 70 LUND Phone: +46 (0)46 286 85 50 The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release. Attachments BioInvent Announces Publication of Preclinical Manuscript on BI-1808 and BI-1910 in Cancer Research SOURCE: BioInvent International View the original press release on ACCESS Newswire

NEWS 肿瘤用药周报 2026年第32周（8月3日-8月9日）数据来源：NMPA、FDA公开信息  |  整理：新唯医学编辑部 本周重点关注 恒瑞瑞康曲妥珠单抗（艾维达®）结直肠癌适应症获批，成为国内首个获批该适应症的HER2 ADC，集齐肺癌、乳腺癌、结直肠癌三大高发实体瘤。 药捷安康替恩戈替尼片获批胆管癌适应症，成为首款FGFR靶向1类新药，报产至获批仅9个月。 FDA加速批准首款溶瘤病毒免疫疗法Tudriqev，为PD-1治疗失败的晚期黑色素瘤患者提供新选择。 诺华Pluvicto（¹⁷⁷Lu-PSMA）前移至激素敏感性前列腺癌，eligible患者群体近翻倍。 礼来新一代KRAS G12C抑制剂Olomorasib获胰腺癌突破性疗法认定。 CSCO结直肠癌诊疗指南（2026版）重大更新，精准分型治疗体系全面升级。 NMPA获批动态 本周国家药监局（NMPA）共批准5项肿瘤相关药物动态，涵盖2项新获批/新适应症和3项申报上市。 日期 药物名称 适应症 类型 8月6日 替恩戈替尼片（药捷安康） 晚期/转移性/不可手术切除胆管癌（既往≥1线系统治疗+FGFR抑制剂治疗失败） 1类新药获批 8月6日 瑞康曲妥珠单抗/艾维达®（恒瑞医药） 经奥沙利铂、氟尿嘧啶和伊立替康治疗失败的HER2阳性结直肠癌 新适应症获批（第3项） 8月4日 安尼妥单抗（石药集团/康宁杰瑞） HER2阳性乳腺癌（一线+新辅助） NDA申报受理 重点解读：替恩戈替尼片是首款获批的FGFR靶向1类新药，用于胆管癌后线治疗，从报产到获批不足9个月。瑞康曲妥珠单抗（艾维达®）成为国内首个获批结直肠癌适应症的HER2 ADC，基于III期HORIZON-CRC01研究：中位PFS 5.5个月 vs 2.8个月（HR=0.33），ORR 40.7% vs 4.5%，已被CSCO结直肠癌诊疗指南（2026版）推荐用于HER2阳性肠癌后线治疗。安尼妥单抗为国产首个获批的HER2双抗，乳腺癌一线及新辅助全病程布局。 FDA获批动态 本周美国FDA共批准/认定5项肿瘤相关药物动态，涵盖1项加速批准、1项适应症扩展和3项重要进展。 日期 药物名称 适应症/进展 类型 8月6日 Tudriqev（Replimune） PD-1治疗后进展的不可切除晚期皮肤黑色素瘤（联合纳武利尤单抗） 加速批准 7月31日 Pluvicto/¹⁷⁷Lu-PSMA（诺华） PSMA阳性转移性激素敏感性前列腺癌（联合ARPI） 适应症扩展 8月6日 Olomorasib/LY3537982（礼来） 经治KRAS G12C突变晚期胰腺癌 突破性疗法认定 8月7日 BI-1808（BioInvent） 铂耐药卵巢癌（联合帕博利珠单抗） 快速通道资格 8月7日 Sonesitatug vedotin（阿斯利康） 晚期胃癌二线及后线（CLARITY-Gastric01 III期成功） III期研究成功 重点解读：Tudriqev（vusolimogene oderparepvec）是基于HSV-1改造的溶瘤病毒免疫疗法，联合PD-1用于抗PD-1治疗失败的晚期黑色素瘤，IGNYTE研究显示ORR 24.2%，中位缓解持续时间14.1个月。Pluvicto联合ARPI将¹⁷⁷Lu-PSMA靶向放射配体疗法前移至激素敏感性阶段， eligible患者群体近翻倍。Olomorasib为新一代KRAS G12C抑制剂，1/2期LOXO-RAS-20001研究在胰腺癌中显示积极结果。BI-1808为首个抗TNFR2单抗，联合PD-1在铂耐药卵巢癌中ORR达24%，DCR 56%。Sonesitatug vedotin靶向CLDN18.2的ADC在晚期胃癌III期研究中显著延长OS，约60%胃癌患者表达该靶点。 重要研发进展 KRAS泛突变降解剂：Arvinas公司口服PROTAC泛KRAS降解剂公布临床前数据，可降解G12C/G12D/G12V/G12R等多种突变蛋白，DC50约3.6nM，最大降解幅度100%，联合PD-1后肿瘤免疫微环境改善。 TIL细胞疗法：LN-145治疗晚期NSCLC的IOV-LUN-202研究显示ORR 25.6%，DCR 71.8%，2例完全缓解，一次性回输即可长效控瘤。 个体化肿瘤疫苗：Diakonos Oncology的DOC1021个体化树突状细胞疫苗完成首批给药，针对PD-1治疗失败的晚期黑色素瘤，利用患者自身肿瘤组织制备，无需基因改造。 脑胶质瘤新突破：耐药免疫疗法（DRI）通过向脑内注射基因改造的γδT细胞，使新诊断胶质母细胞瘤患者中位PFS从8个月翻倍至16.1个月（JCO发表）。 新唯医学 · 医学信息部 ⚠️ 免责声明： 本文仅供医学信息参考，不构成任何用药建议。具体治疗方案请遵医嘱，在专业医生指导下进行。 关于新唯医学 新唯医学成立于2016年，旗下拥有新唯基因研发中心、新唯医学检验实验室及上海新唯生物科技有限公司。聚焦国家级高新技术企业，专注于打造临床分子病理检测服务推广、IVD试剂盒研发和生产、IVD检测仪器研发和生产，三位一体的发展格局，同时形成产、学、研、用高科技成果转化平台，依托安德森癌症中心、霍普金斯医学院、范德堡大学分子病理、中国科学技术大学、安徽医科大学等的学术与技术支持，秉承产学研一体化优势，研发和生产IVD系列产品，通过独立医学实验室为全球医药研发及各类医疗机构提供各种医学检验服务。 新唯医学检验实验室是国内早期开展液态活检的基因检测公司，拥有四大检测平台：NGS测序平台、荧光PCR平台、数字PCR平台、IHC平台，专业的生物信息学分析团队，提供肿瘤精准医疗基因检测产品40+款、精神类及心脑血管类药物安全用药基因检测产品20+款、遗传疾病基因检测产品多款。业务涉及全国多个省市多家医院 。 新唯医学将始终秉承惟精惟一，科技匠心的精神，将为客户提供精准的医疗服务和健康管理作为每一位新唯医学人的责任使命，坚定步伐，锐意前行。 目前集团已获得医疗机构执业许可证、临床基因扩增检验实验室资质，国家高新技术企业、安徽省专精特新企业、安徽省科技型中小企业、合肥市大数据企业，获得基因检测试剂盒等发明专利、实用新型专利及软件著作权40+项，并多次满分通过国家临检中心的室间质评。