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CHENGDU, China, June 20, 2024 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) today announced that Lei Zhang/Renchi Yang's team from the Institute of Hematology, Chinese Academy of Medical Sciences has recently published a research paper entitled "A Novel Anti-CD38 Monoclonal Antibody for Treating Immune Thrombocytopenia" in the New England Journal of Medicine. This is an investigator-initiated, single-arm, open-label phase I/II study evaluating the safety and preliminary efficacy of CM313 in adult patients with primary ITP. A total of 22 patients were enrolled in the study, with one patient dropping out after the first infusion. The remaining 21 patients completed both the 8-week treatment and 16-week follow-up periods. Results showed that 95.5% of patients (21/22) achieved a platelet count of ≥50 × 109/L during the 8-week treatment period, with a median cumulative response duration of 23 weeks (interquartile range, 17 to 24). The median time to first platelet count of ≥50 × 109/L was 1 week (range: 1-3), and the median time to first platelet count of ≥30 × 109/L with a ≥2-fold increase from baseline was 1 week. Additionally, the durable sustained platelet count response rate (defined as a platelet count of ≥50 × 109/L observed six or more times among the final eight platelet counts) was 63.6% (14/22). Throughout the entire study, overall response (complete or partial response) was observed in 21 patients, with 20 patients achieving complete response. The proportion of patients with bleeding decreased from 68.2% (15/22) at baseline to 4.8 (1/21) at week 8. Most patients discontinued concomitant medications due to the restoration of platelet counts to normal or safe levels with CM313 treatment. In summary, CM313 demonstrated rapid and sustained efficacy in 95.5% of ITP patients who had previously received multiple therapies. Safety analyses showed that CM313 was well-tolerated. CM313 is a humanized monoclonal antibody targeting CD38 and the first domestically-developed anti-CD38 antibody with IND approval by the NMPA in China. Previous phase I/II studies have demonstrated the favorable safety profile and encouraging efficacy of CM313 in patients with RRMM and primary ITP. In addition, the potential use of CM313 in SLE is currently under clinical development. About Keymed Biosciences Inc. Keymed Biosciences Inc. (HKEX: 02162) focuses on the urgent unmet clinical needs, and is committed to providing high-quality, affordable, innovative therapies for patients in China and overseas. To accelerate the efficiency of our research and discovery, the Company has established a fully-integrated platform encompassing all of the key functions in the biological drug development which include target validation, lead molecule discovery and optimization, preclinical evaluation, process development, translational research, clinical development and manufacturing. This integrated platform has enabled us to rapidly and cost-effectively identify, build, expand and advance our diversified pipeline of innovative and differentiated antibody-based therapies, including monoclonal antibodies, antibody drug conjugates (ADCs) and bispecific antibodies. SOURCE Keymed

▎药明康德内容团队报道 6月20日，康诺亚宣布，《新英格兰医学杂志》（NEJM）发表了该公司的CD38单抗CM313治疗免疫性血小板减少症（ITP）的研究结果。康诺亚新闻稿指出，该论文前瞻性地评估了CM313治疗ITP的安全性和疗效，并揭示了CD38单抗治疗ITP的可能机制。 免疫性血小板减少症是一种常见的自身免疫性出血性疾病，以抗体介导的血小板破坏加速和生成受损为特征，现有治疗方式仍存在未被满足的临床需求，部分患者面临着严重出血、生活质量降低以及死亡风险增加的威胁。CD38阳性长寿命浆细胞（LLPC）能够持续产生致病性抗体，导致疾病复发或难治，这被认为是仅通过清除CD20阳性B细胞无法实现ITP患者持久临床获益的一个重要原因。通过靶向CD38分子来清除包括长寿命浆细胞在内的抗体分泌细胞，有望为免疫性血小板减少症的治疗提供新的获益。 CM313是康诺亚研发的一款靶向CD38的人源化单克隆抗体。本次在《新英格兰医学杂志》发表的是一项研究者发起的、单臂、开放性1/2期临床研究，共纳入了22例免疫性血小板减少症患者，旨在评估CM313治疗免疫性血小板减少症的安全性和有效性。入组患者接受每周一次的CM313治疗（16mg/kg），共计8周，随后进入16周的观察随访期。安全性以不良事件的发生率及严重程度来评估，有效性以8周内连续2次血小板计数≥50×109/L的患者比例作为主要评估指标。 研究结果显示，CM313治疗免疫性血小板减少症能够快速、持久提升患者血小板计数，降低出血风险。在8周的治疗期间，95.5%的患者 (21/22）实现了血小板计数≥50×109/L，并且血小板计数首次≥50×109/L的中位时间仅为1周。第8周时总有效率为81.8%（18/22），第12周时为86.4%（19/22），第24周时为63.6%（14/22），中位累积缓解持续时间为23周（IQR，17~24）。出血患者的比例从基线时的68.2%（15/22）下降到第8周和第24周时的4.8%（1/21）和9.5%（2/21）。 安全性方面，CD38单抗治疗免疫性血小板减少症未发生治疗相关的严重不良事件，安全性良好。最常见的治疗相关不良事件为输液反应和上呼吸道感染，大多数为1级或2级，其中所有输液反应均发生在首次输液期间。 作用机制方面，该研究探索了免疫性血小板减少症患者经CD38单抗治疗后的外周血免疫状态改变，并利用免疫性血小板减少症小鼠模型对脾脏中单核巨噬的系统变化进行研究。研究提示，CD38单抗除了通过清除免疫性血小板减少症患者体内的抗体分泌细胞，阻断抗体介导的血小板破坏获得持续治疗反应以外，还能抑制单核巨噬细胞系统介导的抗体依赖性细胞毒性作用，通过直接阻断血小板吞噬破坏来迅速提升血小板水平。 康诺亚新闻稿指出，本次发表的研究整体数据显示，CM313在95.5%的既往接受过多种治疗的原发免疫性血小板减少症成人患者中表现出良好的疗效反应，能够快速、持久提升患者的血小板水平，降低出血风险，安全有效，有望为患者提供一种极具应用前景的新型治疗选择。 参考资料： [1]新英格兰医学杂志：CD38单抗CM313在治疗免疫性血小板减少症中显示良好疗效和安全性. Retrieved June 20, 2024, from https://mp.weixin.qq.com/s/K_-Sg1an4zdy81UlVRsPVg 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。转发授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。 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。