喜报！热烈祝贺优替济生新型MSLN CART细胞疗法IND获美国FDA批准

UCLM805是优替济生整合三大核心技术平台研发的创新产品：全人源高通量抗体筛选平台保障了靶向治疗的精准性与安全性；T细胞识别优化技术平台显著增强了CAR-T细胞的特异性杀伤能力；而核心的LACO-Stim®共刺激分子技术则为攻克实体瘤提供了关键解决方案。

LACO-Stim®技术作为一种创新的淋巴细胞-抗原呈递细胞共刺激融合蛋白，具有独特的双功能机制：其一，通过激活树突状细胞和巨噬细胞等抗原呈递细胞，将抑制性的M2型巨噬细胞转化为活化的M1型，促进先天免疫和适应性抗肿瘤免疫反应；其二，高效增强T细胞功能，提升CAR-T细胞的增殖能力, 持久性和对肿瘤的浸润能力，抵制肿瘤微环境的抑制。这种创新设计实现了CAR-T疗法与肿瘤疫苗的协同效应：不仅通过CAR-T细胞直接杀伤肿瘤，还能激活患者自身免疫系统，共同克服肿瘤微环境抑制和异质性导致的治疗挑战。

作为优替济生的合作伙伴，ACROBiosystems百普赛斯为其提供的GMP级别细胞因子等产品助力UCLM805获批IND。未来双方也将继续密切合作，推动药物研发进程！

此外，为支持CAR细胞疗法在血液系统恶性肿瘤及实体瘤中的研究进展，ACROBiosystems百普赛斯利用专业的蛋白研发平台、蛋白标记平台、稳定株开发平台和流式细胞分析平台，开发了一系列包括非标记、生物素标记、荧光标记等多种形式的血液瘤CAR靶点及实体瘤CAR靶点蛋白，可用于免疫、筛选、亲和力检测以及CAR检测质控等研究，全面加速您的CAR细胞疗法药物开发进程。我们也期待继续携手行业伙伴，加速细胞疗法的研发与产业化进程，造福全球患者！

Human PBMCs were cultured in CelThera™ GMP T Cell Expansion Medium (Cat. No. GMP-CM3101) with 50 IU/mL GMP Human IL-2 Protein (Cat. No. GMP-L02H14), 5 ng/mL GMP Human IL-7 Protein (Cat. No. GMP-L07H24) and 1, 10 or 100 ng/mL GMP Human IL-15 Protein (Cat. No. GMP-L15H13) for 13 days. The result shows that Acro's GMP Human IL-15 Protein activity is consistent across batches.

Human PBMCs were activated using 0.2 µg/mL GMP Monoclonal Anti-Human CD3 Antibody (OKT3) (Cat. No. GMP-MC0323) and 1 µg/mL GMP Monoclonal Anti-Human CD28 Antibody (Cat. No. GMP-MC2824), cultured with CelThera™ GMP T Cell Expansion culture medium (Cat. No. GMP-CM3101) supplemented with 500 IU/mL GMP Human IL-2 Protein (Cat. No. GMP-L02H14) for two weeks. The results showed that GMP human IL-2 protein, GMP monoclonal anti-human CD3 antibody (OKT3), GMP monoclonal anti-human CD28 antibody, and CelThera™ GMP T cell expansion medium could be used to culture T cells in a 3L large system. It can efficiently expand cells with high viability.

5e5 of anti-MSLN CAR-293 cells were stained with 100 μL of 1:50 dilution (2 μL stock solution in 100 μL FACS buffer) of PE-Labeled Human Mesothelin (296-580), His Tag Star staining (Cat. No. MSN-HP2H8) and negative control protein respectively (Fig. C and B), and non- transfected 293 cells were used as a control (Fig. A). PE signal was used to evaluate the binding activity (QC tested).

5e5 of PBMCs were stained with PE-Labeled Human Mesothelin (296-580), His Tag Star staining (Cat. No. MSN-HP2H8) and anti-CD3 antibody, washed and then analyzed with FACS. FITC signal was used to evaluate the expression of CD3+ T cells in PBMCs, and PE signal was used to evaluate the non-specific binding activity to PBMCs (QC tested).

Assay of human MSLN protein on the μBeads surface by Flow cytomtry. ActiveMax® Human MSLN μBeads, premium grade (for cells) (Cat. No. MBS-C003) were stained with anti-human MSLN antibody, and then followed by FITC anti-human IgG Fc antibody and analyzed by flow cytometry.

ActiveMax® Human MSLN μBeads, premium grade (for cells) (Cat.No.MBS-C003) can activate MSLN-specific CAR-T cells by detecting the secretion of IFN- γ in vitro.

关于优替济生

优替济生是一家致力于肿瘤免疫治疗细胞药物研发以及生产的生物医药企业。公司成立于2019年，由美国宾夕法尼亚大学世界顶级细胞工程实验室的科学家团队和跨国药企美国强生的科学家联合创办。除UCLM805外，优替济生还有多条在研管线正在推进，包括靶向NY-ESO-1的TCR-T，靶向CD70、GPC3、CDH17及Her2 的CAR-T等。公司将继续秉承“创新为本，生命至上，诚信济世”的核心价值观，致力于开发下一代安全、有效、通用化的T细胞肿瘤免疫治疗产品。

关于ACROBiosystems百普赛斯

百普赛斯集团ACROBiosystems Group（股票代码：301080）是成立于2010年的跨国生物科技公司，是为全球生物医药、健康产业领域提供关键生物试剂产品及解决方案的行业平台型基石企业。子品牌包括Resilient supply、Star Staining、CelThera、Cellectra、ActiveMax、GENPower等，主要产品及服务包括蛋白、抗体、培养基、试剂盒及分析检测服务，应用于肿瘤、自身免疫疾病、心血管病、传染病、脑神经等疾病的药物筛选及优化、临床前实验及临床试验、药物生产过程及工艺控制（CMC）、诊断试剂开发及优化等研发及生产环节。

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