Sound Biologics Announces FDA Allowance of its IND Application for PSB205, an Anti-PD-1/CTLA-4 MabPair, in Relapsed and Refractory Solid Tumors

Sound Biologics复发性与难治性实体瘤药物PSB205临床试验申请获FDA批准

2019-04-10 19:45:31 prnewswire

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标签: 医疗学科 肿瘤
Qilu Puget Sound Biotherapeutic Corp. , an emerging biotechnology company dedicated to developing next generation antibody combination therapies, today announced that U.S. Food and Drug Administration has accepted the Company's Investigational New Drug application and issued authorization to commence a Phase I First-in-Human Clinical Trial of PSB205 for the treatment of patients with relapsed/refractory solid tumors. PSB205 is an immuno-oncology biotherapeutic that represents the first of a new class of therapeutic modality.   PSB205 is a novel bifunctional product that contains a mixture of unique anti-PD-1 and anti-CTLA4 monoclonal antibodies produced by a single cell line via the company's proprietary MabPair technology. MabPair products offer many advantages over bispecific antibodies. The relative ratio of the two antibodies in the MabPair can be well-controlled and each antibody is individually engineered for optimal target coverage, effector function, pharmacokinetics and exposure. PSB205 represents a potentially best-in-class immuno-oncology product that promises to exhibit robust combination activity while being significantly more tolerable to patients than currently approved anti-PD-1/anti-CTLA-4 combinations. "We're pleased to take this critical step toward providing cancer patients with a better therapeutic option for blockade of two key immunotherapy pathways," said Wei Yan, Chief Executive Officer of Sound Biologics. "PSB205 represents the first product to contain two antibodies expressed from one cell line. We're excited to be the first to explore this innovative approach to biologic combinations and look forward to reviewing the initial clinical data in late 2019."
Qilu Puget Sound Biotherapeutic公司,一家新兴的生物技术公司,致力于开发下一代抗体联合疗法。该公司今天宣布,FDA已接受该公司的新药临床试验申请,并授权开始进行 PSB2051第I期人体临床试验,用于治疗复发/难治性实体肿瘤患者。PSB205是一种免疫肿瘤生物治疗药物,代表了第一种新的治疗方式。 PSB205是一种新的双官能产品,通过公司专有的 MabPair 技术,含有由单个细胞株产生的独特抗 PD-1和抗 CTLA4单克隆抗体的混合物。MabPair 产品比双特异性抗体具有许多优势。这两种抗体在 MabPair 中的相对比例可以被很好地控制,并且每个抗体都被单独设计以达到最佳的目标覆盖范围、效应功能、药代动力学和暴露。PSB205是一种潜在的最好的免疫肿瘤产品,承诺表现出强大的组合活动,同时明显比目前批准的抗 PD-1/抗 CTLA-4组合更容易接受患者。 “我们很高兴采取这一关键步骤,为癌症患者提供更好的治疗选择,阻断两个关键的免疫治疗途径,”韦燕说,首席执行官健全生物技术。“ PSB2055是第一个含有两个抗体的产品,从一个细胞株表达。我们很高兴成为第一个探索这种生物组合创新方法的人,并期待着在2019年底回顾最初的临床数据。”