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PsiOxus Therapeutics Announced Updated Agreement with Bristol Myers Squibb to Advance their Clinical Stage Immuno-Oncology Collaboration

PsiOxus Therapeutics Announced Updated Agreement with Bristol Myers Squibb to Advance their Clinical Stage Immuno-Oncology Collaboration

Psioxus Treateutics宣布与百时美施贵宝(Bristol Myers Squibb)达成最新协议,推进他们的临床阶段免疫肿瘤学合作
Benzinga Real-time News ·  2021/04/07 17:35

PsiOxus Therapeutics, Ltd. (PsiOxus) today announced an updated agreement to advance its clinical collaboration with Bristol Myers Squibb (NYSE:BMY) to evaluate the safety, tolerability, and preliminary efficacy of PsiOxus' tumor re-engineering platform, in combination with Bristol Myers Squibb's PD-1 immune checkpoint inhibitor Opdivo® (nivolumab) to treat a range of tumor types in late-stage cancer patients. The first stage of this collaboration combined Bristol Myers Squibb's Opdivo with PsiOxus' enadenotucirev in the Phase 1 SPICE study to determine the safety and tolerability of combining these two agents, and to optimise the combination intravenous dosing regimen. The revised collaboration announced today will build upon the initial study data and will combine Opdivo with PsiOxus' NG-641. NG-641, is a tumor re-engineering product using PsiOxus' proprietary Tumor-Specific Immuno-Gene Therapy (T-SIGn) platform based upon the enadenotucirev vector. NG-641 is a systemically administered product that encodes for the tumor selective delivery of an anti-FAP / anti-CD3 bispecific, interferon alpha, CXCL9 and CXCL10. Fibroblast Activating Protein (FAP) is selectively upregulated on the cancer associated fibroblasts (CAF) that play an important role in the immune suppressive tumor microenvironment found in many stromally dense tumors that are refractory to checkpoint inhibitors. Using a bispecific to drive T-cell mediated killing of CAF is designed to remove stroma and thereby reduce immune suppression within the tumor. A combination of NG-641 and a checkpoint inhibitor such as Opdivo may thus provide an optimal treatment strategy for certain stromally dense tumors. "We are delighted to continue our collaboration with Bristol Myers Squibb and to investigate the clinical combination of NG-641 with Opdivo in several tumor types," stated John Beadle, M.D., Chief Executive Officer, PsiOxus. "We believe that NG-641 provides a unique combination of tumor modulatory elements that may synergise with the known efficacy of Opdivo to bring patient benefits for a wide range of tumor types." Opdivo is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response. By harnessing the body's own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. Opdivo is a registered trademark of Bristol Myers Squibb. Under the terms of this agreement, PsiOxus will be responsible for conducting the Phase 1 study with patient recruitment expected to start in the third quarter of 2021.

PsiOxus治疗有限公司(PsiOxus)今天宣布与百时美施贵宝(纽约证券交易所股票代码:BMY)达成最新协议,加强与百时美施贵宝(纽约证券交易所代码:BMY)的临床合作,以评估PsiOxus的肿瘤重组平台与百时美施贵宝的PD-1免疫检查点抑制剂Opdivo®(Nivolumab)联合使用的安全性、耐受性和初步疗效,以治疗一系列晚期癌症患者的肿瘤类型。这项合作的第一阶段将百时美施贵宝(Bristol Myers Squibb)的Opdivo与PsiOxus的enadotucirev结合在第一阶段的SPICE研究中,以确定将这两种药物结合的安全性和耐受性,并优化联合静脉给药方案。今天宣布的修订后的合作将建立在最初的研究数据基础上,并将结合Opdivo和PsiOxus的NG-641。NG-641是一种肿瘤再工程产品,使用PsiOxus基于enadotucirev载体的专有肿瘤特异性免疫基因治疗(T-SIGN)平台。NG-641是一种全身给药产品,编码抗FAP/抗CD3双特异性、干扰素α、CXCL9和CXCL10的肿瘤选择性递送。成纤维细胞激活蛋白(FAP)在肿瘤相关成纤维细胞(CAF)上选择性上调,CAF在许多对检查点抑制剂无效的间质致密肿瘤中发现的免疫抑制肿瘤微环境中起重要作用。使用双特异性来驱动T细胞介导的对CAF的杀伤,旨在去除间质,从而减少肿瘤内的免疫抑制。NG-641和检查点抑制剂(如Opdivo)的组合可能因此为某些间质密度高的肿瘤提供最佳治疗策略。首席执行官约翰·比德尔说:“我们很高兴继续与百时美施贵宝合作,研究NG-641和Opdivo在几种肿瘤类型中的临床结合。, 帕西奥克斯。我们相信,NG-641提供了一种独特的肿瘤调节成分组合,可以与Opdivo的已知功效协同作用,为多种肿瘤类型的患者带来益处。“Opdivo被设计成独特地利用人体自身的免疫系统来帮助恢复抗肿瘤免疫反应。通过利用人体自身的免疫系统抗击癌症,Opdivo已成为多种癌症的重要治疗选择。Opdivo是百时美施贵宝的注册商标。根据这项协议的条款,PsiOxus将负责进行第一阶段研究,预计将于2021年第三季度开始招募患者。

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