Oncologie, Inc. Announces Clinical Trial Collaboration With Merck to Evaluate Bavituximab in Combination With KEYTRUDA® in Advanced Gastric or Gastroesophageal Cancer


2019-08-13 14:03:00 BioSpace


 Oncologie, Inc., a clinical-stage biopharmaceutical company developing innovative oncology treatments targeting the tumor microenvironment, today announced that it has entered into a clinical collaboration agreement with Merck  to evaluate the combination of Oncologie's investigational drug Bavituximab, an antibody that blocks the activity of phosphatidylserine , and Merck's anti-PD-1 therapy, KEYTRUDA® in patients with advanced gastric or gastroesophageal cancer. Under the terms of the agreement, Oncologie will conduct a Phase 2 single arm open-label study to determine the efficacy and safety of Bavituximab in combination with KEYTRUDA in patients who have advanced gastric and gastroesophageal cancer, after they have failed at least one line of treatment.  The study is expected to enroll approximately 80 patients in the U.S., United Kingdom, Korea and Taiwan. The study is anticipated to start enrollment in the second half of 2019. "Gastric cancer is an area of significant unmet medical need in many parts of the world and we are committed to understanding the clinical benefit of Bavituximab and KEYTRUDA in this difficult-to-treat cancer," said Laura Benjamin, Ph.D., Founder and CEO of Oncologie. "This collaboration reflects a shared commitment to the goal of improving the lives of cancer patients in meaningful ways." Keytruda® is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.  About Bavituximab Bavituximab is an investigational chimeric monoclonal antibody that targets the activity of phosphatidylserine (PS). Bavituximab is believed to reverse PS-mediated immunosuppression by blocking the engagement of PS with its receptors.  PS-targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses.  This mechanism may play an important role in allowing other cancer therapies to more effectively attack tumors by reversing the immunosuppression that limits the impact of those treatments. Importantly, Bavituximab has also demonstrated a manageable safety and tolerability profile in previous clinical trials conducted to date, which may allow it to be combined effectively with other agents.  About Oncologie, Inc. Oncologie, Inc. is an innovative biopharmaceutical company committed to delivering better outcomes for cancer patients through improved approaches to patient selection and clinical trial design.  Our current pipeline includes clinical programs that improve treatment outcomes by modulating the tumor micro-environment and enhancing the immune response to targeting cancer cells.  From its headquarters in Boston, Massachusetts and Shanghai, China, Oncologie is working with global partners to acquire and develop innovative drugs for cancer patients around the world.
肿瘤生物制药公司,一家临床阶段的生物制药公司,开发以肿瘤微环境为目标的创新肿瘤治疗,今天宣布,它已与默克(Merck)公司签订临床合作协议,评估肿瘤药物 Bavituximab 的联合研究。一种阻断磷脂酰胆碱活性的抗体,以及默克(Merck)公司的抗 PD-1疗法 KEYTRUDA ®用于晚期胃癌或胃食道癌患者。 根据协议条款,肿瘤科将进行第二期单臂开放标签研究,以确定 Bavituximab 联合 KEYTRUDA 治疗晚期胃癌和胃食道癌的疗效和安全性,在至少一条治疗路线失败后。这项研究预计将在美国、英国、韩国和台湾招收大约80名患者。这项研究预计将于2019年下半年开始招生。 肿瘤创始人兼首席执行官 Laura Benjamin 博士说:“胃癌是世界许多地区尚未得到满足的重大医疗需求领域,我们致力于了解 Bavituximab 和 KEYTRUDA 在这一难以治疗的癌症中的临床益处。”“这种合作反映了对以有意义的方式改善癌症患者生活的共同承诺。” 可瑞达(Keytruda)®是 Merck Sharp & Dohme Corp .的注册商标,默克(Merck)& Co ., Inc ., Kenilworth , NJ , USA 的子公司。 关于 Bavituximab 巴维妥昔单抗是一种以磷脂酰胆碱( PS )活性为靶点的嵌合单克隆抗体。Bavituximab 被认为通过阻断 PS 与其受体的结合来逆转 PS 介导的免疫抑制。以 PS 为靶标的抗体已被证明转移了肿瘤中免疫细胞的功能,导致免疫激活和抗肿瘤免疫应答的多重信号。这一机制可能发挥重要作用,使其他癌症疗法更有效地打击肿瘤,扭转免疫抑制,限制这些治疗的影响。重要的是, Bavituximab 在迄今进行的临床试验中也显示了可控的安全性和耐受性,这可能使它与其他药物有效结合。 关于肿瘤公司。 肿瘤学公司是一家创新的生物制药公司,致力于通过改进患者选择和临床试验设计的方法为癌症患者提供更好的结果。我们目前的管道包括通过调节肿瘤的微环境和增强针对癌细胞的免疫反应来改善治疗结果的临床方案。在其位于波士顿、马萨诸塞州和中国上海的总部,肿瘤学正与全球合作伙伴合作,为世界各地的癌症患者获取和开发创新药物。