在以色列TBX-3400-003临床试验中，Taiga治疗了第一位癌症患者

StephenW

Taiga Treats First Cancer Patient in TBX-3400-003 Clinical Trial in Israel

    14 hrs ago

AURORA, Colo. & PETACH TIQWA, Israel--(BUSINESS WIRE)--Feb 9, 2021--

Taiga Biotechnologies, a cell-based immunotherapy company, announced today that a colorectal cancer patient at the Davidoff Cancer Center, Beilenson Hospital, Rabin Medical Center, Petach Tikva, was the first recipient of a treatment designed to treat drug-resistant solid tumors in the company’s recently approved Israeli trial. ( NCT04640246 ).

“The initiation of this study, under the aegis of the Israeli Ministry of Health, represents a significant milestone in the clinical development of the TBX-3400 program. We now have four clinical programs that have begun in the past 18 months,” said Dr. Yosef Refaeli, Chief Executive Officer at Taiga Biotechnologies. “We hope to generate critical data that will enable us to focus the development of TBX-3400 in the human clinical space,” said Dr. Brian C. Turner, Chief Scientific Officer.

“We are eager to explore the ability of TBX-3400 to treat multiple tumor types in patients whose disease no longer responds to commonly used therapies,” said Professor Salomon M. Stemmer, head of the research unit at the Davidoff Center and Primary Investigator of the study. “This novel approach for liberating the patient’s own immune system against the tumor may also hold promise for many different types of malignancy in both adults and children,” said Dr. Jerry Stein, head of Bone Marrow Transplantation Unit, Schneider Childrens’ Medical Center, who is overseeing production of TBX-3400 for the Israeli clinical trial.

About TBX-3400

Taiga has developed a proprietary recombinant protein that can passively enter cells without the need for binding and uptake by a cell surface receptor, which can transiently alter intracellular levels of a critical protein involved in survival and proliferation called “MYC.” Normally, white blood cells of the immune system that come into contact with a tumor within a patient are crippled by multiple suppressive signals generated by the tumor. Treating these immune cells with the special protein enables them to break free from the cancer-derived dampening signals. Treated cells are called “TBX-3400.” To make TBX-3400 for a cancer patient, blood-derived white blood cells are incubated with Taiga’s recombinant protein in a certified lab under the most exacting standards of Good Manufacturing Practice. The cells are rinsed in a machine and then formulated in a standard solution before they are infused back into the patient in the ambulatory clinic. This approach results in a transient increase in immune function by allowing the immune cells to target the cancer. This treatment may be beneficial for a variety of solid tumors and infectious diseases. Viruses such as hepatitis B, like cancers, can escape from the immune system by triggering suppressive signals in white blood cells. Cells that are treated with the patented protein are temporarily liberated, allowing them to fight the virus infected cells.

Summary of TBX-3400 clinical programs

As mentioned above, Taiga has begun several clinical programs in the past year and a half.

Taiga has successfully completed a first-in-human safety and early efficacy pilot study in adults, covered by the regulations of the Japanese Ministry of Health, Labour and Welfare. These patients did not experience any significant treatment-related adverse events and the treatment was well tolerated. In addition, early signs of efficacy were observed in several of the subjects treated.

Taiga has an active Investigational New Drug (IND) on file with the US FDA (NCT03385486). The US study (TBX-3400-001) is enrolling patients with stage III or IV melanoma which has become refractory or resistant to immune checkpoint inhibitors. The study is now open at two major medical centers in the US.

Taiga is also conducting a pilot study on the use of TBX-3400 to treat patients with chronic hepatitis B virus (HBV) associated hepatocellular carcinoma (HCC) in Thailand. This study is currently recruiting patients and is measuring both tumor markers as well as Hepatitis B viremia following the immunotherapy.

About Taiga Biotechnologies, Inc.

Taiga Biotechnologies, Inc. is a clinical stage biotechnology company focused on harnessing the power of the immune system to fight solid tumors and infectious disease. Taiga has an additional program related to bone marrow stem cell transplantation as well as a broad preclinical research and development pipeline. For more information, please visit the company’s website ( www.Taigabiotech.com ).

StephenW

在以色列TBX-3400-003临床试验中，Taiga治疗了第一位癌症患者

    14小时前

科罗拉多州奥罗拉和以色列佩奇·迪卡瓦-（美国商业资讯）-2021年2月9日-

基于细胞的免疫疗法公司Taiga Biotechnologies今天宣布，位于Petach Tikva Rabin医学中心，Bailenson医院，Davidoff癌症中心，Davidoff癌症中心的一名结直肠癌患者是首例设计用于治疗耐药性实体瘤的疗法的接受者。公司最近批准了以色列的审判。 （NCT04640246）。

“在以色列卫生部的主持下，这项研究的启动代表了TBX-3400计划临床开发的重要里程碑。 Taiga Biotechnologies首席执行官Yosef Refaeli博士说：“我们现在有四个临床计划已在过去18个月内开始。”首席科学官Brian C. Turner博士说：“我们希望生成关键数据，使我们能够将TBX-3400的开发重点放在人类临床领域。”

“我们迫切希望探索TBX-3400在疾病不再对常用疗法产生反应的患者中治疗多种肿瘤类型的能力，”戴维多夫中心大卫·霍夫研究中心负责人Salomon M. Stemmer教授说。研究。施耐德儿童医学中心骨髓移植部门负责人杰里·斯坦（Jerry Stein）博士说：“这种释放患者自身针对肿瘤的免疫系统的新颖方法也可能为成人和儿童带来许多不同类型的恶性肿瘤。”他正在为以色列的临床试验监督TBX-3400的生产。

关于TBX-3400

Taiga开发了一种专有的重组蛋白，该蛋白可以被动进入细胞，而无需细胞表面受体的结合和摄取，该蛋白可以瞬时改变参与生存和增殖的关键蛋白在细胞内的水平，称为“ MYC”。通常，与患者体内的肿瘤接触的免疫系统的白细胞被肿瘤产生的多种抑制信号所削弱。用特殊的蛋白质处理这些免疫细胞，可使它们摆脱源自癌症的减毒信号。经过处理的细胞称为“ TBX-3400”。为了为癌症患者生产TBX-3400，将血液中的白细胞与Taiga的重组蛋白一起在经过认证的实验室中按照“良好生产规范”的最严格标准进行孵育。在机器中将细胞冲洗干净，然后配制成标准溶液，然后再将其注入门诊诊所。通过允许免疫细胞靶向癌症，该方法导致免疫功能的短暂增加。这种治疗对于多种实体瘤和传染病可能是有益的。像癌症一样的乙型肝炎病毒，可以通过触发白细胞中的抑制信号从免疫系统逃逸。用专利蛋白质处理过的细胞会暂时释放，从而使它们能够对抗感染了病毒的细胞。

TBX-3400临床程序摘要

如上所述，Taiga在过去的一年半中已启动了多个临床程序。

根据日本厚生劳动省的规定，Taiga已成功完成了一项针对成人的首次人体安全性和早期疗效试验研究。这些患者没有经历任何与治疗相关的重大不良事件，并且治疗耐受性良好。此外，在一些接受治疗的受试者中观察到了疗效的早期迹象。

Taiga在美国FDA（NCT03385486）处备有有效的研究用新药（IND）。美国研究（TBX-3400-001）正在招募已变得难治或对免疫检查点抑制剂产生抵抗力的III或IV期黑色素瘤患者。该研究现已在美国的两个主要医疗中心开放。

Taiga还在泰国进行了关于使用TBX-3400治疗慢性乙型肝炎病毒（HBV）相关的肝细胞癌（HCC）患者的试验研究。该研究目前正在招募患者，并在免疫治疗后同时测量肿瘤标志物和乙型肝炎病毒血症。

关于Taiga Biotechnologies，Inc.

Taiga Biotechnologies，Inc.是一家临床阶段生物技术公司，致力于利用免疫系统的力量对抗实体瘤和传染病。 Taiga还有一个与骨髓干细胞移植有关的附加计划，以及广泛的临床前研究开发渠道。有关更多信息，请访问公司的网站（www.Taigabiotech.com）。