Feb 9, 2021

February 09, 2021 09:00 AM Eastern Standard Time AURORA, Colo. & PETACH TIQWA, Israel--( BUSINESS WIRE )--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 ). Forward looking statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the potential benefits of Taiga Biotechnologies' product candidates, including TBX-3400; its plans and timelines for the clinical development of TBX-3400; and the benefit of its strategic plans and focus. The words "expect," "intend," "may," "plan," "potential," "hope," "could," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from Taiga Biotechnologies’ current expectations and beliefs. For example, there can be no guarantee that TBX-3400 or any other product candidate Taiga Biotechnologies is developing will successfully complete necessary clinical development phases, or that development of such product candidates will successfully continue. There can be no guarantee that any positive developments in Taiga Biotechnologies’ business will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other important factors, including: Taiga Biotechnologies’ results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Taiga Biotechnologies’ ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials; unplanned cash requirements and expenditures; and Taiga Biotechnologies’ ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing. Any forward-looking statements contained in this press release speak only as of the date hereof, and Taiga Biotechnologies expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts