TBX-3400 FOR SOLID TUMORS
Received Orphan Drug Designation from the U.S. FDA for the treatment of malignant melanoma stages IIB to IV.
Completed a first-in-human safety study in patients with advanced solid tumors. Results showed no severe adverse events, was well tolerated and has been approved by the Japanese Ministry of Health, Labor and Welfare.
Expanded Access Policy
At Taiga Biotechnologies, Inc., we are committed to developing TBX-3400 to improve and extend the lives of patients with solid tumors. Our current focus is to complete our ongoing clinical trials to demonstrate safety and efficacy in order to obtain regulatory approval and provide widespread availability of TBX-3400.
Prior to regulatory approval by the U.S. Food and Drug Administration (FDA) and foreign regulatory authorities, patients gain access to investigational treatments, such as TBX-3400, by participating in clinical trials. Expanded access, also called compassionate use, enables some patients with serious or life-threatening diseases, who would not have otherwise met the enrollment criteria for the clinical trials in progress, to gain access to investigational treatments. Unlike the use of an investigational new drug in a clinical trial setting, the primary purpose of expanded access is to use the investigational drug for patient treatment purposes, rather than to gather data on safety, tolerability, and effectiveness.
Currently, Taiga Biotechnologies, Inc. does not offer an expanded access program and does not accept expanded access requests. We believe that access to TBX-3400 should be limited to controlled clinical trials until such time as its safety, tolerability, and effectiveness for a particular indication has been determined and confirmed by regulatory authorities. Patient access to TBX-3400 outside of a controlled clinical trial may interfere with the conduct of our ongoing and future clinical trials, and may also disrupt the progress of our development program, which would then delay access to many patients in need.
While clinical trials are ongoing, we believe participation in our clinical trials is the only safe and appropriate way to access TBX-3400.
Taiga’s TBX-3400 is currently being tested in human clinical trials as a treatment for various solid tumors. Due to the agnostic nature of TBX-3400, a variety of solid tumors are being tested.
We have two active clinical trials evaluating TBX-3400 against solid tumors and plan to initiate two additional trials by the end of the year.
TBX-3400 FOR INFECTIOUS DISEASE
Taiga’s TBX-3400 is currently being tested in a pilot study as a treatment for chronic hepatitis B virus (HBV) associated hepatocellular carcinoma in Thailand. The study is currently recruiting patients and is measuring both tumor markers as well as hepatitis B viremia.
A Phase 2 clinical trial for HBV associated hepatocellular carcinoma is anticipated to begin in Singapore during the first half of 2022.
Many infectious diseases can further develop into cancer, particularly hepatitis B’s progression to hepatocellular carcinoma and HPV’s association with head and neck cancer. Taiga’s goal is to provide treatment for the infectious disease prior to disease progression.
TBX-2400 FOR BONE MARROW TRANSPLANTS
Received Orphan Drug Designation from the U.S. FDA and the European Medicines Agency.
Received Advanced Therapy Medicinal Product from the European Medicines Agency.
Granted Rare Pediatric Disease Designation by the U.S. FDA.
Taiga has initiated a clinical trial to assess the safety and early efficacy of TBX-2400 in enhancing engraftment in patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) for the treatment of acute myeloid leukemia or myelofibrosis.
Phase 1/2 Adult BMT Trial (ClinicalTrials.gov #NCT04709458)
A clinical trial for pediatric patients is projected to begin in the next twelve months.
RED BLOOD CELLS
We have developed a process to treat donated blood products with our protein that enables the blood products to maintain stability while stored at 37°C for an extended period of time, removing the need for cold storage.
Possible areas where this technology may be used:
National Defense applications
Natural Disaster applications
Storage of rare blood types
In addition, we have developed a method to produce an almost unlimited supply of red blood cells in the laboratory. Preclinical studies have shown that these red blood cells maintain function similar to naturally produced red blood cells.
HEMATOPOIETIC STEM CELLS
We are developing methods to expand hematopoietic stem cells ex vivo for use in stem cell transplantation and drug screening.
This technology is in preclinical development, yet has shown promise of accelerating the expansion of stem cells.