TZ 101 is our phase 3 ready, off-the-shelf medical kit comprised of fucosyltransferase enzyme VI and a small molecule product. Its purpose is to prevent and reduce the risks of various life-threatening side effects associated with standard-of-care toxic cancer therapies. These side effects include serious viral, bacterial, and fungal infections, graft-versus-host disease, hemorrhaging, and stem cell engraftment failure. The market for such therapies is estimated by Coherent Market Insights to reach $44.9 billion in revenues by 2030. The product has been awarded an FDA Phase 3 Special Protocol Assessment, which provides a clear regulatory pathway for FDA marketing approval.
This user-friendly medical kit can be easily administered at the patient’s bedside in a cancer center, along with peripheral blood, cord blood, or marrow transfusions. It provides immediate potentially preventive care treatment for terminally ill cancer patients, as well as those with auto-immune and blood diseases who are undergoing standard-of-care cancer therapies such as intense chemotherapy and hematopoietic stem cell transplantation.
In contrast to alternative cell expansion and genetic engineering products that aim to reduce serious cancer therapy side effects like GVHD and engraftment failure, TZ 101 enables immediate and more affordable patient treatment. It eliminates the need for patients to endure weeks of disease progression before receiving treatment. The simplified steps for administering TZ 101 are outlined below.
Reconstitute & mix TZ 101 to the blood cell preparation
Incubate blood cells with TZ 101 for 30 minutes at room temperature
By potentially preventing and reducing the risks of multiple serious side effects associated with standard-of-care toxic cancer therapies such as hematopoietic stem cell transplantation, TZ 101 may help reduce the need for patients to receive numerous supportive care drugs, often exceeding 10 or 20, each treating a single morbidity along with their associated costs and side effects.
Based on Phase 2 clinical trial safety and efficacy data, we believe that TZ 101 has the potential to improve both survival and quality of life for patients undergoing standard-of-care curative therapies such as hematopoietic stem cell transplantation. This could enable patients to live longer with a better quality of life. Additionally, we believe that TZ 101 will help reduce the overall cost of curative cancer therapies, as well as the lifetime cost of care for patients.