TC BioPharm Highlights Need for Disruptive Treatment as Acute Myeloid Leukemia Cases Rise Globally
TC Biopharm (NASDAQ: TCBP) announced a significant rise in acute myeloid leukemia (AML) diagnoses globally, increasing by 34.6% among men and 7.9% among women from 1990 to 2019, according to a recent study. In response, the Company highlighted the urgency for innovative cancer therapeutics, specifically its allogeneic gamma-delta T cell therapy, OmnImmune, currently in Phase 2B/3 trials. The FDA has granted Orphan Drug status to OmnImmune, with promising early results indicating low toxicity and potential effectiveness as a standalone and combination therapy. The Company aims to launch this treatment in 2023.
- 34.6% rise in AML diagnoses among men and 7.9% among women indicates a growing market.
- OmnImmune is in Phase 2B/3 clinical trials, showing promising early results.
- FDA granted Orphan Drug status to OmnImmune, highlighting its potential value.
- No toxicity reported in OmnImmune trials suggests safety for patients.
- Company plans to bring OmnImmune to market in 2023.
- None.
EDINBURGH, Scotland, May 31, 2022 /PRNewswire/ -- TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer treatment, today announced that Acute myeloid leukemia (AML) diagnoses have risen globally according to a recent study entitled, "EPR22-104: A Comparison of the Burden of Leukemia Amongst Various Regions of the World, 1990-2019," published in the Journal of the National Comprehensive Cancer Network.
The authors analyzed data from the World Health Organization from 1990 to 2019 and found that AML incidences grew by
"The Global increase of AML cases marks an urgent need for the healthcare industry to invest in the most promising therapeutics to combat this cancer, this message is further amplified by orphan disease designation by regulatory agencies," said Bryan Kobel, CEO of TC BioPharm. "OmnImmune, our allogeneic unmodified Gamma Delta therapeutic for AML, is currently in phase 2B/3 clinical trials and has seen very promising early results in Phase 1b/2a human trials. The lack of a toxicity in our OmnImmune trials points to potential value in AML as a stand-alone therapeutic and also as a potential combination therapy to help patients with no existing treatment options. We hope to bring the product to market in 2023 with our Orphan drug status granted and look forward to making significant impact in the lives of AML patients and the treatment of this devastating disease."
TC BioPharm manufactures young, active gamma-delta T cells exogenously using donor blood, expanding the gamma delta t-cell population into the billions and infusing these healthy donor cells into cancer patients. The FDA has granted Orphan Drug status for OmnImmune®.
TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer and viral infections with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue. TC BioPharm uses an allogeneic approach in both unmodified and CAR modified gamma delta t-cells to effectively identify, target and eradicate both liquid and solid tumors in cancer.
TC BioPharm is the leader in developing gamma-delta T cell therapies, and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line - Phase 2b/3 pivotal trial for OmnImmune® in treatment of acute myeloid leukemia and Phase I trial for ImmuniStim in treatment of Covid patients using the Company's proprietary allogenic CryoTC technology to provide frozen product to clinics worldwide. TC BioPharm also maintains a robust pipeline for future indications in solid tumors and other aggressive viral infections as well as a significant IP/patent portfolio in the use of CARs with gamma delta t-cells and owns our manufacturing facility to maintain cost and product quality controls.
This press release may contain statements of a forward-looking nature relating to future events. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions. These statements reflect our current beliefs, and a number of important factors could cause actual results to differ materially from those expressed in this press release. We undertake no obligation to revise or update any forward-looking statements, whether as a result of new information, future events or otherwise. The reference to the website of TC BioPharm has been provided as a convenience, and the information contained on such website is not incorporated by reference into this press release.
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SOURCE TC BioPharm
FAQ
What recent increase in AML cases has TC Biopharm reported?
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