TC BioPharm Announces Submission of Investigational New Drug (IND) Application to U.S. FDA for Treatment of Relapse/Refractory AML
EDINBURGH, Scotland , Oct. 23, 2023 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, today announced submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of TCB-008 in the treatment of relapse/refractory Acute Myeloid Leukemia. TCB-008, an allogeneic unmodified gamma delta t-cell, is the Company's lead product and is currently in Phase 2b trials in the U.K. for the treatment of AML.). The IND application leverages pioneering research on the use of Gamma Deltas in the treatment of relapse/refractory Acute Myeloid Leukemia. TCB-008 has been designated Orphan Drug Status in the treatment arena of AML previously. "Filing of the IND for TCB-008 is the next step in the clinical development of TCB-008 and aligns with our strategic refocus announced in Q2 of this year to target our clinical strategy to US trials in the future." said Bryan Kobel, Chief Executive Officer of TC BioPharm. "The IND application leverages supporting clinical study data from ongoing studies in patients with Acute Myeloid Leukemia and is also a reflection of substantial pre-clinical IND enabling work done over the course of the last 6 months by the TCB team. I would like to thank our entire team, who worked tirelessly to complete the Company's first ever US FDA trial filing. We look forward to working closely with the FDA to garner acceptance of our IND over the coming 30 days and advancing our lead candidate through clinical phases of development." The FDA will review the application and determine the acceptability of the data before TC BioPharm begins its first clinical trial for TCB-008 It is possible that the FDA will require additional information.
Despite significant progress, cancer continues to be the second-largest cause of death in the U.S.
It comes as no surprise that big names like Pfizer and Bristol Myers Squibb are scrambling to lead in oncology therapies. The industry is lucrative as much as it is devastating.
The unique players in the arena with a different approach to fighting cancer may get the most attention and could see explosive growth potential ahead. This puts the spotlight on an underfollowed NASDAQ company called TC Biopharm (Holdings) which trades under the ticker symbol " TCBP." Why should you have TCBP on your radar?
NASDAQ currently has a "STRONG BUY" rating on the stock as seen HERE.
The stock has a $6.82 price target which can be seen HERE.
The company aims to become a leading commercial-stage company that could help revolutionize the way we treat cancers.
The company is a leader in developing gamma-delta T cell therapies.
Lead candidate TCB-008 is an extremely promising therapeutic in cancer.
The company is the first to conduct phase II/pivotal clinical studies in oncology.
The company is heading towards U.S. trials with an anticipated FDA IND filing in Q3 of 2023.
Revenues are increasing. Full year 2022 results revealed that revenue was up 94% from FY 2021.
What does TCBP do? Trading at mere pennies, TC BioPharm is a clinical-stage biotech company that is developing gamma-delta T cell therapies. It 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 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 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. What is TCBP doing that is unique? 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. The company is developing and manufacturing its lead product TCB-008. What is TCB-008? TCB-008 is anallogeneic gamma-delta T cell therapies for cancer. Following an analysis of current and emerging trends in the cell therapy landscape, TCBP intends to pursue exclusive partnerships for test research and combination trial with complimentary therapies using allogeneic gamma delta t-cells, subvariant 2 ("GDT v2s"), the company's lead asset TCB-008. The company's current plans are based on the advancement of TCB-008 as a monotherapy for Acute Myeloid Leukemia and the ability to manufacture the product to GMP standards, which will continue with an FDA IND filing in Q3 of 2023 . This will continue as scheduled and as the final monotherapy trial for TCB-008. "TCB-008 is an extremely promising therapeutic in cancer, and given its versatility, its mechanism of action, and the numerous arenas where other companies are attempting to activate, interact with or draw gamma delta t-cells to tumors, we believe TCB-008 will be a best-in-class asset for these companies to partner with in the future. This will give TCBP multiple shots on goal and maintain our leadership position as the de facto partner for companies looking to explore gamma delta t-cells sub variant 2 in combination with their asset," said Bryan Kobel, CEO of TC BioPharm. "Prioritizing partnerships as we head towards US trials realigns us with our long-term goal of becoming a leading commercial-stage company. These partnerships will expand the data set on TCB-008, give us more knowledge around both our product and GDTs and provide investors with multiple shots on goal and additional inflection points at a lower cash expenditure," added Kobel. Additionally, TCBP has a CAR modified gamma-delta T cell. A collaborative integration of the primary asset, TCB-008, will further enable the company to expand operations into CAR Therapy with a focus on binder B7H3 for the treatment of ovarian cancer. TCBP has executed three research collaborations around TCB-008 in combination with complementary approaches and expects to finalize a partnership from one of these collaborations in 2023 for trial in 2024. The company will increase the focus on the CAR program, looking to shorten the timeline to completing a pre-clinical package and pursuing a US Phase I trial. The current target indication will be Ovarian cancer, with more than 313,000 new cases of ovarian cancer in 2020. The five-year relative survival rate is 49.7%. This is an exciting time to be watching closely for any developments from the company!! In summary…. Biotech is always exciting to watch as question marks linger over which companies will be the next darlings and see their share price explode. Trading at pennies, TCBP could be a contender in seeing major growth ahead and should be at your attention. Especially with a price target that indicates potential gains of over 1,500%!
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