7 patients received treatment and 2 patients (enrolled in the low dose cohort) did not reach day 28 assessment and were not evaluable for efficacy per protocol with the third patient being available for safety inclusion but not efficacy.
Of the 7 patients treated, three received OmnImmune®, at a low-dose and four received OmnImmune®, at a higher dose of cells. In the low dose cohort one patient achieved MLFS (morphologic leukemia-free state), one patient achieved stable disease characterized as near complete response and one patient met safety endpoints but was lost to follow-up due to disease co-morbidity (bilateral pneumonia unrelated to OmnImmune® treatment). In the higher dose cohort, 50% of patients achieved complete responses, one patient had progressive disease and one patient exhibited significantly reduced cancer blast count at day fourteen (prior to the study being cut short due to CV19).
"We are extremely pleased to receive such positive data from our phase 1b/2a study demonstrating OmnImmune® as safe and tolerable among patients with advanced acute Myeloid Leukemia," said Bryan Kobel, Chief Executive Officer of TC BioPharm. "These results underline OnmImmune's potential in becoming a viable AML treatment. We look forward to reporting additional phase 2/3 clinical data during the first half of 2022."
"These results are very encouraging in such late-stage unresponsive patients, most of whom had very advanced cancer, were fourth or fifth line with no further therapeutic options," said Dr. Sebastian Wanless, Senior Clinical Director at TC BioPharm. "OmnImmune® comprises allogeneic gamma delta T cells sourced from healthy donors, expanded and activated in large numbers before being purified and formulated for infusion into patients. Our Phase 2b/3 trial will take this therapeutic another step further, incorporating our frozen/thawed product generated from our proprietary universal cell banks of gamma deltas, for a true off the shelf allogeneic cell therapy. During 2022 we plan to evaluate OmnImmune® efficacy in unresponsive first-line of treatment AML patients and expand our clinical trial efforts into multiple blood cancer indications."
Allogeneic gamma-delta T cell persistence was evaluated in two patients treated. In one patient allogenic product remained detectable after 100 days following three infusions. Another patient demonstrated haematological recovery with sustained elevation in key immune cells over 100 days following the initial infusion.
Clinical data provided evidence of good safety and tolerability profile of OmnImmune® as no product related safety concerns were raised during Safety Review Committee meetings. Moreover, no graft vs host disease, immune effector cell-associated neurotoxicity syndrome or cytokine release syndrome was reported in any of the treated patients.
The two patients exhibiting complete response and stable disease were re-dosed with allogeneic product, and the patient with and morphologic leukemia-free state received two further infusions of OmnImmune®. No toxicities were documented following these repeat infusions.
Dr. Michael Leek, Founder and Executive Chairman commented, "Apart from matched bone-marrow stem cell transplants, patients with unresponsive AML are presented with few viable treatment options. At TC BioPharm we are developing affordable allogeneic cell therapies for blood cancers such as AML, we believe such cell therapies will become a future mainstream standard of care for hematological malignancies."
Read the full article here.
No. 2 TCBP Potential Catalyst - A Low Float Profile
According to the Yahoo Finance website, TCBP has a low float.
The website reports this profile to have approximately 9.92Mn shares in its float.
Why is that important? It's important on one crucial level. Volatility.
With so few shares available for trading, other potential catalysts (like big news) could spark a vertical move in the short-term.
No. 3 TCBP Potential Catalyst - Oversold Leaning Technicals Could Signal Reversal Potential
As of close on Wednesday, Barchart was reporting this profile to have several oversold leaning technicals.
These technicals could be signaling a healthy reversal in the near term.
Here's the definition of a "reversal" from Investopedia:
"A reversal is a change in the price direction of an asset. A reversal can occur to the upside or downside. Following an uptrend, a reversal would be to the downside. Following a downtrend, a reversal would be to the upside. Reversals are based on overall price direction and are not typically based on one or two periods/bars on a chart."
Now, here are some key technicals (as of close Wednesday) that could signal TCBP to be leaning oversold and on the verge of a potential reversal.
- 9-Day Relative Strength Index: 37.47%
- 14-Day Relative Strength Index: 30.40%
When these numbers drop down to the 30% range and lower, they can be viewed as being in oversold territory. While in this territory, they can paint the picture of a profile that is undervalued.
- 14-Day Raw Stochastic: 21.37%
- 14-Day Williams %R: 78.63%
As the Raw Stochastic nears the 10% range and lower and the Williams %R nears the 90% range or higher, these technical indicators may also be viewed as oversold and undervalued.
Keep an eye on these technicals closely.
No. 4 TCBP Potential Catalyst - Company Uplists To Nasdaq, Could Draw Significant New Attention
TC BioPharm Begins Trading on Nasdaq Today Under Symbol "TCBP"
- Listing highlights TC BioPharm's vertically integrated cell therapy platform, in-house manufacturing and R&D capabilities
- Company is at a pivotal stage in growth cycle with pending clinical results for the treatment of Acute Myeloid Leukemia
EDINBURGH, Scotland, Feb. 11, 2022 /PRNewswire/ -- TC BioPharm (Holdings) plc ("TC BioPharm"), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications is pleased to announce that American Depositary Shares representing the Company's ordinary shares will commence trading today on the Nasdaq Capital Market (the "Nasdaq") under the ticker symbol "TCBP".
"Listing to the Nasdaq is an important milestone for TC BioPharm and serves as a testament to our ability to build a platform technology for universal off-the-shelf therapy using gamma-delta T Cells," said CEO, Bryan Kobel. "Trading on the Nasdaq grants us access to one of the world's largest capital markets and will enhance our visibility in the marketplace, and ultimately unlock shareholder value."
Read the full article here.
No. 5 TCBP Potential Catalyst - New Board Members Provide Invaluable Experience
TC Biopharm Announces Appointment of New Board Members
EDINBURGH, Scotland, Feb. 22, 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 and viral indications, is pleased to announce the appointment of 4 new members to its Board of Directors.
Joining the board are Mark Bonyhadi, James Culverwell, Arlene Morris and Edward Niemczyk. The new additions became effective upon completion of TC BioPharm's recent IPO. These appointments bring the Company's total board membership to 7.
"We are excited to welcome these new independent directors to our Board," said Bryan Kobel, CEO of TC BioPharm. "They bring decades of expertise and leadership in key areas such as dr-ug commercialization, capital markets and strategic implementation. I am confident that they will provide valuable perspectives as we continue to execute our strategy of developing safe, cost-effective cell therapies for cancer and severe viral infection."
Read the full article here.
Complete TCBP Recap - 5 Potential Catalysts For This New Nasdaq Profile
No. 1 - Positive Interim Data From Phase 1a/2b Study
No. 2 - A Low Float Profile
No. 3 - Oversold Leaning Technicals Could Signal Reversal Potential
No. 4 - Company Uplists To Nasdaq, Could Draw Significant New Attention
No. 5 - New Board Members Provide Invaluable Experience
Coverage is officially initiated on TCBP. When you have time, do this: