The Average Daily Volume is 392,917
Staggering Volume Blasts Through 1,000,000 Shares Traded
Kevin Vander here with another winning alert TC Biopharm (NASDAQ: TCBP) that's currently trending to blow through a staggering 1,000,000 shares traded and the day is still not over!
The daily volume average for TCBP is 392,917...
Get this... TCBP is just about to smash through 1,000,000 shares traded for the day any second now!
The stock also hit a high of $.46 and is currently still trending in the green.
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Read the news in bold below:
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.
Bullish Catalyst H.C. Wainwright Analyst Issued a Buy rating on
TC Biopharm with a price target of $7.00.
According to H.C. Wainwright Analyst, TC Biopharm (NASDAQ: TCBP) has 1,607% upside potential, based on the analysts' price target.
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 First Company to Conduct
Phase II Clinical Trials Oncology
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 using the Company's proprietary allogeneic CryoTC technology to provide frozen product to clinics worldwide.
Robust Development Pipeline And Significant IP/Patent Portfolio
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 their manufacturing facility to maintain cost and product quality controls.
In the biopharma space, cancer is king. Some of the biggest biopharma deals of the last few years have centered on targeted cancer treatments.
The largest drug delivery-related acquisition ($1.9 BIL) took place last year between Amgen (NSDQ:AMGN) and Five Prime Therapeutics (NSDQ:FPRX) to support the former's strategy for international expansion and add to its oncology portfolio.
And take Juno Therapeutics as another example. Founded in Seattle in 2013 to develop immunotherapy drugs, the company was acquired in 2018 by Celgene, a Biotech giant, for a whopping $9 BIL.
Did you know that the FDA's time to approve cancer drugs in the decade ending in 2018 was 48% shorter than it was for treatments in other therapeutic fields?
Immunotherapies that show the potential to revolutionize Cancer treatment could be a top priority for the FDA.
TC Biopharm (NASDAQ: TCBP) New Focus Is To
Really "Target FDA Clinical Trials"
"MD Anderson is the world's leading oncology clinic and we were able to sign a significant agreement with them working with the immunotherapy lab," said the CEO of the Company, Bryan Kobel, noting the Company's additional research collaborations. "We are expecting some fruition from them this year," added Kobel. "The new focus of the company is to really target FDA clinical trials," he continued. "We have been able to execute on a number of initiatives over the last twelve months, which are now bearing fruit, and that is only going to continue."
TC Biopharm a company that has only recently debuted on the NASDAQ, is developing groundbreaking, pioneering, and disruptive therapies with unrivaled applicability to a wide range of cancers and infectious diseases!
Whether the market was up, down, or sideways, there has been a flurry of biopharma companies hitting the public equity markets as the search for coronavirus-related innovation in treatments and vaccines has led to increased public and investor interest in the industry.
TC Biopharm Announces Grant Funding Collaboration University of London
EDINBURGH, Scotland, Sept. 5, 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, is proud to announce it has entered into a collaboration agreement with Queen Mary University of London (QMUL) to research the therapeutic potential of gamma-delta T cells for the treatment of mucosal infections. The collaboration recently received grant funding from The Impact Fund arm of QMUL. TC BioPharm will be working in conjunction with Dr. Neil McCarthy's lab out of QMUL.
"We are grateful for the support from the Queen Mary University of London Impact Fund and appreciate Dr. McCarthy and his team taking this initiative on with enthusiasm," said Bryan Kobel, CEO of TC BioPharm. "Dr. McCarthy's lab is a leading institution in the gamma delta field focusing on gut health and microbial infections, a great area of interest for TCB. This is an exciting oppor∙tunity for our company and QMUL, the collaboration is a good starting point for both groups with the potential to extend into future engagements and asset spinoffs, while simultaneously expanding the TCB-008 platform into new indications. We believe the data set here and in future endeavors will further showcase the therapeutic benefit of the gamma delta T-cells centering around their role in immunotherapy's future.
"My team is excited about working with TC Biopharm to explore the anti-microbial potential of γδ cell therapies," stated Dr. McCarthy. "Our data suggests this could be a promising approach to preventing gut barrier damage in context of mucosal infection and inflammation. We look forward to learning more from this new collaboration and exploring novel routes for translating γδ cell potency into the clinic."
TC Biopharm (NASDAQ: TCBP) Positions Itself With Incredible
Leadership For Maximum Upside Potential
What if there was a revolutionary way to potentially kill tumor cells? A way that isn't getting nearly enough attention as it should...
The biopharma space is a treasure hunt for investors who scope the markets for promising companies that may hold the future of cancer treatment in their hands.
TC Biopharm therapies are focused on leveraging the inherent biological capabilities of gamma delta T cells (GDT cells) together with an integrated cell engineering approach!
What TCBP is doing could be a game-changer for cancer treatment moving forward...
Unlike the alpha beta T cells commonly used in CAR-T immunotherapy, gamma delta T cells play a role in the innate immune response, which constitutes the first, faster line of defense of the immune system.
Human gamma delta T cells (GDT cells) have extraordinary properties, including the capacity for tumor cell killing. These cells have the potential to overcome many problems in cancer therapy, especially for tumors with no known treatment.
GDT cells constantly monitor the body for signs of biological stress, such as cancerous or infected cells, and are one of the first lines of defense against disease.
How do they do this? By detecting changes in the cells, mediated by a complex series of events, the effect of which is common across all cancers and infections.
H.C. Wainwright Analyst Target Price Represents 1,607% Upside Potential
They activate a wider immune response through antigen presentation and cytokine/chemokine release.
They are completely safe for healthy cells and will not kill them, even when introduced at very high numbers.
They are naturally cytotoxic via a number of different mechanisms.
They are primed to infiltrate tissue, seeking sites of cellular stress and are biologically equipped to enter, reside and survive in a hostile tumor environment.
The GDT cell receptor is not MHC-restricted. This means that if GDT cells from a donor are transferred to a patient, the GDT cells don't recognize the patient's body as foreign and don't cause graft versus host disease (GvHD). This makes them ideal for allogeneic "off the shelf" therapies.
They can be gathered from healthy donors, expanded to very high numbers, banked and frozen, using our validated GMP methods, providing a readily available starting material for manufacturing multiple products.
H.C. Wainwright Analyst Target Price Represents 1,607% Upside Potential
TCBP - Clinical Expertise with a Game - Changing Approach
TCBP's broad platform technology allows the company to design specific therapies to treat a broad range of cancers and infectious diseases with "off the shelf" allogeneic gamma delta T cell (GDT) products.
The company 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's lead candidate, TCB002, is in phase 1 for acute myeloid leukemia. TCBP is also developing a cell therapy for COVID-19!
TCBP is conducting two clinical trials for its unmodified gamma-delta T cell product ImmuniStim - a phase II/III pivotal trial in treatment of acute myeloid leukemia and a Phase I trial in treatment of COVID-19 patients.
ImmuniStim uses the company's proprietary allogenic CryoTC technology to provide frozen product to clinics worldwide.
The company 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 its manufacturing facility to maintain cost and product quality controls.
The company's stepwise approach to clinical development has enabled TCBP to take a logical, safer, and more agile approach to their clinical trials!
By starting with an autologous, unmodified gamma delta product, the company was able to establish safety prior to entering the clinic in 2018 with their unmodified allogeneic product.
Now, TCBP's focus is on clinical development and refinement of products based on the ideal GDT vehicle with a proprietary genetic CAR-T arsenal to fight a range of cancers.
TCBP - Exciting Oppor∙tunities Exist for the Massive Cancer Market
Cancer is a curse, undoubtedly, but it is also a growth market for investors:
According to Precedence Research, the global cancer drug market size is expected to be worth around $272 BIL by 2030 from at $136.2 BIL in 2020, growing at a CAGR of 7.2% from 2021 to 2030.
The American Cancer Society has found that over 1.8 million new cancer cases and 606,520 deaths were reported in the US in 2020.
According to researchers at Penn State College of Medicine, in 2018 the top 15 types of cancer cost the U.S. more than $156 BIL. The National Cancer Institute projects that cancer-related medical costs will skyrocket to $246 BIL by the end of this decade.
It is the increasing awareness regarding the availability of various new therapies to treat cancer that is fueling the demand for cancer drugs and treatments among global cancer patients.
TCBP is the latest contender in the enormous biopharma space that includes giants like Bristol-Myers Squibb and Pfizer...
The company's focus on ground-breaking T-cell therapy could quickly catapult it to the frontline.
TCBP is on a mission to develop safer, less expensive treatments that could target more cancers and potentially save more lives!
Analysts are anticipating that large drug makers will have big piles of ca∙sh to deploy this year, which could lead to some major mergers and acquisitions.
According to a recent interview with CEO of the Company, Bryan Kobel "The Company is preparing to expand into the UK, while also working on launching their Phase 1B in the US. "There is an oppor∙tunity here to really change how cancer is treated."
TC Biopharm (NASDAQ: TCBP) New Focus Is To
Really Target FDA Clinical Trials
"MD Anderson is the world's leading oncology clinic and we were able to sign a significant agreement with them working with the immunotherapy lab," said Kobel, noting the Company's additional research collaborations. "We are expecting some fruition from them this year," added Kobel. "The new focus of the company is to really target FDA clinical trials," he continued. "We have been able to execute on a number of initiatives over the last twelve months, which are now bearing fruit, and that is only going to continue."
Conclusion:
Between the breaking news that was just released, and enormous surge in volume, I predict it going very well for us.
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