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TC BioPharm (Holdings) PLC (NASDAQ: TCBP) is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative immunotherapy products. The company leverages its proprietary allogeneic gamma-delta T (GD-T) cell platform to create novel therapies aimed at treating cancer and viral infections.
Gamma-delta T cells are unique immune cells that possess characteristics of both the innate and adaptive immune systems, enabling them to distinguish between healthy and diseased tissues. TC BioPharm's approach uses these cells to develop effective treatments for various cancers, including both liquid and solid tumors.
Notable achievements include the initiation of phase 2b/3 pivotal trials for OmnImmune® in the treatment of acute myeloid leukemia (AML) using their proprietary allogeneic CryoTC technology, which allows for the distribution of frozen cell products to clinics worldwide. The company also maintains a robust pipeline targeting solid tumors and has built a significant intellectual property portfolio.
Recent developments highlight TC BioPharm's dynamic progress:
- March 1, 2024: CEO Bryan Kobel featured on 'The Big Biz Show,' discussing the company's ongoing advancements.
- March 18, 2024: An institutional investor exercised warrants resulting in a net cash infusion of $1.17M, strengthening the company’s financial position.
- March 19, 2024: The company adjourned its General Meeting to gather additional information for a shareholder vote.
- April 2, 2024: Announcement of a new streamlined manufacturing process to increase patient treatment capacity and reduce costs by 85%.
- April 4, 2024: Execution of a non-binding letter of intent to acquire assets focused on CAR-NK cell therapies, enhancing their cancer treatment capabilities.
- May 6, 2024: Agreement for the immediate exercise of certain warrants, raising approximately £3.1M for clinical trials and operations.
- May 6, 2024: Announcement of a second letter of intent to acquire a company developing CAR-T therapies for solid tumors and autoimmune diseases.
- May 15, 2024: Launch of a compassionate use program in the UK for TCB-008, providing new treatment options for patients ineligible for clinical trials.
TC BioPharm continues to focus on expanding its therapeutic platform, leveraging strategic partnerships, and advancing its clinical trials, all while upholding its commitment to improving patient outcomes.
TC BioPharm (NASDAQ: TCBP) reported progress in its ACHIEVE Phase 2b clinical trial, with 3 patients completing the full-dose regimen without drug-related adverse events. The trial evaluates TCB008 in patients with AML or MDS/AML. Current enrollment status: 10 patients received first dose, 9 second dose, 4 third dose, and 3 completed all four doses. Nine patients are in Cohort A (relapsed/refractory patients), and one in Cohort B (remission with detectable residual disease). The trial aims to recruit 14 patients initially in each cohort, with potential for 10 more per cohort, totaling 48 patients. The 5mL TCB008 dose shows good tolerability with no drug-related adverse events.
TC BioPharm (NASDAQ: TCBP) has announced a special dividend of 0.25 American Depositary Shares (ADSs) for every 1 ADS held by shareholders, subject to shareholder approval. The company will hold a general meeting on December 30, 2024, at 2:00 p.m. (UK time) in Cullen, Scotland. The dividend is expected to be declared on December 30, 2024, with eligibility for shareholders on record as of January 02, 2025.
CEO Bryan Kobel emphasized that this dividend is a reward for shareholder support during challenging market conditions, including what he described as a 'false short and distort campaign.' The specific payment date for ADSs will be announced later.
TC BioPharm (NASDAQ: TCBP), a clinical-stage biotechnology company developing allogeneic gamma-delta T cell therapies, announced a partnership with CareDx (NASDAQ: CDNA) to support the ACHIEVE clinical trial. This phase II, open-label study aims to evaluate the efficacy of TCB008, an allogeneic gamma delta T cell therapy for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS).
CareDx will use its AlloCell solution for pharmacokinetic analysis to monitor the expansion and persistence of TCB008 in patients. The data collected will help understand the duration and effect of TCB008 in reconstituting the immune system of AML patients. Alison Bracchi, EVP of Clinical Operations at TC BioPharm, highlighted the partnership as a significant milestone in developing TCB008. Marica Grskovic, PhD, CareDx Chief Strategy Officer, emphasized the collaboration's role in advancing allogeneic cell therapy for AML patients.
TC BioPharm (NASDAQ: TCBP) provided an update on its ACHIEVE UK Trial for TCB008, a gamma-delta T cell therapy. Over half of Cohort A patients in Stage One have received treatment, showing positive safety signals at the 5mL dose (230 million Gamma Delta T-Cells) with no serious adverse events reported.
The company plans to increase dosage up to 819 million cells to identify optimal levels. Currently, 4 UK clinical sites are recruiting patients, with 2 more sites expected in H1 2025. The trial includes two patient groups: Cohort A (failed standard treatments) and Cohort B (residual disease after initial remission). The company plans to implement increased TCB008 doses alongside a scaled-up manufacturing process in 2025.
TC BioPharm has been awarded a $250,000 non-dilutive grant from ScaleReady's G-Rex® Grant Program to support TCB008 manufacturing process optimizations over the next 18 months. The company aims to increase yields while reducing manufacturing costs by over 80%. The grant will help expedite process optimizations, allowing for expanded yields with a shortened manufacturing process in the first half of 2025, which is 12 months ahead of schedule. The optimizations will increase TCB008 production rate at the existing Maxim Park facility without increasing overhead costs.
TC BioPharm (NASDAQ: TCBP) reported significant progress in 2024, highlighting achievements in its ACHIEVE UK trial for TCB008, where 8 patients have been dosed, including 2 completing all 4 doses. The company expanded trial sites, including Guy's and St. Thomas Hospital, with two more sites planned for Q1 2025. Key developments include signing two LOIs for acquisitions, initiating Mpox treatment research, and forming an AI partnership for donor screening. Financial highlights include a 50% reduction in Q1 cash burn and raising $8 million in Q3. Manufacturing improvements have increased treatment capacity from 52 to over 1,000 patients annually, with an 85% cost reduction per treatment.
TC BioPharm (NASDAQ: TCBP) has officially refuted false social media claims regarding its potential delisting from Nasdaq. The company, which develops allogeneic gamma-delta T cell therapies, addressed rumors from a now-deleted social media post that incorrectly stated the company had filed an 8-K Notice to delist. TC BioPharm confirmed it remains fully compliant with all Nasdaq listing requirements and will continue trading on the exchange. The company indicated it will take action to defend against such misleading claims aimed at creating negative market dynamics.
TC BioPharm (NASDAQ: TCBP) has announced a research planning collaboration with Dr. Carlos Maluquer de Motes for developing a treatment for Monkeypox. Dr. Maluquer de Motes is a Reader and Principal Investigator at the University of Surrey, with expertise in viral diseases. TC BioPharm believes their lead therapeutic TCB008 could play a important role in treating Mpox and other infectious diseases by providing a bolstered level of gamma delta t-cells to generate a more effective immune response.
The company also plans to explore TCB008's use in a prophylactic setting for infectious diseases, potentially supporting immune-compromised patients or those at high risk of infection. Mpox, an infectious viral disease affecting humans and animals, has seen over 100,000 confirmed cases and 200 deaths globally since monitoring began in 2022, according to the World Health Organization.
TC BioPharm (NASDAQ: TCBP) has announced a partnership with Carnegie Mellon University to develop an artificial intelligence solution for optimizing donor screening and matching processes in cell therapy. The company will collaborate with Dr. Wei Wu from the Ray and Stephanie Lane Computational Biology Department to leverage AI in addressing the 'big data problem' of donor variability and patient matching.
The initiative aims to enhance manufacturing yields, improve production processes, and potentially boost patient outcomes. Bryan Kobel, CEO of TC BioPharm, emphasized the significance of this partnership in advancing the cell therapy industry and addressing challenges beyond current HLA matching processes. Dr. Wu highlighted the potential of AI to transform precision medicine and personalized cell therapies.
TC BioPharm (NASDAQ: TCBP) has announced the opening of a new site for its ACHIEVE UK Trial at Guys and St. Thomas Hospital in London. This leading hospital, known for its extensive experience in cell therapy and oncology trials, will contribute to increasing enrollment velocity for the study. Dr. Hugues de Lavallade, a consultant hematologist with over 10 years of experience in myeloid disorders, will serve as the Principal Investigator.
The ACHIEVE clinical trial, which is evaluating TCB008 in patients with AML or MDS/AML, has been progressing positively since a dose increase earlier this year. The company reports strong enrollment and remains on schedule for data release in the first half of 2025. TC BioPharm's Executive VP of Clinical, Alison Bracchi, expressed enthusiasm about the positive feedback from clinicians and the AML community as they continue to activate new sites for this phase II, open-label study.
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