EDINBURGH, Scotland - TC BioPharm (NASDAQ: TCBP), a biotechnology firm specializing in allogeneic gamma-delta T cell therapies, has reported progress in its ACHIEVE Phase 2b clinical trial. The trial, which is currently underway in the United Kingdom, has successfully administered higher dose levels to a total of six patients, with five of these patients also receiving a second dose, and two among them a third dose.
The ACHIEVE trial is an open-label, phase II study aimed at evaluating the efficacy of TCB008, a potential monotherapy for blood cancers such as acute myeloid leukemia (AML) and myelodysplastic syndromes/AML in patients with refractory or relapsed disease. Each 5mL dose contains up to 230 million gamma delta T cells, and patients may receive up to approximately 1 billion gamma delta T cells over the course of four doses.
CEO Bryan Kobel expressed optimism about the trial's progression, citing strong enrollment and retention rates as indicators of the medical community's interest in TCB008. The company highlighted the re-dosing of patients as a positive reflection of the organizational steps taken in late 2023 and early 2024, including amendments to the trial protocol.
TC BioPharm remains on track with its clinical trial plans for 2024 and 2025. This includes the ACHIEVE and ACHIEVE2 trials, as well as the expansion of manufacturing capabilities, which is expected to enhance operational and economic efficiencies.
The company's pioneering work in gamma-delta T cell therapies positions TC BioPharm as a leader in the field, with the distinction of being the first to initiate phase II/pivotal clinical studies in oncology for this type of therapy. The proprietary allogeneic CryoTC technology allows for the provision of frozen product to clinics worldwide, facilitating the treatment process.
TC BioPharm's announcement includes forward-looking statements, which are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from those projected. The company's performance and achievements are contingent upon these factors, and there is no guarantee that the anticipated benefits of the trial will be realized.
Investors and interested parties should note that this information is based on a press release statement, and TC BioPharm undertakes no obligation to update forward-looking statements to reflect future events or circumstances.
In other recent news, TC BioPharm has secured a European patent for its modified gamma delta T cell therapies, aimed at treating cancer and viral indications. The patent was issued by the European Patent Office and is part of the company's strategy to protect and commercialize its cell therapy products in Europe. Additionally, TC BioPharm has announced compliance with Nasdaq's Minimum Stockholders' Equity Requirement, securing its continued listing on the Nasdaq Global Select Market.
The company has also finalized a direct offering of shares and warrants, raising $2 million, and secured approximately $3.9 million from the exercise of warrants, with H.C. Wainwright & Co. acting as the exclusive placement agent. These funds are intended to advance the company's clinical trial for relapse/refractory Acute Myeloid Leukemia and cover general corporate expenses.
Moreover, TC BioPharm has adjusted the ratio of its American Depositary Shares to ordinary shares, effectively implementing a one-for-10 reverse ADS split, overseen by The Bank of New York Mellon (NYSE:BK). The company has also expressed its intention to acquire a biotechnology firm specializing in Chimeric Antigen Receptor T-cell therapies for cancer treatment, subject to satisfactory negotiations, adequate financing, and necessary third-party approvals. These are recent developments at TC BioPharm.
InvestingPro Insights
As TC BioPharm (NASDAQ: TCBP) advances its ACHIEVE Phase 2b clinical trial, it's important for investors to consider the financial health and market performance of the company. According to InvestingPro data, TC BioPharm has a market capitalization of 3.05 million USD, underscoring its status as a small-cap biotechnology firm. The company's performance metrics reveal significant challenges, with an operating income of -17.04 million USD over the last twelve months as of Q1 2024, reflecting the substantial costs associated with its clinical trials and research endeavors.
InvestingPro Tips highlight that TC BioPharm is quickly burning through cash, which is a critical factor for investors to monitor given the company's developmental stage. The company has also suffered from weak gross profit margins and is not profitable over the last twelve months. This information is crucial for understanding the financial risk associated with investing in a company that is still working towards commercializing its therapies.
Despite these challenges, TC BioPharm has seen a significant return over the last month, with a 28.94% increase in price total return, which may indicate growing investor confidence following recent developments in its clinical trials. However, the stock has experienced a substantial decline over the last year, with a price total return of -95.11%, reflecting the volatile nature of investing in early-stage biotech companies.
For investors seeking a comprehensive analysis, there are additional InvestingPro Tips available, offering deeper insights into TC BioPharm's financial health and market performance. These tips can be found at https://www.investing.com/pro/TCBP, and they may provide valuable context for the company's future prospects in the competitive biotechnology sector.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.