On March 7, 2023 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, reported that the company has taken steps to focus its clinical strategy on the planned future FDA trials for TCB-008 in AML as a monotherapy and other oncology indications in combination with additional assets (Press release, TC Biopharm, MAR 7, 2023, View Source [SID1234628278]).
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The pending protocol submission will be a Phase 1b safety trial, with a relatively small patient population and a short timeline to completion. In conjunction with refocusing the clinical team’s efforts on the USA, the Company intends to file the first IND in the third quarter of 2023 with an expected additional IND to be filed in the fourth quarter or early 2024. At this juncture, the Company is anticipating a dose escalating study of approximately 9 patients with an expansion cohort at the optimal dose.
"Our business development efforts over the last 12 months have generated multiple research collaborations and strategic relationships, the majority of which are US based and beginning to come to fruition," said Bryan Kobel, Chief Executive Officer. "Prioritizing US trials realigns us with our long term goal of becoming a leading commercial stage company, with a myriad of oncological treatment applications for TCB-008 (Omnimmune) as both a monotherapy and as a combination therapeutic. We firmly believe in the potential of our asset and the best way to position the Company for success is to commence with this proposed US trial protocol and to pursue future trials through the FDA pathways. Our partnership with MD Anderson will be valuable, both for this study and future FDA trials, and I anticipate that we’re now better positioned for near term success and sustainability, including potentially multiple data readouts in 2024."
TC BioPharm expects this US clinical trial enrollment to be relatively rapid due to the the fact that America offers a significantly greater pool of patients with more than 20,000 AML diagnoses each year. This transition will allow TC BioPharm to become more economically efficient by simplifying its strategy and reducing manufacturing and production efforts.