On February 7, 2023 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, reported the official dosing of its final patient from the safety cohort for ACHIEVE, its phase 2B clinical trial of OmnImmune (TCB008) for treatment of Acute Myeloid Leukemia (AML) (Press release, TC Biopharm, FEB 7, 2023, View Source [SID1234626940]).
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TC BioPharm’s trial involved administering TCB008, the Company’s novel drug to treat AML, to pathologically confirmed diagnosed patients afflicted with this type of cancer. The initial 5 patients of the trial were spaced two weeks apart with safety review by an oversight board.
This safety cohort is in line with TCBP’s stepwise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient. Pending the final review of the Data Safety Monitoring Board (DSMB), the Company will move to open enrolment of the trial, and expect a positive formal review from the DSMB in February.
"Completing dosing of the safety cohort is yet another step in our efforts and firmly plant TCBP as the leader in the allogeneic gamma delta space in regards to clinical data points and clinical stage," said Bryan Kobel, CEO of TC BioPharm. "I am extremely impressed with the effort of our clinical and operational teams, working collectively throughout the early stages of the trial to coordinate and successfully complete dosing our Safety Cohort. While we experienced minor unforeseen delays, as can be expected with trials involving very sick patients, we secured good visibility into positive levels of recruitment from our sites as we move towards open enrolment."
Kobel continued, "The next several months continue to be highlighted by various catalysts, including moving to our interim review to gauge our dosing levels of these patients. At the 19 patient review we will have the opportunity to increase the dose size for treatment based upon our review of the efficacy and the economies of scale. Additionally, we will be opening new sites to expand the reach of the trial and to increase recruitment success. We look forward to moving quickly to the next stages of this trial and continuing our leadership position and creating shareholder value."
The global market for AML is expected to reach $2.6 billion by 2027, growing at CAGR 15.2% over the forecast period, driven by introduction of high-priced products and strong pipeline of upcoming drugs. The Phase 2B clinical trial is ongoing and is expected to enroll approximately 37 patients. TC BioPharm will report additional results as they become available.