That's bonkers. Follow me for a second.
On two separate occasions in 2023, TCBP has made single day moves of 100+%.
Crazy, I know. But the chart doesn't lie.
No. 3 TCBP Potential Catalyst - Key Milestone Achieved Within Phase 2b Clinical Trial
TC BioPharm Begins Dosing Phase 2B Clinical Study Evaluating its Lead Compound, OmnImmune®, in Patients with Acute Myeloid Leukemia
- 3 Patients Dosed in 5 Patient Safety Cohort
EDINBURGH, Scotland, Nov. 22, 2022 /PRNewswire/ -- 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 today announced the dosing of its first three patients within its Phase 2b clinical trial of OmnImmune®, an allogeneic unmodified cell therapy focused on treating Acute Myeloid Leukemia (AML).
The initial 5 patients in the trial are deemed a "safety cohort", spaced two weeks apart with safety review by an oversight board to confirm no drug related toxicity issues, subsequent to 5 patients being dosed the study will advance to open enrollment. This safety cohort is in line with TCBP's step-wise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient.
"The launch of our Phase 2B trial is a key milestone in the development of our lead therapeutic, OmnImmune®, for patients with AML and for TC BioPharm's emerging pipeline of 'off-the-shelf' gamma-delta T cell therapies," said Bryan Kobel, CEO of TC BioPharm. "This study design includes a 5 patient safety cohort prior to open enrollment, we expect to complete the safety cohort before the end of 2022. The next step in the study is a 19 patient interim review, which will allow TCBP to review dosing and increase dosing to a higher level should our team deem it necessary for efficacy, or we can elect to maintain our current dosing level of 7x10^7 or 700 million cells per dose. We look forward to moving ahead with our Phase 2b trial with a target for open enrollment in January 2023, as well as our efforts to expand our clinical efforts in the US in the first half of 2023."
TC BioPharm's Phase 2B trial, dubbed ACHIEVE, will enroll adults diagnosed with AML who have either relapsed or are refractory to prior treatments as well as a cohort for patients with myelodysplastic syndromes (MDS), conditions that can occur when the blood-forming cells in the bone marrow become abnormal. The trial is expected to enroll approximately 37 patients.
Read the full article here.
No. 4 TCBP Potential Catalyst - Another Amazing Achievement For Company's Lead Product OmnImmune®
TC BioPharm Receives MHRA Approval for 18-Month Extrapolated Shelf-Life of Allogeneic Cell Therapy Product, OmnImmune®
EDINBURGH, Scotland, Sept. 13, 2022 /PRNewswire/ -- 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 today announced that it has received approval from the UK regulatory body MHRA to apply an 18-month extrapolated shelf life to its current allogeneic cell therapy product, OmnImmune®.
This award enables TC BioPharm to ship and store sufficient product which can then be held cryopreserved at clinical sites to fulfill the requirements not only for its current Advanced Myeloid Leukemia trial ACHIEVE, but also for future clinical trials and eventually commercial treatment of patients. Additionally, TC BioPharm's in-house quality control department will continue to gather data in order to extend the shelf-life of OmnImmune®.
Kobel continued, "This approval brings OmnImmune® truly to the forefront as an "off the shelf" cell therapy, with the clinician's ability to bring product from the storage facility to the specialty pharmacy for thawing and deliver the therapeutic to the patient in a short window of time. We look forward to progressing our clinical trials in AML as well as other blood cancers and continue to evaluate partnering opportunities for our allogeneic gamma delta platform and advance our modified CAR gamma delta program."
Read the full article here.
TCBP Recap - These Potential Catalyst Could Provide A Near Term Breakout Spark
No. 1 - A Wildly Low Float Could Create Environment For Daily Volatility
No. 2 - A Super Explosive Chart History (See What Happened Friday?)
No. 3 - Key Milestone Achieved Within Phase 2b Clinical Trial
No. 4 - Another Amazing Achievement For Company's Lead Product OmnImmune®
Coverage is officially initiated on TCBP. When time permits, do this: