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Endeavor to focus on expanding understanding of gamma-delta T cells in oncological settings
Edinburgh, Scotland – January 19, 2023 – TC Biopharm (Holdings) PLC (NASDAQ: TCBP) (“TC Biopharm” or the “Company”) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer treatment, this week announces a strategic collaboration with The University of Texas MD Anderson Cancer Center to expand the knowledge base of how gamma-delta T cells work in oncology settings.
The collaboration brings together MD Anderson’s clinical trial infrastructure and the translational research expertise of its immunotherapy platform with the clinical data of TC BioPharm’s targeted gamma-delta T cell oncology pipeline. Under the terms of the three-year agreement, the research teams will work together on both preclinical and clinical studies to evaluate the potential for gamma-delta T cell therapies and to better understand the behaviors of these cells in patients. The collaborators will form a six-person steering committee to drive the development of both the data set and subsequent assays for each study.
The comprehensive immunoprofiling capabilities of MD Anderson’s immunotherapy platform will enable correlative studies on clinical samples to uncover detailed insights on the behavior of gamma-delta T cells and corresponding responses in patients. The platform is co-led by Padmanee Sharma, M.D., Ph.D., professor of Genitourinary Medical Oncology and Immunology, and James Allison , Ph.D., regental chair of Immunology.
Formulating a better picture of what is occurring in patients during gamma delta T cell therapies is expected to allow TC Biopharm to better design future studies as well as form a view towards future targeted cancer studies in other blood cancers and solid tumors potentially.
“We are enthusiastic about working with MD Anderson to further our knowledge of gamma delta T cells in order to help TC Biopharm develop future trials and treatments using our platform therapy OmnImmune,” said Bryan Kobel , CEO of TC BioPharm. “This collaboration reinforces our mutual commitment to accelerating the discovery and development of cell therapies, and it highlights TC Biopharm’s expertise in the gamma delta T cell space.”
About TC BioPharm (Holdings) PLC
TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue. TC BioPharm uses an allogeneic approach in both unmodified and CAR modified gamma-delta T cells to effectively identify, target and eradicate both liquid and solid tumors in cancer.
TC BioPharm is the leader in developing gamma-delta T cell therapies, and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line – Phase 2b/3 pivotal trial for OmnImmune® in treatment of acute myeloid leukemia using the Company’s proprietary allogenic CryoTC technology to provide frozen product to clinics worldwide. TC BioPharm also maintains a robust pipeline for future indications in solid tumors and a significant IP/patent portfolio in the use of CARs with gamma-delta T cells and owns our manufacturing facility to maintain cost and product quality controls.
Forward Looking Statements
This press release may contain statements of a forward-looking nature relating to future events. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions. These statements reflect our current beliefs, and a number of important factors could cause actual results to differ materially from those expressed in this press release. We undertake no obligation to revise or update any forward-looking statements, whether as a result of new information, future events or otherwise. The reference to the website of TC BioPharm has been provided as a convenience, and the information contained on such website is not incorporated by reference into this press release.
SOURCE TC BioPharm
- 3 Patients Dosed in 5 Patient Safety Cohort
Edinburg, Scotland – November 22, 2022 – 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 7×10^7 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.
About TC BioPharm (Holdings) PLC
TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue. TC BioPharm uses an allogeneic approach in both unmodified and CAR modified gamma-delta T cells to effectively identify, target and eradicate both liquid and solid tumors in cancer.
TC BioPharm is the leader in developing gamma-delta T cell therapies, and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line – Phase 2b /3 pivotal trial for OmnImmune® in treatment of acute myeloid leukemia using the Company’s proprietary allogenic CryoTC technology to provide frozen product to clinics worldwide. TC BioPharm also maintains a robust pipeline for future indications in solid tumors as well as a significant IP/patent portfolio in the use of CARs with gamma-delta T cells and owns our manufacturing facility to maintain cost and product quality controls.
Forward Looking Statements
This press release may contain statements of a forward-looking nature relating to future events. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions. These statements reflect our current beliefs, and a number of important factors could cause actual results to differ materially from those expressed in this press release. We undertake no obligation to revise or update any forward-looking statements, whether as a result of new information, future events or otherwise. The reference to the website of TC BioPharm has been provided as a convenience, and the information contained on such website is not incorporated by reference into this press release.
SOURCE TC BioPharm
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About TC Biopharm Holdings Plc
Company Overview
We are developing safer, less expensive CAR-T products which can target more cancers and save more lives. We do this using our integrated model which drives the development of our products through preclinical testing to the clinic. Our mission is to develop and commercialize innovative cell-based products and to treat disease, improve patient health and Quality of Life.
TC BioPharm (Nasdaq: TCBP) is a publicly traded, clinical-stage cell therapy company developing advanced allogeneic CAR-T cell therapy products for the treatment of cancer, as well as developing gamma delta T cell therapies for the treatment of infectious disease. Established in 2014, we have expanded into 5 global locations and have grown to over 100 employees.
History
FEBRUARY 2014
TCB was founded
TCB commenced operations in February 2014, leasing space for its lab, office and cleanroom facilities in April 2014. The initial build was completed within 6 months.
JANUARY 2015
TC BioPharm received MHRA approval to initiate cancer trial
TC BioPharm received a license from MHRA to produce gamma delta T cell therapy products at its clinical manufacturing facility near Glasgow, UK.
JULY 2015
TC BioPharm raised £1.2 million for UK cancer trial
TC BioPharm raised equity and grant funding from Scottish Enterprise and Investing Woman.
DECEMBER 2015
Initiation of ImmuniCell® trial
This was an adaptive clinical trial for TC BioPharm’s autologous gamma delta T cell product for melanoma, lung and kidney cancer.
JANUARY 2017
TC BioPharm raised £6.25 million
Funds raised from NIPRO and Scottish Investment Bank for further clinical development of gamma delta T cell therapies.
AUGUST 2017
TC BioPharm granted €4 million from EU H2020 research and innovation program
The funding supported development of TC BioPharm’s clinical program of unmodified allogeneic gamma delta T cell products for the treatment of cancer in a phase 1 clinical trial.
SEPTEMBER 2017
TC BioPharm licensed CAR-T technology from UCL
The agreement was to progress innovative gene-modified T cell therapies capable of treating childhood and adult cancers of the blood such as acute myeloid leukemia (AML).
DECEMBER 2017
TC BioPharm partnered with bluebird bio
The companies continue to work together to advance TC BioPharm’s lead CAR-engineered gamma delta T cell program into clinical trials as well as on additional hematologic and solid tumor targets.
FEBRUARY 2018
TC BioPharm partnered with NIPRO
The strategic partnership co-develops a novel gamma delta CAR-T product for the treatment of cancer.
FEBRUARY 2018
TC BioPharm opened first overseas office in Japan
TC BioPharm opened the new office as a foundation to expand its cell therapy business through Japan and Asia.
MAY 2018
TC BioPharm partnered with Scotia Biologics
Using Scotia’s unique technology, the two companies are working on a range of cancer-targeting single-chain antibodies, each of which can be formulated to treat a specific type of cancer.
JANUARY 2019
TC BioPharm created allogeneic cell banks for CAR-T
Via funding from H2020, TC BioPharm completes formulation of its first allogeneic gamma delta T cell bank.
FEBRUARY 2019
Strategic partnership established with Trinity College Dublin
The partnership with Dublin’s Trinity College was established for in-house production of V delta 1 gamma delta T cell banks for treatment of solid tumors.
MARCH 2019
TC BioPharm extended space at Glasgow headquarters
TC BioPharm used the new space to facilitate manufacturing of GMP lentivirus, a key starting material in the process for creating their pioneering CAR-T cancer therapies.
APRIL 2019
Initiated phase 1 allogeneic gamma delta T cell trial
The trial, for treatment of patients suffering from Acute Myeloid Leukemia (AML), is being conducted at the Institute of Hematology and Blood Transfusion (ÚHKT) in Prague, Czech Republic.
MAY 2019
TC BioPharm opened offices in London and Leiden
Continued growth saw TC BioPharm expand office space in London, UK and Leiden, The Netherlands.
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