OmnImmune (TCB-008) / TC Biopharm - LARVOL DELTA

TCBP Announces Successful Completion of Cohort A in the ACHIEVE Clinical Trial (PRNewswire) - P2 | N=53 | ACHIEVE (NCT05358808) | Sponsor: TC Biopharm | "TC BioPharm...announced that it has concluded dosing of Cohort A patients in the ACHIEVE Phase 2B UK clinical trial....The available data show a favorable safety and efficacy response in Cohort A patients, patients with relapse or refractory AML. No patients have experienced any drug-related adverse event, and preliminary efficacy data demonstrate a number of patients attaining stable disease following multiple infusions of TCB008."

P2b data • Trial status • Acute Myelogenous Leukemia

TCBP Announces Successful Completion of Initial Cohort B Patient Dosing in the ACHIEVE Clinical Trial (PRNewswire) - "TC BioPharm...today announced the first Cohort B patient in the ACHIEVE Phase 2B UK clinical trial, evaluating TCB008 in Acute Myeloid Leukemia, has completed the full dosing regiment....The initial Cohort B patient has completed the dosing regiment, receiving all four planned doses of TCB008, and is expected to receive an additional fifth dose. Enrolment of a second Cohort B patient has also been initiated....We expect to complete enrolment in the second cohort in the first half of 2025, with data readout anticipated later this year."

P2b data • Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

TCBP Provides Update on Acquisition Strategy and Current Targets (PRNewswire) - "TC BioPharm...today announced it has advanced negotiations with both of its previously aforementioned acquisition candidates....TCBP will be focusing its acquisition efforts on two main areas; Natural Kill cell technologies and CAR-related technologies. The Company intends to move forward with near-term acquisition opportunities in the NK space, reviewing several new opportunities in the allogeneic NK space as well as the CAR-NK space. This would expand the Company's efforts into autoimmune disease as well as additional opportunities in solid tumors and combination therapies using both TCB008 and an allogeneic NK cell in combination....TCB008 is an ideal candidate to be modified with new CAR technologies further to enhance its efficacy in solid tumors and other cancers."

Commercial • Oncology • Solid Tumor

TCBP Advances ACHIEVE Phase 2b Clinical Trial with Final Dosing of 3 Patients (PRNewswire) - "TC BioPharm...today announced 3 patients have now completed the full-dose regimen in the ACHIEVE Phase 2b trial in the UK with no drug-related Adverse Events seen in any of the restart patients...The ACHIEVE UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with AML or MDS/AML, with either refractory or relapsed disease...To date, 10 patients have received their first dose, 9 patients have received their second dose, 4 patients have received their third dose, and 3 patients have received their fourth and final dose...'The TCBP team and I look forward to continued success with recruitment and preliminary data from the ACHIEVE study in 2025...Our immediate clinical focus will be high recruitment on Cohort B in 2025 and completing the Cohort A patient set for data review.'"

P2b data • Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

TCBP Partners with CareDx to Support ACHIEVE Clinical Trial Using AlloCell for Pharmacokinetic Monitoring of Allogeneic Cell Therapy (PRNewswire) - "TC BioPharm (Holdings) PLC...announced a partnership with CareDx, Inc...The Transplant Company who will perform pharmacokinetic analysis using its AlloCell solution in the ACHIEVE clinical trial....CareDx's AlloCell test, a sensitive solution for pharmacokinetic monitoring of allogeneic immune and stem cell therapies, will be used to evaluate the expansion and persistence of TCB008 in patients enrolled in the ACHIEVE trial. It is expected that these expansion and persistence data will provide an understanding of the duration and effect of TCB008 Gamma Delta T-Cells in reconstituting the immune system of acute myeloid leukemia patients enrolled in the ACHIEVE trial."

Commercial • Acute Myelogenous Leukemia

TCBP Provides Quarterly Update on the ACHIEVE (UK) Clinical Trial (PRNewswire) - "Cohort B patients with residual disease after initially achieving remission with existing available treatment continue to be actively recruited into the ACHIEVE study at the current TCB008 dose of 230 million Gamma Delta T-Cells. These patients will be recruited at 1 of the 4 active clinical trial sites....Two more sites will be onboarded in the first half of 2025 for 6 recruiting sites in the United Kingdom."

Trial status • Acute Myelogenous Leukemia

TCBP Awarded Non-Dilutive Funding, ScaleReady's G-Rex Grant (PRNewswire) - "TC BioPharm...announced that it has been awarded non-dilutive funding of $250,000 from the G-Rex Grant Program....The $250,000 grant will support TCB008 manufacturing process optimizations over the next 18 months. Dr. Lauren Bor and her team, who lead process development and commercialization efforts at TC BioPharm, will drive process optimizations."

Financing • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TCBP Announces First Patient Completed the Full Dose Regimen in ACHIEVE Clinical Trial (PRNewswire) - "TC BioPharm...announces the first patient has completed the full dose regimen in the ACHIEVE Phase 2b trial ongoing in the UK with no drug related Adverse Events seen in any of the re start patients. As previously stated, patients are eligible to receive up to 4 total doses of TCB under the ACHIEVE protocol. Based on the amended dosing, this patient received approximately one billion cells in the TCB008 dosing regimen....One patient in Cohort A has successfully completed the full dosing regimen having received all 4 doses. Preliminary safety data indicate the 5mL dose of TCB008 is well tolerated, with no TCB008-related Adverse Events....It's expected that a further three patients will have received their 4th and final dose by the end of September....6 Patients received second dose, 3 Patients received third dose, 1 Patient received fourth dose."

Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

TCBP Announces First Patient Completed the Full Fose Regimen in ACHIEVE Clinical Trial (PRNewswire) - "TC BioPharm...today announces the first patient has completed the full dose regimen in the ACHIEVE Phase 2b trial ongoing in the UK with no drug related Adverse Events seen in any of the re start patients. As previously stated, patients are eligible to receive up to 4 total doses of TCB under the ACHIEVE protocol. Based on the amended dosing, this patient received approximately one billion cells in the TCB008 dosing regimen....One patient in Cohort A has successfully completed the full dosing regimen having received all 4 doses. Preliminary safety data indicate the 5mL dose of TCB008 is well tolerated, with no TCB008-related Adverse Events....We are seeing strong recruitment and enrollment at our active sites and expect to be able to announce a full data set in the first half of 2025 inclusive of primary and secondary endpoints."

P2b data • Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Oncology

TCBP Announces Dosing of 5 New Patients in ACHIEVE (PRNewswire) - "TC BioPharm...announces dosing of 5 new patients in the ACHIEVE Phase 2b trial ongoing in the UK...Currently, the trial has successfully dosed 6 patients with their first of 4 possible doses at the higher dose level. Each 5mL dose contains up to 230 million gamma delta T cells, and a patient is expected to receive up to an approximate 1 billion gamma delta T cells over four doses. Five patients have received their second dose, with 2 of these patients having also received their third dose...New patients will continue to be identified, screened, and enrolled into the study....'TCBP remains poised to execute on our clinical trial plans in 2024 and into 2025, including ACHIEVE and ACHIEVE2, as well as our expanded manufacturing capabilities to enhance our operational capabilities and our economic efficiencies.'"

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

TCBP Announces Dosing of 6th Patient in ACHIEVE Study in Patients with Acute Myeloid Leukemia (PRNewswire) - "TC BioPharm...today announced that on July 16, the sixth patient in ACHIEVE (UK) was treated. This is the first patient treated with a higher dose of TCB-008 post the amendment approved by the MHRA on Feb 22, 2024....Enrolled patients will be treated with an increased dose of TCB-008, containing up to 230,000,000 cells per dose compared to the previous dose of 35,000,000....In addition to dosing our 6th patient and restarting ACHIEVE, we've screened and enrolled additional patients into the trial and expect to dose up to 10 more in 2024 and expect to open at least one additional clinical trial site in Q3."

Trial status • Acute Myelogenous Leukemia • Oncology

ACHIEVE - Efficacy and Effectiveness of Adoptive Cellular tHerapy wIth Ex-Vivo Expanded Allogeneic γδ T-lymphocytes (TCB008) for Patients With Refractory or Relapsed Acute Myeloid Leukaemia (AML) (clinicaltrials.gov) - P2 | N=53 | Recruiting | Sponsor: TC Biopharm | N=148 ➔ 53 | Trial completion date: May 2024 ➔ Dec 2025 | Trial primary completion date: May 2023 ➔ Dec 2025

Enrollment change • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

ACHIEVE2 - Safety and Preliminary Efficacy of Intravenous TCB008 in Patients With Relapse or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)/AML (clinicaltrials.gov) - P1 | N=69 | Not yet recruiting | Sponsor: TC Biopharm

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

TCBP Announces Launch of Compassionate Use Program for TCB008 (PRNewswire) - "TC BioPharm (Holdings) PLC...announced that the company's lead therapeutic TCB008 will be available to patients via a newly launched compassionate use program in the UK....Access to TCB's cell therapy products through the compassionate use program will provide medical practitioners with treatment options for patients who are ineligible to access experimental treatments through ongoing clinical trials."

Commercial • Oncology

TCBP Announces Execution of Non-Binding Letter of Intent for Acquisition of NK Platform Technologies (PRNewswire) - "TC BioPharm (Holdings) PLC...today announced the execution of a non-binding letter of intent as part of its M&A strategy aimed at expanding its therapeutic platform and leveraging NK (natural killer) cells in treating both solid tumors and other indications...The target asset acquisition covers the proprietary manufacturing process of two allogeneic CAR-NK therapeutics, both of which TCB believes are valuable as monotherapies as well as in conjunction with TCB-008 in the future. Initially, the CAR platforms both are targeted towards solid tumors, including a CD-70 CAR NK technology and an HER2 CAR-NK technology...Under the terms of the LOI, TC BioPharm has been granted exclusivity while the parties work in good faith on the drafting of a definitive agreement. There can be no assurance that a definitive agreement will be executed or that the proposed transaction will be consummated on the terms or timeframe currently contemplated."

Licensing / partnership • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TCBP Announces MHRA Acceptance of Amendment for ACHIEVE UK Trial (PRNewswire) - "TC BioPharm...today announced that the MHRA has officially accepted its proposed amendment to the Company's clinical trial authorisation (CTA). The amendment allows for an increase in dosing size of TCB008 (unmodified expanded gamma delta T cell Lymphocytes) to 12x10^7-23x10^7 gamma delta t-cells....Additionally the amendment allows for patients to be treated as 'out patients', easing the burden on patients and lessening the burden on clinical sites as patients will not need to be monitored overnight after the first five patients are dosed."

Clinical protocol • European regulatory • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TCBP Provides Shareholder Update and Highlights Upcoming Milestones (PRNewswire) - "2024 Potential Miletones: Interim data review for ACHIEVE trial studying TCB-008 in Acute Myeloid Leukemia; Management is focused on leveraging existing strategic relationships in order to execute partnerships and or collaborations in combination with TCB-008."

Licensing / partnership • P2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TC BioPharm Announces Formation of Commercial Development Division, Led by Industry Veteran, Dr. Lauren Bor Ph.D (PRNewswire) - "TC BioPharm...announced today that the creation of a new Commercial Development Division, which will be headed by Dr. Lauren Bor, PhD...The new division will focus on optimizing production of TCB-008 in anticipation of ACHIEVE data in 2024 as well as the recent IND clearance for TCB-008 in the US, and preparing a clear regulatory path for commercialization, as well as the research of new and developing technologies for future efficiencies in the manufacturing process."

Commercial • P2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TC BioPharm Announces FDA Clearance of Phase 1B IND for TCB-008 in Acute Myeloid Leukemia (PRNewswire) - "TC BioPharm...announced today that the FDA provides clearance on the Company's investigational new drug (IND) application for a Phase 1B study in relapse/refractory Acute Myeloid Leukemia (AML)....The Phase 1B study, dubbed ACHIEVE2, will be a 9 patient, dose escalating study measuring for safety and dose optimization....Additionally, the Company will be continuing the UK ACHIEVE trial in AML, expecting to submit amendments to the protocol before year-end to align the dosing and other criteria with the ACHIEVE2 trial of TCBP's lead product."

Clinical protocol • IND • New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TC BioPharm Announces Successful Completion of Safety Cohort and Positive DSMB Results (PRNewswire) - "The DSMB review was held after completion of enrollment of the initial cohort of the ACHIEVE trial and examined the safety data from all patients enrolled to ensure of no dose limiting toxicities or drug related serious adverse events. TC BioPharm's trial involves administering TCB008, dubbed OmnImmune in the UK, to treat Acute Myeloid Leukemia in a large swathe of patient population. Management now intends to move the ACHIEVE Trial forward with enrollment and will continue dosing patients for the phase 2B clinical trial beginning in 2024, with an additional 14 patients to be dosed prior to an interim look at data. TC BioPharm expects to propose amendments to the existing protocol of ACHIEVE to better align ACHIEVE and ACHIEVE 2 protocols in dosing and other areas in an effort to generate a more heterogeneous data set across trials."

Clinical protocol • DSMB • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TC BioPharm Announces Streamlined Efficiencies and Reduces Overhead with Selection of Single Global CRO for Clinical Trials (PRNewswire) - "TC BioPharm...announced today that it has selected of Fortrea (FTRE) as the Company's Contract Research Organization (CRO) for global trials, including ACHIEVE and ACHIEVE2."

Commercial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TC BioPharm Selects Excellos as CDMO in Anticipation of Expanded US Clinical Trial Requirements (PRNewswire) - "TC BioPharm (Holdings) PLC...announced it has selected Excellos, a San Diego based Contract Development & Manufacturing Organization (CDMO) spun out of San Diego Blood Bank, for its expanding US clinical trial efforts....TCBP's clinical trial plans in the US were also impactful in the decision to engage a CDMO. The Company intends to expand the clinical trial efforts beyond AML in 2024 with additional IND filings, either as an independent sponsor or in conjunction with partners or investigator sponsored trials....The production of the allogeneic cell banks by Excellos will significantly increase access to FDA compliant donors, expanding the current platform and streamlining delivery of TCB008 clinical trials."

Licensing / partnership • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TC BioPharm Announces Submission of Investigational New Drug (IND) Application to U.S. FDA for Treatment of Relapse/Refractory AML (PRNewswire) - "TC BioPharm...announced submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of TCB-008 in the treatment of relapse/refractory Acute Myeloid Leukemia....The IND application leverages pioneering research on the use of Gamma Deltas in the treatment of relapse/refractory Acute Myeloid Leukemia....The FDA will review the application and determine the acceptability of the data before TC BioPharm begins its first clinical trial for TCB-008 It is possible that the FDA will require additional information."

IND • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TC BioPharm Increases Allogeneic Car and Partnering Focus for Advancement of TCB-008 (PRNewswire) - "TC BioPharm...today laid out a fundamental shift in the ongoing development and manufacture of its lead product TCB-008, an allogeneic gamma-delta T cell therapies for cancer, and the Company's CAR modified gamma-delta T cell....The Company's current plans around the advancement of TCB-008 as a monotherapy for Acute Myeloid Leukemia and the ability to manufacture the product to GMP standards will continue with the FDA IND filing in Q3 of 2023 will continue as scheduled and as the final monotherapy trial for TCB-008....A collaborative integration of TC BioPharm's primary asset, TCB-008, will further enable the Company to expand operations into CAR Therapy with a focus on binder B7H3 for the treatment of ovarian cancer....At present the Company has executed three research collaborations around TCB-008 in combination with complimentary approaches and expects to finalize a partnership from one of these collaborations in 2023 for trial in 2024."

IND • Licensing / partnership • Acute Myelogenous Leukemia • Gynecologic Cancers • Hematological Malignancies • Leukemia • Oncology • Ovarian Cancer

TC Biopharm Announces Corporate Restructuring, Reduction in Overhead (Market Screener) - "TC BioPharm...announced a corporate restructuring plan to reduce costs and prioritize its pending lead US clinical programs. In connection with the restructuring, the Company is reducing its workforce up to 30%, with the majority of the reduction expected to be completed during the first half 2023. The remaining team will support both current and future clinical trials and combination trials of our lead therapeutic TCB-008, as well as the allogeneic CAR modified gamma delta program. In total, these restructuring actions are expected to result in cost savings in excess of $3 million on an annual basis."

Commercial • Oncology