TC BioPharm (Holdings) plc American Depositary Shares - TCBP STOCK NEWS

TC BioPharm (NASDAQ: TCBP) announced a strategic shift toward FDA trials for its TCB-008 therapy targeting acute myeloid leukemia (AML). The company plans to submit a protocol for a Phase 1b safety trial in Q3 2023, followed by additional IND submissions by early 2024. The study aims to include approximately 9 patients, focusing on dose escalation. CEO Bryan Kobel emphasized the importance of U.S. trials to align with their long-term goal of becoming a commercial leader in oncology. This approach aims to simplify operations, improve economic efficiency, and leverage the substantial AML patient pool in the U.S., potentially leading to rapid trial enrollment.

TC BioPharm (NASDAQ: TCBP) has appointed Dr. Michael Leek as Chief Technology Officer, resuming operational duties after previously serving as Executive Chairman since June 2021. With over 35 years in cell-based R&D, Dr. Leek co-founded the company in July 2013 and has extensive experience in clinical development. He aims to drive innovation in gamma-delta T cell therapies for cancer treatment, reporting to CEO Bryan Kobel. TCBP leads in developing these therapies and is conducting pivotal clinical trials for its OmnImmune® product in acute myeloid leukemia, utilizing proprietary allogeneic CryoTC technology to supply clinics globally.

On February 21, 2023, TC BioPharm announced the publication of a Phase I trial paper focused on allogeneic γδ T lymphocytes in treating refractory acute myeloid leukemia (AML). Published in a peer-reviewed journal, the study highlights the safety and feasibility of this cell therapy approach. Dr. Emilio Cosimo expressed pride in the research team's work, supporting further research in the area. CEO Bryan Kobel noted the publication as a significant milestone for the company, which is a leader in developing gamma-delta T cell therapies for cancer. TC BioPharm continues to advance its clinical pipeline targeting liquid and solid tumors.

TC Biopharm, a clinical-stage biotechnology firm focused on gamma-delta T cell therapies for cancer, has appointed Arlene M. Morris as Chair of the Board. Ms. Morris, an independent director since 2022, brings extensive biotech experience, having facilitated high-profile corporate deals and financings exceeding $250 million. CEO Bryan Kobel emphasized her expertise in business development and capital markets, which aligns with TC Biopharm's strategic goals. Morris expressed honor in her new role during a critical growth period for the company, which aims to lead in gamma-delta T cell therapy commercialization. The company is progressing in clinical trials targeting acute myeloid leukemia.

TC BioPharm (NASDAQ: TCBP) has rescheduled its shareholder update call to February 21, 2023, at 12:00 p.m. ET. Originally set for February 20, the call will cover the company's clinical trial plans for gamma-delta T cell therapies in oncology.

Management will provide insights into the company's 2023 outlook and discuss ongoing business development efforts. A Q&A session will follow the opening remarks, allowing investors to submit pre-recorded questions.

TC Biopharm (NASDAQ: TCBP, TCBPW) announced the completion of dosing its final patient in the safety cohort for the phase 2B trial of OmnImmune (TCB008) aimed at treating Acute Myeloid Leukemia (AML).

The trial transition from donor matching to a universal donor model is a significant advancement. The company anticipates a positive review from the Data Safety Monitoring Board (DSMB) in February, enabling open enrollment for 37 patients.

CEO Bryan Kobel expressed confidence in the trial's progress, highlighting recruitment success and upcoming interim reviews to assess dose levels, projecting significant market potential as the global AML market is expected to reach $2.6 billion by 2027.

The acute myeloid leukemia (AML) pipeline is experiencing significant growth, with over 200 companies developing more than 260 pipeline therapies. Notable companies include GlycoMimetics, Takeda Oncology, and TC Biopharm. The report emphasizes the advancement of novel therapies, such as Uproleselan and Pevonedistat, which are in various stages of development including Phase III trials. Additionally, recent designations like orphan drug status from the FDA for AML treatments highlight the urgency in addressing this prevalent disease. The comprehensive analysis covers the therapeutic landscape, including mechanisms of action and routes of administration.

TC BioPharm has appointed Bree Harlin as the new Chief Clinical Officer, effective immediately. With over 20 years of experience in oncology and clinical development, Harlin previously worked at Loxo at Lilly. Her expertise will be crucial as the company aims to expand its clinical trials in the U.S. and submit its first Investigational New Drug (IND) application in the latter half of 2023. TC BioPharm focuses on gamma-delta T cell therapies for cancer treatment and is recognized for its pivotal clinical studies. The company is positioned for growth as it develops its pipeline for various cancer indications.

TC BioPharm, a clinical-stage biotechnology company, will hold a shareholder update call on February 20, 2023, at 10:00 am ET. The meeting will focus on the company's clinical trial plan for allogeneic gamma-delta T cell therapies for cancer, including updates on its ongoing studies for acute myeloid leukemia and future oncology indications. CEO Bryan Kobel and CFO Martin Thorp will lead the call, which will include a Q&A session addressing pre-submitted questions from investors. Interested parties can join via the provided live call numbers or webcast link.