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NASDAQ: TCBP
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TC BioPharm Announces FDA Orphan Drug Status Granted for OmnImmune®
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Hello Everyone,
We have had some tremendous success with our profiles in recent months in a market that has been less than cooperative.
Our last profile was up 12% yesterday in a market where just about everything was red.
This next one was up over 10% yesterday as well with some momentum.
Turn your attention to TCBP immediately.
TC Biopharm (Holdings) Plc, a clinical-stage biopharmaceutical company, focuses on developing immunotherapy products based on its allogeneic gamma delta T cell platform. Its products pipeline includes OmnImmune, an unmodified cell therapy used in the treatment of acute myeloid leukemia; ImmuniStim, an unmodified cell therapy to treat COVID-19; TCB009 for the GI-tract cancer treatment; and TCB005/TCB006 that are allogeneic co-stimulatory GD-T CAR pre-clinical drug candidates would target antigens expressed on various solid tumor types. The company was founded in 2013 and is headquartered in Motherwell, the United Kingdom.
TC BioPharm Announces Positive Phase 1b/2a Data in Late-Stage Acute Myeloid Leukemia Patients Treated with Allogeneic Gamma Delta T Cells
-Complete and near complete responses (morphologic leukemia-free state) observed with OmnImmune® starting at lowest dose level in Phase 1b/2a study for the treatment of relapsed/refractory acute myeloid leukemia
-Results yielded no related serious adverse events, including no Graft v Host Disease, neurotoxicity or cytokine release syndrome at any dose level
Allogeneic product can be stored frozen and used as an ‘off-the-shelf’ cell therapy
EDINBURGH, Scotland, March 8, 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 and viral indications, announces positive interim data its Phase 1a/2b human study evaluating safety and tolerability of TCB-002, OmnImmune®, the Company’s allogeneic unmodified gamma delta t-cell product, a novel therapeutic targeting the potential treatment of relapse/refractory Acute Myeloid Leukemia (“AML”).
7 patients received treatment and 2 patients (enrolled in the low dose cohort) did not reach day 28 assessment and were not evaluable for efficacy per protocol with the third patient being available for safety inclusion but not efficacy.
Of the 7 patients treated, three received OmnImmune®, at a low-dose and four received OmnImmune®, at a higher dose of cells. In the low dose cohort one patient achieved MLFS (morphologic leukemia-free state), one patient achieved stable disease characterized as near complete response and one patient met safety endpoints but was lost to follow-up due to disease co-morbidity (bilateral pneumonia unrelated to OmnImmune® treatment). In the higher dose cohort, 50% of patients achieved complete responses, one patient had progressive disease and one patient exhibited significantly reduced cancer blast count at day fourteen (prior to the study being cut short due to Covid 19).
“We are extremely pleased to receive such positive data from our phase 1b/2a study demonstrating OmnImmune® as safe and tolerable among patients with advanced acute Myeloid Leukemia,” said Bryan Kobel, Chief Executive Officer of TC BioPharm. “These results underline OnmImmune’s potential in becoming a viable AML treatment. We look forward to reporting additional phase 2/3 clinical data during the first half of 2022.”
“These results are very encouraging in such late-stage unresponsive patients, most of whom had very advanced cancer, were fourth or fifth line with no further therapeutic options,” said Dr. Sebastian Wanless, Senior Clinical Director at TC BioPharm. “OmnImmune® comprises allogeneic gamma delta T cells sourced from healthy donors, expanded and activated in large numbers before being purified and formulated for infusion into patients. Our Phase 2b/3 trial will take this therapeutic another step further, incorporating our frozen/thawed product generated from our proprietary universal cell banks of gamma deltas, for a true off the shelf allogeneic cell therapy. During 2022 we plan to evaluate OmnImmune® efficacy in unresponsive first-line of treatment AML patients and expand our clinical trial efforts into multiple blood cancer indications.”
Allogeneic gamma-delta T cell persistence was evaluated in two patients treated. In one patient allogenic product remained detectable after 100 days following three infusions. Another patient demonstrated haematological recovery with sustained elevation in key immune cells over 100 days following the initial infusion.
Clinical data provided evidence of good safety and tolerability profile of OmnImmune® as no product related safety concerns were raised during Safety Review Committee meetings. Moreover, no graft vs host disease, immune effector cell-associated neurotoxicity syndrome or cytokine release syndrome was reported in any of the treated patients.
The two patients exhibiting complete response and stable disease were re-dosed with allogeneic product, and the patient with and morphologic leukemia-free state received two further infusions of OmnImmune®. No toxicities were documented following these repeat infusions.
Dr. Michael Leek, Founder and Executive Chairman commented, “Apart from matched bone-marrow stem cell transplants, patients with unresponsive AML are presented with few viable treatment options. At TC BioPharm we are developing affordable allogeneic cell therapies for blood cancers such as AML, we believe such cell therapies will become a future mainstream standard of care for hematological malignancies.”
About OmnImmune®
OmnImmune® an allogeneic unmodified cell therapy consisting of activated and expanded gamma delta T cells. The trial, for treatment of patients suffering from relapse/refractory Acute Myeloid Leukemia (AML), OmnImmune® comprises GDT cells sourced from healthy donors, expanded and activated in large numbers before being purified and formulated for infusion into patients. OmnImmune® is a frozen and thawed product, now “banked” from donor derived cells. Phase 2/3 trials will begin enrollment in the first quarter of 2022 in the UK with expansion into the US in 2022.
EDINBURGH, Scotland, March 29, 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 and viral indications, announced today that is has received fundamental research coverage from EF Hutton, with a “Buy” opinion rating and a target price of $5.
TC BioPharm Announces Initiation of Equity Analyst Coverage by EF Hutton with a “Buy” Recommendation
The EF Hutton coverage initiation follows TC BioPharm achieving two important recent corporate milestones:
- Positive Phase 1b/2a Data in Late-Stage Acute Myeloid Leukemia Patients Treated with Allogeneic Gamma Delta T Cells
- Announcing orphan drug status had been granted for lead product OmnImmune® for use in Acute Myeloid Leukemia (“AML”)
All reports on EF Hutton prepared by analysts represent the views of those analysts and are not necessarily those of TC BioPharm. TC BioPharm is not responsible for the content, accuracy, or timelines provided by analysts.
A copy of the full analysts’ note can be obtained directly from EF Hutton.
TC BioPharm Announces FDA Orphan Drug Status Granted for OmnImmune®
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Allogeneic unmodified Gamma Delta product can be stored frozen and used as an ‘off-the-shelf’ cell therapy
EDINBURGH, Scotland, March 17, 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 and viral indications, announces orphan drug status has been granted for lead product OmnImmune® for use in Acute Myeloid Leukemia (“AML”). After reviewing the Phase 1b/2a trial results in relapse/refractory AML patients the FDA approved the Company’s application for Orphan Drug Status.
“This is another milestone achieved by TC BioPharm, further strengthening our leadership position in Gamma Delta therapies for oncology,” stated CEO Bryan Kobel. “The granting of orphan drug status provides us a seven-year window post approval of exclusive marketing rights for allogeneic gamma delta use in AML, another added layer of protection around our lead product in a commercial setting beyond our existing strong IP. We look forward to the advancement of OmnImmune® in the Phase 2b/3 trial and to helping patients with AML in the near future.”
Orphan drug status is a designation granted by the Federal Drug Administration for therapies targeting rare diseases. The status allows for a seven-year exclusive marketing window post approval of the drug, certain lowered application fees and tax incentives, broadly.
NEWS
TC BioPharm Announces Positive Phase 1b/2a Data in Late-Stage Acute Myeloid Leukemia Patients Treated with Allogeneic Gamma Delta T Cells
MANAGEMENT
Dr. Michael Leek
Executive Chairman of the Board
Michael Leek, Ph.D., MBA has served as our Chief Executive, co-founder and executive board member since July 2013. Prior to this, Dr. Leek served in senior management and board roles with, Intercytex plc, a cell therapy company he co-founded. While at Intercytex, Dr. Leek was involved in clinical development of cell therapies to treat chromic dermal wounds. Early in his career, he held roles of increasing responsibility at Smith and Nephew from 1989 to 1999 as leader of the Tissue Repair Enabling Technology team. Dr. Leek holds a Ph.D. (Forensic Medicine) from the University of Leeds. He has acted as an honorary lecturer at the School of Medical Sciences, University of Aberdeen since January 2014.
Bryan Kobel
Chief Executive Officer and Board Director
Bryan Kobel serves as our Chief Executive Officer, having joined TC BioPharm, with a view to assuming that role, in June 2021. Prior to joining TC BioPharm he served as Managing Director at EF Hutton from October 2020 as the head of healthcare investment banking. From June 2018 to October 2020, Mr Kobel was Managing Director and head of healthcare/capital markets at the Alberleen Group where he led deal origination and structuring, as well as leading the sales efforts for transactions across the Healthcare and Technology sectors. From April 2017 to June 2018, he was Head of Capital Markets at R.F. Lafferty & Co. From March 2012 to April 2017, Mr Kobel was Managing Director, Capital Markets at Laidlaw & Company. Mr. Kobel holds a BA degree from Franklin & Marshall College and held the FINRA licenses Series 7, 63, 82, 79 and 24.
Angela Scott
Chief Operating Officer
Angela Scott is a co-founder of the Company and served as an executive director of the Company from December 2018 until her resignation from the Board on October 22, 2021. She has served as our Chief Operating Officer since January 2014. Prior to this Ms. Scott was Director of Operations at Angel Biotechnology plc from 2005 to 2012 where she transitioned several cell therapies into clinical trials which included first in man stem cell product for the treatment of stroke. From 2003 to 2004, she served as Development Manager for Cell Culture and Diagnostics at Excell Biotechnology. Prior to this, she served as Senior Research Associate, from 1992 to 2003, at PPL Therapeutics, where she was part of the team that cloned ‘Dolly the sheep’. Ms Scott held roles with increasing responsibility with Imperial Cancer Research Fund from 1981 to 1992. She has acted as an advisory board member of both the ATMP Manufacturing Community and Scottish Stemcell Network. Ms. Scott has a BSc in Biological Sciences from Napier University, Edinburgh.
Martin Thorp
Chief Financial Officer and Board Director
Martin Thorp has been a member of the Board of directors since March 2016 and has served, in an executive capacity, as the Chief Financial Officer since March 2019. From December 2014, Martin was founder (and from 2018 chairman) of a life science financial advisory firm, Copernican Capital Partners Limited (formally NCL Corporate Finance Limited), where he acted as corporate finance adviser to and investor in, several disruptive life science companies. Martin was also a co-founding director of a life science advisory and investment firm NCL Technology Ventures from 2014 to 2018. He was a director of Discovery Park Technology Investments (GP) Limited (and associated investment companies) from September 2016 until July 2018. Martin holds a B.A. in business finance from the University of Kent and qualified as a Chartered Accountant with Arthur Andersen & Co in London in 1977 and became a Fellow of the Institute of Chartered Accountants in England and Wales (ICAEW) in 1986. He was a partner in Arthur Andersen & Co from August 1985, and served in several roles including founder and global managing partner of Arthur Andersen’s international corporate finance business, based latterly in New York. He retired from professional practice in 2002 and consequently ceased to be a member of ICAEW in 2004.
