TC BioPharm (TCBP) Falls Despite FDA Clearing IND for AML Drug
TC BioPharm (Holdings) PLC TCBP announced that the FDA has cleared the investigational new drug (IND) application to begin a clinical study on its lead pipeline candidate, TCB008 (omnImmune), in the United States. The candidate is being developed for the treatment of relapse/refractory acute myeloid leukemia (AML), a type of blood and bone marrow cancer.
Made of activated/expanded gamma delta T cells, TCB008 or OmnImmune is an allogeneic unmodified cell therapy.
Clinical-stage biopharmaceutical company TC BioPharm is planning to begin the phase Ib ACHIEVE2 study, which will measure the safety and dose optimization for TCB008 in the given patient population in the United States.
Per the company, the ACHIEVE2 study will be conducted in two parts (dose escalation followed by dose expansion) and will investigate the safety, persistence/expansion and preliminary efficacy of single and multiple intravenous (IV) doses of TCB008 in nine patients with AML or MDS/AML.
Despite the FDA clearing the IND for TCB008, shares of TC BioPharm were down 25.5% on Monday following the announcement of the news. However, the stock rebounded in after-hours trading and was up 12.2%.
Shares of TC BioPharm have plunged 89.1% so far this year compared with the industry’s decline of 22.9%.
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In October 2023, TCBP submitted the IND for TCB008 to the FDA. The regulatory body had previously granted an Orphan Drug designation to TCB008 for treating AML.
TCB008 is currently being evaluated in the phase IIb ACHIEVE study for the treatment of AML in the United Kingdom.
Zacks Rank & Stocks to Consider
TC BioPharm currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CytomX Therapeutics, Inc. CTMX, Entrada Therapeutics, Inc. TRDA and Puma Biotechnology, Inc. PBYI, sporting a Zacks Rank #1 (Strong Buy) each.You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 10 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 22 cents. Year to date, shares of CTMX have lost 16.9%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. Year to date, shares of TRDA have lost 7.5%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 62 cents. Year to date, shares of PBYI have risen 6.1%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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TC BioPharm (Holdings) PLC Sponsored ADR (TCBP) : Free Stock Analysis Report
