The Molecular Templates Inc (NASDAQ: MTEM) stock price rallied 34% after the United States Food and Drug Administration (FDA) cleared its Investigational New Drug Application (IND) following a review, allowing it to proceed with a clinical trial of its novel MT-8421 ETB program.
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The clinical-stage biopharmaceutical company revealed that its MT-8421 ETB therapy targets CTLA-4 in patients with relapsed/refractory solid tumours previously exposed to checkpoint inhibitors.
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Investors cheered the announcement that paves the way for Molecular Templates to start clinical trials of the MT-8421 ETB program. If successful, it would result in a treatment that targets tumour cells without the toxicity associated with most antibody-based treatments.
The preclinical data gathered by MTEM shows that MT-8421 treatment depleted immune suppressive Tregs in the TME in a transgenic mouse model expressing human CTLA-4 and bearing syngeneic subcutaneous tumours. However, the drug did not affect periphery cells.
In addition, MTEM noted that MT-8421 was well tolerated in a non-human GLP primate toxicology study where it achieved serum levels well above the projected IC50 concentrations for Tregs in the TME.
The company plans to start a first-in-human phase I clinical study with MT-8421 by mid-2023 at a minimum dose of 32 mcg/kg.
Investors cheered the news, as evidenced by the rally in MTEM stock and the over 8.14 million MTEM shares that had changed hands at the time of writing.
Eric Poma, MTEM’s CEO and Chief Scientific Officer, said: “MT-8421 represents a novel approach to target CTLA-4 in a wholly distinct manner from the current monoclonal antibody approaches. MT-8421 was designed to eliminate CTLA-4-expressing Tregs in the tumour microenvironment (“TME”) through a direct cell-kill mechanism independent of the effector cell presence that antibodies rely upon while not affecting Tregs in the periphery, the major mechanism of antibody-mediated autoimmune toxicity.”
*This is not investment advice.
Molecular Templates (MTEM) stock price.
The Molecular Templates (MTEM) stock price surged 34.02% to trade at $0.6299, from Thursday’s closing price of $0.4700.
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