Remix Therapeutics has enrolled and dosed the first subjects in two Phase I clinical trials of REM-422, a treatment candidate for two types of cancer.
The trials target recurrent or metastatic adenoid cystic carcinoma (ACC) and acute myeloid leukaemia/high-risk myelodysplastic syndromes (AML/MDS).
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REM-422, an oral small molecule messenger ribonucleic acid (mRNA) degrader, aims to reduce MYB mRNA levels and protein expression.
Both trials are open-label, non-randomised, multicentre studies and will evaluate the drug’s safety, pharmacokinetics/pharmacodynamics (PK/PD), and anti-tumour activity.
The trials are structured into a dose escalation phase and a dose expansion phase.
This approach allows researchers to determine the optimal dosage of REM-422 before expanding the trial to a larger patient group.
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By GlobalDataThe dose escalation phase will aid in establishing the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of REM-422.
In addition to the trial commencement, Remix announced that REM-422 received orphan drug designation from the Food and Drug Administration (FDA) for the treatment of ACC and AML.
This designation is given to drugs that address rare diseases affecting fewer than 200,000 people in the US, potentially qualifying the company for various development incentives.
Remix Therapeutics co-founder and CEO Peter Smith said: “Advancing REM-422, the first compound from the REMaster discovery platform, into clinic marks a significant milestone for Remix.
“We are pleased with our first look at safety and pharmacokinetics data in patients and we look forward to further investigating the use of REM-422 to target MYB, a previously undruggable oncogenic transcription factor, for people living with ACC and AML/MDS.”
Earlier this year, Remix secured $60m in a financing round led by The Column Group for developing REM-422.
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