Drugs / REM-422
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06297941 | Apr 2024 → Mar 2026 overdue | acute myeloid leukemia, myelodysplastic syndrome | Remix Therapeutics | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06118086 | Dec 2023 → Sep 2027 expected | adenoid cystic carcinoma | Remix Therapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-07-16 | Remix Therapeutics | Results Remix Therapeutics™ to Present at AACR Drug Discovery and Development Conference remixtx.com ↗
Presentation to Highlight Phase 1 REM-422 ACC Data Demonstrating 43% Overall Response Rate and Durable Responses Exceeding One Year with Favorable Safety Results |
| 2026-05-21 | Remix Therapeutics | Results Remix Therapeutics™ Announces Positive Data from Phase 1/2 ARIA Study of First-in-Class MYB mRNA Degrader, REM-422, in Patients with Adenoid Cystic Carcinoma (ACC) at the American Society of Clinical Oncology Annual Meeting 2026 remixtx.com ↗
In the recommended Phase 2 dose (RP2D) biomarker positive cohort, the overall response rate was 43% (3 out of 7 patients) with the duration of response exceeding one year and ongoing. |
| 2026-03-19 | Remix Therapeutics | Regulatory Remix Therapeutics Granted FDA Fast Track Designation for REM-422 for the Treatment of Recurrent, Metastatic or Unresectable Adenoid Cystic Carcinoma remixtx.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to first-in-class small molecule MYB mRNA degrader, REM-422, for the treatment of patients with recurrent, metastatic or unresectable adenoid cystic carcinoma (ACC) whose tumors express MYB transcripts containing a poison exon. |
| 2025-10-24 | Remix Therapeutics | Results Remix Therapeutics™ Announces Positive Preliminary Data from Phase 1 Study of REM-422 in Patients with Adenoid Cystic Carcinoma at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics remixtx.com ↗ |
| 2024-11-20 | Remix Therapeutics | Results Remix Therapeutics™ to Present Preclinical Data Demonstrating Anti-Leukemic Activity of REM-422 in AML at the 66th American Society of Hematology Annual Meeting and Exposition (ASH) remixtx.com ↗ |
| 2024-10-16 | Remix Therapeutics | Results Remix Therapeutics™ to Present Preclinical Data Demonstrating Tumor Regressions Induced by REM-422 in Adenoid Cystic Carcinoma Patient-Derived Xenograft Models at the 2024 EORTC-NCI-AACR Symposium remixtx.com ↗
Anti-tumor activity of REM-422 in these models is associated with a reversal of gene transcriptional programs that are associated with ACC, as assessed by genome-wide RNAseq experiments. |
| 2024-06-13 | Remix Therapeutics | Results Remix Therapeutics™ to Present Preclinical Data Demonstrating Anti-Tumor Activity of REM-422 in AML at the European Hematology Association (EHA) 2024 Congress remixtx.com ↗
The poster presentation will include preclinical data from MYB-dependent AML cell lines and human leukemia xenograft models showing REM-422 is broadly active across various AML models. |
| 2023-12-06 | Remix Therapeutics | Results Remix Therapeutics™ to Present Preclinical Data Demonstrating MYB mRNA Degradation in AML at the 65th American Society of Hematology Annual Meeting and Exposition (ASH) remixtx.com ↗
Results demonstrate oral dosing of REM-422 degrades MYB mRNA, inducing anti-leukemic activity in multiple xenograft models. |
All press releases naming this drug 12 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | REM-422 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06118086 ↗ |
| Action | Inhibit | “reduces expression of the MYB transcription factor” NCT06118086 ↗ |
| Modality | Small molecule | “small molecule mRNA inhibitor” NCT06118086 ↗ |
| Route | Oral | “REM-422 will be administered orally once daily” NCT06118086 ↗ |
| Target | MYB | “reduces expression of the MYB transcription factor” NCT06118086 ↗ |