<img src="https://ml.globenewswire.com/Resource/Download/4facea87-f600-4440-a295-a31bb083c9bd?size=2" nborder="0" align="left" hspace="5" vspace="5" title="remix-logo.png" alt="Remix Therapeutics"/>Phase 1 Data Shows a 43% Overall Response Rate at the Recommended Phase 2 Dose and Durable Responses Exceeding One Year and Ongoing, with a Favorable Safety Profile Anti-Tumor Activity Seen Across ACC Subtypes and Regardless of Prior Lines of Therapy 100% Disease Control Rate with Patients Approaching 2 Years on Treatment WATERTOWN, Mass., May 21, 2026 (GLOBE NEWSWIRE) -- Remix Therapeutics (Remix), Inc., a clinical-stage biotechnology company developing small molecule therapies to modulate RNA processing and address the underlying drivers of disease, today announced positive results from its ongoing Phase 1/2 ARIA clinical trial evaluating REM-422, a first-in-class MYB mRNA degrader, in patients with recurrent or metastatic (R/M) adenoid cystic carcinoma (ACC). The data will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2026, delivered by Renata Ferrarotto, MD, professor of thoracic/head and neck medical oncology at The University of Texas MD Anderson Cancer Center. Results from the Phase 1 dose-escalation cohort found anti-tumor activity in patients with R/M ACC across molecular subtypes and previous lines of therapy, including patients who received antibody-drug conjugates. 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. The disease control rate was 100% with several patients approaching two years on treatment with dosing ongoing. REM-422 was generally well tolerated at the RP2D with no dose-limiting toxicities observed. The most common treatment-related adverse events were epistaxis, fatigue, and anemia, all of which were grade 1 or 2. “Patients with ACC have long lacked effective therapeutic options, and REM-422 represents a novel first-in-class oral mRNA degrader targeting MYB. These data show encouraging anti-tumor activity across biomarker-selected patients, along with a favorable safety profile,” said Dr. Ferrarotto. “Notably, tumor responses were durable and deepened over time suggesting potential for long-term benefit.” REM-422 is the first oral mRNA degrader of MYB demonstrating proof-of-concept in ACC. In this study, pharmacokinetic and pharmacodynamic analyses confirmed robust compound exposure in blood and target engagement with reductions in MYB mRNA and protein levels in tumor biopsies. “These positive ARIA trial data, including a significant overall response rate coupled with meaningful durability, 100% disease control and a favorable safety profile, strongly support the potential of REM-422 for patients with ACC,” said Pete Smith, PhD, Co-Founder and CEO of Remix. “We are working to complete enrollment in the Phase 2 portion of the trial and look forward to progressing the development of REM-422 for patients with ACC who have seen minimal therapeutic progress and have no approved treatment options.” About REM-422  REM-422 is a first-in-class, potent, selective, and oral small molecule mRNA degrader that induces the reduction of MYB mRNA and subsequent protein expression. REM-422 functions by facilitating the incorporation of a poison exon in the MYB mRNA transcript, leading to nonsense-mediated decay of the transcript. REM-422 is currently in Phase 1/2 clinical studies in both Adenoid Cystic Carcinoma (ACC) and Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS). The U.S. Food and Drug Administration granted REM-422 Orphan Drug Designation for ACC and AML and Fast Track designation for ACC.   About the ARIA (A study of REM-422 In Adenoid cystic carcinoma) Clinical Trial   This Phase 1/2, open-label, non-randomized, multicenter study (NCT06118086) is investigating REM-422 in patients with recurrent, metastatic or unresectable Adenoid Cystic Carcinoma (ACC). The study includes a Dose Escalation Phase and a Dose Expansion Phase. The purpose of the Dose Escalation Phase is to determine the maximum tolerated dose and/or recommended Phase 2 dose (RP2D) of REM-422 in patients with recurrent, metastatic, or unresectable ACC. The purpose of Dose Expansion is to further evaluate the safety and anti-tumor activity of the REM-422 RP2D in biomarker positive patients.  About Adenoid Cystic Carcinoma   Adenoid cystic carcinoma (ACC) is a solid tumor that most commonly arises in the salivary glands characterized by frequent recurrent, perineural invasion and dysregulation of the MYB oncogene. Depending on the location of the tumor, symptoms may include numbness of the face, difficulties swallowing, changes in vision, or difficulty breathing, among others. Many therapeutic approaches, such as chemotherapy, kinase inhibitors, and immunotherapy have been studied in ACC with modest or disappointing results, and there remain no approved treatment options.  About Remix Therapeutics  Remix Therapeutics is a clinical-stage biotechnology company developing novel small molecule therapies designed to reprogram RNA processing and address disease drivers at their origin. Remix's REMaster™ technology platform leverages cutting-edge data science, biomolecular sciences and chemistry approaches to identify orally administered compounds that modulate gene expression. Remix's innovative therapeutic approach led to the discovery of REM-422, a first-in-class RNA processing modulator in oncology, now being evaluated in Phase 1/2 clinical studies to treat acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (HR-MDS) and adenoid cystic carcinoma (ACC). For more information visit <a href="https://www.globenewswire.com/Tracker?data=3WdjrJjCM6whnokgSy6oCbp_VDMJfCOSbmASmNqoUGZCi6MCp_ppedMNEX_JkYiXpjFAjINLShjiYmZBEH6BXwo3k1HfY-p4zGWRkghYuFU=" rel="nofollow" target="_blank" title="">www.remixtx.com</a>.  Contacts: Media Contact: Lisa Buffington Buffington Comms <a href="https://www.globenewswire.com/Tracker?data=KJBU_SVzzTCntGB3o5sDQRsPavRvEDxQTlL7onJ9N_oF_7-xaqI3GKATMWob1PjA9fV9oQXhH-wv3AyBoB7TxugLS3Iu1hSyyfiLhcQGH_jj7sUv0h7XEe6_ol2Ww4fr" rel="nofollow" target="_blank" title="lbuffington@remixtx.com">lbuffington@remixtx.com</a> Investor Contact: Will O'Connor   Precision AQ <a href="https://www.globenewswire.com/Tracker?data=sLu7zJ8dwUcnIEOl-jWJnDBKpc0FeMHYw-VPSgMP1fKaWwKCwjPjoSJ26dEOQP1ILOVIzFhgvi7acd3kyQE6tANobYyTbQMpxvkn9dRgucDOlhqkek9DNkNSde2_2Tvr" rel="nofollow" target="_blank" title="Will.OConnor@precisionaq.com">Will.OConnor@precisionaq.com</a> <img alt="" src='https://ml.globenewswire.com/media/OTE1ZDFjNDgtYjIwMy00MTIwLWJkZjQtYzBiYzFlMzVhMTVhLTUwMDA5NzUzNS0yMDI2LTA1LTIxLWVu/tiny/Remix-Therapeutics.png' referrerpolicy='no-referrer-when-downgrade' />

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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

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