Chimerix Announces Data Highlighting Clinical Efficacy and Molecular Mechanisms of Response to ONC201 Treatment of H3 K27M-Mutant Diffuse Midline Gliomas Published in "Cancer Discovery"
17 Aug 2023
Phase 2Phase 3Radiation TherapyClinical Result
Chimerix Announces Data Highlighting Clinical Efficacy and Molecular Mechanisms of Response to ONC201 Treatment of H3 K27M-Mutant Diffuse Midline Gliomas Published in "Cancer Discovery"
Patients Treated with ONC201 Demonstrated Median Overall Survival (mOS) of 21.7 Months in the Front-Line Setting, Post Radiation, Versus 12 Months mOS Historical Control
ONC201 Treatment Disrupts Key Metabolic and Epigenetic Pathways
DURHAM, N.C., Aug. 16, 2023 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced the publication of data in support of the Company’s first-in-class small molecule imipridone, ONC201, as a treatment for H3 K27M-mutant diffuse midline gliomas (H3K27M-DMG) in the peer-reviewed journal, Cancer Discovery, a journal of the American Association for Cancer Research.
The manuscript titled, “Clinical efficacy of ONC201 in H3K27M-mutant diffuse midline gliomas is driven by disruption of integrated metabolic and epigenetic pathways,” reports survival analyses of 71 patients with H3 K27M-DMG treated with ONC201 which demonstrated promising results in a patient population with a poor prognosis and few treatment options. In addition to assessing clinical outcomes, the study corroborated mechanistic findings from laboratory models in samples from treated patients that demonstrated the ability of ONC201 to disrupt metabolic pathways and reverse the epigenetic consequence (H3K27me3-loss) of the H3 K27M mutation.
“H3K27M-DMG represents one of the most difficult tumors to treat,” said Carl Koschmann, M.D., Associate Professor of Pediatric Neuro-Oncology and Clinical Scientific Director of the Chad Carr Pediatric Brain Tumor Center at Michigan Medicine. “Prior to this study, there have been more than 250 clinical trials that have not been able to improve outcomes. These results are potentially a major crack in the armor.”
The complete publication can be accessed here.
About the Phase 3 ACTION Study
The Phase 3 ACTION trial is actively recruiting patients in 11 countries across North America, Europe, the UK, Israel and Asia. The trial enrolls patients shortly after completion of front-line radiation therapy that is the standard of care. The study is designed to enroll 450 patients randomized 1:1:1 to receive ONC201 at one of two dosing frequencies or placebo. Participants are randomized to receive 625mg of ONC201 once per week (the Phase 2 dosing regimen), 625mg twice per week on two consecutive days or placebo. The dose will be scaled by body weight for patients clinicaltrials.gov.
About Chimerix
Chimerix is a biopharmaceutical company with a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The Company’s most advanced clinical-stage development program, ONC201, is in development for H3 K27M-mutant glioma.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things, the relevance of the published survival analyses to the Phase 3 ACTION study, and the confidence and rationale in ONC201’s treatment effect. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks related to the timing, completion and outcome of the Phase 3 ACTION study of ONC201; risks associated with repeating positive results obtained in prior preclinical or clinical studies in future studies; and additional risks set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
CONTACTS:
Michelle LaSpaluto
919 972-7115
ir@chimerix.com
Will O’Connor
Stern Investor Relations
212-362-1200
will@sternir.com
For more details,please visit the original website
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