Key Presentation Highlights Ability of ONC201 to Reverse Epigenetic Signature of H3 K27M Mutation in Glioma Patients

Multiple Preclinical Datasets Support Potential of Imipridone Platform

DURHAM, N.C., April 18, 2023 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced a summary of presentations at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 14-19, 2023 in Orlando, FL.

“We are delighted to share multiple datasets related to our imipridone platform’s potential at this year’s AACR annual meeting among leading cancer researchers,” said Mike Sherman, Chief Executive Officer of Chimerix. “Data presented by Chimerix and our collaborators included preclinical data that further support ONC201’s mechanism of action as an anti-cancer agent with the ability to cross the blood-brain barrier; human clinical data that demonstrate its clinical efficacy; and a trial design to demonstrate clinical benefit in this very vulnerable patient population.”

“These data provide additional evidence for the potential benefit of ONC201 in patients with the H3 K27M mutation,” said Carl Koschmann, MD, Associate Assistant Professor of Pediatrics at the University of Michigan. “This is the first report of any therapy reversing the direct consequence of the oncogenic H3 K27M mutation in tumor tissue from glioma patients and we are excited to further understand these findings and association with activity of ONC201.”  

Results presented by Dr. Koschmann demonstrated that H3 K27M-mutant glioma patients treated with ONC201 experienced a statistically significant reversal of the H3 K27 trimethyl-loss (H3 K27me3-loss) epigenetic signature throughout their tumor compared to patients who did not receive ONC201. Gliomas with the H3 K27M-mutation undergo H3 K27me3-loss, which is a negative prognostic variable among gliomas and thought to be a central pathogenic hallmark of the disease.¹ Concordant findings were also reported in preclinical models that were mechanistically linked to specific metabolic changes induced in tumors by ONC201.

Other presentations at the conference highlighted preclinical oncology studies related to the imipridone platform performed by Chimerix and collaborators at the Brown University Cancer Center. The ongoing ACTION trial, a global Phase 3 clinical trial of ONC201 in newly diagnosed H3 K27M-mutant diffuse glioma, was also highlighted. Further information regarding the data presented at AACR can be found on the Publications page of the Chimerix corporate website.  

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 potential mechanism of action of ONC201 and its activity as an anti-cancer agent. 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 and completion of the Phase 3 ACTION study of ONC201, 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

1. World Health Organization 2021 Classification of Central Nervous System