Press Release

DURHAM, N.C., Jan. 13, 2025 (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, announced today that Dr. Joshua E. Allen, Chief Scientific Officer at Chimerix, will speak at the Biden Cancer Moonshot Mission Report 2024 – And Beyond. Dr. Allen’s remarks will cover the program’s impact on advancing therapies for brain and rare pediatric cancers, including H3 K27M-mutant diffuse glioma.

“The Biden Cancer Moonshot has significantly improved the approach to cancer diagnosis and treatment with, among other achievements, programs to improve health equity in clinical trials as well as broadening patient navigation services for pediatric cancer,” said Mike Andriole, Chief Executive Officer of Chimerix. “The invitation to speak today is an opportunity to share more about the impact of Biden Cancer Moonshot on cooperative efforts to accelerate promising research in pediatric brain cancer drug development and chart new courses for the future.”

“The Biden Cancer Moonshot has provided a critical platform to advance innovation for pediatric and rare cancers where progress has been limited for decades. I am honored to speak today about the tireless collaborative efforts of researchers, physicians, regulators, and patient advocates to improve outcomes for the most challenging forms of brain cancer. The accelerated development of dordaviprone highlights the importance of this forum. The Biden Cancer Moonshot has provided a critical forum for action to occur with the urgency that cancer patients and their families deserve,” said Dr. Allen.

In December Chimerix submitted a New Drug Application (NDA) for dordaviprone to the U.S. FDA, seeking accelerated approval for recurrent H3 K27M-mutant diffuse glioma. The company also requested Priority Review, which, if granted, could result in a Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2025. Dordaviprone has received Rare Pediatric Disease Designation and has applied for a Rare Pediatric Disease Priority Review Voucher as part of the NDA process.      

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, dordaviprone, is in development for H3 K27M-mutant glioma. The Company is conducting Phase 1 dose escalation studies of ONC206 to evaluate safety and PK data.

About Dordaviprone
Dordaviprone (ONC201) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 (DRD2).

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 possible regulatory path forward for dordaviprone, including the potential to seek accelerated approval, Priority Review, rare pediatric disease Priority Review vouchers and approval for marketing authorization; timing and consequences of an NDA submission to FDA; FDA’s acceptance for filings; the initial potential PDUFA timing. 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 ability to obtain and maintain accelerated approval, Priority Review, rare pediatric disease Priority Review vouchers, and approval for marketing authorization; uncertainty on the response of regulators to including additional supportive data to be submitted in the NDA filing, including RANO 2.0 assessments, and uncertainty with respect to the initial potential PDUFA timing; risks related to the clinical development of our clinical candidates; 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.

INVESTOR CONTACT:
Will O’Connor
Stern Investor Relations
212-362-1200

MEDIA CONTACT:
Dana Davis
Steelwire      
dana@steelwire.co

Source: Chimerix, Inc.