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"
16 August 2023 - 4:05PM
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.
“The survival analyses published today in Cancer Discovery
reported that ONC201 frontline treatment, administered post
radiation therapy, demonstrated a statistically significant
increase in mOS from diagnosis versus historical controls (21.7
months mOS vs. 12 months mOS, p<0.0001). These data are
particularly relevant given that enrollment in the ongoing ACTION
study occurs in a similar population. Additionally, these data
further elucidate the underlying novel mechanism of action for
ONC201 in a patient population which has very limited treatment
options,” said Mike Andriole, Chief Executive Officer of Chimerix.
“While these results require validation in prospectively designed
studies, such as the Phase 3 ACTION study, they nevertheless
provide ongoing confidence and rationale for ONC201’s monotherapy
treatment effect and offer hope to the patients, families and
caregivers facing this challenging and life-threatening
cancer.”
“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 StudyThe 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 <52.5kg. OS will be assessed
for efficacy at three alpha-allocated timepoints: two interim
assessments by the Independent Data Monitoring Committee (IDMC) at
164 events and 246 events, respectively, and a final assessment at
327 events. The final progression-free survival (PFS) analysis will
be performed after 286 events, with progression assessed using RANO
HGG criteria by blinded independent central review (BICR).
Secondary endpoints include corticosteroid response, performance
status response, change from baseline in quality of life (QoL)
assessments and change from baseline in neurologic function as
assessed by the Neurologic Assessment in Neuro-Oncology (NANO)
scale. For more information, please visit 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
LaSpaluto919 972-7115ir@chimerix.comWill O’ConnorStern Investor
Relations212-362-1200will@sternir.com
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