Chimerix Announces Successful Launch of ONC201 Phase 3 ACTION Study at Society for Neuro-Oncology Conference and Provides Operational Update
December 08 2022 - 4:00PM
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 provided
an operational update and announced the successful launch of the
ONC201 Phase 3 ACTION study at the recent Society for Neuro
Oncology (SNO) Conference, which took place November 16-20, 2022 in
Tampa, Florida.
“We are very excited to announce the timely opening of
enrollment for the ACTION study at SNO. Physicians have already
initiated the referral process to ensure recently diagnosed
patients have the potential to enroll in the study. We have also
recently concluded the analysis from our Company-sponsored Natural
Disease History study, which collected data from glioma patients
with similar disease characteristics as those included in the Phase
2 efficacy analysis. These data support a potentially meaningful
overall survival (OS) advantage for ONC201 in the recurrent
setting. Additionally, two analyses presented by external parties
at the SNO conference reported meaningful OS advantages for
ONC201-treated patients in frontline and recurrent settings
relative to external controls derived from clinical trials,
institutional experiences, and real-world evidence. Collectively,
these data support the robust ONC201 Phase 2 results and further
reinforce our confidence in the probability of success of the
ACTION study and the ongoing imperative of advancing this agent for
patients as soon as possible,” said Mike Sherman, Chief Executive
Officer of Chimerix.
“Following recent interactions with FDA, we believe the best
path to approval for ONC201 is successful execution of the
randomized controlled ACTION study and we are focusing resources
appropriately. Additionally, as we near completion of the
transition of TEMBEXA® to Emergent BioSolutions, we are reducing
the size of the organization by approximately 25% in order to focus
our development capability and capital allocation to our oncology
pipeline. We are thankful for the commitment of these talented
employees who have contributed so much to the Company. We will be
working closely with those affected to support them in this
transition. Importantly, we are confident that the steps we are
taking today will help position Chimerix for continued success as
we advance our ACTION study,” continued Mr. Sherman.
Company-Sponsored Natural Disease History Study Supports
Poor Prognosis of Recurrent H3 K27M-mutant Glioma
Data from the recently completed Natural Disease History study
across eleven sites in patients who did not receive ONC201
confirmed poor overall survival for patients with H3 K27M-mutant
glioma, consistent with what was expected based on prior literature
and expert consensus. Chimerix limited the number of sites
contributing to this analysis, as it was not likely to be a
critical element of a potential regulatory submission.
Overall Survival Cohort. In relapsed patients who did not
receive ONC201, the median overall survival following first disease
progression was 5.1 monthsi. This is in contrast to the previously
reported ONC201 Phase 2 data set which showed a median OS of 13.7
months from the start of ONC201 treatment following disease
progression. Rates of survival at 12 and 24 months in the ONC201
Phase 2 analysis were more than double the rates observed in this
analysis of patients who did not receive ONC201.
Objective Response Cohort. The Company also evaluated objective
response by RANO-HGG criteria in patients who received therapies
other than ONC201 but met similar selection criteria used for the
Phase 2 analysis of ONC201 designed to isolate single agent
responses. In the two patients who were evaluable, neither achieved
an objective response. The low number of patients who qualified was
primarily due to the high prevalence of ONC201, bevacizumab and
radiotherapy use during that period of relapse, which would
confound an objective response determination.
The company plans to present a more comprehensive analysis of
the Natural Disease History study at a future scientific
conference.
Two External Presentations at SNO Report an OS Advantage
in Patients Who Received ONC201
Overall survival analyses indicating superior outcomes for
patients who received ONC201, either prior to or after disease
progression, compared to patients who never received ONC201, were
reported at SNO by a team of academic investigators who evaluated
clinical trials and institutional experiences in the United States
and Europe. For patients who received ONC201 prior to disease
progression, the same treatment setting being evaluated in the
Phase 3 ACTION study, the median OS for patients who received
ONC201 was 26.3 months (n=35). This was compared to 12 months for
patients who did not receive ONC201 (n=274, p<0.0001). In the
recurrent setting, patients treated with ONC201 (n=37) had a median
overall survival of 16.2 months compared to 8.1 months for those
not treated with ONC201 (n=99, p=0.05). Authors concluded that
ONC201 efficacy was enriched in patients treated prior to
recurrence.i
Separately, a poster presentation at SNO from xCures evaluated
real world outcomes and treatment patterns among patients with DMG,
which also concluded ONC201 meaningfully extends OS in patients
with DMG.ii
About the Phase 3 ACTION Study
The ACTION trial enrolls patients shortly after
they have completed 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 will be 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.
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 StatementsThis
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
initiation and probability of success of the Phase 3 ACTION study.
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; risks that positive results
observed in prior studies may not be repeated or observed in future
clinical studies, risks that the benefits from our planned
workforce reduction may not be realized; 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.com
Will O’ConnorStern Investor
Relations212-362-1200will@sternir.com
Nick Lamplough / Dan Moore / Tanner
KaufmanJoele Frank, Wilkinson Brimmer Katcher(212)
355-4449
_______________i The median OS was 5.1 months for both patients
with H3 K27M-mutant and/or diffuse midline glioma (N=43) and the
subgroup of patients with H3 K27M-mutant diffuse glioma excluding
DIPG, CSF dissemination, spinal or leptomeningeal disease
(N=12).
ii Sunjong Ji, B.S. et al, “Clinical efficacy and predictive
biomarkers of ONC201 in H3 K27M-mutant diffuse midline glioma, SNO
2022
iii
https://xcures.com/wp-content/uploads/2022/11/20221118-SNO_2022_Poster_xCures_DMG.pdf
Chimerix (NASDAQ:CMRX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Chimerix (NASDAQ:CMRX)
Historical Stock Chart
From Jul 2023 to Jul 2024