Chimerix announces launch of ONC201 phase 3 ACTION study

Chimerix "provided an operational update and announced the successful launch of the ONC201 Phase 3 ACTION study at the recent Society for Neuro Oncology Conference, which took place November 16-20, 2022 in Tampa, Florida. CEO Mike Sherman says: "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. 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(R) 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."