ONCY 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-12

• During the second quarter of 2026, we continued with site initiation and expect that approximately half of the planned clinical sites will be activated during the third quarter of 2026.

• In July 2026, the FDA granted Fast Track designation to pelareorep in combination with a checkpoint inhibitor for the treatment of patients with inoperable, locally recurrent or metastatic SCAC who have progressed on or were intolerant to one or more prior lines of systemic therapy.

• In June 2026, we announced initial data from a preclinical study evaluating pelareorep in combination with RAS inhibitor modalities in a solid tumor model, which demonstrate evidence of greater anti-tumor activity in combination than with the individual approaches alone. Based on these findings, we …

• In 2026, our clinical objectives will primarily revolve around our randomized second-line mCRC clinical study. We are actively evaluating multiple strategic partnership options and continue to engage with collaborators, academic partners, and other stakeholders to determine the most effective path f…

• In June 2026, we secured a new U.S. patent protecting our proprietary manufacturing process for pelareorep. Developed through our contracted collaboration with the National Research Council of Canada (“NRC”), this jointly arising intellectual property is automatically assigned to NRC and exclusively…

相对上期删除的文字 · 来源:10-Q · 2026-05-14

• Second-line or later squamous cell carcinoma of the anal canal (“SCAC”)

• First-line metastatic pancreatic ductal adenocarcinoma (“mPDAC”)

• In a randomized two-arm cohort, pelareorep is being evaluated in combination with modified FOLFIRINOX with or without atezolizumab to gain greater clarity regarding the contribution of the checkpoint inhibitor to the efficacy achieved in GOBLET Cohort 1. In that cohort, pelareorep combined with gemc…

• In the first quarter of 2026, we made the determination that we had sufficient patients enrolled in Cohort 5 that would allow us to properly analyze the combinations being tested in the cohort. We expect to present preliminary analysis of the data in the second half of 2026 once survival data has ma…

• We participated in a Type C meeting with the FDA in the fourth quarter of 2025 and agreed on the key elements of a Phase 3 trial of pelareorep in combination with standard-of-care therapy for the first-line treatment of mPDAC. This trial would evaluate pelareorep and gemcitabine/nab-paclitaxel with …