Oncolytics Biotech Inc ONCY

Primary Symbol: T.ONC

Healthcare Biotechnology

Oncolytics Biotech Inc. is a clinical-stage biotechnology company. The Company is focused on developing pelareorep, an intravenously delivered immunotherapeutic agent that activates the innate and adaptive immune systems and weakens tumor defense mechanisms. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype turning cold tumors hot through innate and adaptive immune responses to treat a variety of cancers. This improves the ability of the immune system to fight cancer, making tumors more susceptible to a broad range of oncology treatments. The Company’s primary focus is to advance its programs in hormone receptor-positive / human epidermal growth factor 2- negative (HR+/HER2-) metastatic breast cancer and advanced/metastatic pancreatic ductal adenocarcinoma to registration-enabling clinical studies. In addition, it is exploring opportunities for registrational programs in other gastrointestinal cancers through its GOBLET platform study.

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Oncolytics Biotech Inc > AstraZeneca's ADC disappoints - on severe adverse events

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Comment by Noteableon Nov 30, 2023 3:45pm

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Post# 35761958

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:AstraZeneca's ADC disappoints - on severe adverse events

https://investor.immunogen.com/news-releases/news-release-details/immunogen-announces-fda-accelerated-approval-elaheretm

MIRASOL, the confirmatory Phase 3 randomized trial designed to convert the accelerated approval of ELAHERE to full approval, and top-line data was released in May 2023.

MIRASOL demonstrated an ORR of 32% and mDOR 6.9 months seen in the singlearm Phase 2 SORAYA study to support accelerated approval by the FDA.

During the Biologics License Application review, FDA requested ImmunoGen submit preliminary ORR and DOR data from both arms of MIRASOL. To maintain data integrity for the ongoing MIRASOL trial, an independent third-party statistician performed the analyses and submitted the outputs directly to FDA.

The study met its primary and key secondary endpoints with statistically significant results in PFS (INV), ORR (INV), and OS

https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.17_suppl.LBA5507

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