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Oncolytics Biotech Inc T.ONC
Alternate Symbol(s): ONCY
Healthcare Biotechnology
Oncolytics Biotech Inc. is a 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 phase 3 licensure-enabling studies. In addition, it is exploring opportunities for registrational programs in other gastrointestinal cancers through its GOBLET platform study.
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Comment by Noteableon May 19, 2024 9:59am
70 Views Post# 36047873
RE:RE:RE:RE:RE:RE:Type C Meeting Timings
ONCY has earlier stated that they submitted a "compelling" brief, that happens to be documentation that suffficiently supports the purpose of the requested meeting, which in
At timestamp 24:20 Matt Coffey said the following "... We have submitted a request for a Type C meeting with the agency. We'll have that later in the month and they have 35 days to give us their definitive (undiscernible) but I think this was a much more efficient way to get us to a BLA .."
So as it stands the Type C meeting will happen before ASCO 2024, which is in 2 weeks time, and that means that ONCY's meeting package has been received by the FDA for review (and which ONCY had already stated is 'quite compelling'), with the FDA's definitive response coming 35 days after the meeting. So ONCY will have a "heads-up" from the FDA later this month, and the FDA's definitive response towards the end of June.
ONCY's case is to guide a discussion with the FDA to align on the design and objectives of the registrational trial for pelareorep in breast cancer.
One could surmise that based on what ONCY has stated, the alignment with the FDA will be on the use of clinically identified biomarkers and conventional surrogate endpoints of ORR, PFS and OS to drive the accelerated approval of pelareorep in an expanded HER2 failed breast cancer population of patients, that includes all patients from early stage to late stage metastatic breast cancer, who have failed both estrogen and ADC therapy, and where a significant "unmet treatment need" exists.
By moving into the expanded treatment of breast cancer with pelareorep, such a strategy would open up the breast cancer market to pelareorep and set the stage for pelareorep to be subsequently used in combination with ADC and immune checkpoint inhibition in synergistic triplet combination therapies, that is highly more effective than when therapies are used as a monotherapy, as is currently the practice.