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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Oncolytics Biotech Inc > Before the following is removed from the Yahoo message board

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Comment by Noteableon Aug 14, 2021 5:19pm

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Post# 33706565

RE:RE:RE:Before the following is removed from the Yahoo message board

And so it is ... Unotable on this message board is posting as "R" on the Yahoo message board to which the following responses by "L" were provided:

Guidelines

20 hours ago

ONCY's partner will run the Phase 3 trial and they will decided which endpoint best suits their objective for approval. ONCY will may have input with the partner but the decision of which endpoint will be the partner's since they will be paying the full cost. The rest is speculation that neither you or I can answer so there is no reason to try imagine the what-ifs.

5 hours ago

The following was removed from my responses yesterday ...

OS is the gold standard and no one suggested that the IND-213 trial was the trial that would prompt a partnership. This has already been discussed so I don't know how you couldn't have remembered if you were observant enough.
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Also the IND-213 mBC study was reviewed by the FDA as they granted Fast Track approval and a special protocol assessment (SPA) for a Phase 3 clinical trial with pelareorep + paclitaxel.

The purpose of a SPA is to allow a company to run or initiate a clinical trial of an experimental drug without fear that the FDA will object to the trial design itself, when the company subsequently applies for product approval.

Providing FDA with a clear picture of how the results from a successful study (i.e. IND-213) supports the label claim for the intended indication, an adaptive SPA process is a way to speed product development, like using pelareorep in combination with checkpoint inhibitors.

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Having a predictive / prognostic biomarker serves both to reduce the number of patients in a Phase 3 trial and potentially trial timeline and review process.

3 hours ago

And with respect to any study starting earlier - you might have forgotten that we are still undergoing a pandemic and that many trials were placed on hold since March 2020. Fortunately for ONCY the immuno-oncology cancer research group PrECOG, is running the BRACELT-1 Phase 2 study, and has found ways to re-engage clinical patient enrollment into the trial.
3 hours ago

Given that pelareorep will serve a $56 Billion CPI market - and a CPI partner will pay and undertake the Phase 3 trial - then it's necessary and no time has been wasted in the increase of value generated from the biomarker + CPI work coming from the AWARE-1 and BRACELET-1 studies.

You keep missing the point that that the CPI partner will be paying for the Phase 3 and that both the aforementioned studies were to satisfy both the FDA and the potential CPI partner. What should be of equal importance is that the BRACELET-1 study will be fully enrolled in the next couple of months and that a partner directed Phase 3 will be started a couple months thereafter.