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Oncolytics Biotech Inc T.ONC

Alternate Symbol(s):  ONCY

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.


TSX:ONC - Post by User

Comment by itntdfon Nov 04, 2023 10:30am
192 Views
Post# 35717339

RE:itntdf

RE:itntdfThat would seem to be a case of 1 + 1 equals 0 and That doesn’t seem to square with the facts.
 
When PanCan selected Oncy, it was to go into a Phase 3 clinical trial as stated in the following PR:
 
SAN DIEGO, CA and CALGARY, AB, June 22, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced pelareorep has been selected for inclusion as a new investigational treatment in Precision PromiseSM, an innovative adaptive Phase 3 clinical trial. The Precision Promise study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel. If successful, the clinical study is expected to support approval of the studied combination as a treatment for first-line metastatic pancreatic ductal adenocarcinoma (PDAC).  
 
In contrast, the $5 million grant was for an EARLY-PHASE clinical trial.  It would make no sense to postpone an immediate Phase 3-ready situation to wait for something to go through a Phase 1/Phase 2 undertaking so that both could be rolled into a Phase 3 trial.
 
If that were the case, Oncy MIGHT be ready to market around 2030.
 
The following is from the $5 million grand announcement:
 
The Therapeutic Accelerator Award enables the next phase of research for this exciting work by funding an early-phase clinical trial testing the investigational treatment combination: Oncolytics’ proprietary reovirus pelareorep in combination with modified FOLFIRINOX chemotherapy with or without an immune checkpoint inhibitor. If the results are encouraging, the goal is to pursue later-stage clinical trial testing through the PanCAN Precision PromiseSM adaptive clinical trial platform.
 
The following taken from the Precision Promise announcement might be why the 90 day  time frame was not met:
 
"Our next step is to engage with stakeholders to finalize the protocol for Precision Promise's pelareorep-containing investigational treatment so that we can enter into this study...” 
 
Those stakeholders reference might well be Bristol-Myers Squibb which manufactures nab-paclitaxel and Eli Lilly and Co. which manufactures gemcitabine as well as the company which manufactures the checkpoint inhibitor which will be used in the trial.
 

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