Oncolytics Biotech Inc T.ONC

And That's Not All

[Proboscises]

During the year end conference call a few other items were mentioned by Heineman and de Guttadauro besides stuff about breast and pancreatic cancer.

Tom Heineman: "Lastly, before handing off the call to Andrew, I would like to remind all listening that in addition to its pancreatic cancer cohort, GOBLET also includes cohorts evaluating pela atezolizumab combinations in metastatic colorectal and advanced anal cancer. We expect to have additional updates from these cohorts over the course of the year and have been pleased with the overall enrollment to date."

Andrew de Guttadauro: "One final note, we continue to advance our preclinical CAR-T program in ongoing discussions with multiple potential biopharma and research partners and maintain constructive conversations on a potential clinical trial."

In these conference calls time is limited and company participants tend to mention only those things they consider important.  In this case Heineman mentioned metastatic colorectal and anal cancer, and de Guttadauro mentioned CAR-T. As I discussed in earlier posts I believe we are getting hints that outcomes in the trials with Pela in colorectal and anal cancer, and the animal trial with Pela in combination withb CAR-T are looking good. 

Notice what was said in the year end Financial Results and Operational Highlights:

2023 Anticipated Milestones and Catalysts

• Overall response rate, progression-free survival, and evolving overall survival data from phase 2 BRACELET-1 metastatic breast cancer study: Q2 2023
• Preclinical data from the combination of pelareorep and CAR T therapy: Q2 2023
• Updated advanced/metastatic PDAC data from the GOBLET study: H2 2023
• Updates on the metastatic colorectal and advanced anal cohorts from the GOBLET study: H2 2023
• Guidance for the registration paths for HR+/HER2- metastatic breast cancer and advanced/metastatic PDAC: H2 2023

[jimsenior]

@proboscises. Thank you for your fine read of the call. I only read the release; I thought it very well written and complete. The use of the word - advanced - caught my attention.  I had to look up the meaning. Search Understanding Advanced and Metastatic Cancer. Hope to add again at the end of the month if it doesn't get away from me. Cheers

[jimsenior]

Cohort 1 of GOBLET was for first-line metastatic PDAC patients.  On December 1, 2022 we are advised that ONC/ONCY has received FDA Fast Track Designation for Advanced/Metastatic PDAC. Can one assume that Advanced and Metastatic are the same thing. I do not think the term Advanced was used in the beginning. I guess I am asking if the Fast Track designation applies to a broader group than

[jimsenior]

to myself. A better question. If the EMA or FDA grant Accelerated Approval would all Advanced/Metastatic PDAC patients  potentially be eligible for treatment. Yes I think. I would not be surprised if AA happened.  Time will tell, and yes I know, patience may be required.

[inthno]

Hello all and this is my take only in regards upon who would be eligible. My guess is that it would basically encompass most first line patients as if you look at the onc presentation on their website there was one person who had no metastisis. 18 GOBLET PDAC Patient Profiles: Evaluable Patients PDAC: Pancreatic ductal adenocarcinoma Patient # Age (years) Sex ECOG score Metastases (location

[jimsenior]

@inthno. Agreed. I was only guessing, and your take is more likely. I just found the following, and it is a bit dated. From First Line to Sequential Treatment in the Management of Metastatic Pancreatic Cancer.

[jimsenior]

@inthno. Advanced cancers can be locally advanced or metastatic. Locally advanced means that cancer has grown outside the body part it started in but not yet spread to other part parts of the body. I believe the CR was locally advanced, so using the term Advanced covers that patient. A very important trial for all concerned. Patiently we wait. Best.

[inthno]

It is hard to say what they will include in the trial protocols and please and hope that they use the biomarkers that they keep touting. Basically I think that it will be almost any first line panc patient and they can break it down into sub groups as I think that the first line will respond the best IMO only of course as as they stated in the cc, it would be inhumane to make anyone in the trial