Oncolytics Biotech Inc T.ONC

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

[Noteable]

Here are other relevant posts that have been removed from the Yahoo message board as reported today:

  L

The majority of my posts have been removed once again .... and this is one example of one of them:

This study rationale is the reason for the timeline on the 3 studies as the AWARE-1 and BRACELET-1 were undertaken to validate the findings of the IND-213 study which demonstrated that pelareorep + paclitaxel doubled overall survival in a specific subset of mBC patients which turned out to be HR+/ HER2 Negative mBC patients. The AWARE-1 study confirmed the doublet effect and went on to identify a biomarker which would determined which patients would also benefit from the addition of a checkpoint inhibitor. The BRACELET-1 study is confirming all of the above while the pancreatic cancer study demonstrated how pelareorep turns a cold tumor hot for immune checkpoint addition in breast cancer which is another cold tumor.

Unfortunately some confused puppies here don't understand this.

…
Overall survival rate was not one of the endpoints of the pancreatic study. The rationale for the pancreatic trial was based on the following:

• In prior studies, pelareorep and pembrolizumab did not add
significant toxicity to chemotherapy and showed
encouraging efficacy in second line PDAC patients1
• Prior studies in first-line PDAC achieved encouraging 1 & 2
year-survival rates of 46% & 24%, respectively with
chemotherapy and pelareorep treatment2
• On-treatment biopsies have shown that pelareorep induces
an inflammatory phenotype in the tumor micro-environment
that facilitates synergy with checkpoint blockade therapy
(see pelareorep mechanism of action, Fig 1)1,3,4
• hypothesis was that pelareorep in combination with
pembrolizumab in patients with PDAC would lead to
improved responses and anti-tumor immunological
changes within peripheral blood and tumor biopsies in
responding patients.

The announced data came from this phase 2 trial evaluating pelareorep in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA®) in pancreatic adenocarcinoma patients who progressed after first-line treatment. Findings from the trial indicated that pelareorep and pembrolizumab synergize and showed anti-cancer activity in these difficult-to-treat patients, which is mediated through the complementary immunotherapeutic effects of the two agents.

Key data and conclusions that were presented at ASCO 2021 were :

- Disease control was achieved in 42% (5/12) of patients, with one patient achieving a partial response and four patients achieving stable disease
- On-treatment tumor biopsies showed pelareorep replication and increased infiltration of CD8+ T cells and PD-L1+ cells relative to pre-treatment samples
- Patients achieving disease control showed reductions in pro-tumor regulatory T (Treg) cells in the peripheral blood and tumor tissue compared to those with progressive disease
- Patients achieving disease control showed increased activation of anti-cancer CD8+ T cells in the peripheral blood compared to those with progressive disease
- Pelareorep-pembrolizumab combination therapy was found to be well tolerated, with most treatment-related adverse events being grade 1 or 2

ONCY's PR included the following:

"The findings from this study highlight the broad applicability of pelareorep's immunotherapeutic mechanism of action as they are consistent with what has been seen in clinical trials in other indications such as breast cancer," added Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. "The compelling findings from this phase 2 study highlight the potential of pelareorep to address the critical unmet need in pancreatic cancer by reversing the immunosuppressive TMEs that often limit the efficacy of checkpoint inhibitors. The anti-cancer activity demonstrated in this study bodes well for a successful outcome in our GOBLET trial, which includes a cohort evaluating pelareorep and the PD-L1 inhibitor atezolizumab in combination with chemotherapy as first-line therapy in metastatic pancreatic cancer patients."

.........

Re: In response to pancreatic cancer

Perhaps the sickest of the sickest "indigent" were placed on treatment while the control group were in a far lesser worse condition. Even so .... the investigator found a 42% control rate with the pelareorep + pembrolizumab treated group versus the nontreated control group. The study investigators concluded the effectiveness of the treatment doublet in converting an otherwise immunosuppressive TME in the treated group versus the non-treated since patients achieving disease control showed increased activation of anti-cancer CD8+ T cells in the peripheral blood compared to those with progressive disease.  Patients achieving disease control also showed reductions in pro-tumor regulatory T (Treg) cells in the peripheral blood and tumor tissue compared to those with progressive disease, once again demonstrating the treatment doublet was able to overcome an immunosuppressive TME and by deduction lead to the reversal of t-cell exhaustion, seen with immune checkpoint inhibitor resistance.