Oncolytics Biotech Inc T.ONC

ONCY announces Pelareorep ≥50% ORR & mPFS Improvements

[Noteable]

31% week-16 overall response rate and 9.6-month median progression-free survival with pelareorep plus paclitaxel vs. 20% and 6.4 months with paclitaxel alone as of Oct. 2022 ASCO abstract cut-off date.

https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-positive-randomized-phase-2-data-from-bracelet-1-metastatic-breast-cancer-trial-demonstrating-pelareorep-drives-50-improvements-in-orr-and-mpfs-in-an-asco-annual-meeting-abstract-301835201.html

[Noteable]

Dr. Thomas Heineman, Chief Medical Officer, commented, "BRACELET-1 was a well-conducted study in a randomized setting that included a control arm that performed as expected and a test arm that provides significant evidence of pelareorep's ability to provide additional meaningful clinical benefit in HR+/HER2- breast cancer patients. Mechanistic data from prior clinical trials

[Noteable]

Andrew de Guttadauro added, "BRACELET-1's data greatly enhance our pipeline's value proposition, bringing our breast cancer program to pivotal trial-readiness and confirming pelareorep's potential to address large markets by synergistically combining with other anti-cancer agents. Looking ahead, we believe our data in breast cancer, together with the second registration

[fox7mf]

This positive data is only up to October 2022. We only get the fully updated data (up to May 2023) at ASCO. ASCO gave Oncy a primo oral presentation...ASCO is privy to updated results...we should expect something outstanding. My opinion. 

[westcoast1000]

Good points, fox. 

[Noteable]

The Bracelet-1 results have confirmed ONCY's earlier IND213 study results as well as showing that adding an immune checkpoint inhibitor increases disease control in breast cancer patients were heavily pre-treated and in relapse prior to being entered into ONCY's Bracelet-1 Phase 2 trial. So the very good results coming from this trial is another reason why the Bracelet-1 results were

[Noteable]

Should read: ".... in breast cancer patients who were heavily pre-treated and in relapse prior to being entered into ONCY's Bracelet-1 Phase 2 trial."

[Noteable]

ONCY's Bracelet-1 Phase 2 trial had enrolled heavily pre-treated who had failed earlier therapy including CDK 4/6 inhibitors that Pfizer, Novartis and Eli Lilliy currently have on the market. https://www.globenewswire.com/en/news-release/2022/01/27/2374587/0/en/Global-CDK-4-6-Inhibitor-Drugs-Market-to-Witness-Remarkable-Growth-Backed-by-Growing-Incidences-of-Breast-Cancer-Worldwide-Market-to

[Noteable]

Demonstratng pelareorep's single agent efficacy is critically important for pelareorep's synergistic combination with various immuno-oncology agents including immune checkpoint inhibitors, CAR-T therapy, bispecifics and ADCs, and small molecules PARP and CDK 4/6 inhibitors. Furthermore, along with confirming pelreorep's single agent effectiveness, Bracelet-1 is also demonstrating

[Noteable]

To repeat -  along with confirming pelreorep's single agent effectiveness, Bracelet-1 is also demonstrating pelareorep synergy in combination with an immune checkpoint inhibitor as witnessed by pelareorep + ICIs ORR, PFS, and DCR in Cohort 3 at the time the study abstract was submitted on October 22, 2022 and in advance of the ASCO meeting in June 2023.  Demonstratng pelareorep

[Noteable]

Looks like armedescapade's and Brad's old friends keep popping up and posting their 'wisdom' on this message board.

[Noteable]

ONCY's chart gap closed at $1.74 today. ONC.TO's gap to close on Monday at $2.33. - Ad that's why the stock was down today - not some manipulators' wisdom on how the company is performing, as they would like to suggest.

[Noteable]

Excuse me - ONCY's $1.74 gap was closed this Tuesday before the price closed at $1.79. This weekend's Memorial Day holiday and US congressional bickering over the debt gave ONCY's manipulators everything else they needed for today's sell-off.  

[Noteable]

So getting back to the basics .... pelareorep works as a single agent and in combination with checkpoint inhibitors.

[Noteable]

BRACELET-1's Phase 2 results in a randomized setting that provided significant evidence of pelareorep's ability to produce significant ORR and PFS improvements over the control arm and meaningful clinical benefit in HR+/HER2- breast cancer patients sets the stage for an accelerated approval request in concert with the commencement of a Phase 3 registration study in this partciular

[Noteable]

 ORR and PFS surrogate endpoints improvements are prerquisites for the FDA to grant an accelerated approval request. Bracelet-1 demonstrated that the addition of pelareorep showed significant improvements in these surrogate endpoints, and thus successfully met the primary objectives of the study. Next would be to seek an accelerated approval for pelareorep upon the filing of a Phase 3

[Noteable]

"The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.  A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical

[Noteable]

And ONCY's Phase 2 Bracelet-1 clinical data sets up the scenario for ONCY that Evercore's note surmised. May 17, 2023 - "Thawing of interest in mega-deals would invariably shift consolidation focus to smaller and earlier-stage biotech companies – and more of them," Evercore analysts said in a note.

[Noteable]

And with ONCY's Phase 2 Bracelet-1 clinical data with ORR and PFS endpoints being surpassed, these results set up the scenario for ONCY that Evercore's note surmises. May 17, 2023 - "Thawing of interest in mega-deals would invariably shift consolidation focus to smaller and earlier-stage biotech companies – and more of them," Evercore analysts said in a note.

[Noteable]

Should read:..."And with ONCY's Phase 2 Bracelet-1 clinical data demonstrating at 6 months that ORR and PFS endpoints were surpassed ....  these results set up the scenario for ONCY that Evercore's note surmises."

[Noteable]

From surrogate endpoints and FDA approval to Portland. Who wudda guessed. So getting back to what is relevant to ONCY .... "The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.  A surrogate endpoint is a marker, such as a laboratory

[Noteable]

" The ASCO Phase 2 Bracelet-1 clinical study presentation to May 2023 revealed that pelareorep as a single agent (Cohort 2 - pela+pax) demonstrated a very strong PFS reading of 86% which sets pelareorep up for a accelerated approval with the near full enrollment of a Phase 3 registration study. "The FDA instituted its Accelerated Approval Program to allow for earlier

[Noteable]

The ASCO presentation further confirmed that pelareorep's anti-cancer effects are derived from its ability to reverse immunosuppressive tumor microenvironments and stimulate the expansion of anti-cancer T cells. BRACELET-1's results show an association between T cell expansion and efficacy. and align with earleir study data.

[Azzak34]

Noteable can you just tell everyone it's good news and tomorrow should be positive for the share price please? 

[Noteable]

The Phase 2 Bracelet-1 results provided good news showing that pelareorep works as a single agent, with a significant PFS of 86%, thus making pelareorep now eligible for an Accelerated Approval on its own and in combination with other I/O agents. ONCY has also demonstrated pelareorep MOA in remodeling the TME and expanding T-cells to overcome T-cell exhaustion and escape that other I/O agents

[Noteable]

January 04, 2024 - HR+/HER2- Metastatic Breast Cancer Program and the BRACELET-1 study Promising Randomized Phase 2 Data Readout Supports Previous Near Doubling of Median Overall Survival: Data presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting showed that pelareorep in combination with paclitaxel (cohort 2) resulted in a near tripling of confirmed overall

[Noteable]

Of particular note is that pelareorep (monotherapy) in combination with paclitaxel (cohort 2) resulted in a near tripling of confirmed overall response rate (ORR), a surrogate endpoint (biomarker) that could prompt the filing of an accelerated approval, given that advanced/metastatic HR+/HER2 (-) negative breast cancer is the most common cancer diagnosed in women and is still a cancer with an

[ENEMENEMYNEMO]

World peace? Bot

[Noteable]

Important in the last reported Bracelet-1 results is that pelareorep as a monotherapy in combination with paclitaxel (cohort 2) resulted in a near tripling of confirmed overall response rate (ORR), a surrogate endpoint (biomarker), that could prompt the filing of an accelerated approval.