Oncolytics Biotech Inc ONCY

Primary Symbol: T.ONC

Healthcare Biotechnology

Oncolytics Biotech Inc. is a clinical-stage 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 registration-enabling clinical 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 > New Press Release - Oncolytics Biotech® Reports Favorable Results for BRACELET-1 Breast Cancer Study Reinforcing Path to Funding of a Registration-Enabling Study

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Comment by Noteableon Sep 19, 2024 11:31am

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Post# 36231069

RE:RE:RE:RE:RE:RE:RE:RE:New Press Release - Oncolytics Biotech® Reports Favorable Results for BRACELET-1 Breast Cancer Study Reinforcing Path to Funding of a Registration-Enabling Study

Great News on what the FDA considers the primary clinical benefit for an Accelerated Approval of a drug, that of overall survival (OS).

Today's press release demonstrated that Bracelet-1 two (2) year median overall survival (mOS) (24 months) for the pelareeorep + paclitaxel treatment cohort was near 2X over the control group (paclitaxel alone) and the long term OS continues to mature. These results reproduce the Bracelet-1 12 month results and the significantly significant IND-213 Phase 2 overall survival results.

A further take-away is that a confirmed surrogate of overall response rate (ORR) also proved successful over the control cohort. Now ONCY has affirmed that it would be funding the mBC registration study that is the pathway to an Accelerated Approval .

Additionally, the final median progression-free survival (PFS) for BRACELET-1 was 12.1 months in the pelareorep + paclitaxel arm vs. 6.4 months in the paclitaxel monotherapy arm, representing a 5.7-month benefit with a hazard ratio of 0.39.

Final BRACELET-1 Results:

	Paclitaxel (PTX) Monotherapy (n=15)	PTX + Pelareorep (n=16)	PTX + Pelareorep + Avelumab (n=17) 2
Confirmed ORR Over Course of Trial	2 (13.3 %)	6 (37.5 %)	3 (17.6 %)
Median PFS (months)	6.4 (95% CI: 3.7, NR)	12.1 (95% CI: 6.6, 15.9)	6.4 (95% CI: 4.0, 7.5)
PFS Hazard Ratio vs. PTX Monotherapy	-	0.39 (95% CI: 0.12, 1.24)	1.43 (95% CI: 0.49, 4.12)
Median OS (months)	18.2	Not Reached	21.7
Median OS (months)	18.2	Estimate: 32.11	21.7
OS Hazard Ratio vs. PTX Monotherapy	-	0.48 (95% CI: 0.17, 1.35)	1.08 (95% CI: 0.45, 2.57)
24-month OS Rate	33 %	64 %	39 %