SAN DIEGO and CALGARY, AB - Oncolytics Biotech Inc. (NASDAQ: NASDAQ:ONCY) (TSX: ONC), a biotechnology company focused on the development of oncology therapeutics, announced today the positive outcomes from its BRACELET-1 Phase 2 study on pelareorep, a cancer immunotherapy treatment for HR+/HER2- advanced or metastatic breast cancer.
The final results of the BRACELET-1 study revealed that the median overall survival (OS) has not been reached in the pelareorep plus chemotherapy arm since over half of the patients were still alive at the study's conclusion. In contrast, the median OS for the control group receiving chemotherapy alone was recorded at 18.2 months. The estimated median OS for the pelareorep plus chemotherapy arm would be at least 32 months if the follow-up had continued beyond two years.
The data also showed a near doubling of the two-year survival rate for patients treated with the pelareorep combination therapy compared to those receiving only chemotherapy. Furthermore, the study found a significant improvement in progression-free survival (PFS) for patients receiving pelareorep, with a median PFS of 12.1 months versus 6.4 months in the control group.
Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors, expressed that the results highlight the potential of pelareorep treatment in extending the lives of breast cancer patients. Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics, added that the overall survival and PFS outcomes surpassed expectations and support the further development of pelareorep-based combination therapies.
The company is now looking to secure funding for a registration-enabling study, having discussed key design elements with the FDA. The BRACELET-1 study randomized 45 patients into three cohorts, with the primary endpoint being the overall response rate at week 16. The study also explored progression-free survival, immune response markers, and safety.
Christophe Degois, VP of Business Development for Oncolytics, mentioned the potential market impact of pelareorep, citing an opportunity to affect approximately 55,000 patients in the U.S. alone.
This news is based on a press release statement from Oncolytics Biotech Inc. and contains forward-looking statements regarding the potential and benefits of pelareorep as a cancer therapeutic. The company's plans for future studies and commercial opportunities involve known and unknown risks that could affect actual results.
In other recent news, Oncolytics Biotech Inc. has received FDA endorsement for a potential registration-enabling trial for its drug candidate pelareorep, aimed at HR+/HER2- metastatic breast cancer. This significant regulatory development came after a Type C meeting with the U.S. Food and Drug Administration. The upcoming trial will enroll patients who have not responded to hormonal therapy and have undergone no more than one line of antibody-drug conjugate therapy.
In further developments, the company announced a change in leadership due to President and CEO Matt Coffey taking a medical leave of absence. Wayne Pisano, current Chair of Oncolytics' Board of Directors, will assume the role of interim CEO. Pisano's extensive experience in the pharmaceutical industry will serve him well in this interim role.
Investors will be looking forward to the overall survival data from Oncolytics' BRACELET-1 breast cancer study, expected in the second half of the year. The company's commitment to bringing pelareorep to patients is supported by Fast Track designations from the FDA for its breast and pancreatic cancer programs. These are the recent developments in Oncolytics Biotech.
InvestingPro Insights
In light of Oncolytics Biotech Inc.'s recent announcement regarding the positive outcomes from its BRACELET-1 Phase 2 study, InvestingPro provides some financial metrics and analytical tips that may be of interest to investors evaluating the company's prospects.
InvestingPro Data reveals that Oncolytics Biotech Inc. holds a market capitalization of approximately $17.45 million USD. Despite the promising clinical results, the company's financials show a Price to Earnings (P/E) ratio of -4.21 for the last twelve months as of Q2 2024, reflecting the market's anticipation of future earnings challenges. The data also indicates a Gross Profit Margin of 63.34% for the same period, which suggests that while the company can generate a robust gross profit on each dollar of revenue, it is currently not translating into net profitability due to other expenses.
Among the InvestingPro Tips, two particularly stand out for Oncolytics Biotech Inc.:
1. The company is quickly burning through cash, which is a critical factor for investors to consider given the high costs associated with advancing clinical trials and potential commercialization.
2. Analysts do not anticipate the company will be profitable this year, which aligns with the negative P/E ratio and could impact investment decisions.
These insights, along with additional InvestingPro Tips available at https://www.investing.com/pro/ONC, can provide a deeper understanding of the company's financial health and market position. As of now, there are a total of 8 InvestingPro Tips listed for Oncolytics Biotech Inc., offering a comprehensive analysis for potential investors.
While the clinical outcomes are promising for Oncolytics Biotech Inc., the InvestingPro Insights suggest that the company's financial position is an important consideration for stakeholders and potential investors looking to understand the full picture of the company's market potential and risks.
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