Street Calls of the Week
SAN DIEGO - Oncolytics Biotech Inc. (NASDAQ:ONCY), a biotech company with strong market momentum showing a 76% year-to-date return according to InvestingPro data, on Monday outlined the proposed design for its registration-directed clinical trial in first-line pancreatic ductal adenocarcinoma (PDAC), ahead of a scheduled meeting with the U.S. Food and Drug Administration in mid-November 2025.
The planned study will feature a three-arm design where patients will be randomized to receive either standard chemotherapy (gemcitabine plus nab-paclitaxel), the chemotherapy combined with pelareorep, or the chemotherapy with both pelareorep and a checkpoint inhibitor.
The trial will measure overall survival as its primary endpoint and will be statistically powered to detect significant differences between the investigational arms and the control arm. The company has incorporated an interim efficacy analysis to enable early assessment of potential clinical benefit.
According to a company statement, the design builds on a post-hoc, pooled clinical analysis which found that adding pelareorep to chemotherapy achieved an approximate 22% two-year survival rate, compared to 9% for patients treated with chemotherapy alone in historical benchmarks.
Jared Kelly, Chief Executive Officer of Oncolytics, said the company aims to "position this program to deliver meaningful data for patients and regulators alike."
Pelareorep is an investigational intravenously delivered immunotherapeutic agent designed to convert immunologically "cold" tumors to "hot" through activation of immune responses. The FDA has granted Fast Track designation to the company’s development programs for pelareorep in both metastatic pancreatic and breast cancers.
The information is based on a press release statement from Oncolytics Biotech.
In other recent news, BeOne Medicines has reported a series of significant developments. The company announced positive topline results from a Phase 1/2 study of sonrotoclax for relapsed/refractory mantle cell lymphoma, achieving its primary endpoint of overall response rate. This trial involved 125 patients who had previously been treated with a Bruton’s tyrosine kinase inhibitor and anti-CD20 therapy. Additionally, BeOne Medicines secured a $950 million royalty deal with Royalty Pharma, involving the sale of its royalty rights on global sales of Amgen’s IMDELLTRA®, with an upfront payment of $885 million.
Furthermore, the European Commission approved BeOne’s TEVIMBRA for non-small cell lung cancer, demonstrating significant overall survival benefits in a Phase 3 trial. Analyst firm Barclays initiated coverage on BeOne Medicines with an Overweight rating, citing upcoming pivotal data readouts as potential growth catalysts. Citizens JMP also reiterated its Market Outperform rating, highlighting key value drivers for the company. These developments reflect a dynamic period for BeOne Medicines, with implications for its future growth and market positioning.
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