Pelareorep shows promising results in colorectal cancer treatment

SAN DIEGO - Oncolytics Biotech Inc. (NASDAQ:ONCY), a $106 million market cap biotechnology company whose stock has surged over 50% in the past six months, reported Monday that its immunotherapy drug pelareorep demonstrated significant survival benefits in patients with KRAS mutant metastatic colorectal cancer (mCRC), according to a company press release. InvestingPro data shows the stock trading near its Fair Value, with strong momentum indicators catching analysts’ attention.

In the REO 022 trial, pelareorep combined with FOLFIRI and bevacizumab achieved a median progression-free survival of 16.6 months in second-line KRAS mutant mCRC patients, compared to 5.7 months with standard treatment. The median overall survival reached 27.0 months versus 11.2 months with standard regimens. These promising results have contributed to three analysts revising their earnings estimates upward for the upcoming period, according to InvestingPro data.

The drug also showed efficacy in the GOBLET study’s third-line mCRC cohort, where pelareorep combined with atezolizumab and TAS-102 met predefined endpoints with disease control rates exceeding historical benchmarks.

Translational data from multiple studies confirmed pelareorep’s mechanism of action, showing viral replication in colorectal tumors and immune activation, including dendritic cell maturation and CD8+ T cell activation.

"These studies validate pelareorep’s mechanism of action and present a clear opportunity to accelerate the pursuit of a registration-enabled study in the underserved KRAS mutant subset of mCRC patients," said Jared Kelly, CEO of Oncolytics, in the statement.

Dr. Sanjay Goel, professor at Rutgers University, plans to initiate an investigator-sponsored trial to further explore the drug’s potential in KRAS mutant mCRC.

The company intends to work with investigators and regulators to define a path to registration in mCRC, including the design of a confirmatory study leveraging data from the KRAS mutant patient setting.

Pelareorep has previously demonstrated promising results in pancreatic and breast cancer studies, with both indications receiving Fast Track designation from the FDA.

In other recent news, Oncolytics Biotech announced positive developments regarding its cancer immunotherapy, pelareorep. Integrated biomarker analyses from multiple clinical studies confirmed the drug’s mechanism of action and therapeutic potential. The studies, GOBLET and AWARE-1, showed consistent immune activation signatures, including viral replication in cancer cells and increased interferon signaling. Additionally, there was enhanced tumor infiltration by immune cells following treatment. Meanwhile, H.C. Wainwright maintained its Buy rating for Oncolytics Biotech, with a price target of $5.00. The firm noted the company’s strategic focus under new leadership, following the appointments of Jared Kelly as CEO and Andrew Aromando as Chief Business Officer. Both executives have a history of significant achievements, including their roles in Johnson & Johnson’s acquisition of Ambrx Biopharma. These developments highlight the company’s ongoing efforts to strengthen its leadership and strategic direction.

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