Oncolytics Biotech advances in cancer immunotherapy trials

SAN DIEGO and CALGARY, AB - Oncolytics Biotech Inc. (NASDAQ: NASDAQ:ONCY) (TSX: ONC), a $24.63 billion market cap biotechnology company specializing in cancer immunotherapy, has announced continued progress in its clinical trials, particularly with its drug pelareorep, an immunotherapeutic agent. According to InvestingPro data, the company maintains impressive gross profit margins of 83.67%, highlighting its operational efficiency in drug development. The company has received regulatory clearance to proceed with full enrollment in its pancreatic cancer study and has also presented new data supporting pelareorep’s efficacy and safety in gastrointestinal cancers.

The German Paul-Ehrlich-Institute (PEI) has approved the continuation of patient enrollment for the GOBLET study’s pancreatic cancer trial, following a positive safety review. The trial will now progress toward full enrollment, with a planned 30 patients in Stage 1 across two treatment arms. Pelareorep is being tested in combination with modified FOLFIRINOX with and without atezolizumab. An initial efficacy readout from the study is expected later this year.

At the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, Oncolytics presented new clinical data suggesting pelareorep’s potential in treating anal and pancreatic cancers. For anal cancer, patients treated with pelareorep and atezolizumab showed stronger responses than those reported in studies with checkpoint inhibitors alone. In pancreatic cancer, pelareorep demonstrated a strong efficacy signal when administered with gemcitabine, nab-paclitaxel, and atezolizumab, and recent data supports a favorable safety profile with a modified FOLFIRINOX regimen.

These developments are seen as de-risking pelareorep’s development and could lead to larger registration-enabling clinical trials for these hard-to-treat cancers. Looking ahead, Oncolytics anticipates additional data readouts from ongoing trials and interactions with regulatory agencies that could expedite future studies and move pelareorep closer to potential registration-enabling studies in breast cancer and gastrointestinal cancers. The company’s stock has shown strong momentum, delivering a 55.74% return over the past year and currently trading near its 52-week high of $248.16.

The GOBLET study is a phase 1/2 trial exploring treatment combinations with pelareorep in advanced or metastatic gastrointestinal tumors. Conducted at 17 centers in Germany, the study aims to evaluate the objective response rate, disease control rate, and safety, along with additional efficacy assessments and potential biomarkers.

Wayne Pisano, Interim CEO and Chair of Oncolytics’ Board of Directors, expressed optimism for the coming year, citing clinical validation across multiple studies and the potential for pelareorep to move to registration-enabling studies in breast and gastrointestinal cancers. With the next earnings report scheduled for February 27, 2025, investors can access comprehensive financial analysis and additional insights through InvestingPro, which offers 13 additional investment tips for Oncolytics Biotech.

This article is based on a press release statement from Oncolytics Biotech Inc.

In other recent news, Oncolytics Biotech has been notified of non-compliance with Nasdaq’s minimum bid price rule, as the company’s share price remained below $1.00 for 30 consecutive business days. The biotechnology firm now has 180 days to address this deficiency and regain compliance. This development does not impact the company’s business operations or the trading of its shares.

Meanwhile, the U.S. Food and Drug Administration has approved BeiGene (NASDAQ:ONC)’s TEVIMBRA for use in combination with chemotherapy for certain types of advanced gastric cancer. This approval was supported by the results of the global Phase 3 RATIONALE-305 trial, showing a significant improvement in overall survival among patients treated with TEVIMBRA and chemotherapy.

In other developments, BeiGene announced a ticker change to ’ONC’ from ’BGNE’ for its American Depository Shares, effective January 2, 2025. This administrative change does not affect the company’s operations, strategy, or share structure.

On the analyst front, TD Cowen reiterated its Buy rating on BeiGene, highlighting the strength of its oncology pipeline, while Morgan Stanley (NYSE:MS) resumed coverage of BeiGene with an Overweight rating and set a new price target of $300.00. Both firms expressed confidence in BeiGene’s ongoing research and potential for future growth in the oncology market.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.