Pancreatic Cancer Survival Gains Accelerate as New Therapies Move Forward – Company Announcement
Issued on behalf of Oncolytics Biotech Inc.
, /CNW/ -- USANewsGroup.com (https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/) News Commentary – Scientists have developed an antibody treatment that reawakens the immune system to target pancreatic tumors by blocking the sugar-coated disguises cancer cells use to hide. Researchers have also engineered an off-the-shelf immunotherapy that consistently slows tumor growth across multiple preclinical pancreatic cancer models while remaining potent in challenging tumor environments. These advances position Oncolytics Biotech Inc. (NASDAQ: ONCY), Immuneering Corporation (NASDAQ: IMRX), Tango Therapeutics, Inc. (NASDAQ: TNGX), Moderna, Inc. (NASDAQ: MRNA), and Royalty Pharma plc (NASDAQ: RPRX) as leaders pursuing breakthrough approaches in one of oncology’s most difficult indications.
A 63% objective response rate was achieved in mismatch repair-deficient cancers when two checkpoint inhibitors were combined. Several institutions have started therapeutic vaccine trials targeting pancreatic and lung cancers, with early pancreatic vaccine data showing immune responses linked to reduced recurrence risk.
Oncolytics Biotech Inc. (NASDAQ: ONCY) has obtained FDA alignment on its pivotal Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning the company to launch the only immunotherapy registration trial planned for this disease. After a Type C meeting, the FDA and Oncolytics agreed on key trial parameters, creating a clear path toward potential approval in a cancer that currently lacks immunotherapy options.
“We now have regulatory clarity to begin a pivotal study and, ultimately, the chance to bring the first approved immunotherapy option to the pancreatic cancer treatment landscape,” said Jared Kelly, CEO of Oncolytics Biotech. “The data speak for themselves, but we are grateful to the FDA for helping us clear this initial hurdle. While work remains, we are laser-focused on delivering potential treatments to pancreatic cancer patients who urgently need more options.”
The trial will feature three arms: standard chemotherapy (gemcitabine plus nab-paclitaxel) alone, the same chemotherapy with pelareorep, and chemotherapy with both pelareorep and a checkpoint inhibitor. Overall survival is the primary endpoint, with either experimental arm capable of independently proving success.
“The FDA’s feedback confirms that our design is suitable to support registration if successful,” said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. “We are now finalizing administrative steps to start the program, including protocol finalization, supporting documents, and site selection. We also plan to announce the lead principal investigator once these preparations are complete.”
The protocol allows checkpoint inhibitor flexibility based on ongoing partnership discussions. Pelareorep has successfully paired with multiple checkpoint inhibitors across gastrointestinal and other cancers.
Oncolytics recently reported anal cancer data showing response rates more than double the current standard, reinforcing pelareorep’s platform potential across gastrointestinal tumors. Previous pancreatic cancer data demonstrated a 62% response rate and two-year survival rates more than double historical benchmarks.
The company also established a Gastrointestinal Scientific Advisory Board to push pelareorep beyond pancreatic cancer alone.
Pelareorep holds FDA Fast Track and Orphan Drug designations for pancreatic cancer, enabling expedited review and potential market exclusivity.
CEO Jared Kelly and Chief Business Officer Andrew Aromando were pivotal in Ambrx Biopharma’s $2 billion acquisition by Johnson & Johnson, demonstrating a track record of advancing assets through value-adding transactions.
With site selection underway and protocol finalization progressing, Oncolytics stands at the cusp of turning clinical promise into regulatory reality as the only immunotherapy registration trial in first-line pancreatic cancer.
CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
In other recent industry developments:
- Immuneering Corporation (NASDAQ: IMRX) reported an extraordinary 86% overall survival at 9 months in first-line pancreatic cancer patients treated with atebimetinib plus modified gemcitabine/nab-paclitaxel (mGnP), and raised $225 million in cumulative financing, including a $25 million private placement with Sanofi. Its cash position of $227.6 million as of Sept 30, 2025, extends runway into 2029, including topline results from its planned Phase 3 trial. CEO Ben Zeskind noted the year as transformational, with updated survival data expected in H1 2026 and the first patient to be dosed in the pivotal Phase 3 program by mid-2026.
- Tango Therapeutics, Inc. (NASDAQ: TNGX) reported vopimetostat data showing a median progression-free survival of 7.2 months in second-line MTAP-del pancreatic cancer, a 49% overall response rate, and 9.1 months median PFS in a histology-selective cohort of 13 late-line cancer types. The company secured $225 million in gross proceeds in October 2025, extending its runway into 2028, and reported 2025 Q3 collaboration revenue of $53.8 million. Its CEO Barbara Weber highlighted momentum heading into 2026 with a planned pivotal trial in 2L MTAP-del pancreatic cancer.
- Moderna, Inc. (NASDAQ: MRNA) outlined a three-year strategy aiming for up to 10% revenue growth in 2026, while advancing nine oncology-focused Phase 2/3 programs, including three Phase 3 trials for its intismeran autogene. The plan also envisions expanding its seasonal vaccine portfolio from three to as many as six products by 2028, with profits from marketed vaccines reinvested into oncology and rare disease programs. CEO Stéphane Bancel emphasized building a large seasonal vaccine franchise while growing the oncology pipeline.
- Royalty Pharma plc (NASDAQ: RPRX) delivered strong Q3 results, with portfolio receipts up 11% to $814 million and net cash from operating activities of $703 million, while raising 2025 guidance to $3.2–3.25 billion. The company expanded its oncology holdings with royalties on Amgen’s Imdelltra for extensive-stage small cell lung cancer, Zenas BioPharma’s obexelimab, and Alnylam’s Amvuttra. CEO Pablo Legorreta highlighted double-digit top-line growth and active deal-making, including a $2.0 billion capital deployment for the year. Positive clinical updates on Revolution Medicines’ daraxonrasib for first-line metastatic pancreatic cancer support a Phase 3 initiation in late 2025, and the FDA awarded a Commissioner's National Priority Voucher to accelerate development and review. Royalty Pharma also repurchased 4 million Class A shares for $152 million in Q3 2025, bringing year-to-date buybacks to $1.2 billion.
Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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