Pancreatic Cancer Survival Advances Accelerate as New Therapies Move Forward
Issued on behalf of Oncolytics Biotech Inc.
USANewsGroup.com – News Commentary: Scientists have developed an antibody that reawakens the immune system to target pancreatic tumors by removing the sugar-coated disguises cancer cells use to hide from detection. Researchers also engineered an off-the-shelf immunotherapy that consistently slows tumor growth across multiple preclinical pancreatic cancer models, even in challenging tumor environments. These breakthroughs 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) at the forefront of innovative strategies in one of oncology’s most difficult challenges.
A 63% objective response rate has been reported in mismatch repair-deficient cancers when combining two checkpoint inhibitors. Several institutions have launched therapeutic vaccine trials targeting pancreatic and lung cancers, with early pancreatic vaccine results showing immune responses linked to a reduced risk of recurrence.
Oncolytics Biotech Inc. (NASDAQ: ONCY) has achieved FDA alignment on the design of its pivotal Phase 3 study for pelareorep in first-line metastatic pancreatic cancer, setting the stage to launch the first immunotherapy registration trial planned for this disease.
After a Type C meeting, the FDA and Oncolytics agreed on essential trial parameters, outlining a clear pathway toward potential approval in a cancer that currently lacks immunotherapy options.
“We now have regulatory clarity that enables us to initiate a pivotal study and, ultimately, offer the first approved immunotherapy option in pancreatic cancer,” stated Jared Kelly, CEO of Oncolytics Biotech. “The data are compelling, and we’re grateful to the FDA for helping us clear this initial hurdle. While challenges remain, we’re laser-focused on delivering potential treatments to pancreatic cancer patients who urgently need more choices.”
The trial will evaluate three arms: standard chemotherapy (gemcitabine plus nab-paclitaxel) alone, chemotherapy with pelareorep, and chemotherapy with pelareorep plus a checkpoint inhibitor. Overall survival is the primary endpoint, with either experimental arm capable of meeting success criteria on its own.
“The FDA’s feedback confirms our design is suitable to support registration if outcomes are favorable,” said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. “We’re wrapping up administrative tasks to start the program, including finalizing the protocol, compiling supporting documents, and selecting trial sites. We also plan to announce the lead principal investigator once preparations are complete.”
The protocol allows flexibility in checkpoint inhibitor use based on ongoing partnership discussions. Pelareorep has demonstrated synergy with several checkpoint inhibitors across gastrointestinal and other cancers.
Recent Oncolytics data from anal cancer showed response rates more than double the current standard of care, underscoring pelareorep’s potential across GI tumors. Prior pancreatic cancer data revealed a 62% response rate and two-year survival rates exceeding historical benchmarks.
To advance pelareorep beyond pancreatic cancer, the company recently established a Gastrointestinal Scientific Advisory Board. Pelareorep has received FDA Fast Track and Orphan Drug designations for pancreatic cancer, enabling expedited reviews and potential market exclusivity.
CEO Jared Kelly and Chief Business Officer Andrew Aromando played pivotal roles in Ambrx Biopharma’s $2 billion acquisition by Johnson & Johnson, highlighting their track record in advancing assets through value-creating deals.
With site selection underway and protocol finalization in progress, Oncolytics stands at the threshold of turning clinical promise into regulatory reality as the sole immunotherapy registration trial in first-line pancreatic cancer.
CONTINUED… For more news on Oncolytics Biotech, visit: 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 and raised $225 million in financing, including a $25 million private placement with Sanofi. The company’s cash position of $227.6 million as of September 30, 2025, extends its runway into 2029, including a topline readout of its planned Phase 3 trial. “The third quarter was transformational for Immuneering, with remarkable survival data and strong financing,” said Ben Zeskind, Ph.D., CEO. “We expect updated survival data in H1 2026 and plan to dose the first patient in our pivotal Phase 3 program by mid-2026.” Two new case studies showed a complete response in one patient and a response strong enough to pursue radiation and curative surgery in another.
Tango Therapeutics, Inc. (NASDAQ: TNGX) presented vopimetostat data showing a median progression-free survival of 7.2 months in second-line MTAP-del pancreatic cancer, with a 49% overall response rate and 9.1 months median PFS in a histology-selective cohort spanning 13 difficult-to-treat cancer types. The company secured $225 million in gross funding in October 2025, extending its cash runway into 2028, and reported Q3 collaboration revenue of $53.8 million. “We end 2025 with strong momentum, supported by vopimetostat data that could redefine treatment for MTAP-del cancers, starting with pancreatic cancer,” commented Barbara Weber, M.D., Tango’s president and CEO. “We anticipate a pivotal trial in 2L MTAP-del pancreatic cancer to begin in 2026.” Vopimetostat appeared to offer a best-in-class safety profile, with no drug-related discontinuations at 250 mg daily and only an 8% dose-reduction rate. Ongoing combination studies with Revolution Medicines’ RAS(ON) inhibitors are expected to yield data in 2026. Tango’s TNG456, a brain-penetrant PRMT5 inhibitor for glioblastoma, received FDA Orphan Drug Designation, while TNG260 showed a median PFS of 27 weeks in checkpoint-inhibitor–resistant STK11-mutant/KRAS-wild-type lung cancer, outperforming standard care.
Moderna, Inc. (NASDAQ: MRNA) outlined a three-year plan aiming for up to 10% revenue growth in 2026, supported by nine oncology-focused Phase 2 and Phase 3 programs, including three Phase 3 trials for intisimeran autogene. The company intends to expand its seasonal vaccine portfolio from three to as many as six products by 2028, using proceeds from marketed products to fund oncology and rare-disease programs. “Over the next three years, we aim to build a large seasonal vaccine franchise and reinvest the cash flow into oncology and rare-disease therapeutics,” said Stéphane Bancel, Moderna’s CEO. Moderna’s oncology pipeline includes mRNA-4157 (intisimeran autogene) in collaboration with Merck, spanning eight Phase 2/3 trials across multiple cancers. The company projected higher operating expenses through 2027 but remains on a path toward cash breakeven by 2028, with an estimated year-end 2025 cash position of $7.1–$7.6 billion.
Royalty Pharma plc (NASDAQ: RPRX) reported strong third-quarter results, with portfolio receipts up 11% to $814 million and net cash from operations of $703 million, and raised full-year guidance to $3.2–$3.25 billion. The firm expanded its oncology holdings by acquiring royalties on Amgen’s Imdelltra for extensive-stage small cell lung cancer ($950 million), Zenas BioPharma’s obexelimab ($300 million), and Alnylam’s Amvuttra ($310 million). “We posted solid Q3 results, higher full-year guidance, and continued double-digit top-line growth,” said Pablo Legorreta, Royalty Pharma’s founder and CEO. The company also highlighted clinical updates from Revolution Medicines’ daraxonrasib, which showed encouraging first-line metastatic pancreatic cancer data and supports a planned Phase 3 initiation in late 2025, along with a National Priority Voucher from the FDA to accelerate development and review. Additionally, the firm repurchased four million Class A shares for $152 million in Q3, bringing year-to-date repurchases to $1.2 billion.
Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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