PALM BEACH, Fla., Nov. 19, 2025 (GLOBE NEWSWIRE) -- FN Media Group News Commentary - The precision oncology sector is experiencing unprecedented transformation as biomarker-driven therapies and platform immunotherapies reshape treatment paradigms for historically difficult cancers. Leading researchers showcased breakthrough advances in immunotherapy at recent oncology conferences, highlighting next-generation approaches that selectively target tumor-specific vulnerabilities. This wave of innovation is propelling companies developing targeted therapies across gastrointestinal, blood, and solid tumor cancers, including Oncolytics Biotech Inc. (NASDAQ: ONCY), ALX Oncology Holdings Inc. (NASDAQ: ALXO), Erasca, Inc. (NASDAQ: ERAS), Immuneering Corporation (NASDAQ: IMRX), and Prelude Therapeutics Incorporated (NASDAQ: PRLD).

The precision oncology market reached $106.21 billion in 2025, growing at an 11% compound annual rate driven by expanding adoption of genomics-based diagnostics and targeted cancer therapies. Analysts project the market will accelerate to $158.9 billion by 2029 as novel immunotherapy modalities including antibody-drug conjugates and biomarker-selected combinations demonstrate superior efficacy in clinical trials, creating favorable conditions for companies with platform technologies targeting multiple tumor types and mutation-driven cancers.

Oncolytics Biotech Inc. (NASDAQ: ONCY) has achieved FDA alignment on its pivotal Phase 3 study design for pelareorep in first-line metastatic pancreatic ductal adenocarcinoma, marking a critical inflection point as the company prepares to launch the only immunotherapy registration trial currently planned in this indication.

Following a recent Type C meeting, the FDA and Oncolytics agreed on key trial parameters, providing a clear regulatory pathway toward potential approval in a cancer type with no existing immunotherapy options.

"We now have regulatory clarity to allow us to start a pivotal study and ultimately the chance to bring the first approved immunotherapy treatment option to the pancreatic cancer treatment landscape," said Jared Kelly, CEO of Oncolytics Biotech. "The data speaks for itself, but we want to sincerely thank the FDA for its great work in helping us clear this initial regulatory hurdle. Although we still have work to do, we are laser-focused on bringing potential treatments to pancreatic cancer patients who desperately need more options."

The pivotal trial will evaluate three treatment arms: gemcitabine plus nab-paclitaxel with pelareorep and a checkpoint inhibitor, gemcitabine plus nab-paclitaxel with pelareorep, and gemcitabine plus nab-paclitaxel as the control. Overall survival serves as the primary endpoint, with progression-free survival and objective response rate as secondary measures. Either experimental arm can independently meet the success criteria, providing multiple pathways to regulatory success.

“The FDA’s feedback confirms that our design is appropriate to support registration if successful,” said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. “We are now completing the administrative activities necessary to initiate the program, including finalizing the protocol, generation of supporting documents, and site selection. We also plan to announce the lead principal investigator once these preparations are complete.”

The protocol allows flexibility in checkpoint inhibitor selection based on ongoing partnership discussions. Pelareorep has demonstrated successful combinations with multiple checkpoint inhibitors, including atezolizumab, pembrolizumab, nivolumab, and retifanlimab across gastrointestinal and other tumor types. This optionality strengthens Oncolytics' position in potential partnership negotiations while maintaining scientific rigor.

The FDA alignment builds on compelling clinical momentum across gastrointestinal cancers. Oncolytics recently reported updated anal cancer data showing a 30% objective response rate, more than double the current standard of care in this rare but deadly malignancy. These results reinforce pelareorep's potential as a platform immunotherapy capable of transforming treatment across multiple gastrointestinal tumor types.

Previous pancreatic cancer data demonstrated pelareorep's breakthrough potential, with patients achieving a 62% objective response rate in 13 evaluable patients and a two-year survival rate of 21.9%, more than double the 9.2% historical benchmark with standard chemotherapy. This mechanistic approach converts immunologically cold tumors into hot targets responsive to checkpoint inhibitors, potentially unlocking immunotherapy effectiveness in pancreatic cancer, which has historically remained resistant to these treatments.

Oncolytics recently established a Gastrointestinal Tumor Scientific Advisory Board to advance pelareorep's development across multiple indications. This strategic move signals the company's commitment to maximizing pelareorep's platform potential beyond pancreatic cancer alone.

Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer, facilitating expedited review processes once trial data mature. These regulatory designations provide potential advantages in development timelines and market exclusivity.

Leadership experience reinforces execution capability. CEO Jared Kelly and Chief Business Officer Andrew Aromando were both crucial contributors to Ambrx Biopharma's$2 billion acquisition by Johnson & Johnson, demonstrating proven ability to advance assets from clinical development through value-creating transactions.

With site selection activities now underway and protocol finalization in progress, Oncolytics is at the transition point where clinical promise becomes regulatory reality. The company's active pursuit of strategic partnerships, combined with its status as the only immunotherapy registration trial in first-line pancreatic cancer, positions pelareorep as an increasingly compelling commercial opportunity in a multibillion-dollar market desperate for treatment advances.   CONTINUED… Read this and more news for Oncolytics Biotech at:   https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/

In other recent industry developments and happenings in the biotech market include:

ALX Oncology Holdings Inc. (NASDAQ: ALXO) has demonstrated compelling clinical benefit in patients with high CD47-expressing HER2-positive gastric cancer, with its lead candidate evorpacept achieving a 65.0% objective response rate versus 26.1% for standard therapy in the ASPEN-06 trial. The treatment demonstrated a median duration of response of 25.5 months compared to 8.4 months for standard therapy, with progression-free survival of 18.4 months versus 7.0 months. Data presented at the Society for Immunotherapy of Cancer Annual Meeting identified CD47 overexpression as a key predictive biomarker for response in patients with retained HER2 expression.

"We are pleased to share data at SITC this weekend from an analysis of our ASPEN-06 trial demonstrating compelling benefit in all outcomes measured for patients with high CD47-expressing HER2-positive gastric cancer treated with evorpacept in combination with trastuzumab, ramucirumab, and paclitaxel," said Jason Lettmann, CEO of ALX Oncology. "This insight is guiding our targeted clinical development strategy for breast cancer where we will be enrolling patients with HER2-positive tumors that have previously received ENHERTU and we will evaluate responses by CD47-expression level in our Phase 2 ASPEN-09-Breast Cancer trial."

Erasca, Inc. (NASDAQ: ERAS) has secured intellectual property protection for its pan-RAS molecular glue ERAS-0015 through 2043 with the issuance of U.S. Patent No. 12,458,647. The composition of matter patent titled "Macrocyclic Derivative And Use Thereof" provides exclusivity that may be extended further through patent term adjustments or extensions. The company is evaluating ERAS-0015 in the AURORAS-1 Phase 1 trial in patients with RAS-mutant solid tumors.

"This U.S. patent is a foundational milestone for our ERAS-0015 program, further highlighting our efficient execution across this program since its in-licensing in May 2024," said Jonathan E. Lim, M.D., CEO of Erasca. "Covering ERAS-0015 until at least 2043, this patent is among a series of patent filings designed to form a strong and durable intellectual property portfolio for our RAS-targeting franchise. We look forward to initial Phase 1 monotherapy data for ERAS-0015 and pan-KRAS inhibitor ERAS-4001, both of which are expected in 2026."

Immuneering Corporation (NASDAQ: IMRX) has reported extraordinary survival results showing 86% overall survival at 9 months in first-line pancreatic cancer patients treated with atebimetinib in combination with modified gemcitabine/nab-paclitaxel in its Phase 2a trial.

The company raised $225 million in cumulative financing, including a $175 million underwritten public offering and a $25 million private placement with Sanofi, extending its cash runway into 2029 through the topline readout of its planned pivotal Phase 3 trial. The U.S. Patent and Trademark Office granted a composition of matter patent for atebimetinib expected to provide exclusivity into 2042.

"The third quarter was truly transformational for Immuneering," said Ben Zeskind, Ph.D., CEO of Immuneering. "We announced extraordinary overall survival data from our ongoing Phase 2a trial of atebimetinib in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer and raised $225 million of cumulative financing on the strength of the data. I'm excited to say that the company is now funded into 2029 and, importantly, through the topline readout of our planned pivotal Phase 3 program in pancreatic cancer."

Prelude Therapeutics Incorporated (NASDAQ: PRLD) is advancing two promising programs toward clinical development, with its mutant selective JAK2V617F JH2 inhibitor expected to file an IND in the first quarter of 2026 and its highly selective oral KAT6A degrader on track for an IND filing in mid-2026.

The JAK2V617F program targets the primary driver mutation responsible for disease progression in approximately 95% of polycythemia vera patients, 60% of essential thrombocythemia patients, and 55% of myelofibrosis patients. Preclinical data from both the JAK2V617F JH2 inhibitor program and CALR-targeted degrader antibody conjugate program were accepted for oral presentations at the American Society of Hematology 67th Annual Meeting in December.

"Last week, we announced a number of strategic updates that significantly strengthen and shape our path forward heading into 2026," said Kris Vaddi, Ph.D., CEO of Prelude Therapeutics. "We have two promising programs advancing rapidly towards clinical development – our mutant selective JAK2V617F inhibitor program and our highly selective KAT6A degrader program. Both programs target clinically validated mechanisms in disease areas of significant unmet need for patients with clear paths to differentiation in early clinical development."

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