Precision Oncology Breakthroughs Draw Institutional Backing As Markets Crack Treatment Resistance

2025-11-19 10:15:25 ET

Issued on behalf of Oncolytics Biotech Inc.

VANCOUVER – USA News Group News Commentary – The precision oncology market is accelerating toward $158.9 billion by 2029 as targeted therapies demonstrate unprecedented efficacy in cancers previously resistant to standard treatments[1]. Scientists recently achieved a breakthrough in blocking cancer growth pathways while sparing healthy cells, validating the precision medicine approach that has transformed oncology development[2]. This momentum positions companies with differentiated platforms addressing high-value tumor types as capture opportunities for investors seeking exposure to the next generation of cancer therapeutics, including Oncolytics Biotech Inc. (NASDAQ: ONCY), Zymeworks Inc. (NASDAQ: ZYME), Verastem Oncology (NASDAQ: VSTM), Actinium Pharmaceuticals, Inc. (NYSE-American: ATNM), and Fennec Pharmaceuticals Inc. (NASDAQ: FENC) (TSX: FRX).

Institutional capital is flowing into early-stage oncology companies, with a specialized biotech fund recently raising over €650 million to back breakthrough therapies targeting treatment-resistant solid tumors[3]. Meanwhile, researchers unlocked mechanisms behind treatment resistance in HER2-positive cancers, opening pathways for next-generation therapeutics that could transform outcomes in populations where current standards fail[4].

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://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/

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

Zymeworks Inc. (NASDAQ: ZYME) announced positive Phase 3 results from the HERIZON-GEA-01 trial evaluating Ziihera® (zanidatamab-hrii) in HER2-positive gastroesophageal adenocarcinoma. Ziihera plus chemotherapy demonstrated statistically significant improvement in progression-free survival versus trastuzumab, while the combination of Ziihera plus Tevimbra® (tislelizumab) and chemotherapy showed clinically meaningful and statistically significant improvements in both overall survival and progression-free survival. Both investigational arms demonstrated improved objective response rates and duration of response with no new safety signals observed.

“The topline results from HERIZON-GEA-01 represent a true turning point for patients with HER2+ gastroesophageal adenocarcinoma, marking real progress in an indication that has historically had limited treatment options and poor outcomes,” said Kenneth Galbraith, CEO of Zymeworks. “These data highlight the potential of zanidatamab to transform the standard of care in HER2+ indications, demonstrate the strength of our Azymetric™ platform to engineer novel and differentiated multifunctional biologics, and reinforce the strategic value of our partnership strategy with Jazz and BeOne in bringing this critical therapy to patients worldwide.”

Partner Jazz Pharmaceuticals plans to submit a supplemental Biologics License Application in the first half of 2026 to support Ziihera as a first-line treatment for patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma. Zymeworks is eligible for additional regulatory and commercial milestones, as well as tiered royalties on net sales of Ziihera from Jazz and BeOne Medicines.

Verastem Oncology (NASDAQ: VSTM) reported third quarter 2025 net product revenue of $11.2 million in the first full quarter following the accelerated approval and launch of AVMAPKI™ FAKZYNJA™ CO-PACK for KRAS-mutated recurrent low-grade serous ovarian cancer. The company’s KRAS G12D inhibitor VS-7375 cleared the first two monotherapy dose levels with no dose-limiting toxicities, with no nausea, vomiting or diarrhea greater than Grade 1 observed at the 400 mg and 600 mg daily doses. Of the five efficacy evaluable patients with at least one scan, four experienced tumor reduction and remain on treatment.

“Our performance in Q3, which was the first full quarter since our accelerated approval and launch of AVMAPKI FAKZYNJA CO-PACK, exceeded expectations with net revenue of over $11 million and demonstrated the strength of our growing commercial business and consistent adoption by both academic and community oncologists for the first treatment approved by the FDA specifically for patients with KRAS-mutated recurrent LGSOC,” said Dan Paterson, CEO of Verastem Oncology. “Particularly for our KRAS G12D (ON/OFF) inhibitor, VS-7375, preliminary safety, tolerability, and anti-tumor activity are promising, and we believe in line as a potential best-in-class option for patients with pancreatic, lung, and other KRAS G12D-mutated solid tumor cancers.”

The company has initiated patient enrollment for the first dose escalation combination cohort evaluating VS-7375 with cetuximab in patients with advanced solid tumors, including colorectal cancer, and expects to select the recommended Phase 2 dose for both monotherapy and combination expansion cohorts in the first half of 2026. Verastem ended Q3 2025 with $137.7 million in cash and cash equivalents, with expected cash runway extending into the second half of 2026.

Actinium Pharmaceuticals, Inc. (NYSE-American: ATNM) will highlight ATNM-400 data in hormone-resistant and HER2-resistant breast cancer at the 2025 San Antonio Breast Cancer Symposium, expanding the pan-tumor profile of this Actinium-225 antibody radioconjugate across three major solid tumor indications. Preclinical data demonstrate ATNM-400’s anti-tumor activity in tamoxifen and trastuzumab resistant breast cancer models, addressing the need for new treatment options in the $4.0 billion HER2-targeted therapy market led by Herceptin®. In prostate cancer, ATNM-400 showed superior efficacy and durability versus 177Lu-PSMA-617 (active agent in Pluvicto®) and enzalutamide (Xtandi®), with the ability to overcome resistance to these standard-of-care agents.

“We’re excited to present ATNM-400’s breast cancer data at SABCS which expands our demonstration of its potential across multiple solid tumors,” said Sandesh Seth, CEO of Actinium Pharmaceuticals. “The strong single-agent efficacy of ATNM-400 and its ability to overcome resistance when coupled with enzalutamide (Xtandi®) in prostate cancer and osimertinib (TAGRISSO®) in lung cancer showcases Actinium’s capability for innovation by exploiting the power of a radiotherapeutic directed to a target linked to resistance and poor prognosis.”

In non-small cell lung cancer, ATNM-400 demonstrated 3-5x greater tumor growth inhibition versus front-line osimertinib (Tagrisso®), second-line Dato-DXd (Datroway®), and third-line amivantamab (Rybrevant®), with these EGFR-targeting therapies generating combined 2024 sales exceeding $7 billion. The data package across breast, prostate, and lung cancer supports ATNM-400’s development as a monotherapy, combination therapy, or treatment alternative in high-value oncology segments representing over 800,000 new cases annually in the United States.

Fennec Pharmaceuticals Inc. (NASDAQ: FENC) (TSX: FRX) reported third quarter 2025 net product revenue of $11.2 million in the first full quarter since the FDA approval and U.S. launch of PEDMARK® for reducing the risk of ototoxicity associated with cisplatin treatment in pediatric cancer patients. In the first nine months of 2025, net product sales surpassed total net product sales for the full year of 2024, with adoption accelerating across both academic and community oncology centers. The company achieved positive cash flow from operations in Q3 2025, with its cash position growing to $21.9 million from $18.7 million at June 30, 2025.

“Today marks an inflection point for Fennec as we delivered the strongest quarter in our history. Record net product sales, four consecutive quarters of double-digit growth, and our first profitable quarter from operations, clearly demonstrate that our strategy is working,” said Jeff Hackman, CEO of Fennec Pharmaceuticals. “With continued discipline in executing against our strategic priorities, we believe we are well positioned to sustain the growth trajectory of PEDMARK®.”

Preliminary results from the investigator-initiated clinical trial (STS-J01) evaluating PEDMARK® in Japan are expected in the fourth quarter of 2025, with the company planning to pursue registration in Japan and explore partnering opportunities if the data are positive. Multiple investigator-initiated studies have been submitted to Fennec and are currently under review, with several others in advanced contracting or evaluation stages to further strengthen the clinical and commercial foundation for PEDMARK®.

Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/

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SOURCES CITED:
1. https://www.globenewswire.com/news-release/2025/11/05/3181144/0/en/Precision-Oncology-Research-Report-2025-Market-to-Hit-158-9-Billion-by-2029-as-Genomics-Diagnostics-Liquid-Biopsies-Single-Cell-Sequencing-and-Patient-Specific-Cancer-Vaccines-Acce.html
2. https://www.sciencedaily.com/releases/2025/10/251018102122.htm
3. https://european-biotechnology.com/latest-news/sofinnova-partners-surpasses-target-with-e650m-fund-to-back-up-early-stage-biotech/
4. https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-discovery-of-breast-cancer-treatment-resistance-can-lead-to-new-hope-for-some/

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