The $537B Precision Pivot: Why Molecular Monitoring is the New Oncology Standard

Issued on behalf of Oncolytics Biotech Inc.

VANCOUVER – Baystreet.ca News Commentary – The war on cancer is moving into a high-tech era of molecular-guided defense. The genomics in cancer care market is now projected to hit a staggering $69.16 billion by 2032 as precision profiling becomes a mandatory standard for every stage of treatment[1]. This shift reached a fever pitch in January 2026 as clinical labs began deploying AI-driven monitoring panels to enable ultrasensitive disease tracking and truly personalized care[2]. This strategic convergence of diagnostic power and delivery infrastructure is the primary driver for the 2026 investment case for Oncolytics Biotech Inc. (NASDAQ: ONCY), Personalis, Inc. (NASDAQ: PSNL), The Oncology Institute, Inc. (NASDAQ: TOI), Pyxis Oncology, Inc. (NASDAQ: PYXS), and NovaBridge Biosciences (NASDAQ: NBP).

The financial momentum behind this transition is massive, with the precision medicine market forecast to expand from $138.67 billion in 2026 to over $537.17 billion by 2035[3]. As global healthcare systems move toward value-based care, biomarker-driven treatment pathways have emerged as the critical catalysts reshaping the entire oncology landscape[4]. For retail investors, 2026 represents a ground-floor opportunity to own the infrastructure that is finally turning the tide against metastatic spread.

Clinical-stage biotech company Oncolytics Biotech Inc. (NASDAQ: ONCY) is fortifying its intellectual property position while advancing pelareorep, an investigational immunotherapy designed to activate the immune system against cancer.

In early Q3 2025, Oncolytics filed a Track 1 prioritized examination patent application with the United States Patent and Trademark Office focused on manufacturing-related innovations for pelareorep. If granted, this patent could extend protection to 2044, significantly lengthening pelareorep's commercial runway. The company received initial written feedback from the USPTO in Q4 2025 and expects a final action on this manufacturing patent application in Q3 2026.

Oncolytics plans to file additional patent applications covering novel therapeutic uses of pelareorep, which could provide IP protection beyond 2044. "Extending our intellectual property runway is a core pillar of our strategy," said Jared Kelly, Chief Executive Officer of Oncolytics. "As pelareorep continues to demonstrate meaningful clinical activity across gastrointestinal cancers, it is critical that we protect the innovation behind both how the therapy is manufactured and how it is used."

This strategic IP expansion comes as pelareorep delivers compelling clinical results across multiple gastrointestinal cancers. The company recently announced efficacy data showing pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer patients when combined with standard chemotherapy. This triples the historical 6-11% response rate for chemotherapy alone in this difficult-to-treat population, addressing a colorectal cancer market projected to reach $20 billion by 2033.

Equally compelling anal cancer results showed a 30% response rate in second-line squamous cell anal carcinoma, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response reached 15.5 months compared to 9.5 months for standard care, with two durable complete responses.

This clinical momentum has attracted elite academic validation. Oncolytics expanded its Gastrointestinal Tumor Scientific Advisory Board with three globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center. The company has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease.

CEO Jared Kelly and Chief Business Officer Andrew Aromando were both crucial contributors to their previous employer, Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson.

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:

Personalis, Inc. (NASDAQ: PSNL) announced publication in Clinical Cancer Research detailing results from Dr. Rodrigo Toledo and the team at Vall d'Hebron Institute of Oncology demonstrating the clinical utility of NeXT Personal for monitoring immunotherapy response across solid tumors. The study analyzed 202 patients with stage IV solid tumors spanning 24 cancer types treated with immune checkpoint inhibitors, showing that the ultrasensitive tumor-informed molecular residual disease assay detected ctDNA in 98% of patients at baseline.

"We are excited about these results showing how NeXT Personal can be used to monitor therapy in late-stage metastatic patients," said Rich Chen, Chief Medical Officer and Executive Vice President of R&D at Personalis. "This study, together with our previous publications, shows the broad potential impact of ultrasensitive ctDNA testing, both in early and late stage cancers."

Key findings demonstrated that patients with decreasing ctDNA levels early in treatment had significantly higher overall survival, while patients achieving durable molecular clearance had 100% overall survival in the study. Personalis' NeXT Personal test tracks up to 1,800 tumor-specific variants unique to each patient's tumor, achieving ultrasensitive detection of circulating tumor DNA.

The Oncology Institute, Inc. (NASDAQ: TOI) announced the appointment of Mark Stolper to its Board of Directors effective January 2, 2026. Stolper serves as Executive Vice President and Chief Financial Officer of RadNet, Inc. and brings extensive public markets experience, having previously served on the board of 21st Century Oncology Holdings, Inc., one of the nation's leading radiation and medical oncology companies at the time.

"We are very pleased to have a seasoned public company CFO like Mark join our board," said Anne McGeorge, Chairman of the Board of The Oncology Institute. "Mark brings tremendous experience in capital markets, fundraising strategies, strategic financial planning and payor strategy that will be invaluable to TOI in our next phase of growth."

The Oncology Institute operates over 180 employed and affiliate clinicians across more than 100 clinics and affiliate locations of care in five states, providing value-based cancer care to approximately 1.9 million patients. The company delivers cutting-edge, evidence-based oncology services, including clinical trials and transfusions in community settings.

Pyxis Oncology, Inc. (NASDAQ: PYXS) announced positive preliminary Phase 1 data for micvotabart pelidotin in recurrent/metastatic head and neck squamous cell carcinoma, demonstrating 46% confirmed objective response rate and 92% disease control rate as monotherapy at 5.4 mg/kg. In combination with pembrolizumab, MICVO achieved 71% confirmed ORR and 100% DCR across first-line and second-line settings, with responses occurring across varying PD-(L)1 CPS scores.

"The preliminary data for MICVO as monotherapy and in combination with pembrolizumab add to the growing body of evidence supporting MICVO's therapeutic potential and highlight its agility as a novel potential treatment option across the recurrent/metastatic head and neck squamous cell carcinoma landscape," said Lara Sullivan, President, Chief Executive Officer and Chief Medical Officer of Pyxis Oncology. "The emerging response rates and disease control observed across these studies are highly encouraging, and the lack of early disease progression supports confidence in the durability profile as we advance MICVO in clinical development."

Pyxis Oncology expects to present updated monotherapy data mid-2026 and combination therapy data in second half 2026. MICVO received FDA Fast Track Designation for R/M HNSCC treatment.

NovaBridge Biosciences (NASDAQ: NBP) recently presented positive dose expansion data for givastomig at a major medical conference, demonstrating encouraging clinical activity in the targeted patient population. The dose expansion cohort provided important efficacy and safety data supporting continued development of the investigational therapy across multiple solid tumor indications where significant unmet medical needs exist.

The company's presentation included updated response rates, duration of response metrics, and safety profiles that reinforce givastomig's potential therapeutic benefit. NovaBridge Biosciences continues enrolling patients in ongoing clinical studies evaluating givastomig as both monotherapy and in combination with other anticancer agents to optimize treatment approaches for difficult-to-treat malignancies.

NovaBridge is advancing its clinical development program with plans to expand into additional tumor types based on emerging data. The company maintains a robust pipeline of novel therapeutics targeting key pathways in oncology, with givastomig representing a potentially differentiated approach to addressing resistance mechanisms that limit the effectiveness of current standard-of-care treatments.

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/2026/01/05/3212639/0/en/Genomics-in-Cancer-Care-Market-Size-to-Hit-USD-69-16-Billion-by-2032-Growing-at-a-CAGR-of-16-04-SNS-Insider.html

2. https://www.openpr.com/news/4337223/cancer-biomarker-market-to-reach-us-62-49-billion-by-2033

3. https://www.precedenceresearch.com/precision-medicine-market

4. https://www.oncology-central.com/a-journey-through-value-based-oncology-care/