Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer

Rhea-AI Summary

Oncolytics (Nasdaq: ONCY) announced the FDA granted Fast Track Designation for pelareorep plus bevacizumab and FOLFIRI in 2L KRAS‑mutant MSS metastatic colorectal cancer. Clinical signals cited include a 33% ORR, median PFS 16.6 months and median OS 27 months, versus SOC benchmarks of ~10% ORR, 5.7‑month PFS and 11.2‑month OS. The company plans a controlled 2L study, first site activation in March, up to 11 sites, with interim data expected by year‑end 2026. The Fast Track may enable more FDA engagement and possible accelerated pathways.

Positive

• FDA Fast Track Designation for pelareorep in 2L KRAS‑mutant MSS mCRC
• Objective response rate (ORR) reported at 33%
• Median progression‑free survival (PFS) of 16.6 months
• Median overall survival (OS) of 27 months
• Planned controlled 2L study with first site activation in March 2026
• Estimated 2L KRAS‑mutant MSS mCRC market of $3–5 billion

Negative

• Controlled randomized data pending; current signals derive from existing dataset
• Interim clinical data expected by year‑end 2026, timeline subject to trial enrollment

Key Figures

ORR (pelareorep combo): 33% PFS (pelareorep combo): 16.6 months OS (pelareorep combo): 27 months +5 more

8 metrics

ORR (pelareorep combo) 33% KRAS-mutant MSS 2L mCRC pelareorep-based therapy

PFS (pelareorep combo) 16.6 months Median progression-free survival vs standard-of-care in 2L KRAS-mutant MSS mCRC

OS (pelareorep combo) 27 months Median overall survival vs standard-of-care in 2L KRAS-mutant MSS mCRC

ORR (SOC) 10% Approximate objective response rate with standard-of-care in this population

PFS (SOC) 5.7 months Median progression-free survival with standard-of-care

OS (SOC) 11.2 months Median overall survival with standard-of-care

Annual CRC cases 2 million Estimated new colorectal cancer cases globally per year

TAM 2L KRAS MSS mCRC $3–5 billion Estimated annual total addressable market for the subgroup

Market Reality Check

Price: $0.9000 Vol: Volume 1,310,191 is rough...

normal vol

$0.9000 Last Close

Volume Volume 1,310,191 is roughly in line with the 20-day average of 1,367,240 (relative volume 0.96). normal

Technical Shares at 0.8778 are trading below the 0.95 200-day MA and about 41.87% under the 52-week high.

Peers on Argus

ONCY is down 9.35% with several oncology peers also lower today (e.g., ACTU, HUR...

1 Down

ONCY is down 9.35% with several oncology peers also lower today (e.g., ACTU, HURA, CRDF), while ZURA is up, suggesting a generally weak biotech tape with mixed individual moves.

Previous Clinical trial Reports

3 past events · Latest: Jan 12 (Positive)

Same Type Pattern 3 events

Date	Event	Sentiment	Move	Catalyst
Jan 12	Anal cancer efficacy	Positive	+2.5%	Updated GOBLET Cohort 4 data showing ~29% ORR and long response duration.
Oct 28	Anal cancer data	Positive	+0.8%	GOBLET anal cohort data with 30% ORR versus 13.8% historical benchmark.
Sep 02	Pelareorep safety data	Positive	+10.6%	Updated safety profile across 1,200+ patients including 300+ GI cancer patients.

Pattern Detected

Clinical trial updates for pelareorep have historically led to modest positive moves, averaging about 4.63% in the next session, with all recent same-tag events showing aligned, positive reactions.

Recent Company History

Over the past six months, Oncolytics has repeatedly highlighted pelareorep’s clinical profile across gastrointestinal tumors. On Sep 2, 2025, the company reported favorable safety data across more than 1,200 patients, including 300+ GI cancer patients, which was followed by a 10.58% gain. Subsequent anal cancer efficacy updates on Oct 28, 2025 and Jan 12, 2026 showed objective response rates above historical benchmarks and produced smaller positive moves. Today’s Fast Track news extends this clinical narrative into KRAS-mutant MSS mCRC.

Historical Comparison

clinical trial

+4.6 %

Average Historical Move

Historical Analysis

Clinical trial updates previously moved ONCY about 4.63% on average. A -9.35% move on this Fast Track news would represent a sharp divergence from that pattern.

Typical Pattern

Recent same-tag events show a progression from broad pelareorep safety data to increasingly specific efficacy signals in anal cancer, now expanding into KRAS-mutant MSS metastatic colorectal cancer with Fast Track support.

Market Pulse Summary

This announcement highlights FDA Fast Track Designation for pelareorep in KRAS‑mutant MSS metastatic...

Analysis

This announcement highlights FDA Fast Track Designation for pelareorep in KRAS‑mutant MSS metastatic colorectal cancer, backed by a 33% ORR, 16.6‑month PFS, and 27‑month OS versus historical standard‑of‑care benchmarks. It extends a pattern of supportive safety and efficacy data across GI tumors. Investors may watch for activation of up to 11 clinical sites, interim data expected by year‑end 2026, and ongoing FDA interactions as key milestones shaping pelareorep’s late‑stage development path.

Key Terms

fast track designation, objective response rate, progression-free survival, overall survival, +4 more

8 terms

fast track designation regulatory

"announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation"

A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.

objective response rate medical

"The Fast Track Designation is supported by clinical data demonstrating a 33% objective response rate"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

progression-free survival medical

"pelareorep combination therapy was associated with a median progression-free survival (“PFS”) of 16.6 months"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

overall survival medical

"and a median overall survival (“OS”) of 27 months, compared to 11.2 months with SOC"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

microsatellite-stable medical

"KRAS (“Kirsten rat sarcoma”)-mutant, microsatellite-stable (“MSS”) metastatic colorectal cancer"

Microsatellite-stable describes tumors whose short, repeated stretches of DNA remain unchanged, meaning the cell’s internal “proofreader” is effectively catching copying errors. Investors care because this molecular trait affects which therapies and clinical trials are likely to work — some immunotherapies and targeted drugs perform differently in stable versus unstable tumors, influencing a drug’s market potential, trial success and regulatory path.

metastatic colorectal cancer medical

"microsatellite-stable (“MSS”) metastatic colorectal cancer (“mCRC”) in the second-line"

Metastatic colorectal cancer is cancer that started in the colon or rectum and has spread to other parts of the body, most often the liver or lungs, making it harder to treat. For investors, it matters because advanced disease drives demand for more intensive treatments, ongoing clinical trials, and long-term care costs; think of it like a fire that has jumped from one room to multiple rooms, requiring bigger, more expensive responses and creating larger market opportunities and regulatory scrutiny.

standard-of-care medical

"33% objective response rate (“ORR”) for pelareorep-based therapy compared to approximately 10% ORR with standard-of-care"

The standard-of-care is the widely accepted medical treatment or procedure that doctors typically use for a particular illness, based on current evidence and clinical practice. For investors it matters because new drugs or devices must beat or match this baseline to be adopted, reimbursed and widely sold—think of it as the default recipe a market expects; a new product must prove it’s tastier, cheaper, or faster to replace it.

priority review regulatory

"may be eligible for Accelerated Approval and Priority Review if relevant criteria are met"

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

AI-generated analysis. Not financial advice.

Strong efficacy signals showing 33% ORR, 16.6-month PFS, and 27-month OS, improving on the SOC by 2-3X in a difficult-to-treat population

Company to launch controlled study in second-line KRAS-mutant MSS mCRC with interim data expected by the end of 2026

Pelareorep now has Fast Track Designation for two gastrointestinal cancers, solidifying its potential as an immunotherapeutic platform therapy in gastrointestinal cancers

SAN DIEGO, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech^® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation to pelareorep in combination with bevacizumab (Avastin^®) and leucovorin, fluorouracil, irinotecan (“FOLFIRI”) for the treatment of patients with KRAS (“Kirsten rat sarcoma”)-mutant, microsatellite-stable (“MSS”) metastatic colorectal cancer (“mCRC”) in the second-line (“2L”) setting. As part of the Company’s increased focus on gastrointestinal cancer and analysis of the existing colorectal data set in the fall, the Company applied for and has now received Fast Track Designation.

The Fast Track Designation is supported by clinical data demonstrating a 33% objective response rate (“ORR”) for pelareorep-based therapy compared to approximately 10% ORR with standard-of-care (“SOC”) in this patient population.^1-2 In addition, pelareorep combination therapy was associated with a median progression-free survival (“PFS”) of 16.6 months, compared to 5.7 months with SOC, and a median overall survival (“OS”) of 27 months, compared to 11.2 months with SOC.¹

KRAS-mutant MSS metastatic colorectal cancer represents one of the most challenging diseases in gastrointestinal oncology, as few effective treatment options exist following first-line progression, and available immune-based therapies provide little benefit. There are an estimated 2 million new colorectal cancer cases each year globally, with an annual total addressable market of approximately $3-5 billion for the 2L KRAS-mutant MSS mCRC subgroup.^3-7

“This designation is an important validation of our focus on pelareorep’s potential as a platform immunotherapy for gastrointestinal cancers like colorectal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Adding pelareorep to the standard-of-care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate in a market that is estimated to be worth several billion dollars. Pelareorep offers the potential to help a meaningful number of patients, and I look forward to continuing to collaborate with the FDA to address this treatment gap as expeditiously as possible.”

Oncolytics expects to initiate a controlled clinical study in second-line KRAS-mutant MSS mCRC comparing standard-of-care therapy alone versus standard-of-care plus pelareorep. The first clinical site is expected to be activated in March, with up to 10 additional sites anticipated to open shortly thereafter. Interim data from the study are expected by year-end. Further details regarding the study design and milestones are forthcoming.

The Fast Track Designation enables more frequent meetings and communication with the FDA to ensure alignment on development plans and the collection of clinical data needed to support approval. Furthermore, clinical programs with Fast Track Designation may be eligible for Accelerated Approval and Priority Review if relevant criteria are met. For conditions where an available treatment exists, a candidate therapy regimen must show some advantage over the available treatment, such as superior effectiveness, to be granted Fast Track Designation.

References

1. Bennouna J. Lancet Oncol (14):29-37, 2013
2. Iwamoto S. Ann Oncol. Jul;26(7):1427-33, 2015
3. International Agency for Research on Cancer. (n.d.). Colorectal cancer. World Health Organization – IARC. https://www.iarc.who.int/cancer-type/colorectal-cancer/
4. Amado RG, et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol. 2008 Apr 1;26(10):1626-34. doi: 10.1200/JCO.2007.14.7116. Epub 2008 Mar 3. PMID: 18316791
5. Cohen R, et al. Association of Primary Resistance to Immune Checkpoint Inhibitors in Metastatic Colorectal Cancer With Misdiagnosis of Microsatellite Instability or Mismatch Repair Deficiency Status. JAMA Oncol. 2019 Apr 1;5(4):551-555. doi: 10.1001/jamaoncol.2018.4942. PMID: 30452494; PMCID: PMC6459114.
6. Snider J, et al. Metastatic colorectal cancer (mCRC) treatment patterns in the Medicare population. J Clin Oncol. 2018;36(4_suppl):823. https://doi.org/10.1200/JCO.2018.36.4_suppl.823
7. American Health & Drug Benefits. (2013). Metastatic colorectal cancer: Treatment patterns and costs. https://ahdbonline.com/issues/2013/february-2013-vol-6-no-1-special-issue/article-1294
   
   

About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses.

The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.

Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the anticipated design, timelines, milestones, and outcomes of current and future studies; the estimated size of the total addressable market of the 2L KRAS-mutant MSS mCRC subgroup; expected benefits of the Fast Track Designation, including increased collaboration with regulatory bodies; the Company’s goals, strategies, and objectives; and its belief in the clinical promise of pelareorep in colorectal and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.

Company Contact
Jon Patton
Director of IR & Communication
jpatton@oncolytics.ca

Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com

Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
oblaschak@lifescicomms.com

FAQ

What is the FDA Fast Track decision for Oncolytics (ONCY) announced February 4, 2026?

The FDA granted Fast Track Designation for pelareorep with bevacizumab and FOLFIRI in 2L KRAS‑mutant MSS mCRC. According to the company, the designation follows clinical data showing improved ORR, PFS and OS versus standard‑of‑care benchmarks.

What clinical results support pelareorep's Fast Track for ONCY in KRAS‑mutant MSS mCRC?

Pelareorep‑based therapy showed a 33% ORR, PFS 16.6 months, and OS 27 months. According to the company, these compare with ~10% ORR, 5.7‑month PFS and 11.2‑month OS for standard‑of‑care benchmarks.

When will Oncolytics (ONCY) start the controlled 2L KRAS‑mutant MSS mCRC study and when is interim data expected?

Oncolytics expects first site activation in March 2026 and up to 11 sites to open. According to the company, interim data from the controlled study are expected by year‑end 2026.

How might Fast Track affect ONCY's development pathway for pelareorep in colorectal cancer?

Fast Track enables more frequent FDA interactions and alignment on development plans. According to the company, it may support eligibility for Accelerated Approval or Priority Review if relevant criteria are met.

How large is the addressable market cited for 2L KRAS‑mutant MSS mCRC for Oncolytics (ONCY)?

The company estimates an annual total addressable market of approximately $3–5 billion for this 2L subgroup. According to the company, this figure reflects global incidence and treatment needs in the segment.