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New Alert: Oncolytics Biotech® Inc. (Nasdaq: ONCY)
ONCY is our new NASDAQ high growth biotech alert.
ONCY has a history of experiencing massive upside breakouts.
Now, ONCY could be on the verge of another big opportunity.
ONCY trades under 1.00 and has a chart setup that could be on the cusp of a big rally higher.
ONCY has multiple recent accomplishments that could have been overlooked by markets so momentum could build very quickly here.
The company is in one of the hottest sectors today - biotech and immunotherapy.
ONCY is developing what could be a transformational approach to treating some of the deadliest cancers in the world.
ONCY is a NASDAQ listed “clinical-stage immunotherapy company”.
ONCY is “developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent.”
It is “designed to induce anti-cancer immune responses by converting immunologically "cold" tumors to "hot" through the activation of innate and adaptive immune responses.”
According to the company, “GI cancers are the largest unmet medical need in oncology”.
Colorectal cancer remains one of the largest oncology markets globally, with significant unmet need in later-line settings.
Pelareorep has been “administered to over 1,200 patients, and clinical studies have demonstrated pelareorep's potential to enhance the activity of checkpoint inhibitors and other anti-cancer therapies across multiple solid tumor types.”
ONCY 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, anal, and pancreatic cancer.”
Fast Track designation is intended to facilitate the development and expedite the review of therapies that treat serious diseases and address significant unmet medical needs.
The designation provides opportunities for more frequent interactions with the FDA throughout development, rolling review of a future Biologics License Application, and eligibility for Priority Review, if applicable.
In July, ONCY received “Fast Track designation in SCAC is the third gastrointestinal cancer designation granted to pelareorep by the FDA, following designations in KRAS-mutated metastatic colorectal cancer in February 2026 and pancreatic cancer in late 2022.”
“Together, these designations underscore pelareorep's potential to address significant unmet medical needs and further validate the Company's strategy of pursuing registration in high-value gastrointestinal cancer indications.”
As the company further explains:
“SCAC is a rare cancer with limited treatment options in the second-line and later setting, and outcomes remain poor following progression on first-line treatment.”
“The World Health Organization estimates that there are approximately 54,000 cases of anal cancer globally each year, and the anal cancer market is expected to double to $2.3 billion from 2025 to 2035.”
ONCY is “actively pursuing strategic partnerships to accelerate development and maximize commercial impact.”
ONCY has “139 patents issued worldwide” & “New patent extends manufacturing protection to 2044 and expecting method of use protection into 2046”.
Manufacturing is also a differentiator: pelareorep is a "non-genetically modified Reovirus" with "high yield and low cost of goods" - "made in Carlsbad, California from products generally sourced in the USA" - with no special handling requirements and an "easy to scale for large studies or commercial launch in multiple indications" profile.
Earlier this year, the company announced:
“Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer”
Here are the highlights:
“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”
As the company further explained:
“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.”
Sadly, as the company explains:
“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.”
In May, the company announced:
“Oncolytics Biotech® Reports Durable Responses in Second-Line RAS-Mutant MSS Colorectal Cancer”
Here are the highlights:
“2L KRAS-Mutant MSS mCRC Demonstrates ~3–4x Improvement in Duration of Response vs. Historical 4–6 Month Benchmark”
“Company Engaged with FDA to Support Potential Accelerated Approval Pathway in 2L RAS-Mutant MSS mCRC”
Importantly:
“Pelareorep-based combination therapy demonstrated a 19.5-month median duration of response in second-line (“2L”) KRAS-mutant MSS mCRC patients in the REO 022 study, compared to historical benchmarks of approximately 4–6 months in this setting.1 Additional data from this study include an objective response rate of 33% for patients receiving pelareorep, bevacizumab, and FOLFIRI, tripling the 6-11% for the standard of care.”
In June, the company announced:
“Oncolytics Biotech® Secures New U.S. Patent Protecting Commercial Manufacturing of Pelareorep into 2044”
Here are the highlights from this press release:
“Intellectual property update confirms pelareorep's unique manufacturing process and scalability”
“Previously filed method-of-use patent application expected to provide protection into 2046”
“Additional patent filings planned in 2026 to further expand the pelareorep intellectual property estate”
Here are some of the company’s comments from this press release:
"Building a strong intellectual property estate around pelareorep is an important part of our strategy as we advance the program toward potential registration and commercialization," said Jared Kelly, Chief Executive Officer of Oncolytics. "This newly issued patent strengthens our protection around the manufacturing of pelareorep and supports our ability to produce the product at commercial scale. Combined with our previously filed method-of-use patent application and additional planned filings, we continue to build a durable patent portfolio designed to support the long-term value of pelareorep. Checking this box represents another important milestone as we execute on our strategy and move pelareorep into its next phase of development."
In July, the company announced:
“Oncolytics Biotech® Reports FDA Regulatory Milestone and Strong Clinical Progress in Randomized RAS-Mutant MSS Colorectal Cancer Trial”
Here are the highlights:
“Half of planned clinical sites will be activated this month; more than 20 patients have been pre-identified across participating centers”
“Company to hold Type D meeting with FDA to discuss a potential registrational pathway through the addition of Part B to the existing REO 033 trial design”
“Part B will be a randomized study designed to support potential accelerated and full approval”
Here are some of the company’s comments from this press release:
"The magnitude and durability of the efficacy observed in REO 022 warrant earnest evaluation in a randomized setting," said Dr. Sanjay Goel, Global Lead Principal Investigator for REO 033 and Professor of Medicine and Director of the Phase I Program at Rutgers Cancer Institute of New Jersey. "It is encouraging to see REO 033 expanding rapidly across leading academic centers, and I believe this study has the potential to further define the role of pelareorep in RAS-mutant MSS metastatic colorectal cancer."
"Launching a global randomized study with multiple high-quality sites in a short period of time reflects the operational capabilities of our clinical organization and our investigators," said Jared Kelly, Chief Executive Officer of Oncolytics. "Just as importantly, our ongoing interactions with the FDA have enabled us to focus on efficiently transitioning REO 033 into a registration-directed program built upon the existing trial infrastructure. We believe this strategy has the potential to significantly reduce development timelines while maintaining scientific rigor as we work to bring a much-needed immunotherapeutic option to patients in a treatment landscape that desperately needs innovation."
In July, the company also announced:
“Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer”
Here are the highlights:
“Designation supports development in an estimated $1 billion market where there are no FDA-approved therapies for patients whose disease progresses following first-line standard of care therapy”
“Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics' regulatory momentum and continues to advance the Company's path toward registration”
ONCY “believes the designation further validates pelareorep's potential to address a significant unmet need in advanced SCAC and follows the positive feedback received during its April 2026 meeting with the FDA regarding a potential registrational development strategy for the program.”
“Based on the FDA's feedback, Oncolytics believes it has a clear regulatory framework in place to advance pelareorep toward a pivotal study in this indication.”
Jared Kelly, Chief Executive Officer of Oncolytics commented:
"This Fast Track designation represents another important regulatory milestone for Oncolytics and reflects the significant progress we have made over the past twelve months in advancing pelareorep toward potential registration."
"During that time, we have received Fast Track designation in both metastatic colorectal cancer and squamous cell anal carcinoma, achieved important FDA alignment on registrational development strategies, strengthened our intellectual property portfolio, and continued to generate compelling clinical data across our gastrointestinal oncology programs. Our April meeting with the FDA provided important clarity regarding a potential registrational pathway for pelareorep in second-line and later anal cancer, reinforcing our confidence in the program and our strategy to address an area of significant unmet need. We believe these milestones continue to de-risk our development programs while positioning the Company to deliver meaningful value for patients and shareholders."
As the company further explains:
“The designation is supported by encouraging efficacy demonstrated in the Company's GOBLET study evaluating pelareorep in combination with a checkpoint inhibitor in patients with advanced SCAC whose disease had progressed following prior therapy.”
“Previously reported clinical results demonstrated an objective response rate of approximately 30%, more than double historical response rates reported in this setting, a median duration of response of approximately 15.5 months versus 9.5 months, and 12-month overall survival rate of 82% compared to 45.7%.”
In August, the company announced:
“Oncolytics Biotech® Aligns with FDA on Registrational Path for Second-Line RAS-Mutant MSS Colorectal Cancer”
Here are the highlights from this press release:
“FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study”
“Proposed pathway offers potential accelerated approval based on objective response rate and progression-free survival supporting full approval”
“Pivotal expansion to follow initial clinical data from the ongoing randomized Part A”
Most recently, the company announced:
“Oncolytics Biotech® Announces Positive Preclinical Results Combining Pelareorep with a Pan-RAS Inhibitor in Colorectal Cancer”
Here are the highlights from this press release:
“Preclinical results demonstrate pelareorep activity is maintained in the presence of RAS inhibition”
“Findings support further evaluation of pelareorep's potential to deepen and prolong responses to RAS-targeted therapy”
Here are some of the comments from this press release:
"These results provide an encouraging first look at combining pelareorep with one of the most important emerging classes of targeted cancer therapies," said Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics. "We observed pelareorep activity during the initial intensive dosing period as well as biologic compatibility between pelareorep and RAS inhibition, supporting the continued evaluation of pelareorep/RAS inhibitor combination therapy. Because acquired resistance remains a major limitation of RAS-targeted therapies, we believe these findings provide a compelling rationale to investigate whether sustained pelareorep activity can deepen and prolong responses to RAS inhibition and potentially delay the emergence of resistance. Similarly, pelareorep, because of its unique mechanism of action, may offer a treatment option for patients who become resistant to RAS inhibitors."
We believe ONCY could be positioned for high growth.
Make sure to do your own due diligence.
Happy Trading!
SmallCapStocks Team
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