FDA Fast-Track Cancer Treatments Drive $900B Market Growth Forecast
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – Baystreet.ca News Commentary – In the United States, federal budget cuts threaten to slow the nation’s progress in the fight against cancer, but the private sector appears to be filling some of the gap. In 2025 alone, oncology ventures have attracted hundreds of millions in venture capital funding, underscoring strong investor appetite for innovation. A recent Senate move to reinstate $15 million for the Pancreatic Cancer Research Program (PCARP) was a welcome win, though the earlier elimination of the program, the only one dedicated solely to pancreatic cancer research, highlighted just how precarious public funding can be. In this environment, investors are gravitating toward companies with differentiated science, robust pipelines, and the operational discipline needed to navigate the regulatory path. These are qualities found in Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), ImmunityBio, Inc. (NASDAQ: IBRX), Nuvation Bio Inc. (NYSE: NUVB), Absci Corporation (NASDAQ: ABSI), and Sana Biotechnology, Inc. (NASDAQ: SANA).
The oncology market continues to post strong growth, with Global Market Insights pegging its 2025 value at US$345.1 billion and forecasting a rise to US$866.1 billion by 2034, driven by a 10.8% CAGR. The U.S. share is projected to hit $377.1 billion over that period. Vision Research Reports offers an even more bullish outlook, anticipating the global cancer drug market will top US$900 billion in sales by 2034.
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has officially entered the most critical phase of its development journey—pursuing a potential registration-enabling trial in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) for its flagship asset, pelareorep.
In its latest Q2 2025 report, the company confirmed it has begun formal discussions with the U.S. Food and Drug Administration (FDA) aimed at finalizing a pivotal study design, with trial start-up activities expected to begin as early as Q4 2025.
For investors and potential partners, this represents a clear transition from promising clinical data to potential regulatory approval in one of medicine's most challenging cancer types.
"We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year," said Jared Kelly, CEO of Oncolytics. "As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors."
The strategic focus on mPDAC reflects both compelling clinical results and a significant market opportunity. Pelareorep is a systemically delivered oncolytic virus designed to convert immunologically "cold" tumors—those typically invisible to the immune system—into "hot" tumors that can respond to immunotherapy. In first-line pancreatic cancer studies, pelareorep-based regimens have demonstrated a notable 21.9% two-year overall survival rate, compared to a 9.2% historical benchmark for standard chemotherapy alone.
Even more compelling, when pelareorep was combined with chemotherapy and a checkpoint inhibitor, researchers recorded a 62% objective response rate—particularly significant given that checkpoint inhibitors are not currently approved for use in this indication. These results stem from pelareorep's dual mechanism: it both replicates within cancer cells and activates the body's immune response against tumors.
"This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME—all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep."
Translational data from the GOBLET and AWARE-1 studies demonstrate how pelareorep transforms the tumor microenvironment, increasing PD-L1 expression, heightening interferon signaling, and mobilizing tumor-infiltrating lymphocytes in the blood—changes that correlate with tumor size reduction. This mechanistic validation, combined with survival data from over 1,100 patients across multiple studies, has solidified the company's decision to prioritize this indication.
Oncolytics' execution-focused strategy is being led by Jared Kelly and Andrew Aromando, who both played key roles in Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Kelly was appointed CEO earlier this year, while Aromando recently joined as Chief Business Officer. In line with their focus on capital efficiency, the company has terminated its At-the-Market and Equity Line of Credit facilities, citing sufficient resources to advance key milestones without near-term shareholder dilution.
Regulatory advantages are already in place to accelerate development. Pelareorep holds Fast Track and Orphan Drug designations for pancreatic cancer from the FDA, meaning the agency has already recognized both the drug's potential and the serious unmet need in this patient population. These statuses streamline review processes and enhance the program's attractiveness to potential pharmaceutical partners.
The context underscores the opportunity: pancreatic cancer remains one of the deadliest common cancers, with a five-year survival rate of less than 14%. Unlike other cancers where immunotherapies have transformed treatment, mPDAC has largely resisted immunotherapeutic approaches—making pelareorep's immune-activating mechanism particularly promising for this underserved patient population.
Back in July, Oncolytics hosted a key opinion leader event featuring gastrointestinal cancer experts who reviewed survival outcomes for patients and biomarker validation. The expert panel reinforced the view that pelareorep's mechanism of activating innate and adaptive immune responses is both biologically sound and commercially relevant for first-line mPDAC treatment.
With this latest milestone, Oncolytics is entering a phase where FDA feedback will shape both clinical plans and potential commercial partnerships. If the agency accepts the company's proposed trial framework centered on an overall survival endpoint, the resulting study could provide definitive proof of pelareorep's market potential in mPDAC.
The company expects to provide an updated clinical timeline in Q3 2025, with trial start-up activities potentially beginning as early as Q4 2025. With compelling survival data, regulatory designations in place, and an experienced leadership team driving execution, Oncolytics is positioning pelareorep for a pivotal test in one of oncology's most challenging and underserved markets.
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:
ImmunityBio, Inc. (NASDAQ: IBRX) reported breakthrough results showing its experimental cancer treatment completely eliminated tumors in patients with a hard-to-treat blood cancer called Waldenstrom macroglobulinemia, a type of non-Hodgkin lymphoma, without using harsh chemotherapy that typically makes patients very sick. The treatment uses engineered immune cells that can be given to patients in an outpatient setting rather than requiring hospital stays, potentially making this life-saving therapy much easier for cancer patients to receive.
"The preliminary findings we have submitted for presentation at the American Society of Hematology annual meeting provides the first evidence that novel immunotherapy combinations without chemotherapy lymphodepletion can provide deep and durable remissions in WM even after multiple prior treatments," said Dr. Jackie Thomson, Wits University Donald Gordan Medical Center, Johannesburg, South Africa and the lead author of the paper. "Recruitment in this rare subset of lymphoma is ongoing to confirm these findings and to establish this chemo-free strategy as a viable treatment option for relapsed WM."
ImmunityBio's approach could revolutionize cancer treatment by offering the effectiveness of cutting-edge cell therapy without the severe side effects and logistical challenges that limit current treatments.
Nuvation Bio Inc. (NYSE: NUVB) received FDA approval for its new lung cancer pill called IBTROZI and quickly started treating 70 patients within just seven weeks, generating over $1 million in product revenue from channel stocking and new patient starts for only 13 business days from FDA approval to the end of June.
"With FDA approval of IBTROZI, we’re proud of our swift evolution into a commercial‐stage company executing across functions to deliver a differentiated therapy to 70 patients in just seven weeks," said David Hung, M.D., Founder, President, and CEO of Nuvation Bio. "Meanwhile, we’re advancing our broader pipeline with urgency, moving safusidenib toward one or more pivotal trials in IDH1-mutant glioma and advancing NUV-1511 through an early study in advanced solid tumors. We look forward to sharing our progress from these programs later this year."
The drug is specifically designed for a rare type of lung cancer and can penetrate the brain to fight cancer that has spread there, addressing a major challenge since the brain is where this cancer commonly spreads. Nuvation Bio also has several other experimental cancer drugs in development, including treatments for brain tumors, positioning the company to potentially help thousands of cancer patients with limited treatment options.
Absci Corporation (NASDAQ: ABSI) reported progress on cancer drugs designed entirely by artificial intelligence, including a treatment for skin cancers that showed promising early results and could work against tumors that resist current therapies.
“The past few months have been a period of strong execution for Absci, and we are positioned to build on this momentum,” said Sean McClain, Founder and CEO of Absci. “ABS-101 is advancing through clinical trials, ABS-201 is on track to enter the clinic early next year, and we recently announced a key milestone in our collaboration with Almirall. With a strengthened balance sheet and runway into the first half of 2028, we are well positioned to deliver on our mission.”
The company's AI platform can rapidly design new cancer antibodies, including one targeting breast cancer that worked against tumors resistant to existing treatments like Herceptin.
Absci's technology could dramatically speed up cancer drug discovery while creating more effective treatments for patients whose cancers have stopped responding to standard therapies.
Sana Biotechnology, Inc. (NASDAQ: SANA) presented positive results from ongoing cancer trials and is developing treatments that turn a patient's own immune cells into cancer fighters, with the goal of creating more effective therapies than current options.
The company is testing treatments for cancers that have returned after other therapies failed, and developing a revolutionary approach that could create cancer-fighting cells directly inside patients without requiring the complex procedures current treatments demand. Sana's technology aims to make powerful cell-based cancer treatments available to more patients by eliminating many of the barriers that currently limit access to these potentially life-saving therapies.
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