Cancer Treatment Revolution Drives $903B Market as New Therapies Gain Momentum
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – Baystreet.ca News Commentary – Researchers at Moffitt Cancer Center have uncovered a promising new therapeutic strategy that could potentially overcome resistance to current immunotherapies in advanced melanoma patients, marking another pivotal moment in a sector experiencing unprecedented momentum. The global oncology market is now projected to surpass $903.81 billion in revenue by 2034, driven by cancer immunotherapy market growth from $152.10 billion in 2025 to $250.01 billion by 2030. These breakthroughs position Oncolytics Biotech Inc. (NASDAQ: ONCY), Karyopharm Therapeutics Inc. (NASDAQ: KPTI), BriaCell Therapeutics Corp. (NASDAQ: BCTX) (TSX: BCT), Citius Oncology, Inc. (NASDAQ: CTOR), and MacroGenics, Inc. (NASDAQ: MGNX) to capitalize on this opportunity.
Oncology emerged as the top therapy area with 53 venture capital deals facilitated by 115 investors in Q2 2025. The institutional capital flow reflects confidence in a sector where the FDA issued 13 new oncology approvals in the second quarter of 2025, including treatments for rare cancers and head and neck cancer.
Oncolytics Biotech Inc. (NASDAQ: ONCY) has reached a pivotal inflection point, advancing toward what could become a registration-enabling trial for its breakthrough immunotherapy, pelareorep, in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).
Recently, the company confirmed active discussions with the U.S. Food and Drug Administration (FDA) to finalize pivotal study parameters, positioning Oncolytics for potential initiation of trial activities by Q4 2025. This regulatory engagement represents a critical milestone, transitioning from proof-of-concept research to regulatory-stage development in one of oncology's most challenging therapeutic areas.
The strategic emphasis on mPDAC builds on compelling survival data and addresses a massive unmet medical need. Pelareorep functions as a systemically delivered oncolytic virus that transforms immunologically "cold" tumors into "hot" targets responsive to immune-based treatments. Clinical data reveals pelareorep combinations achieved a remarkable 21.9% two-year overall survival rate in first-line pancreatic cancer patients, substantially outperforming the 9.2% historical benchmark established by standard chemotherapy protocols.
Importantly, pelareorep demonstrated a 62% objective response rate when combined with chemotherapy and checkpoint inhibitors. This outcome carries particular weight given checkpoint inhibitors currently lack approval for pancreatic cancer treatment, suggesting pelareorep may unlock immunotherapy effectiveness in historically resistant tumor 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 mechanism behind these outcomes involves pelareorep's dual action profile. The virus selectively replicates within cancer cells and activates broad immune responses against tumor tissue. Translational studies from GOBLET and AWARE-1 trials demonstrate how treatment elevates PD-L1 expression, amplifies interferon signaling, and mobilizes tumor-infiltrating lymphocytes throughout the bloodstream.
"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."
These mechanistic insights, combined with survival data from over 1,100 patients across multiple clinical programs, have shaped management's focus on pancreatic cancer as the lead indication for regulatory advancement.
Leadership changes reflect Oncolytics' execution-oriented approach. CEO Jared Kelly and Chief Business Officer Andrew Aromando both contributed to Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Kelly assumed the CEO role in June 2025, while Aromando joined a few weeks later to oversee business development initiatives. The company has also eliminated its At-the-Market and Equity Line facilities, signaling confidence in current cash resources to reach key development milestones.
Regulatory momentum supports accelerated development timelines. Pelareorep maintains both Fast Track and Orphan Drug designations from the FDA specifically for pancreatic cancer, acknowledging both therapeutic promise and critical patient need. These designations facilitate expedited review processes and can enhance partnership attractiveness with major pharmaceutical companies.
The broader market context highlights the commercial opportunity. Pancreatic cancer maintains among the lowest survival rates of common malignancies, with five-year survival below 14%. While immunotherapies have revolutionized treatment across multiple cancer types, mPDAC has remained largely resistant to immune-based approaches, creating substantial unmet need for effective therapeutic combinations.
During July, Oncolytics conducted a key opinion leader event featuring gastrointestinal oncology specialists who analyzed patient survival outcomes and biomarker validation studies. Expert feedback reinforced that pelareorep's immune activation mechanism addresses fundamental treatment gaps in first-line mPDAC therapy.
Current FDA discussions center on study design parameters that could support regulatory submission for commercial approval. Should the agency accept Oncolytics' proposed framework emphasizing overall survival endpoints, the resulting trial would provide definitive evidence of pelareorep's clinical and commercial viability in pancreatic cancer treatment.
Oncolytics anticipates sharing updated clinical development timelines during Q3 2025, with trial initiation activities potentially commencing by Q4 2025. With robust survival data, established regulatory plans, and experienced leadership driving strategic execution, the company appears well-positioned to advance pelareorep through its most critical development phase.
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:
Karyopharm Therapeutics Inc. (NASDAQ: KPTI) delivered strong performance in the second quarter of 2025 with total revenue reaching $37.9 million and U.S. XPOVIO net product revenue of $29.7 million, up 6% year-over-year. The commercial-stage pharmaceutical company is completing enrollment in its pivotal Phase 3 SENTRY trial for myelofibrosis, with patient screening expected to have recently closed and top-line results anticipated in March 2026. The company reaffirmed full-year 2025 total revenue guidance of $140 million to $155 million while updating U.S. XPOVIO net product revenue guidance to $110 million to $120 million.
"As we continue to seek potential financing and strategic alternatives to extend our cash runway and enhance liquidity, I am excited to announce that we are in our final weeks of enrolling our Phase 3 SENTRY trial and are on track to report top-line data from this pivotal trial in March 2026," said Richard Paulson, President and CEO of Karyopharm.
The company's XPOVIO represents a first-in-class oral exportin 1 (XPO1) inhibitor and the first of Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds for cancer treatment. With $52.0 million in cash as of June 30, 2025, Karyopharm is exploring financing transactions and strategic alternatives to extend operations beyond the October 2025 maturity of its convertible notes.
BriaCell Therapeutics Corp. (NASDAQ: BCTX) (TSX: BCT) has been selected for Memorial Sloan Kettering (MSK) Cancer Center's Therapeutics Accelerator 2025 Cohort program to accelerate clinical development of Bria-OTS+, the company's next-generation personalized off-the-shelf immunotherapy. This collaboration with one of the world's foremost cancer research institutions aims to expedite development for multiple cancer indications, including metastatic breast cancer, prostate cancer, and other cancers. Through the MSK program, BriaCell will explore access to expertise and institutional resources, including GMP manufacturing services, Investigational New Drug (IND) application preparation, and regulatory strategy support.
"We are honored to work with the scientific and clinical experts at MSK Therapeutics Accelerator," said Dr. William V. Williams, BriaCell's President and CEO.
BriaCell specializes in developing novel immunotherapies to transform cancer care, with Bria-OTS+ representing a potentially transformative platform technology. The company's participation in MSK's accelerator program represents another step toward achieving itsr vision of meaningful advances in efficacy and safety for thousands of patients.
Citius Oncology, Inc. (NASDAQ: CTOR) has deployed an innovative AI platform to support its commercial team with advanced data analytics ahead of the anticipated launch of LYMPHIR, a novel FDA-approved therapy for cutaneous T-cell lymphoma. The proprietary system uses machine learning to identify patterns in treatment and diagnosis, enabling the commercial team to target prescribers whose patients may benefit from LYMPHIR, which received FDA approval a year ago. The platform continuously refines its ability through integration of real-world U.S. claims data and marketing performance analytics.
"We look forward to having this innovative AI platform amplify the precision and impact of our experienced commercial and marketing teams," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharma. “This proprietary platform is designed to augment the clinical expertise and experience of our salesforce.”
LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma indicated for Stage I-III disease after at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million and is preparing for commercial launch in the second half of 2025.
MacroGenics, Inc. (NASDAQ: MGNX) reported strong financial progress in the second quarter of 2025 with total revenue reaching $22.2 million, more than double the $10.8 million reported in Q2 2024, driven by increased contract manufacturing revenue and collaboration agreements. The clinical-stage biopharmaceutical company reduced its net loss to $36.3 million from $55.7 million year-over-year and maintains a strong cash position of $176.5 million. The company completed a $70 million royalty monetization with Sagard Healthcare Partners for ZYNYZ royalties and remains eligible for up to $379.5 million in additional milestones from Sanofi's TZIELD program.
"Over the past several years, MacroGenics has established itself as a pioneer in the field of antibody-based therapeutics for patients battling cancer," said Eric Risser, President and CEO of MacroGenics. “Today, we have a promising portfolio spanning antibody drug conjugates and multi-specifics that we believe has the potential to generate significant value for both patients and shareholders alike.”
The company is advancing multiple clinical programs including lorigerlimab's Phase 2 trials in metastatic castration-resistant prostate cancer and platinum-resistant ovarian cancer, with clinical updates expected in the second half of 2025. MacroGenics anticipates its current cash runway will support operations through the first half of 2027.
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