Palazestrant

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Aug. 14, 2025 /PRNewswire/ -- Equity Insider News Commentary – Despite alarming federal budget cuts that stand to potentially harm the national battle against cancer, it appears that the private sector continues to step up, with hundreds of millions of VC dollars pouring into oncology ventures so far in 2025. While there has been a recent victory in the Senate to restore $15 million for the Pancreatic Cancer Research Program (PCARP), the prior elimination of the only federal program dedicated solely to researching pancreatic cancer served as a stark reminder of these ongoing funding challenges. This dynamic is setting the stage for a "flight to quality" among investors, who are now more than ever looking for innovative leaders with strong pipelines and clear paths to regulatory execution, a key milestone that can separate a promising biotech from a potential breakthrough like Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), ProPhase Labs, Inc. (NASDAQ: PRPH), IO Biotech, Inc. (NASDAQ: IOBT), Olema Pharmaceuticals, Inc. (NASDAQ: OLMA), and PDS Biotechnology Corporation (NASDAQ: PDSB). According to a report from Global Market Insights, the global oncology market was estimated at US$345.1 billion in 2025, and while growing at an impressive 10.8% CAGR, is projected to reach US$866.1 billion by 2034 — with $377.1 billion of that coming from the USA alone. Even more optimistic is a report from Vision Research Reports, which sees the global cancer drug sector surpassing 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: In other recent industry developments and happenings in the market include: ProPhase Labs, Inc. (NASDAQ: PRPH) announced it received a U.S. patent for its BE-Smart test that can detect early signs of Barrett's esophageal cancer, a deadly disease that kills most patients because it's usually caught too late. The test works with simple brush and forceps biopsies and achieved over 95% accuracy in clinical testing, potentially allowing doctors to catch this cancer when it's still treatable. "This achievement, coming on the heels of our BE-Smart™ validation demonstrating greater than a 95% technical success rate and dual compatibility with both brush and forceps biopsies, solidifies our leadership in medical innovation and brings us one step closer to transforming early detection and treatment strategies for this serious condition," said Ted Karkus, CEP of ProPhase. "With this newly issued patent, we believe we are well positioned to accelerate commercialization and broaden clinical access to BE-Smart." ProPhase's breakthrough could save thousands of lives by identifying patients at high risk for esophageal cancer before the disease becomes incurable, representing a major advancement in early cancer detection. IO Biotech, Inc. (NASDAQ: IOBT) recently announced that its experimental cancer vaccine (Cylembio) meaningfully extended the time before advanced melanoma patients got worse, with patients living 19.4 months without disease progression compared to 11 months for those on standard treatment alone. The vaccine works by training the immune system to attack both cancer cells and the cells that help tumors hide from treatment, and it showed particularly strong results in patients whose tumors were PD-L1 negative and unlikely to respond to current immunotherapies. "In this study, we observed a highly encouraging improvement in progression free survival and consistent trend in overall survival in patients treated with Cylembio," said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. "The magnitude and durability of clinical effect observed consistently across subgroups supports our confidence in Cylembio and its potential as a treatment for advanced melanoma patients. We look forward to engaging with the FDA to determine a potential path to approval based on these data." IO Biotech plans to meet with the FDA this fall to discuss approval for this treatment that could become a new standard of care for the deadliest form of skin cancer. Olema Pharmaceuticals, Inc. (NASDAQ: OLMA) reported progress on its experimental breast cancer pill called palazestrant, which is designed to completely block estrogen signals that fuel most breast cancers and is currently being tested in two large Phase 3 trials expected to finish in 2026. "Having achieved regulatory alignment on the selected dose for our pivotal palazestrant program during the second quarter, we are focused on accelerating enrollment in OPERA-01, which is on track for top-line data in the second half of 2026," said Sean P. Bohen, M.D., Ph.D., President and CEO of Olema. "Palazestrant's demonstrated activity and combinability with multiple compounds offers the potential for it to become a best-in-class, backbone endocrine therapy for metastatic breast cancer." The company is also developing OP-3136, a pill that targets a different pathway cancer cells use to grow and spread, with early results expected in 2026. Olema's drugs are designed to work where current treatments fail, potentially offering hope to the thousands of breast cancer patients whose tumors eventually become resistant to existing therapies. PDS Biotechnology Corporation (NASDAQ: PDSB) reported promising results from a colorectal cancer study where its experimental treatment achieved impressive response rates, leading to expansion of the trial to treat more patients with this hard-to-treat cancer. "Our second quarter of 2025 and recent weeks have been a productive period for PDS Biotech, highlighted by the continued progress in our VERSATILE-003 Phase 3 clinical trial," said Frank Bedu-Addo, Ph.D., President and CEO of PDS Biotech. "We look forward to publishing the full data set for this trial later this year, as we continue to progress our VERSATILE-003 trial, the only registrational stage trial specifically targeting HPV16-positive HNSCC patients." The company's lead program targets head and neck cancers caused by HPV, the same virus that is a major cause of cervical cancer, and is currently being tested in the only late-stage trial specifically designed for these patients. PDS Biotech's approach uses its immune-boosting technology to help the body's natural defenses better recognize and destroy cancer cells, potentially offering new hope for patients with limited treatment options. Source: CONTACT: Equity Insider [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. 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