Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – USA News Group News Commentary – Each October, breast cancer awareness gains momentum through impactful campaigns and advancements in treatment. However, this October brings unsettling news: a new report reveals a sharp rise in breast cancer diagnoses among women under 50. The study estimates over 310,000 new cases of invasive breast cancer will be diagnosed in 2024, with more than 42,000 deaths expected, while a BREM poll shows a third of women are skipping recommended screenings due to cost. Fortunately, a September report indicates that although diagnoses are rising, survival rates are improving. As Breast Cancer Awareness Month continues, biotech developers are actively advancing treatments, with recent market updates from: Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Jaguar Health, Inc. (NASDAQ: JAGX), BriaCell Therapeutics Corp. (NASDAQ: BCTX), Roche Holding AG (OTCQX: RHHBY, RHHVF), and Processa Pharmaceuticals, Inc. (NASDAQ: PCSA).
Straits Research projects that the global breast cancer diagnostics market will grow at a 7.62% CAGR, reaching $9.65 billion by 2033. Similarly, Polaris Market Research and Consulting forecasts the breast cancer therapy market to reach $63.13 billion by 2032, driven by an 8.5% CAGR.
Oncolytics Biotech® Announces Key Progress and Upcoming Studies for Breast and Pancreatic Cancer Treatments, Prepares for FDA Accelerated Approval Path
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, recently announced key progress and upcoming studies for pelareorep, its lead intravenously administered immunotherapy, in breast and pancreatic cancer trials.
New clinical efficacy results from the BRACELET-1 trial in HR+/HER2- breast cancer have set the stage for a study supporting accelerated US Food and Drug Administration (FDA) approval. The corporate update also highlights key milestones in gastrointestinal cancer trials anticipated in 2025, with potential for additional registration-enabling studies.
“We’re excited by the recent BRACELET-1 results, which exceeded our expectations and substantiate the strong efficacy signal previously observed in breast cancer patients treated with pelareorep,” said Wayne Pisano, Interim CEO and Chair of Oncolytics’ Board of Directors. “Having treated well over 100 HR+/HER2- metastatic breast cancer patients in multiple clinical studies, these results provide the basis for a development path leading to an accelerated approval. The BRACELET-1 results, combined with recent feedback from the FDA, give us confidence in our development approach, and we look forward to initiating a clinical trial designed to support the approval of pelareorep as a novel breast cancer therapeutic.”
The positive BRACELET-1 results lay the groundwork for a larger trial to seek accelerated FDA approval. In early 2025, Oncolytics plans to initiate a study of the pelareorep + paclitaxel combination in about 180 patients with HR+/HER2- advanced or metastatic breast cancer who have progressed on or are ineligible for treatments like Enhertu, addressing a U.S. population of approximately 55,000. The trial aims to demonstrate a progression-free survival (PFS) benefit of at least 4.3 months, building on BRACELET-1’s 5.7-month PFS improvement over chemotherapy alone, with enrollment expected to begin in the first half of 2025.
“With the continuing evolution of breast cancer treatment, we have designed our breast cancer program with the guidance of leading experts in the field,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “Our plan is designed to obtain a regulatory approval with fewer patients, in a shorter time, and requiring less funding than traditional regulatory pathways.”
Oncolytics has key milestones lined up for 2025, including the start of a registrational study for pelareorep with paclitaxel in HR+/HER2- breast cancer and expected safety and efficacy data from GOBLET study cohorts in pancreatic and anal cancers. By year-end, Oncolytics aims to finalize the master protocol with GCAR and initiate discussions with the FDA.
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 industry developments and happenings in the market this week include:
Jaguar Health, Inc. (NASDAQ: JAGX), a commercial stage pharmaceuticals company, recently reported statistically significant improvement in breast cancer patients in its Phase 3 OnTarget trial for its cancer supportive care drug Crofelemer. Patients with breast cancer accounted for nearly 180 of the 287 participants in this unprecedented prophylactic clinical trial recently conducted by Jaguar family company Napo Pharmaceuticals for diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy.
"The breast cancer results from OnTarget are a responder analysis, as was the primary endpoint in the phase 3 ADVENT trial that led to FDA approval of crofelemer for its currently commercialized indication for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy," said Lisa Conte, President and CEO of Jaguar. "This data in breast cancer patients has been submitted to a relevant oncology conference by the study's primary investigators, and a full study report for the breast cancer results is expected to be submitted to a peer-reviewed journal."
BriaCell Therapeutics Corp. (NASDAQ: BCTX), a clinical-stage biotechnology company, recently reported a dramatic anti-tumor response including complete resolution of temporal lobe breast cancer metastasis in a patient treated in the Phase 2 study of BriaCell’s Bria-IMT™ plus an immune checkpoint inhibitor regimen. The patient demonstrated an initial partial response at 2 months in the brain lesion with no detectable disease following 8 and 11 months of treatment.
“Bria-IMT™’s potential therapeutic impact is unprecedented in metastatic breast cancer (MBC) in a brain metastasis setting,” said Dr. William V. Williams, President and CEO of BriaCell. “Our clinical findings, demonstrating significant tumor shrinkage in metastatic brain legions, may transform the way we treat MBC patients with brain metastasis, and offers hope to cancer patients and their families fighting this devastating disease. These results support Bria-IMT™ as a potential new therapeutic option for MBC patients with brain metastasis. We look forward to evaluating the brain metastasis patient subgroup in our ongoing pivotal Phase 3 study in metastatic breast cancer.”
In a recent report by Reuters, the CEO of Roche Holding AG (OTCQX: RHHBY, RHHVF), a leading global pharmaceutical company, reportedly stated that Roche’s experimental oral breast cancer drug giredestrant could enter a market worth at least 10 billion Swiss francs (~US$12 billion) annually if it clears two key trials on early treatment of the disease, which are expected to yield results in 2025 and 2026.
"Giredestrant, if it works, would be a product in a market with a potential of 10 billion-plus," said Thomas Schinecker, CEO of Roche, at a media event in Mannheim, Germany, adding he was confident in the company's oncology efforts even as it diversifies into other therapy areas. Giredestrant belongs to a class known as oral selective oestrogen receptor degraders (SERD) to fight tumours that grow in response to oestrogen, which are estimated to account for up to 80% of all breast cancer cases.
Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), a clinical-stage pharmaceutical company focused on developing next-generation chemotherapeutic drugs, recently announced that the first patient has been dosed in a Phase 2 clinical trial evaluating NGC-Cap for the treatment of advanced or metastatic breast cancer. To date, three clinical trial sites, including some with multiple clinical locations, have received institutional review board approval to participate in this study and are recruiting patients, as Processa plans to activate approximately 30 sites worldwide.
“Dosing the first patient in this Phase 2 trial is a significant step in the development of NGC-Cap as a more effective and better tolerated treatment than widely used capecitabine and 5-FU,” said David Young, PharmD, Ph.D., President of Research and Development at Processa. “We expect this Phase 2 trial to build upon NGC-Cap’s positive Phase 1b findings and we look forward to announcing the results from our interim analysis of this Phase 2 trial in mid-2025.”
Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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