USA News Group News Commentary
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, BC, Dec. 2, 2024 /PRNewswire/ -- USA News GroupNews Commentary - Despite death rates for some cancers being on the decline, there is a global surge in cancer cases among people under 50, with new cases up by 79% overall. Windpipe and prostate cancers are rising fastest, while breast, windpipe, lung, bowel, and stomach cancers have the highest death tolls. The United Nations projects cancer rates to increase by 77% by 2050. To combat this trend, researchers are advancing new therapies, with the FDAapproving 16 oncology treatments between July and September 2024. Behind the scenes, biotech developers are making strides, with recent market updates from: Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Akoya Biosciences, Inc. (NASDAQ: AKYA), Checkpoint Therapeutics, Inc. (NASDAQ: CKPT), BriaCell Therapeutics Corp. (NASDAQ: BCTX), and Arcus Biosciences, Inc. (NYSE: RCUS).
There's plenty of tech advancements as well, with the Global AI in Oncology Market growing at a rapid 35% CAGR, towards US$13.6 billion by 2032. Analysts at Spherical Insights project the global oncology drug market is poised to grow at a CAGR of 11.5% towards US$564.50 billion by 2033.
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 ongoing breast and pancreatic cancer trials.
Recent clinical efficacy results from Oncolytics' BRACELET-1 trial in HR+/HER2- breast cancer set the stage for a clinical study aimed at supporting accelerated FDA approval. Additionally, Oncolytics' corporate update highlights key milestones anticipated in its gastrointestinal cancer trials in 2025, with the potential for new 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 promising efficacy results from BRACELET-1 lay the groundwork for a large clinical trial aimed at supporting accelerated FDA approval. In early 2025, Oncolytics plans to submit a pelareorep + paclitaxel combination therapy trial for breast cancer. The study will enroll around 180 patients with HR+/HER2- advanced or metastatic breast cancer who have progressed on, are ineligible for, or cannot tolerate antibody-drug conjugates (ADCs) like Enhertu-representing an approximately 55,000 patients in the US.
The study is designed with sufficient statistical power to achieve a p-value of < 0.05 for a progression-free survival (PFS) benefit of at least 4.3 months. Notably, the BRACELET-1 study showed a 5.7-month PFS advantage for the pelareorep + paclitaxel combination over chemotherapy alone. Enrollment for this registration-enabling study is anticipated 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. Our thorough understanding of pelareorep's mechanism of action makes us confident that pelareorep-based combination therapy will continue to deliver strong clinical benefits to HR+/HER- breast cancer patients within the current treatment approach."
Oncolytics has several major milestones planned for 2025. In the first half of the year, the company aims to launch a registrational study of pelareorep with paclitaxel in HR+/HER2- breast cancer and expects safety run-in data from cohort 5 of the GOBLET study, which examines pelareorep and modified FOLFIRINOX (mFOLFIRINOX), with or without atezolizumab, in newly diagnosed pancreatic cancer. Additionally, updated efficacy data from cohort 4 of the GOBLET study on pelareorep and atezolizumab in later-line anal cancer is anticipated. Once the master protocol is finalized with the Global Coalition for Adaptive Research (GCAR), Oncolytics plans to approach the FDA by year-end. In the second half of 2025, initial efficacy results from cohort 5 of the GOBLET study in pancreatic cancer patients are expected.
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:
Akoya Biosciences, Inc. (NASDAQ: AKYA), which calls itself the Spatial Biology Company®, recently announced that its PhenoCycler® Fusion and PhenoImager® HT platforms will support the UK-funded MANIFEST program. This multimillion-dollar initiative, backed by the Office of Life Sciences and the Medical Research Council, aims to enhance cancer immunotherapy research by examining immune cell interactions in tumors. Akoya's technology will help identify biomarkers that may predict patient responses and potential side effects.
"Akoya Biosciences is proud to be a part of the MANIFEST consortium, contributing our spatial proteomics leadership and expertise with the aim of improving patient care through this groundbreaking effort," said Brian McKelligon, CEO of Akoya Biosciences. "Our technology can help to identify key biomarkers, supporting the consortium's efforts to advance personalized medicine and ensure that more cancer patients can benefit from the potential of immunotherapy."
Checkpoint Therapeutics, Inc. (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, recently presented longer-term data from its pivotal trial of cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, in locally advanced and metastatic cutaneous squamous cell carcinoma ("cSCC"). With 16 months of additional follow-up, cosibelimab achieved objective response rates of 54.8% in locally advanced and 50.0% in metastatic cutaneous squamous cell carcinoma (cSCC), with durable responses still ongoing. The treatment showed a manageable safety profile, with low rates of severe adverse events and a 6.3% treatment discontinuation rate, mostly due to COVID-19.
"These longer-term results for cosibelimab presented at the ESMO Congress demonstrate a deepening of response over time, with higher objective response and complete response rates than initially observed at the primary analyses, and continue to expand the evidence supporting the efficacy and safety of cosibelimab as a potential new treatment for advanced cSCC," said James Oliviero, President and CEO of Checkpoint. "We look forward to our upcoming December 28, 2024, Prescription Drug User Fee Act ("PDUFA") goal date for our Biologics License Application for cosibelimab, and believe, if approved, cosibelimab's dual mechanisms of action and safety profile may position the product, over time, as the preferred immunotherapy of U.S. oncologists."
BriaCell Therapeutics Corp. (NASDAQ: BCTX), a clinical-stage biotech company developing novel immunotherapies to transform cancer care, recently reported 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.
"We believe that the complete tumor resolution in this patient with brain metastasis, plus other cases of significant anti-cancer clinical responses in our Phase 2 MBC patients with brain metastasis, highlight the potential application of Bria-IMT in treating similar MBC patients," said Dr. Giuseppe Del Priore, Chief Medical Officer of BriaCell. "The protracted time on therapy, now one year, attests to the excellent tolerability of the Bria-IMT regimen in combination with an immune checkpoint inhibitor which is being used in our pivotal Phase 3 study."
Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage global biopharmaceutical company, recently announced a clinical trial agreement with AstraZeneca to evaluate Arcus's investigational HIF-2a inhibitor casdatifan (AB51) in combination with volrustomig, AstraZeneca's investigational PD-1/CTLA-4 bispecific antibody, in patients with clear cell renal cell carcinoma (ccRCC).
"We believe casdatifan has best-in-class potential, based on the observed PK and PD profiles and the emerging clinical data from our ARC-20 study in patients with ccRCC," said Terry Rosen, Ph.D., CEO of Arcus. "This agreement will enable Arcus and AstraZeneca to collaborate and assess the potential for the novel combination of casdatifan with volrustomig to improve outcomes for patients with ccRCC."
Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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