Breast Cancer Awareness Month Sees Biotech Advancements and Worrying Trends for Young Women
USA News Group News Commentary
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, BC, Oct. 15, 2024 /CNW/ -- With every October, breast cancer awareness surges thanks to very effective campaigns and new developments in breast cancer treatment. However, this October has started with some chilling data, including a new report showing that breast cancer diagnoses are spiking among women under 50. Not only did the study estimate that more than 310,000 new cases of invasive breast cancer will be diagnosed in women in 2024 (with more than 42,000 people dying from the disease), but new poll data from BREM also showed that a third of women are skipping recommended screenings due to cost. Thankfully, a report from September showed that while cancer diagnoses are rising, so is the chance of surviving. As Breast Cancer Awareness month continues, so too do biotech developers and their developments, with recent market updates from: Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Hologic, Inc. (NASDAQ: HOLX), Novartis AG (NYSE: NVS), Kazia Therapeutics Limited (NASDAQ: KZIA), and Atossa Therapeutics, Inc. (NASDAQ: ATOS).
According to Straits Research, the global breast cancer diagnostics market is projected to grow at a 7.62% CAGR towards reaching a US$9.65 billion by 2033. As well, according to analysts at Polaris Market Research and Consulting the breast cancer therapy market is set to increase to US$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.
Recent clinical efficacy results from the BRACELET-1 trial in HR+/HER2- breast cancer have paved the way for a new study to support accelerated US Food and Drug Administration (FDA) approval. The corporate update also outlines key milestones in gastrointestinal cancer trials expected in 2025, with the 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 promising results from BRACELET-1 provide a foundation for a larger trial aimed at securing accelerated FDA approval. In early 2025, Oncolytics plans to submit a pelareorep + paclitaxel combination trial for HR+/HER2- advanced or metastatic breast cancer, targeting around 180 patients who have progressed on or are ineligible for antibody-drug conjugates like Enhertu, representing an approximately 55,000 patients in the U.S. This study aims to demonstrate a progression-free survival (PFS) benefit of at least 4.3 months, with BRACELET-1 previously showing a 5.7-month PFS improvement over chemotherapy alone. Enrollment is expected to start 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 for 2025, including the launch of a registrational study for pelareorep with paclitaxel in HR+/HER2- breast cancer and anticipated safety and efficacy data from the GOBLET study cohorts in pancreatic and anal cancers. By year-end, Oncolytics plans to finalize the master protocol with GCAR and approach 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:
Hologic, Inc. (NASDAQ: HOLX), a global leader in women's health, kicked off Breast Cancer Awareness Month by ringing the Nasdaq opening bell for the 18th year and unveiled its #BustTheMyth campaign to debunk breast cancer myths and to empower women.
Earlier this year, Hologic completed its acquisition of Endomagnetics Ltd (Endomag), a privately held UK-based developer of breast cancer surgery technologies, for approximately $310 million. The transaction added Endomag's wireless breast surgery localization and lymphatic tracing solutions to Hologic's portfolio, expanding options and enhancing the experience for breast surgeons and radiologists.
"We are thrilled to complete the acquisition of Endomag and are looking forward to working with our new colleagues to increase access to their innovative technologies, which complement and diversify our expanding interventional breast health portfolio," said Erik Anderson, President of Breast and Skeletal Health Solutions at Hologic. "With our shared commitment to advancing women's health globally, we are excited to improve outcomes for patients and, together with our customers, redefine the standard of care for breast cancer intervention."
Novartis AG (NYSE: NVS), an innovative medicines company, announced back in mid-September that the US Food and Drug Administration (FDA) had approved Kisqali® (ribociclib) in combination with an aromatase inhibitor (AI) to reduce the risk of recurrence in people with HR+/HER2- early breast cancer. The approval came just days after Novartis announced updated analysis from the pivotal Phase III NATALEE trial, which showed a reduction in the risk of recurrence by 28.5% in a broad population of patients with early breast cancer.
"With this approval, we are redefining treatment options for a broader population of people impacted by breast cancer and facing the persistent risk of recurrence," said Victor Bultó, President, US, Novartis. "We continue to transform cancer care with Kisqali, building on its established profile in the metastatic setting and now helping a wide range of people as they strive to stay cancer-free following an early-stage diagnosis."
Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, also announced back in mid-September that it had executed an agreement with QIMR Berghofer Medical Research Institute, one of Australia's foremost cancer research centers, to obtain an exclusive license to certain intellectual property rights in relation to combination therapies consisting of PI3K inhibitor drugs, and one or more immunotherapy or PARP inhibitor drugs (PI3K combination).
"This is an exciting evolution in our partnership with QIMR Berghofer and an important milestone for not only Kazia's development of paxalisib, but also the company's commercial portfolio as we secure the licence of a significant cancer immunotherapy pathway," said Dr. John Friend, CEO of Kazia. "We are very pleased to have obtained the potential intellectual property rights around PI3K inhibitors, which is a significant step forward as we continue to explore cancer treatments beyond the brain, including novel therapeutics in solid tumours such as breast cancer."
Atossa Therapeutics, Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company developing innovative medicines in breast cancer, opened October by announcing its recognition and support of Breast Cancer Awareness Month, highlighting the FDA's recent implementation of its updated rule that requires healthcare providers to notify women of their breast density results following a mammogram. Atossa is currently evaluating its lead asset, (Z)-endoxifen, in multiple phase 2 clinical trials, including the Karisma-Endoxifen study, which is investigating the potential for (Z)-endoxifen to reduce mammographic breast density in premenopausal women with measurable density, with trial data expected in Q4 2024.
"While significant progress has been made, continued research is critical to improve outcomes for the millions of women impacted by breast cancer every year," said Steven Quay, M.D., Ph.D., President and CEO of Atossa. "At Atossa, we are dedicated to advancing innovative treatments and increasing awareness of risk factors, such as dense breast tissue, that can contribute to missed diagnoses."
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