Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – USA News Group News Commentary – Immunotherapy is revolutionizing oncology by harnessing the power of the immune system to fight cancer in transformative ways. Recent advancements include a bioengineered therapeutic platform designed to boost immune responses, providing targeted solutions for challenging-to-treat cancers. Additionally, the development of an mRNA-based immunotherapy platform shows promise in targeting tumors with precision while minimizing harm to healthy tissue. These innovations underscore the relentless progress in oncology aimed at improving outcomes for patients. Key players driving recent advancements in the field include Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), AbbVie Inc. (NYSE: ABBV), ImmunityBio, Inc. (NASDAQ: IBRX), Autolus Therapeutics plc (NASDAQ: AUTL), and Iovance Biotherapeutics, Inc. (NASDAQ: IOVA).
The article continued: The oncology field is poised for continued innovation, with MarketsAndMarkets forecasting the Artificial Intelligence in Oncology Market to reach $11.52 billion by 2030, driven by a 29.4% CAGR. Similarly, Nova Advisor projects the Personalized Cell Therapy Market to grow at a 23.53% CAGR, reaching $251.37 billion by 2034.
Oncolytics Biotech® Highlights 2024 Achievements and Prepares for an Influential 2025 with Promising Breast and GI Cancer Data
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, recently released a recap of major accomplishments from 2024 and a preview of anticipated milestones for the next 12 months. Following the promising BRACELET-1 readout, Oncolytics expects additional data readouts across its clinical development program in 2025, forming what it believes is a clear pathway to future commercialization opportunities.
“This past year produced highly encouraging clinical developments that we believe set the stage for significant progress, headlined by the robust efficacy results from the BRACELET-1 breast cancer study,” said Wayne Pisano, Interim CEO and Chair of Oncolytics Biotech’s Board of Directors. “In addition, our gastrointestinal cancer program continues to impress, resulting in meaningful collaborations with well-respected experts in the field. Key opinion leaders in both breast and GI cancers continue to be excited by pelareorep’s potential as we move into 2025. Based on these insights from leading oncologists, we believe pelareorep has the potential to become a transformational immunotherapy—and that pelareorep-based combination therapies could accelerate our path toward regulatory approval. We are very optimistic about our plans for the next year, and we look forward to showcasing our latest clinical progress early in the new year at the ASCO GI Symposium—an event that could provide key catalysts for our ongoing gastrointestinal cancer programs. Unlike many immunotherapies that struggle to convert ‘cold’ tumors to ‘hot,’ pelareorep’s unique mechanism of action following intravenous delivery has shown the potential to significantly boost patients’ immune responses—making previously unresponsive tumors more susceptible to treatment. I would like to say thank you to our shareholders, clinical collaborators, study sites and their staff, the patients who participate in our trials, and the employees of Oncolytics Biotech who have stepped up in a significant way in the temporary absence of our CEO, Matt Coffey.”
Oncolytics Biotech continues to advance pelareorep, its innovative immunotherapy for multiple cancer indications. Final efficacy results from the BRACELET-1 study in HR+/HER2- metastatic breast cancer demonstrated a median overall survival benefit exceeding one year and a two-year survival rate nearly double that of paclitaxel monotherapy. These findings, supported by earlier IND-213 data, further reinforce pelareorep’s transformative potential. With FDA alignment on a planned registration-enabling study, Oncolytics Biotech aims to offer improved treatment options for approximately 55,000 U.S. patients annually.
Significant progress has also been made in pancreatic cancer, with plans for a registration-enabling study supported by collaborations with the Global Coalition for Adaptive Research (GCAR) and Roche. This follows the GOBLET study’s outcomes, which more than doubled response rates in first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients. Additionally, the PanCAN-funded GOBLET cohort evaluating pelareorep plus mFOLFIRINOX, with or without atezolizumab, has completed safety run-in enrollment, receiving positive feedback from the Data Safety Monitoring Board. Key findings from this cohort, alongside progress in anal cancer, will be presented at the ASCO GI Symposium in January 2025.
Looking ahead, Oncolytics Biotech will present at the Biotech Showcase on January 13, 2025, and host investor meetings during the J.P. Morgan Healthcare Conference that same week. These events will provide a platform to highlight its clinical advancements and reinforce its commitment to addressing critical unmet needs in oncology.
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:
AbbVie Inc. (NYSE: ABBV), a biotech company with a focus on multiple blood cancers while advancing investigational therapies across a range of cancer types, recently shared new results from two ongoing clinical trials evaluating epcoritamab, a CD3xCD20 bispecific T-cell-engaging antibody, in patients with diffuse large B-cell lymphoma (DLBCL) at the ASH Annual Meeting. In the Phase 1b/2 EPCORE® NHL-2 trial, combining epcoritamab with R-CHOP therapy for untreated high-risk DLBCL patients achieved a 100% overall response rate (ORR) and an 87% complete response (CR) rate, with 83% of complete responders remaining in remission after two years. Meanwhile, the Phase 2 EPCORE® NHL-1 trial evaluating epcoritamab monotherapy in relapsed or refractory large B-cell lymphoma (LBCL) reported an ORR of 59% and a median CR duration of 36.1 months, demonstrating durable responses in heavily pretreated patients.
"The results from these epcoritamab studies help provide confidence in our ongoing Phase 3 trials and highlight our commitment to advancing treatment standards for this challenging type of cancer," said Mariana Cota Stirner, M.D., Ph.D., Vice President, therapeutic area head for hematology, AbbVie. "We remain dedicated to exploring epcoritamab both as a monotherapy and in combination with other therapies for earlier lines of treatment, as well as establishing it as a core therapy across B-cell malignancies."
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, recently announced that its QUILT 3.032 study of ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with BCG for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC CIS) achieved a 71% complete response (CR) rate among 100 patients, with durable responses extending up to 54 months. These results, aligning with previous findings published in NEJM Evidence (Chamie 2022), will support a Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) in Q4 2024. This milestone highlights ANKTIVA's potential to deliver durable responses for patients with limited treatment options.
"We are encouraged by the consistent complete response rates observed in our expanded patient cohort," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "These results highlight the potential of ANKTIVA to transform the treatment landscape for patients with BCG-unresponsive NMIBC CIS, offering hope for improved outcomes and cystectomy avoidance, especially with the prolonged duration of response now ranging as much as 54 months in this 100-patient analysis. Duration of complete response is the key efficacy element in driving cystectomy avoidance in this BCG-unresponsive population. I am pleased that this updated ANKTIVA data confirms that one of the highest durable responses is achieved when compared to other approved products in this indication."
Autolus Therapeutics plc (NASDAQ: AUTL), an early-commercial stage biopharmaceutical company developing next-generation programmed T cell therapies, recently announced FDA approval of AUCATZYL® (obecabtagene autoleucel) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL), based on results from the FELIX clinical trial. AUCATZYL demonstrated a 63% overall complete remission rate with a median duration of remission of 14.1 months, along with low rates of severe Cytokine Release Syndrome (3% Grade 3, no Grade 4 or 5) and manageable safety concerns. Manufactured at Autolus’ Nucleus facility in the UK and distributed in the U.S. by Cardinal Health, AUCATZYL is expected to address significant unmet needs for patients with r/r B-ALL, with regulatory reviews ongoing in the EU and UK.
“We are so pleased to now be able to offer AUCATZYL, our first commercial product, to adult r/r B-ALL patients in the U.S.,” said Dr. Christian Itin, CEO of Autolus. “This approval would not have been possible without the support of all the patients, their families and caregivers, their treating physicians and the nurses and investigators at the treatment centers – thank you.”
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotech company, recently reported significant operational updates, including the successful U.S. launch of Amtagvi (lifileucel), the first FDA-approved T cell therapy for advanced melanoma after anti-PD-1 and targeted therapy. With over 56 U.S. ATCs onboarded and manufacturing turnaround times meeting expectations, the company is set to expand access to more than 20,000 patients annually, including planned regulatory submissions in global markets through 2025. Additionally, Iovance continues to advance its TIL cell therapy pipeline with ongoing trials in melanoma, NSCLC, and endometrial cancer, alongside next-generation innovations like PD-1 inactivated TIL therapies and modified interleukin-12 TIL therapies, supported by a robust manufacturing and patent strategy ensuring long-term exclusivity.
“Iovance is executing a successful U.S. commercial launch of Amtagvi™ for patients with previously treated advanced melanoma,” said Frederick Vogt, Ph.D., J.D., Interim President and CEO of Iovance. “Robust demand for Amtagvi and Proleukin® continues to grow as our expanding network of authorized treatment centers (ATCs) and outreach to community oncologists broaden the utilization of Amtagvi, driving a higher volume of patient referrals. Demand trends are expected to accelerate growth throughout the remainder of the year and over the following years. As such, we are actively pursuing additional regulatory approvals to expand our commercial footprint, driving growth beyond the U.S. into new markets with a high prevalence of advanced melanoma.”
Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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