USA News GroupNews Commentary – As the 2024 American Society of Clinical Oncology (ASCO) annual meeting approaches, excitement builds over the latest in cancer treatment advancements, particularly in Antibody-Drug Conjugates (ADCs). From May 31 to June 4, industry leaders will unveil new data on late-stage and approved therapies. Recent FDA approvals are also enriching the treatment landscape, offering patients innovative and improved cancer therapies. This pivotal event highlights the ongoing momentum in oncology research and treatment development, spotlighted by several developments recently announced by biotech companies, including: Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Merk & Co., Inc. (NYSE: MRK), Roche Holding AG (OTCQX: RHHBY), Amgen Inc. (NASDAQ: AMGN), and BioNTech SE (NASDAQ: BNTX).
The article continued: According to the National Cancer Institute, there will be an estimated 2,001,140 new cases of cancer diagnosed in the USA in 2024, with an expected 611,720 people projected to die from the disease. Throughout 2023, the FDA granted a total of 50 approvals for various oncology drugs.
Oncolytics Biotech® ASCO Abstracts Highlight Pelareorep’s Potential in Pancreatic Cancer and Immunotherapeutic Mechanism of Action
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced it has presented two abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. One is a trial-in-progress abstract discussing cohort 5 of the GOBLET study, which will evaluate the combination of pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients. The second describes pelareorep’s ability to induce the expansion of tumor-infiltrating lymphocytes (TILs) across multiple cancers and the correlation between TIL expansion and tumor response.
“The two abstracts that we are sharing at ASCO this year are in synch with our mission of advancing pelareorep towards registrational trials. The first abstract outlines the design of a new GOBLET PDAC cohort that could significantly expand the potential of the company’s pancreatic cancer program,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. “The chemotherapy regimens of mFOLFIRINOX and gemcitabine/nab-paclitaxel are the two most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab yielded tumor response rates nearly triple historical results. Should the combination of pelareorep and mFOLFIRINOX produce a similarly positive outcome, an even broader range of metastatic PDAC patients may benefit from pelareorep-based therapy. This cohort is being funded by a US$5 million grant in the form of the Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN). We anticipate enrollment in this cohort will begin this quarter.”
Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics stated, “Pelareorep stimulates a proinflammatory response that primes tumors for immunologic killing and also activates both innate and adaptive immune responses. Our second ASCO abstract provides additional support for pelareorep’s immunotherapeutic mechanism of action by describing its ability to stimulate the expansion of pre-existing and new TIL clones in the blood, which correlate with treatment response. These results build upon previously reported data from the AWARE-1 study in breast cancer to expand our understanding of pelareorep’s immune-based mechanism of action, and it supports further investigation of TIL expansion as a potential biomarker of clinical activity in patients treated with pelareorep.”
At the ASCO 2024 meeting, Oncolytics will present findings from its research on pelareorep in metastatic pancreatic ductal adenocarcinoma. This research is part of a Phase 1/2 randomized, multicenter study in which one cohort evaluates pelareorep combined with modified FOLFIRINOX with and without atezolizumab. Initially, the study will include 15 patients in each treatment group, focusing on the treatment’s safety and effectiveness, with plans to expand if initial success criteria are met. Additionally, another presentation at ASCO will explore how pelareorep enhances tumor-infiltrating lymphocytes (TILs) in the blood in patients with pancreatic, breast, and colon cancer, showing promising signs that TIL expansion correlates with better treatment responses. A copy of the PDAC poster presentation will be available on Oncolytics' website after the meeting concludes and the abstracts are available on the ASCO website, providing valuable insights into pelareorep's potential to improve outcomes in various cancers.
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In other industry developments and happenings in the market this week include:
Merk & Co., Inc. (NYSE: MRK), a global healthcare company that develops, manufactures, and markets a wide range of pharmaceuticals, vaccines, and animal health products, recently announced it will also present new data at the 2024 ASCO Annual Meeting, demonstrating advancements in novel oncology treatment approaches across their broad portfolio and diverse pipeline. The new data comes from four approved oncology medicines and four pipeline candidates in more than 25 types of cancer.
"At ASCO, the breadth of data across multiple types of cancer and stages of disease underscores our efforts to drive innovations that have potential to shape the future of oncology," said Dr. Marjorie Green, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. "This year’s ASCO is also particularly meaningful as we approach 10 years since KEYTRUDA was first approved in the U.S. Reflecting back, it is remarkable to see just how much the oncology treatment landscape has transformed, thanks to the significant contributions from patients, researchers and physicians around the world."
Roche Holding AG (OTCQX: RHHBY), through its leading wholly-owned biotechnology subsidiary Genentech, recently announced that the FDA has granted Breakthrough Therapy Designation to its proprietary inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PICK3CA mutation. Breakthrough Therapy Designation expedites the development and review of drugs meant to treat serious or life-threatening conditions, especially when initial clinical evidence suggests they may offer significant improvements over existing treatments.
"We are pleased that the FDA granted Breakthrough Therapy Designation for inavolisib in recognition of the substantial clinical benefit observed with this regimen," said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. "This promising inavolisib-based regimen could transform the PI3K inhibitor class, potentially becoming the standard of care for this patient population in the first-line setting."
Amgen Inc. (NASDAQ: AMGN), a biotech company that develops innovative therapeutics in areas including oncology, nephrology, and cardiology, announced that the FDA has approved its asset IMDELLTRA™ as the first and only T-cell engager therapy for the treatment of extensive-stage small cell lung cancer. IMDELLTRA has received accelerated approval based on positive results observed in clinical studies, including the response rate and duration of response. The continued approval for this treatment may depend on further confirmation and detailed outcomes from additional clinical trials.
"The FDA's approval of IMDELLTRA marks a pivotal moment for patients battling ES-SCLC. This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients," said Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen. "This approval further demonstrates our commitment to addressing aggressive cancers through our second FDA-approved Bispecific T-cell Engager (BiTE®) molecule. IMDELLTRA offers these patients who are in urgent need of new innovative therapies hope, and we're proud to deliver this long-awaited effective treatment to them."
BioNTech SE (NASDAQ: BNTX), a global next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, announced it will present clinical trial data for selected programs from the company’s diversified immuno-oncology pipeline at ASCO 2024. BioNTech will present epidemiological and real-world data from two observational studies in patient populations for which product candidates are being developed in its respective clinical programs.
“Our aim is to develop innovative treatment options across the continuum of cancer disease and establish new treatment paradigms that have the potential to address the fundamental challenges of treating cancer to drive meaningful improvements in the long-term survival rates for patients,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “The data from the interventional and observational studies that we will present at this year’s ASCO are of relevance for progress towards our goal as they will contribute to informing the direction of further development of several of our priority product candidates as well as the design of planned pivotal and later-stage clinical trials across all three key pillars of our diversified oncology pipeline, including novel immunomodulators, targeted therapies such as cell therapies and ADCs, and mRNA-based therapeutic cancer vaccines.”
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