Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – USA News Group News Commentary – As the new year begins, the American Association for Cancer Research (AACR) has highlighted expert predictions pointing to groundbreaking advancements in cancer research. From cutting-edge AI applications to novel therapies and innovative cancer vaccines, 2025 promises to build on the momentum of 2024, a year that saw over 50 oncology drug approvals, including the first-ever tumor-infiltrating lymphocyte cell therapy. With biotech stocks expected to stay in focus this year, recent updates have come from key oncology players that include Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Compass Therapeutics Inc. (NASDAQ: CMPX), C4 Therapeutics, Inc. (NASDAQ: CCCC), Tyra Biosciences, Inc. (NASDAQ: TYRA), and Zentalis Pharmaceuticals, Inc. (NASDAQ: ZNTL).
The article continued: According to Statista, the oncology drugs market is projected to reach $208.9 billion in revenue by 2025. Additionally, Global Market Insights estimates the global oncology market, valued at $320.3 billion in 2024, will expand at a compound annual growth rate (CAGR) of 10.8% through 2034, ultimately hitting $866.1 billion.
Regulatory Approval Clears Path for Oncolytics Biotech® to Advance Promising Pancreatic Cancer Treatment, Following a Review of Safety Data
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Germany’s medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study. This cohort is evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients.
Following a positive safety review by the independent Data Safety Monitoring Board (DSMB), which recommended continuation, the PEI’s approval allows Cohort 5 to progress to full enrollment. Early safety data will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium later this month, with initial efficacy results expected in the second half of the year.
“Pelareorep has the potential to meaningfully improve outcomes for patients with metastatic pancreatic cancer,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. “Encouraging tumor response rates observed in an earlier cohort of the GOBLET study underscore pelareorep’s promise in this disease. GOBLET Cohort 5 extends our evaluation by testing pelareorep with a different chemotherapy regimen, mFOLFIRINOX, which broadens the range of pancreatic cancer patients who may benefit from this innovative therapy. Positive results from this cohort may ultimately enable pelareorep to benefit the large majority of metastatic pancreatic patients for whom improved treatment options are badly needed.”
The Phase 1/2 GOBLET study is testing pelareorep, an oncolytic reovirus, in combination with other treatments for advanced gastrointestinal cancers, including pancreatic, colorectal, and anal cancers. Conducted at 17 centers in Germany, the study aims to evaluate response rates, safety, and biomarkers across multiple treatment arms, with promising cohorts advancing to further testing.
AIO is a non-profit organization that evolved from the medical oncology working group within the German Cancer Society (DKG). Dedicated to advancing science and research in medical oncology, AIO has grown into a prominent sponsor and study management company. Over the years, it has established a strong reputation both within Germany and on the international stage for its contributions to oncology research and study development.
Oncolytics Biotech’s work represents a significant step forward in the fight against metastatic pancreatic cancer, addressing a critical need for more effective treatment options in this aggressive disease. By leveraging the innovative potential of pelareorep in combination with established therapies, the company is paving the way for breakthroughs that could transform outcomes for patients and unlock value for investors.
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:
Compass Therapeutics Inc. (NASDAQ: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, recently announced a corporate and financial update hat included progress across multiple programs. Highlights include the anticipated top-line Phase 2/3 data for tovecimig (CTX-009) in biliary tract cancer by the end of Q1 2025 and plans to file an IND for CTX-10726 (a PD-1 x VEGF-A bispecific) by year-end 2025. With an estimated $127 million in cash expected to sustain operations into Q1 2027, Compass is also advancing biomarker trials and dose-escalation studies, with key data readouts planned for 2025.
“We are approaching a key catalyst for the company with the top-line data readout at the end of the first quarter for our Phase 2/3 combination study of tovecimig, which is our new nonproprietary name for CTX-009, in patients with advanced BTC,” said Thomas Schuetz, MD, PhD, CEO of Compass and Vice Chairman of the Board of Directors. “In addition, we are very excited to announce our new drug candidate, CTX-10726, a novel PD-1 x VEGF-A bispecific antibody. CTX-10726 builds on our deep VEGF-IO expertise and our research team has been rigorously advancing this candidate for the past year. We expect to submit an IND by year-end with initial proof-of-concept clinical data in 2026.Finally, we are making good progress on designing our two new Phase 2 biomarker studies with tovecimig and CTX-471 and continue to expect initiation of these clinical trials in mid-2025.”
C4 Therapeutics, Inc. (NASDAQ: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, recently announced its anticipated 2025 milestones as it continues its evolution into becoming a fully integrated biotechnology company focused on orally bioavailable degraders. C4’s Cemsidomide has shown a best-in-class profile and is advancing to the next phase of development for multiple myeloma and non-Hodgkin’s lymphoma, while the Phase 1 trial of CFT1946 for BRAF V600X solid tumors is on track to complete dose escalation in early 2025, with key data expected later in the year. Meanwhile, CFT8919 is progressing through Phase 1 in Greater China, and with a cash runway extending into 2027, C4 Therapeutics is well-positioned to advance its pipeline and solidify its leadership in protein degradation science.
“Stellar execution in 2024 has set up 2025 to be a pivotal year for the company as we work to generate important data that will position us to advance programs and bring degrader medicines to patients searching for new therapeutic options,” said Andrew Hirsch, President and CEO of C4 Therapeutics. “We are excited about the degrader rationale for these programs, which we believe have the potential to deliver value for patients, caregivers, physicians and shareholders.”
Tyra Biosciences, Inc. (NASDAQ: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, recently announced that the FDA cleared its Investigational New Drug (IND) application for TYRA-300 allowing the company to proceed with a Phase 2 clinical trial of TYRA-300 in low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC).
"Receiving FDA IND clearance is an important milestone in the advancement of TYRA-300 and for patients with NMIBC who urgently need better tolerated therapeutic options," commented Doug Warner, Chief Medical Officer of TYRA. "We expect to initiate patient dosing in the second quarter of this year, with initial three-month CR data to follow."
Zentalis Pharmaceuticals, Inc. (NASDAQ: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, recently announced that the FDA has granted Fast Track Designation to azenosertib for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (PROC) who are positive via Cyclin E1 immunohistochemistry for protein levels.
"Zentalis is sharply focused on our goal of bringing azenosertib to patients with gynecological malignancies,” said Ingmar Bruns, Chief Medical Officer of Zentalis. “The FDA’s decision to grant Fast Track Designation for azenosertib in Cyclin E1 positive ovarian cancer patients underscores the unmet medical need in this patient population which has historically been associated with resistance to chemotherapy and poor patient outcomes. This designation provides meaningful benefits, including those that may expedite the regulatory review of this product candidate in this patient population. We look forward to sharing updated azenosertib clinical data and a regulatory update, including plans for registration-intent studies, at our corporate event on January 29.”
Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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