Darolutamide

Issued on behalf of Oncolytics Biotech Inc. USA News Group News Commentary VANCOUVER, BC, Jan. 15, 2025 /PRNewswire/ -- As 2025 begins, the American Association for Cancer Research (AACR) recently published forecasts from experts showcasing transformative advances in cancer research, including cutting-edge AI technologies, novel targeted therapies, and innovative cancer vaccines. With over 50 oncology drug approvals in 2024, including the first tumor-infiltrating lymphocyte cell therapy, this year holds great promise for precision medicine and immunotherapy. Amid growing expectations for an active year for biotech stocks in 2025, developers of new cancer therapies are already releasing important developments, with recent news coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Adaptive Biotechnologies Corporation (NASDAQ: ADPT), NeoGenomics, Inc. (NASDAQ: NEO), Elevation Oncology, Inc. (NASDAQ: ELEV), and ORIC Pharmaceuticals, Inc. (NASDAQ: ORIC). The article continued: Statista analysts project that the oncology drugs market will generate an estimated revenue of $208.9 billion in 2025. Meanwhile, Global Market Insights reports that the global oncology market, valued at approximately $320.3 billion in 2024, is expected to grow at a compound annual growth rate (CAGR) of 10.8% from 2025 to 2034, reaching $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: In other recent industry developments and happenings in the market include: Adaptive Biotechnologies Corporation (NASDAQ: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, NeoGenomics, Inc. (NASDAQ: NEO), a leading oncology testing services company, recently announced a multi-year exclusive strategic commercial collaboration that will advance minimal residual disease (MRD) monitoring options for patients with select blood cancers. Adaptive's clonoSEQ® is the first and only FDA-cleared test for detecting minimal residual disease (MRD) in lymphoid cancers, while NeoGenomics' COMPASS® and CHART® offer comprehensive and personalized testing for complex blood cancers. By combining clonoSEQ with these advanced services, oncologists can develop tailored treatment plans, assess patient risk more accurately, and gain real-time insights into disease progression, enhancing care for blood cancer patients. "As a leader in oncology testing with an extensive menu of precision oncology offerings, NeoGenomics is a natural partner for us," said Chad Robins, CEO and Co-Founder of Adaptive Biotechnologies. "We are proud of this collaboration, which expands access to the valuable insights that clonoSEQ MRD results offer, ultimately helping more providers and patients benefit from knowing their MRD status." Under a new agreement, clinicians using NeoGenomics' COMPASS diagnostic tool for blood cancers like multiple myeloma, B-ALL, CLL, and DLBCL can now include Adaptive Biotechnologies' clonoSEQ Clonality (ID) test at diagnosis to identify patient-specific DNA sequences for ongoing MRD (minimal residual disease) tracking. This integration allows seamless monitoring of disease burden throughout treatment using CHART, giving patients access to clonoSEQ insights and increasing eligibility for clinical trials that rely on MRD testing to guide therapy decisions. All clonoSEQ testing will be conducted at Adaptive's specialized laboratory, ensuring accurate and consistent results. Adaptive and NeoGenomics are preparing to implement the infrastructure for their partnership, with cross-promotional efforts expected to launch later this year, though financial terms remain undisclosed. iBio, Inc. (NYSE-American: IBIO) an AI-driven innovator of precision antibody immunotherapies, in collaboration with AstralBio Inc., recently announced they've developed a breakthrough antibody targeting Activin E, a key protein linked to cardiometabolic disorders and obesity. This achievement demonstrates the strength of iBio's platform in tackling challenging targets and advancing innovative therapies, with plans for rapid testing of this and other candidates in advanced disease models. "Developing a functional antibody against Activin E, an achievement we believe to be an industry first, is a significant milestone for iBio," said Martin Brenner, Ph.D., DVM, iCEO and Chief Scientific Officer of iBio. "This breakthrough strengthens our efforts to expand our therapeutics pipeline for the treatment of cardiometabolic disorders and obesity with innovative next-generation solutions." Elevation Oncology, Inc. (NASDAQ: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, recently announced program updates and upcoming milestones. The company is advancing its pipeline with EO-3021, a potentially best-in-class antibody drug conjugate targeting Claudin 18.2 in advanced gastric/GEJ cancer, showing promising early results with a 42.8% overall response rate and a differentiated safety profile. The ongoing Phase 1 trial includes monotherapy and combination studies, with additional data expected in 2025 and 2026, while EO-1022, a HER3-targeting ADC for solid tumors, is progressing toward preclinical data release in 2025 and an IND filing in 2026. "We are rapidly advancing EO-3021 to address significant unmet needs in treating earlier lines of advanced gastric/GEJ cancer, where we believe we have a unique ability to improve on the standard of care," said Joseph Ferra, President and CEO of Elevation Oncology. "As we enter 2025, we are honing our focus, leveraging the competitive anti-tumor activity and differentiated safety profile of EO-3021 to explore combination approaches in the first- and second-line settings." ORIC Pharmaceuticals, Inc. (NASDAQ: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, recently provided early Phase 1b combination data for ORIC-944, operational highlights for 2024, and anticipated upcoming milestones. ORIC-944, a potent PRC2 inhibitor, has shown strong potential in treating metastatic castration-resistant prostate cancer (mCRPC), with deep and durable PSA responses and a favorable safety profile in early Phase 1b combination trials with apalutamide and darolutamide. Alongside advancements in ORIC-114 for NSCLC, ORIC's 2024 milestones include promising clinical data, strategic collaborations with Johnson & Johnson and Bayer, and a robust cash position expected to support operations into late 2026, positioning the company for continued progress in oncology drug development. "We made strong progress on multiple fronts in 2024, most notably with the initiation of multiple cohorts for ORIC-114 in NSCLC and ORIC-944 in mCRPC," said Jacob M. Chacko, M.D., President and CEO of Oric. "We also forged three strategic collaborations with leading pharma partners, strengthened our leadership team to expand functional capabilities, and completed a $125 million PIPE financing, extending our cash runway into late 2026. These accomplishments position us well for 2025 and beyond, with seven anticipated data readouts over the next 18 months as we advance toward potentially initiating registrational studies for ORIC-114 in the second half of 2025 and for ORIC-944 in early 2026." Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. 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WHIPPANY, NJ, USA I January 14, 2025 I On the occasion of the 43rd J.P. Morgan Healthcare Conference in San Francisco, Bayer AG announces further progress in its pharmaceutical growth strategy with multiple regulatory filing submissions underway for key growth drivers darolutamide, finerenone, and elinzanetant. “We are successfully delivering on our ambitious business goals despite significant headwinds. At the same time, the value of our pipeline is growing by accelerating breakthrough innovations,” said Stefan Oelrich, Member of the Board of Management, Bayer AG, and President of Bayer’s Pharmaceuticals Division. “Our new operating model is visibly becoming a key enabler to drive growth and efficiency gains.” Topline improved and poised for future growth Bayer continues to strengthen its leadership position in prostate cancer with the anticipated launch of a third indication in 2025 for the oral androgen receptor inhibitor (Ari)darolutamide, marketed under the brand name NUBEQA ® ,supported by data from the ARANOTE trial. Darolutamide plus androgen deprivation therapy (ADT) now has positive data both with and without chemotherapy (docetaxel) based on two pivotal Phase III studies (ARASENS and ARANOTE) in metastatic hormone-sensitive prostate cancer (mHSPC). Bayer recently submitted an application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for this third indication for darolutamide in addition to filings in the U.S. and the EU earlier in 2024. NUBEQA achieved global blockbuster status in September 2024 after crossing the threshold of one billion euros in annual sales. Additionally, NUBEQA is now the fastest growing androgen receptor inhibitor in the U.S., with nearly 45,000 patients in the U.S. and 100,000 patients globally treated as of the end of 2024. For important risk and use information about NUBEQA, please see the full Prescribing Information . In Cardiovascular, Bayer submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) and CDE of China’s NMPAfor finerenone, marketed as KERENDIA ® , for the treatment of patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, initiating a major step forward in expanding its reach. Further regulatory filings are planned with a potential market launch by the end of 2025. Filing submissions are based on positive results from the Phase III FINEARTS-HF trial that showed finerenone achieved a statistically significant reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as either an unplanned hospitalization for HF or an urgent HF visit, by 16% in patients with HF and a LVEF of ≥40% compared to placebo in addition to a patients’ prescribed treatment regimen. The robust data from Kerendia’s clinical development program underscore its potential to become a pillar of therapy for patients with chronic kidney disease associated with Type 2 Diabetes and patients with heart failure with an LVEF of ≥40%. For important risk and use information about KERENDIA, please see the full Prescribing Information . In Women´s Healthcare, another significant clinical milestone for investigational compound elinzanetant was secured in early 2025 following three positive Phase III readouts in 2024 (OASIS 1,2,3). OASIS 4, which was conducted outside of the U.S., is a Phase III study evaluating elinzanetant as a non-hormonal treatment for moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy in women with breast cancer or at high risk of developing breast cancer. Elinzanetant successfully met the primary endpoints of the study demonstrating statistically significant reductions in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 4 and 12 compared to placebo. The study also achieved all secondary endpoints demonstrating reductions in severity of VMS at week 4 and 12, VMS frequency reduction at week 1 as well as maintaining the effects over the study period. The detailed results from OASIS 4 are planned to be presented at an upcoming scientific congress. Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause. In Radiology, Bayer is advancing its pipeline. A significant milestone was achieved with its Phase III QUANTI clinical development program, which evaluated the investigational compound gadoquatrane. The first data from the program showed that gadoquatrane successfully achieved its primary endpoint, highlighting its potential to offer a low dose contrast agent option to patients. The QUANTI program showcases Bayer’s leadership in radiology and its commitment to advancing innovation in medical imaging. Pipeline value improved and early lead positions strengthened Bayer is making significant progress with its cell and gene therapy platform, achieving important clinical trial milestones, especially in the field of Parkinson´s disease. Bemdaneprocel will directly advance to Phase III clinical development in Parkinson’s disease, based on positive data from the Phase I exPDite trial. Bemdaneprocel is an investigational stem cell-based therapy that surgically implants dopamine-generating nerve cell precursors into the brain. The FDA granted bemdaneprocel Regenerative Medicine Advanced Therapy (RMAT) designation for its innovative potential in treating Parkinson’s disease. AB-1005 is advancing in Phase II with the randomization of participants in the REGENERATE-PD clinical trial focusing on patients with moderate-stage Parkinson’s disease. AB-1005 is an investigational AAV-based gene therapy that delivers the human glial cell line-derived neurotrophic factor (GDNF) transgene to the brain to potentially protect and restore dopamine-generating neurons. AB-1005 has received U.S. FDA Fast Track and UK Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Passport designations, highlighting its potential to address significant unmet medical needs. As part of its transformation, Bayer has sharpened its focus in R&D to build a highly differentiated pipeline for long-term growth in oncology, cardiology and renal diseases, neurology and rare diseases, and immunology. Through rigorous assessment and prioritization, Bayer Pharmaceuticals is now fully focused on the areas of greatest unmet need and highest value potential. Targeted investments in R&D and platform companies in recent years are already strengthening Bayer’s early and late pipelines. With Vividion´s acquisition of the precision oncology platform company Tavros Therapeutics, Bayer continues to leverage its chemoproteomics platform technology to unlock traditionally undruggable targets with precision small-molecule therapeutics. It has initiated Phase I trials with oral KEAP1 activator in solid tumors and oral STAT3 inhibitor in solid and hematologic malignancies and has IND-enabling programs including a RAS-P13KCA program for RAS-driven cancers. Additionally in the field of precision oncology, investigational BAY 2927088, an oral, small molecule, tyrosine kinase inhibitor as a potential new targeted therapy for patients with non-small cell lung cancer (NSCLC) harboring HER2 activating mutations, showed promising results as a second line therapy in the ongoing Phase I/II SOHO-01 study evaluating safety and efficacy. Its potential is underscored by Breakthrough Therapy Designations from both the FDA and Chinese CDE. Beyond the SOHO-01 trial, BAY 2927088 is also being assessed for its potential as a first-line therapy in patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations in the SOHO-02 trial. Further, a Phase I clinical trial with BAY3498264, an investigational oral selective Son of Sevenless Homologue 1 (SOS1) inhibitor, has recently been initiated (outside of the US). The open-label, first-in-human, dose escalation study will evaluate patients with KRAS G12C-mutated metastatic cancer. This innovative approach has the potential to enhance the treatment options available for patients, offering the possibility to reduce or stop tumor progression. Targeted Radionuclide Therapy (TRT) is a strategic area of focus in Oncology precision drug development at Bayer, building on more than 10 years of real-world experience with radium Ra 223 dichloride injection therapy, marketed as XOFIGO ® , for patients with metastatic castration-resistant prostate cancer. Bayer´s evolving TRT portfolio includes novel targeting approaches which combine alpha radionuclides such as actinium-225 with different targeting moieties, including antibodies, small molecules or peptide-based molecules. 225 Ac-pelgifatamab (BAY 3546828) and 225 Ac-PSMA-Trillium (BAY 3563254), two candidates targeting PSMA (prostate specific membrane antigen), are currently in Phase I clinical trials in patients with advanced metastatic castration resistant prostate cancer (mCRPC). For important risk and use information about XOFIGO, please see the full Prescribing Information . In the field of cardiovascular diseases, Bayer is making progress with its Phase II assets. With BAY3283142, an investigational soluble guanylate cyclase (sGC) activator in patients with chronic kidney disease (CKD), Bayer has entered into a Phase II clinical study. By modulating sGC via a heme-independent pathway, the investigational sGC activator now represents a new class of potential future drugs that could offer an advantage in conditions of high oxidative stress such as in diabetic nephropathy. With the anti-alpha2 antiplasmin antibody program, Bayer is developing a new modality and mechanism of action-based thrombolytic agent. Based on investigational research, the antibody works by specifically blocking the endogenous plasmin inhibitor, α2AP, potentially leading to the lysis of acute embolic or thrombotic clots with a tolerable safety profile. The investigational antibody is currently being evaluated in Phase II in patients with deep vein thrombosis and could be used for indications of high medical relevance. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com . © 2025 Bayer BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer. Find more information at www.pharma.bayer.com Our online press service is just a click away: www.bayer.us/en/newsroom Follow us on Facebook: http://www.facebook.com/pharma.bayer Follow us on X: https://X.com/BayerUS SOURCE: Bayer