Latest news with #ARPIs
Business Wire
3 days ago
- Health
- Business Wire
Artera Presenting Validation Data at 2025 ASCO Annual Meeting Highlighting How Multimodal AI Platform (MMAI) is Advancing Personalized Cancer Care
SAN FRANCISCO--(BUSINESS WIRE)-- Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, today announced the presentation of two new abstracts at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, including an oral presentation selected for Best of ASCO 2025, an honor reserved for studies with the greatest potential to shape the future of cancer care. The featured oral presentation showcases the first validated MMAI algorithm—used in the ArteraAI Prostate Test —to identify high-risk, non-metastatic prostate cancer patients who are likely to benefit from adding androgen receptor pathway inhibitors (ARPIs) to standard therapy. The STAMPEDE trial helped to establish ARPIs as the standard of care treatment for high-risk patients, but adoption of ARPIs has been uneven, likely due to concerns over side effects and follow-up care. The study, conducted as part of the STAMPEDE trial, evaluated the addition of ARPIs—specifically abiraterone acetate + prednisolone—to standard androgen deprivation therapy (ADT) and radiation. Artera's model identified that only 25% of high-risk patients derived meaningful benefit from ARPI intensification, suggesting the opportunity to spare up to 75% of this cohort from unnecessary toxicities. 'This data helps answer one of the most critical questions in cancer care: which patients will benefit from added treatment, and which will not,' said Nick James, MD, PhD, Professor of Prostate and Bladder Cancer Research at The Institute of Cancer Research, London, and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust. While traditional tests flag patients at risk of poor outcomes, they don't personalize treatment decisions. Our collaboration with Artera allows us to uncover patterns invisible to the human eye and optimize treatments like never before. The AI tool allows us to connect beneficial treatments to the patient, while sparing those who may suffer unnecessary side effects, or even premature death, if they receive ARPIs they don't need.' In addition to the oral presentation, Artera will also present a poster featuring external validation of its MMAI platform in men who have undergone radical prostatectomy (RP) for localized prostate cancer. The study demonstrates that the RP MMAI model is an independent prognostic tool for predicting biochemical recurrence (BCR) and long-term outcomes, even when controlling for clinical risk models. Artera's solution works with routine pathology and clinical data and does not require extra tissue or complex molecular testing, making it broadly scalable, cost-effective, and faster to implement. 'We are proud to see Artera's MMAI platform recognized with two abstracts at ASCO, including an oral presentation selected for Best of ASCO,' said Timothy Showalter, Chief Medical Officer of Artera. 'These studies reinforce our commitment to the rigorous clinical validation of the ArteraAI Prostate Test and our broader MMAI platform. Together, they reflect our mission to empower clinicians and patients with personalized, actionable insights that support confident, shared decision-making in prostate cancer care.' The studies presented by Artera add to the growing body of evidence that its MMAI platform can inform real-time clinical decisions and bring personalized cancer care to broader patient populations. For more information on Artera, visit Presentations at the 2025 ASCO Annual Meeting include: Oral Presentation: Multimodal artificial intelligence (MMAI) model to identify benefit from 2nd-generation androgen receptor pathway inhibitors (ARPI) in high-risk non-metastatic prostate cancer patients from STAMPEDE. Abstract Number: 5001 Session Type and Title: Oral Session - Genitourinary Cancer—Prostate, Testicular, and Penile Date and Time: Tuesday, June 3rd at 9:45 a.m. CT Poster Presentation: External validation of a pathology-based multimodal artificial intelligence biomarker for predicting prostate cancer outcomes after prostatectomy. Abstract Number: 5106 Session Type and Title: Poster Session - Genitourinary Cancer—Prostate, Testicular, and Penile Date and Time: Monday, June 2nd at 9:00 a.m. CT About Artera Artera is a leading precision medicine company developing AI tests to personalize cancer therapy. Artera offers an AI-enabled test that is the first of its kind to provide both prognostic and predictive results for patients with localized prostate cancer: ArteraAI Prostate Test. Artera's multimodal artificial intelligence (MMAI) biomarker test leverages a unique algorithm that assesses digital images from a patient's biopsy and their clinical data. The AI combines this information to determine their prognosis and predict whether a patient will benefit from a particular therapy and has been validated using many Phase 3 randomized trials. Artera's laboratory is CLIA-certified and College of American Pathologists (CAP) accredited. The ArteraAI Prostate Test is clinically available through Artera's laboratory in Jacksonville, Florida, and can be ordered online at
Yahoo
28-04-2025
- Business
- Yahoo
ORIC® Pharmaceuticals Presents Preclinical Data to Support the Potential of ORIC-944 as a Best-in-Class PRC2 Inhibitor for the Treatment of Prostate Cancer at the 2025 American Association for Cancer Research (AACR) Annual Meeting
SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, April 28, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced the presentation of a poster at the 2025 American Association for Cancer Research (AACR) Annual Meeting, highlighting preclinical data on ORIC-944, a potent, highly selective, orally bioavailable allosteric inhibitor of PRC2, which demonstrated synergistic activity and improved progression-free survival (PFS) when combined with androgen receptor pathway inhibitors (ARPIs) in models of prostate cancer. 'We are excited by the potential of ORIC-944 to be a best-in-class PRC2 inhibitor for the treatment of prostate cancer,' said Lori Friedman, PhD, chief scientific officer. 'The data presented at AACR demonstrate the strong synergy of ORIC-944 when combined with standards of care, reversing the evolution of prostate cancer, and improving progression-free survival in both castration-resistant and castration-sensitive prostate cancer models - validating the clinical exploration of ORIC-944 across the continuum of prostate cancer.' Poster presentation: ORIC-944, a PRC2 inhibitor with best-in-class properties, restores luminal features and restricts adaptation in prostate cancer models, conferring synergy with AR pathway inhibitors Key findings of the presentation: ORIC-944 increased progression-free survival (PFS) when combined with ARPIs in both castration-sensitive and castration-resistant prostate cancer models. ORIC-944 demonstrated transcriptional synergy and antitumor synergy when combined with ARPIs in prostate cancer cells. In preclinical prostate cancer models, ORIC-944 demonstrated robust inhibition of PRC2, enhanced luminal cell state, and consistently restricted lineage transcription factor accessibility through chromatin remodeling, thereby reenforcing the luminal state and preventing access to plasticity programs. Results position ORIC-944 as a potential best-in-class PRC2 inhibitor that, through both transcriptional and chromatin mechanisms, blocks prostate tumor adaptation, restores luminal features, and sensitizes tumors to ARPIs. ORIC-944 is currently being evaluated in combination with ERLEADA® (apalutamide) and in combination with NUBEQA® (darolutamide) in an ongoing Phase 1b trial for prostate cancer. About ORIC-944ORIC-944 is a potent and selective allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit that demonstrates best-in-class drug properties in preclinical studies, including potency, solubility, and pharmacokinetics, with half-life supporting once daily dosing. ORIC-944 was initially evaluated as a single agent in a Phase 1b trial in patients with advanced prostate cancer and demonstrated potential best-in-class drug properties, including clinical half-life of approximately 20 hours, robust target engagement and a favorable safety profile. ORIC-944 is currently being evaluated in combination with ERLEADA® (apalutamide) and in combination with NUBEQA® (darolutamide) in an ongoing Phase 1b trial for prostate cancer (NCT05413421). About ORIC Pharmaceuticals, Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) ORIC-114, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to and follow us on X or LinkedIn. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the advantages of ORIC-944 in preclinical models, including synergies with AR pathway inhibitors and improved PFS; the continued clinical development of ORIC-944; the potential best-in-class properties of ORIC-944; the potential advantages of ORIC-944 and ORIC's other programs; and plans underlying ORIC's clinical trials and development. Words such as 'believes,' 'anticipates,' 'plans,' 'expects,' 'intends,' 'will,' 'goal,' 'potential' and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC's plans to develop and commercialize its product candidates; the potential for clinical trials of ORIC's product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts on ORIC's operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC's license and collaboration agreements or its clinical trial collaboration and supply agreements; the potential market for ORIC's product candidates, and the progress and success of competing therapeutics currently available or in development; ORIC's ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC's reliance on third parties, including contract manufacturers and contract research organizations; ORIC's ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section titled 'Risk Factors' in ORIC's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the 'SEC') on February 18, 2025, and ORIC's future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Contact:Dominic Piscitelli, Chief Financial
Yahoo
06-04-2025
- Business
- Yahoo
Prostate cancer drug now available to more patients with aggressive form of disease
A newly expanded prostate cancer drug could bring new hope to patients with a common form of the disease. Novartis, a Switzerland-based pharmaceutical company, announced on March 28 that the U.S. Food and Drug Administration (FDA) has expanded approval for Pluvicto (lutetium Lu 177 vipivotide tetraxetan), a targeted radioligand therapy (RLT) that is given before chemotherapy. (RLTs are a form of targeted nuclear medicine that doctors use to treat multiple types of cancer, according to Novartis.) Prostate Cancer Risk Increases By 45% Among Men Who Share One Troubling Behavior The drug is intended for patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have received one round of androgen receptor pathway inhibitors (ARPIs), a class of drugs used in the treatment of metastatic prostate cancer. Pluvicto first got FDA approval on March 23, 2022, but this new expanded approval triples the number of patients eligible to receive the drug, according to a Novartis press release. Read On The Fox News App The drug is administered through an IV into the bloodstream, where it attaches to prostate cancer cells and either keeps them from replicating or kills them. Prostate Cancer Cases Spike In This Us State As Doctors Share Likely Reason "The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC," said lead study author Michael Morris, MD, prostate cancer section head at Memorial Sloan Kettering Cancer Center in New York. "It offers a targeted therapy that better delays disease progression compared to a second ARPI. This approval is a significant step forward and should open the doorway to a therapy that has clear clinical advantages for the patient with mCRPC who has progressed on one ARPI and has not received chemotherapy." This is a form of prostate cancer that has spread to other parts of the body and does not respond to standard hormone therapy, according to WebMD. It also has high levels of prostate-specific membrane antigen (PSMA), a protein produced by prostate cancer cells. In clinical trials, Pluvicto "significantly reduced the risk of progression or death" by 59% in mCRPC patients, Novartis reported. IMAGE "The FDA's expanded approval of [lutetium Lu 177 vipivotide tetraxetan] marks a transformative step forward in the treatment of mCRPC, underscoring the growing impact of precision oncology," Jorge A. Garcia, MD, a genitourinary medical oncologist and chair of the Solid Tumor Oncology Division at University Hospitals Seidman Cancer Center/Case Western Reserve University in Cleveland, Ohio, told OncLive. "By enabling access to this targeted radioligand therapy prior to chemotherapy, we are not only broadening treatment options, but also redefining the standard of care for PSMA-positive disease." Prostate cancer is the second leading cause of death among men; mCRPC makes up a majority of the deaths and 20% of all metastatic prostate cancer cases. Studies have shown that approximately 10% to 20% of patients with prostate cancer develop mCRPC within five years of follow-up after initial therapy, and cases of metastatic patients have risen 4% to 5% each year since 2011. Click Here To Sign Up For Our Health Newsletter Sixty percent of prostate cancers are diagnosed in men who are 65 or older, according to the American Cancer Society. The risk of being diagnosed with metastatic prostate cancer typically occurs between 65 and 74. Adverse effects of Pluvicto included dry mouth (61%), fatigue (53%), nausea (32%) and constipation (22%), the release stated. The patients receiving the drug were able to proceed with chemotherapy after taking it. Novartis is committed to delivering Pluvicto to the nearly 600 RLT treatment sites in the U.S., the company stated. For more Health articles, visit Looking ahead, Novartis said it plans to investigate the use of RLTs for other types of advanced cancers, including breast, colon, neuroendocrine, lung and pancreatic article source: Prostate cancer drug now available to more patients with aggressive form of disease
