Non-metastatic prostate cancer

LOS ANGELES, March 14, 2024 /PRNewswire/ -- The Prostate Cancer Foundation (PCF) today announced the 2023 Class of PCF Team Challenge Award recipients and a total of more than $21 million in funding for innovative prostate cancer research. PCF Challenge Awards fund international, multi-institutional, cross-disciplinary teams of investigators conducting highly innovative research with the greatest potential for accelerating new and improved treatments for advanced prostate cancer. Following a rigorous peer review process that assessed each project's scientific merit and potential patient impact, 20 highly coveted PCF Challenge Awards totaling $21.3 million were granted to teams at some of the world's leading cancer research institutions. For full project descriptions visit . 2023 James Cox Foundation, GTSN-PCF Challenge Award Project Title: Targeting Neuroendocrine Cells in Prostate Cancer with Small Molecule and Targeted Radionuclide Therapies Principal Investigators: Andrew Armstrong, MD, and Jiaoti Huang, MD, both of Duke University (Studying the efficacy of and developing biomarkers for two new treatment approaches for neuroendocrine prostate cancer to address an unmet need encompassing precision immunotherapy for the treatment of highly aggressive forms of castration-resistant prostate cancer.) 2023 Republic National Distributing Company (RNDC)-PCF Challenge Award Project Title: Development of a CBP/p300 Degrader for the Treatment of Castration-Resistant Prostate Cancer Principal Investigators: Arul Chinnaiyan, MD, PhD; Shaomeng Wang, PhD; Ulka Vaishampayan, MBBS; Abhijit Parolia, PhD, all of University of Michigan (Developing a new therapy that targets the prostate cancer oncogenes CBP and p300, this project will provide preclinical efficacy data and analyze biomarkers of response from a phase 1/2 clinical trials in patients with metastatic castration-resistant prostate cancer.) 2023 Bayer-PCF Health Equity Research Award Project Title: Incorporating Patient Education into Germline Testing in Black Patients with Prostate Cancer Principal Investigator: Burcu Darst, PhD, Fred Hutchinson Cancer Center (With the aim of reducing prostate cancer health disparities, this project will examine whether a tailored education program increases the likelihood of Black patients to undergo genetic testing and further the understanding of how this information impacts disease management decisions.) 2023 PCF Challenge Award Project Title: Personalizing Treatment Decisions Through Composite Next Generation Imaging and Liquid Biomarker Development Within a Phase II Randomized Trial of Enzalutamide (+/- 177Lu-PSMA-617) (ENZAp) Principal Investigator: Louise Emmett, MD, MBBS, St. Vincent's Hospital, Sydney, Australia (Studying molecular imaging and liquid biopsies from patients on a clinical trial testing LuPSMA plus enzalutamide versus enzalutamide alone as first-line therapy in patients with metastatic castration-resistant prostate cancer to better understand the mechanisms of synergy and resistance and develop biomarkers to guide individualized treatment decisions for patients.) 2023 Sun Pharma-PCF VAlor Special Challenge Award Project Title: A Phase 2 Randomized Study of YONSA® (Abiraterone Acetate), Enzalutamide or Apalutamide as First Line Therapy in Veterans with Castrate-Sensitive Prostate Cancer Principal Investigators: Antonio Tito Fojo, MD, and Susan Bates, MD, both of James J. Peters Veterans Affair Medical Center (Studying the effectiveness of an abiraterone-first strategy in the management of patients with castration-sensitive prostate cancer at the time when cancer recurrence is first documented.) 2023 PCF Challenge Award Project Title: Identifying Drivers of Aggressive Prostate Cancer and Racial Disparities in Patients Presenting with Low-Grade Disease Principal Investigators: Vanessa Hayes, PhD, The University of Sydney; Gail Prins, PhD, University of Illinois at Chicago; Riana Bornman, MD, University of Pretoria (Identifying genetic and genomic risk factors of lethal prostate cancer in African ancestry patients and translating this information into new criteria for classifying, managing and treating prostate cancer in these patients in order to reduce racial health disparities.) 2023 Bayer-PCF Health Equity Research Award Project Title: Impact of Genetic Ancestry and DNA Methylation on Prostate Cancer in African and African-American Patients Principal Investigator: Brian Joyce, PhD, Northwestern University (Investigating the usefulness of DNA methylation profiling of patient samples for the early detection and risk stratification of prostate cancer in Black men.) 2023 John Black Charitable Foundation-PCF Challenge Award Project Title: Metabolic Imaging and Targeted Radionuclide Combination Treatment of Prostate Cancer Bone Metastases Principal Investigators: Edward O'Neill, PhD, Claire Edwards, PhD, both of University of Oxford (Studying the role of tumor metabolism in treatment responses to 177Lu-PSMA-617 radioligand therapy to identify potential biomarkers and therapeutic targets in advanced prostate cancer.) 2023 Bayer-PCF Health Equity Research Award Project Title: Molecular Evaluation of Prostate Saturation and Progression Biopsies for Risk Assessment and Early Intervention Principal Investigator: Nallasivam Palanisamy, PhD, MSc, Henry Ford Health System (Analyzing at the molecular level prostate tumor samples from Black and white patients to understand racial differences in prostate cancer biology and disease progression, potentially leading to improved biomarker-based risk assessment tools for Black patients to improve health outcomes and reduce disparities.) 2023 Digital Science Press-PCF Challenge Award Project Title: Intercepting the Cancer Endocycle to Cure Lethal Prostate Cancer Principal Investigators: Kenneth Pienta, MD, Johns Hopkins University; Sarah Amend, PhD, Johns Hopkins School of Medicine; Emma Hammarlund, PhD, Lund University (Investigating whether a dormant "endocycling" state underlies cancer cells' ability to survive and resist therapy and testing new therapies to target cancer cells in this state.) 2023 Bayer-PCF Darolutamide Challenge Award Project Title: Darolutamide to Augment Radiotheranostic Therapy in Biochemically Recurrent Prostate Cancer (DART-BCR) Principal Investigators: Praful Ravi, MD, Harvard: Dana-Farber Cancer Institute; David Einstein, MD, Beth Israel Deaconess Medical Center (Examining the efficacy of darolutamide alone or in combination with PSMA-targeted radioligand therapy to identify biomarkers for patients most likely to benefit from this combination therapy, and determining how PSMA, the target of prostate cancer treatments and PET imaging, is regulated.) 2023 Durden Foundation-PCF Challenge Award Project Title: Characterizing Imaging, Genomic and Immune Predictors of 177Lu-PSMA (Lu-PSMA) and Olaparib Response in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) Principal Investigators: Shaneen Sandhu, MBBS, and Belinda Parker, PhD, both of the University of Melbourne (Testing the efficacy of a combination of Lu-PSMA and Olaparib for certain patients with mCRPC and defining the biological impacts of this combined therapy to maximize its effectiveness.) 2023 John and Daria Barry Foundation-PCF VAlor Challenge Award Project Title: Germline Influence on Prostate Cancer Metastasis and Response to Androgen Deprivation Therapy Principal Investigators: Tyler Seibert, MD, PhD, and Rana McKay, MD, of University of California San Diego; and Paul Boutros, PhD, MBA, of University of California Los Angeles (Using previously identified genetic variants that increase prostate cancer aggressiveness to develop a new genetic test that can predict individuals at high risk for developing lethal prostate cancer and their response to treatment.) 2023 Hamptons Coalition-PCF Challenge Award Project Title: Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance in Metastatic Prostate Cancer Principal Investigators: Karen Sfanos, PhD, Johns Hopkins University; Cathy Marshall, MD, MPH, Mark Markowski, MD, PhD, both of Johns Hopkins Medicine; Jason Ridlon, PhD, University of Illinois Urbana-Champaign (Developing and testing therapeutic strategies to prevent androgen production by gut bacteria in order to prolong the clinical response to anti-androgen therapies.) 2023 Regeneron-PCF Special Challenge Award Project Title: A Pilot Presurgical Trial of REGN5678 (Anti-PSMAxCD28) in Patients with High-Risk, Localized Prostate Cancer Followed by Radical Prostatectomy Principal Investigators: Padmanee Sharma, MD, PhD, Sumit Subudhi, MD, PhD, Brian Chapin, MD, Bilal Siddiqui, MD, all of The University of Texas MD Anderson Cancer Center (Investigating the efficacy of a new immunotherapy treatment, anti-PSMAxCD28 (REGN5678), that enables T cells to directly bind with and kill prostate cancer cells.) 2023 PCF Challenge Award Project Title: Modulation of Anti-Androgen Response by NSD2 in Castration-Resistant Prostate Cancer Principal Investigators: Michael Shen, PhD, Andrea Califano, PhD, of Columbia University Medical Center; Johann de Bono, MD, PhD, The Institute of Cancer Research; Charles L. Sawyers, MD, Memorial Sloane Kettering Cancer Center (Elucidating the mechanisms of NSD2 action, a critical driver and promising therapeutic target against highly aggressive neuroendocrine prostate cancer, to provide a foundation for early-phase trials of NSD2 inhibitors.) 2023 Bayer-PCF Darolutamide Challenge Award Project Title: Darostep: Evaluating Step Counts as a Biomarker and its Relationship on Treatment Outcomes in Vulnerable Patients with Metastatic Hormone-Sensitive Prostate Cancer on Darolutamide and Androgen Deprivation Therapy Principal Investigators: Russell Szmulewitz, MD, Nabiel Mir, MBBS, Megan Huisingh-Scheetz, all of The University of Chicago (Evaluating the impact of treatment with darolutamide on age-related outcomes in vulnerable, older patients with metastatic hormone-sensitive prostate cancer.) 2023 Movember, Todd Boehly, Shmuel Meitar, Richard Merkin, MD, Marcel Claure-PCF Challenge Award Project Title: Identification of Patients at High-Risk of Metastatic Disease After Neoadjuvant Intensive Androgen Signaling Inhibition Principal Investigators: Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute; Steven Balk, MD, PhD, Beth Israel Deaconess Medical Center (Developing biomarkers for identifying patients with high-risk localized prostate cancer who are likely to benefit from neoadjuvant androgen receptor signaling inhibitors (ARSI) which could lead to a new treatment paradigm that will cure more patients at the localized disease stage.) 2023 Igor Tulchinsky-PCF Challenge Award Project Title: ctDNA Determinants of Resistance to 177Lu-PSMA-617 versus Taxane-Based Chemotherapy Principal Investigators: Alexander Wyatt, PhD, Vancouver Prostate Centre; Arun Azad, MD, Michael Hofman, Peter MacCallum Cancer Centre; Kim Chi, MD, BC Cancer (Developing new blood-based biomarker tests to predict how well patients with metastatic castration-resistant prostate cancer will respond to 177Lu-PSMA-617 versus taxane chemotherapy while identifying new molecular mechanisms that drive treatment resistance.) 2023 Richard Solomon, Igor Tulchinsky, Darius Bikoff, John Paulson, Richard Sandler, Bill Mack, Jason Safriet-PCF Challenge Award Project Title: New Targeted Epigenetic Therapy for Androgen Receptor-Negative Prostate Cancer Principal Investigators: Ming-Ming Zhou, PhD, Icahn School of Medicine at Mount Sinai; Kunhong Xiao, PhD, Allegheny Health Network Cancer Institute (Establishing the mechanisms of action and preclinical efficacy of a novel BRD4- targeted therapy for diverse subtypes of metastatic castration-resistant prostate cancer.) About the Prostate Cancer Foundation The Prostate Cancer Foundation (PCF) is the world's leading philanthropic organization dedicated to funding life-saving prostate cancer research. Founded in 1993 by Mike Milken, PCF has been responsible for raising more than $1 billion in support of cutting-edge research through more than 2,250 research projects at 245 leading cancer centers, with a global footprint spanning 28 countries. Since PCF's inception, and through its efforts, patients around the world are living longer, suffering fewer complications, and enjoying better quality of all life. PCF is committed to creating a global public square for prostate cancer, in service to our mission of ending death and suffering from the disease. Learn more at pcf.org. MEDIA CONTACT: Staci L. Vernick Prostate Cancer Foundation [email protected] [email protected] 610-812-6092 SOURCE Prostate Cancer Foundation

The FDA approval positions Wyost as a treatment to prevent skeletal-related events. Credit: BigPixel Photo / Shutterstock.com. The US Food and Drug Administration (FDA) has approved Sandoz ’s Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), marking the introduction of the first FDA-approved denosumab biosimilars. These biosimilars are authorised to treat all indications of their reference medicines. With a concentration of 120mg/1.7mL (70mg/mL), Wyost is indicated as interchangeable with its reference medicine, a human monoclonal antibody that acts on the RANKL protein, which is essential for the activation of osteoclasts. This approval positions Wyost as a treatment to prevent skeletal-related events in patients with multiple myeloma and for those with bone metastases caused by solid tumours. Wyost is also sanctioned for use in adults and skeletally mature adolescents with giant cell tumours in bone that are either unresectable or where surgical resection could cause significant morbidity. See Also: A2 Bio’s cell therapy gains FDA orphan drug status for colorectal cancer FDA doubles down on patient engagement to support rare disease research It is also approved for treating hypercalcaemia of malignancy resistant to bisphosphonate treatment. Jubbonti is indicated to address several conditions related to bone health. It is approved for treating high fracture risk in postmenopausal women with osteoporosis, for improving bone mass in men with osteoporosis at similar risk, and for managing glucocorticoid-induced osteoporosis in anyone with this risk. Jubbonti is also approved to augment bone mass in men at high fracture risk due to undergoing androgen deprivation treatment for non-metastatic prostate cancer, and women receiving adjuvant aromatase inhibitor therapy for breast cancer. Extensive clinical studies support the latest regulatory approval in the US for these biosimilars and include safety warnings within the labelling. The approval of Jubbonti is paired with the sanctioning of Sandoz’s Jubbonti Risk Evaluation and Mitigation Strategy (REMS) programme. The programme is tailored to educate prescribers and patients about potential severe hypocalcaemia risk, particularly in those with advanced chronic kidney disease, including those dependent on dialysis. Sandoz North America president Keren Haruvi stated: “Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events […] disease states that can profoundly reduce the quality of life for patients.” The latest development comes after Sandoz acquired US biosimilar CIMERLI from Coherus BioSciences .

NEEDHAM, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced the Company will present a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting taking place April 5-10, 2024, in San Diego, CA. The presentation will describe the second candidate from the enLIGHTEN™ Discovery Platform, a first-in-class multimodal immunotherapy candidate for induction of tertiary lymphoid structures as a novel therapeutic strategy for solid tumors. This abstract presentation at AACR accelerates the milestone associated with the unveiling of the second enLIGHTEN™ program, which was originally planned for the third quarter of 2024. Presentation details are as follows: Presentation Title: A first-in-class multimodal immunotherapy for induction of tertiary lymphoid structures as a novel therapeutic strategy for solid tumorsPresenter: Anne R. Diers, PhD, Senior Director, Research, Candel TherapeuticsAbstract Number: LB263Session Date and Time: Tuesday, April 9, 2024; 9:00 AM - 12:30 PM PTSession Title: Late-Breaking Research: Experimental and Molecular Therapeutics 3Location: San Diego Convention Center All regular abstracts are available for viewing via AACR’s online itinerary planner, located here. About the enLIGHTEN™ Discovery Platform The enLIGHTEN™ Discovery Platform is a systematic, iterative herpes simplex virus (HSV)-based discovery platform leveraging human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors. The enLIGHTEN™ Discovery Platform has been designed to deconvolute the characteristics of the tumor microenvironment related to clinical outcomes. These discoveries are rapidly translated into optimized multi-gene payloads of tumor modulators that can be delivered to the tumor microenvironment for specific indications, disease stages, and rationally designed therapeutic combinations. In 2022, the Company announced a discovery partnership with the University of Pennsylvania Center for Cellular Immunotherapies to create new viral immunotherapies that could enhance the efficacy of chimeric antigen receptor T cell (CAR-T) therapy in solid tumors. During the Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting and the 2023 International Oncolytic Virus Conference, Candel presented encouraging data on the first candidate from this platform, Alpha 201-macro-1, which was designed to interfere with the CD47/SIRP1a pathway, in mouse models of breast cancer and lung cancer. About Candel Therapeutics Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1 clinical trial in recurrent high-grade glioma (HGG). Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: www.candeltx.com Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of development programs, including the timing and availability of announcement of the second candidate from the enLIGHTEN™ Discovery Platform. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from our pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, and strategic plans for the Company’s business and product candidates, and other risks identified in the Company’s SEC filings, including the Company’s most recent Quarterly Report on Form 10-Q filed with the SEC, and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Media ContactAljanae ReynoldsDirectorWheelhouse Life Science Advisorsareynolds@wheelhouselsa.com Investor ContactSylvia WheelerPrincipalWheelhouse Life Science Advisorsswheeler@wheelhouselsa.com