BRD4

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

-- Study follows ongoing Phase 1 trial in U.S. and will enroll patients in China to evaluate the first protein degrader developed using Ranok’s innovative CHAMP® technology BOSTON & HANGZHOU, China--(BUSINESS WIRE)-- Ranok Therapeutics, a clinical-stage biopharmaceutical company that is developing a novel approach to targeted protein degradation for the treatment of cancers, today announced the initiation of patient dosing in China for a Phase 1 study of RNK05047, its first protein degrader candidate. The study, which mirrors an ongoing Phase 1 study in the U.S., will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RNK05047 in Chinese patients with advanced solid tumors or lymphomas. Ranok anticipates preliminary data from both the US and China Phase 1 studies by the end of 2024. “RNK05047, which has been developed using Ranok’s proprietary CHAMP® technology, is the first BRD4-selective protein degrader to have entered clinical testing in China. This extends our ongoing clinical study of RNK05047 in the U.S. to an Asian patient population, which we believe will provide important insights,” said Weiwen Ying, Ph.D, Founder and Chief Executive Officer of Ranok. “RNK05047 degrades BRD4 protein preferentially in tumors, which may potentially lead to improved safety and efficacy. We look forward to sharing initial results from both the US and China studies later this year.” “BRD4 is an epigenetic target of great interest for the treatment of many different cancer types,” said Ning Li, M.D., Professor and Vice President of the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) in Beijing China, as well as Lead Principal Investigator for this study. “The Cancer Hospital is the first and largest cancer hospital in China for the diagnosis and treatment of cancer. We are excited to be participating in this study and are hopeful that RNK05047 will provide an important new therapeutic option for cancer patients.” Additional information can be found at (CTR20233943) and (NCT05487170). About Ranok’s CHAMP® platform Ranok’s proprietary Chaperone-mediated Protein Degradation (CHAMP®) platform takes advantage of the cellular chaperone network, which regulates the folding and stability of proteins, distinguishing it from other targeted protein degradation approaches. CHAMPs have a number of unique advantages, such as the evasion of mechanisms of drug resistance, and are designed to improve safety and efficacy due to the selective targeting of disease tissues. About RNK05047 RNK05047 is a first-in-class, small-molecule, tumor- and BRD4-selective protein degrader that was discovered and developed using Ranok’s proprietary approach to targeted protein degradation, CHAMP®. The bromodomain transcription factor BRD4 is a key epigenetic regulator of oncogenes such as MYC and BCL2 and is involved in diverse cancer types. Phase 1 trials of RNK05047 are currently underway in both the U.S. and China to assess its safety, tolerability and pharmacokinetics, and also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints. Initial results are expected by the end of 2024. About Ranok Therapeutics Ranok is a privately held biopharmaceutical company that is pioneering CHAMP®, an innovative approach to targeted protein degradation for the discovery and development of novel therapeutics. Our R&D team brings deep biological insight and chemistry expertise to rapidly identify and advance CHAMP degraders for a variety of important disease targets, with the goal to create transformative medicines that benefit patients around the world suffering from cancer and other serious diseases. For more information, please visit the company website at or follow us on Twitter (@RanokTx) and LinkedIn.

ZEN-3694 Expands Development to Include Multiple Rare Oncology Indications Calgary, Alberta--(News - February 29, 2024) - Zenith Epigenetics Ltd. ("Zenith" or the "Company") announces its support of Rare Disease Day by highlighting our expanded development efforts of BET inhibitor ZEN-3694 for rare oncology diseases. Rare Disease Day takes place every year on the last day of February, with this leap year day being the rarest of all Rare Disease Days. This event is a global movement to promote equity in healthcare, and access to diagnosis and therapies for individuals living with rare diseases. We are developing ZEN-3694 for the treatment of two aggressive rare cancers with very poor prognosis and no effective approved therapies, NUT carcinoma (NC) and malignant peripheral nerve sheath tumors (MPNST). In addition to clinical trials, we have also provided ZEN-3694 for compassionate use to multiple patients with these diseases and are excited to soon announce results from these important studies. "We are proud to be developing ZEN-3694 to help patients with aggressive, rare forms of cancer, who currently have no access to effective therapies. We are very pleased that NUT carcinoma patients receiving ZEN-3694 in clinical trial and compassionate use settings have benefitted from our drug," said Donald McCaffrey, CEO of Zenith Epigenetics. "Our goal is to improve outcomes and quality of life for NUT carcinoma patients, and we are committed to developing ZEN-3694 through registration for the treatment of this disease. We are also excited about exploring the activity of ZEN-3694 in MPNST, a rare cancer with devastating impact on patients' lives." NC is a highly aggressive type of squamous cell cancer with very poor prognosis that often forms in the head, neck, or lungs. There are currently no effective treatments for this devastating disease that primarily affects adolescents and young adults with a median survival of only 6 months. New diagnostic technologies have allowed for much better diagnosis of NC. The diagnosis rate is increasing rapidly with growing awareness and analytical testing for this disease. ZEN-3694 is being developed in two separate NC clinical trials. The first NC trial, NCT05019716, which combines ZEN-3694 with chemotherapy (etoposide/platinum), is active and recruiting patients. The second trial NCT05372640, combines ZEN-3694 with the CDK4/6 Inhibitor Abemaciclib and is also accruing patients. Both of these trials have shown promising activity. MPNST is a cancer of the cells that form the sheath that covers and protects peripheral nerves. The prevalence of MPNST in the general population is one in 100,000 and comprises 5-10% of all soft-tissue sarcomas. MPNST is most common in young adults, and the prognosis of patients with metastatic disease is extremely poor, with a median survival of less than one year. A clinical trial with ZEN-3694 is in the late planning stage and initiation is expected in the second half of 2024. About NUT Carcinoma and BET inhibition NUT carcinoma is driven by NUTM1 genetic alterations, most commonly fusion to BRD4 (bromodomain-containing protein 4) resulting in a fusion oncoprotein. ZEN-3694 is a BET bromodomain inhibitor that directly binds to NUT fusion proteins, disrupts their activity, and inhibits cancer growth. NUT carcinoma is diagnosed by testing tumor tissue for the fusion protein using immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) or by DNA sequencing to identify the NUT fusion oncogene. About MPNST and BET inhibition MPNST is driven by NF1 gene mutation in 40% of cases. Researchers have identified a BET protein dependency in these NF1-mutant MPNST tumors, and thus ZEN-3694 may disrupt this dependency and inhibit cancer cell growth. About Zenith and ZEN-3694 Zenith Epigenetics Ltd., a wholly owned subsidiary of Zenith Capital Corp., is a clinical stage biotechnology company focused on the discovery and development of novel therapeutics for the treatment of cancer and other disorders with significant unmet medical need. Zenith Epigenetics is developing various novel combinations of BET inhibitors with other targeted agents. Our lead compound, ZEN-3694, is in clinical development for various oncologic indications such as metastatic castration resistant prostate cancer, NUT carcinoma, ovarian cancer and RAS activated tumors. Several of these studies are sponsored by NCI under the NCI-Zenith Cooperative Research & Development Agreements (CRADA) and CRADAs between NCI and other NCI collaborators. For further information, please contact: Investor Relations Phone: 587-390-7865 Email: info@zenithepigenetics.com Website: Forward-Looking Statement This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts" and other similar expressions. In particular, this news release includes forward looking information relating to the Company's development activities involving ZEN-3694 in NUT carcinoma, malignant peripheral nerve sheath tumor, prostate cancer, ovarian cancer, RAS activated tumors, and other tumor types, as a single agent, or in combination with chemotherapies, including etoposide/platinum, CDK4/6 inhibitors, and other chemotherapy agents, as well as our partnerships, agreements, and collaborations in furtherance of these development activities. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our most recent MD&A which are incorporated herein by reference and are available through SEDAR+ at . The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. Zenith disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. To view the source version of this press release, please visit