NSD2

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

Poster to be presented Sunday, December 10, 2023 CAMBRIDGE, Mass., Dec. 4, 2023 /PRNewswire/ -- K36 Therapeutics, Inc. ("K36"), a clinical-stage biotech company focused on developing its first-in-class MMSET inhibitor KTX-1001 for t(4;14) multiple myeloma, today announced that its abstract evaluating KTX-1001 in relapsed and refractory multiple myeloma has been accepted for presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, which will be held December 9-12, 2023, in San Diego, California, and online. Dr. Jesús G. Berdeja, the Director of Multiple Myeloma Research at Tennessee Oncology, will deliver the presentation as part of the Trials in Progress session. "I am delighted to be presenting the trial progress of KTX-1001 in high-risk subsets like translocation t(4;14)," stated Dr. Berdeja. "There still remains an unmet need for new personalized oral therapies to treat multiple myeloma and novel precision therapeutics like KTX-1001 to address the challenges seen in high-risk patients with translocation t(4;14)." "We are seeing significant interest and momentum in our Phase 1 trial, and I would like to thank the patients, investigators and their staff for their commitment to generate important data from our trial," said Terry Connolly, Ph.D., Chief Executive Officer of K36. "KTX-1001 has demonstrated encouraging preclinical activity and a favorable tolerability profile establishing the potential to create a breakthrough therapy for multiple myeloma patients who have exhausted available standard of care treatments." Presentation Details: Title: Trial in Progress: A Phase 1 Study of KTX-1001, an Oral, First-in-Class, Selective MMSET Inhibitor in Patients with Relapsed and Refractory Multiple Myeloma Poster Number: 3391 Session Name: 653. Multiple Myeloma: Prospective Therapeutic Trials: Poster II Date: Sunday, December 10, 2023 Time: 6:00 PM - 8:00 PM PT Location: San Diego Convention Center, Halls G-H Full abstracts can be found at the ASH Annual Meeting website at . About KTX-1001 KTX-1001 is a novel, first-in-class, potent, and selective methyltransferase inhibitor of the catalytic activity of lysine H3K36. It is an orally administered small molecule being developed initially for the treatment of relapsed and refractory multiple myeloma, with a focus on patients with the t(4;14) translocation. This inhibitor offers a promising avenue for addressing this challenging high risk patient population. About the KTX-1001 Phase 1 Clinical Trial The Phase 1 clinical trial is a single-arm, open-label study in subjects with relapsed and refractory multiple myeloma. It is a multi-part clinical trial with dose escalation followed by an expansion cohort in patients with the genetic translocation t(4;14) to evaluate the safety, tolerability, and preliminary efficacy of different doses of KTX-1001. For more information and participating centers visit NCT05651932. About K36 Therapeutics, Inc. Founded in February 2021, K36 is a privately held biotech company backed by Atlas Venture, F-Prime Capital, Eight Roads Capital, Nextech and Bristol Myers Squibb (NYSE:BMS). Our mission is to translate epigenetic modulation of oncogenic pathways into first-in-class small molecule therapeutics for the benefit of cancer patients worldwide. For more information, please visit and follow us on LinkedIn. SOURCE K36 Therapeutics

Additional industry veterans recruited to strengthen clinical, translational medicine and preclinical teams K36 positioned to expand the opportunity for KTX-1001 to earlier treatment lines in multiple myeloma and the treatment of solid tumor indications CAMBRIDGE, Mass., Nov. 15, 2023 /PRNewswire/ -- K36 Therapeutics, Inc. ("K36"), a clinical-stage biotech company focused on developing its first-in-class MMSET inhibitor KTX-1001 for t(4;14) multiple myeloma, today announced that Benjamin Winograd, MD, PhD, has been appointed Chief Medical Officer to lead the Medical and Clinical teams. Dr. Winograd joins K36 with a wealth of experience and a remarkable track record of bringing innovative medicines for hematological and solid tumor disease treatments to patients. "Recruiting a leader with Dr. Winograd's expertise, reputation and track record of advancing transformative therapies validates the potential opportunity that KTX-1001 will deliver," said Terry Connolly, PhD, President and Chief Executive Officer of K36. "Benjamin will play an integral role in our continued advancement of the Phase 1 study of KTX-1001 and in supporting our translational medicine team in preparing for KTX-1001's potential use in combination with other multiple myeloma standard-of-care agents, and in earlier lines of therapy." Dr. Winograd's esteemed reputation in the multiple myeloma field stems from a distinguished career at Celgene where, as Vice President of Clinical Development and Head of Clinical Hematology/Oncology, he led the successful development and approval of transformative therapies REVLIMID®, POMALYST® and Abecma®. Prior to Celgene, Dr. Winograd held roles of increasing responsibility at Schering Plough, Pharmacia and BMS that led to the approvals of Temodar and Taxol. Most recently, Dr. Winograd was the Chief Medical Officer at Lava Therapeutics B.V. Dr. Winograd brings over 30 years of industry experience to K36, and will lead clinical development, translational medicine, regulatory affairs, and medical affairs. "K36 is embarking on a new precision medicine approach to personalized oral therapies that has the potential to transform the industry," said Dr. Winograd. "The search for a selective MMSET inhibitor for myeloma patients has been ongoing for over a decade and I am excited to continue the development of KTX-1001 for multiple myeloma in high-risk patients with translocation t(4;14) and to explore additional unmet needs in solid tumors." K36 also announced today that it has bolstered its clinical, translational medicine and preclinical teams with the recent appointments of Soo Bang as Senior Vice President of Strategy and Operations, Erin Flynt, PhD, as Executive Director of Translational Medicine, Sanjana Miskin as Director of Clinical Science, Julie Vazquez as Director of Clinical Operations, and Lan Xu, PhD, as Vice President of Preclinical and Translational Development. Soo Bang brings over 25 years of industry experience at Pfizer, Celgene and Bristol Myers Squibb. At Celgene, Ms. Bang was part of the business development group where she managed complex alliances and played key roles in business strategy and late-stage asset transitions and most recently, led integration efforts at BMS. Erin Flynt, PhD, brings over 10 years of Translational Medicine, Communications, and Strategy experience in myeloma to the company based on her tenure at Celgene and Bristol Myers Squibb. During this time, she led various disease-focused strategic projects and collaborated with Dr. Winograd in the development of several multiple myeloma agents. Sanjana Miskin has extensive clinical development experience across early and late-stage studies. She previously supported Phase 1 studies in heme malignancies and prostate cancer, global Phase I and Phase III studies in solid tumors, and an NDA approval while at Lava Therapeutics, GlaxoSmithKline and TG Therapeutics, respectively. Julie Vazquez joins the company with nearly 20 years of healthcare and clinical research experience through her in-hospital research work as a registered nurse at the MUSC General Clinical Research Center, and extensive experience in monitoring and clinical trial management with both CROs and sponsors. Most recently, she led the BCMA and CD-70 cell therapy study teams at Allogene Therapeutics. Lan Xu, PhD, will lead the preclinical effort to expand KTX-1001 into the treatment of solid tumors. Dr. Xu has over 20 years of experience in cancer research, drug discovery, and translational sciences, and has had roles of increasing responsibility at Blueprint Medicines, Foghorn Therapeutics, and Ikena Oncology supporting multiple targeted oncology and immuno-oncology programs in early clinical development. These appointments further strengthen K36's ability to exploit the full potential of KTX-1001. K36 remains committed to developing KTX-1001 for t(4;14) multiple myeloma and will continue its journey of developing novel agents and improving patient outcomes for those underserved by currently available therapies. Despite multiple new drug introductions into the multiple myeloma armamentarium, patients with a t(4;14) translocation have not benefitted as much as other multiple myeloma patient populations. About KTX-1001 KTX-1001 is a novel, first-in-class, potent, and selective inhibitor of the catalytic activity of MMSET. It is an investigational and orally administered small molecule being developed initially for the treatment of relapsed and refractory multiple myeloma, with a focus on patients with the t(4;14) translocation. About the KTX-1001 Phase 1 Clinical Trial The Phase 1 clinical trial is a single-arm, open-label study in subjects with relapsed and refractory multiple myeloma. It is a multi-part clinical trial with dose escalation followed by an expansion cohort in patients with the genetic translocation t(4;14) to evaluate the safety, tolerability, and preliminary efficacy of different doses of KTX-1001. For more information and participating centers visit NCT05651932. About K36 Therapeutics, Inc. Founded in February 2021, K36 is a privately held biotech company backed by Atlas Venture, F-Prime Capital, Eight Roads Capital, Nextech and Bristol Myers Squibb. Our mission is to translate epigenetic modulation of oncogenic pathways into first-in-class small molecule therapeutics for the benefit of cancer patients worldwide. For more information, please visit and follow us on LinkedIn. SOURCE K36 Therapeutics