H3B-6545

37 Cutting-Edge Study Results Presented at Global Gathering, Six Oral Presentations.2024 ASCO Annual Meeting abstracts featuring FCS research: 1015, 1051, 1056, 1105, 1594, 1631, 2521, 2582, 2588, 2599, 2618, 3074, 3597, 4046, 4136, 5554, 5607, 6014, 8521, 8556, 8585, 9010, 9051, 449374, e14587, e15014, e23059, LBA8500, TPS1128, TPS3160, TPS3165, TPS3166, TPS3173, TPS3178, TPS4607, TPS5637 FORT MYERS, Fla., May 29, 2024 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) physicians will present findings from multiple clinical studies that are contributing to global advancements in cancer care at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting in Chicago. Clinical research originating from trials conducted at the three FCS Phase 1 Drug Development Units and late-phase studies at FCS clinics throughout Florida are among those being published or presented during the five-day international gathering of oncology physicians and professionals. Continue Reading Florida Cancer Specialists & Research Institute research featured in 37 presentations/publications at 2024 ASCO. Post this 16 researchers from Florida Cancer Specialists & Research Institute will be featured in 37 abstracts and presentations during the 2024 ASCO Annual Meeting in Chicago. "It is gratifying to see how FCS continues to expand the understanding of cancer worldwide," said FCS President & Managing Physician Lucio N. Gordan, MD. "Our clinical research efforts are patient centric. Each discovery enables us to target treatments with greater precision and impact for patients." Manish Patel, MD, FCS director of drug development, notes that much of the clinical research being presented is focused on targeted treatments and biological combinations. Dr. Patel said, "The phase 1/2 trials offered at FCS provide patients early access to the most promising therapies and consistently lead to expedited FDA approvals that expand availability on a global scale." Several FCS principal investigators are first authors of four abstracts that will be presented throughout the meeting: Manish Patel, MD Preliminary results from a phase 1 study of AC699, an orally bioavailable chimeric estrogen receptor degrader, in patients with advanced or metastatic breast cancer Safety and preliminary efficacy of EIK1001 in combination with atezolizumab in participants with advanced solid tumors. Dr. Patel is a co-author of eight additional presentations Judy Wang, MD, FCS associate director of drug development Phase 1/2 study of NGM707, an ILT2/ILT4 dual antagonist antibody, in advanced solid tumors: Interim results from dose-escalation. She also is first author of the published abstract, A novel oral microtubule inhibitor utidelone capsule (UTD2): A phase 1 clinical study to assess the tolerability, safety, and efficacy in advanced solid tumors, of which Dr. Manish Patel is a co-author. Dr. Wang is also a co-author of six additional presentations Maen Hussein, MD – NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Updated overall survival analysis with 29-month follow-up of NAPOLI 3. FCS hematologist and medical oncologist Cesar Augusto Perez, MD will present an oral education session titled, "Emerging Data for Antibody Drug Conjugates in Head and Neck Squamous Cell Carcinoma." The following FCS principal investigators will have their abstracts presented during oral presentations of research results and other clinical findings which they have co-authored: Kapisthalam Kumar, MD, FACP – Are we bridging the gap? A ten-year probe into NIH grants for early-career and independent investigators in oncology. Manish Patel, MD – Safety and preliminary efficacy of EIK1001 in combination with pembrolizumab in participants with advanced solid tumors Vipul Patel, MD – Primary results from the phase 3 EVOKE-01 study of sacituzumab govitecan (SG) vs docetaxel (doc) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) previously treated with platinum (PT)-based chemotherapy (chemo) and PD(L)-1inhibitors (IO). Cesar Augusto Perez, MD, Amir Harandi, MD, MS – Phase 2 study of petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC) Cesar Augusto Perez, MD – Updated phase 1 results of efficacy and safety of sigvotatug vedotin, an investigational ADC, in non-small cell lung cancer FCS Associate Director of Drug Development Judy Wang, MD, Gail Lynn Shaw Wright, MD, FACP, FCCP, Fadi Kayali, MD -- H3B-6545 in women with locally advanced/metastatic estrogen receptor-positive (ER+), HER2 negative (–) breast cancer (BC). "We're winning. We're beating cancer," said Bradley Monk, MD, gynecologic oncologist and FCS medical director of late-phase clinical research. "Our discoveries through clinical trials are helping patients live longer and better lives." Dr. Monk is co-author of four presentations at ASCO, including the results of the international phase 3 OUTBACK trial of racial disparities and survival outcome of patients with locally advanced cervix cancer. Results from additional FCS co-authors will also be presented in various sessions, 26 in total, highlighting a variety of cancer types and treatment modalities: Faithlore Gardner, MD Todd Gersten, MD Lucio N. Gordan, MD with FCS Senior Director of Partnerships, Managed Care Kiana Mehring Joel Grossman, MD Elizabeth Guancial, MD "Our commitment to oncology research is stronger than ever and clearly demonstrated by sheer volume of abstracts presented by FCS researchers at this global symposium," stated FCS Chief Executive Officer Nathan H. Walcker. "The insights and breakthroughs revealed here fortify our resolve to tirelessly innovate and improve outcomes for patients worldwide." FCS will be featured in 37 presentations and publications over the course of the conference. All abstracts and presentations are available to view at ASCO® 2024 Annual Meeting. The American Society of Clinical Oncology (ASCO®) represents nearly 50,000 physicians and oncology professionals representing 150 countries who care for people living with all forms of cancer. ASCO® works to conquer cancer through research, education, policy and promotion of high quality and equitable patient care. View a full list of the FCS abstracts presented here: FLCancer.com/FCS-2024-ASCO-Presentations-052924.pdf About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. The majority of new cancer drugs recently approved for use in the U.S. were studied in clinical trials with FCS participation.* Recognized for our research, FCS is a recipient of the national Clinical Trials Participation Award presented by the American Society of Clinical Oncology (ASCO). FCS physicians, trained in prestigious medical schools and research institutes, are consistently ranked nationally as Top Doctors by U.S. News & World Report. Celebrating its 40th year in 2024, FCS has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research, cutting-edge technologies and advanced treatments, including targeted therapies genomic-based treatment and immunotherapy. Our highest values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians and staff. *Prior to approval SOURCE Florida Cancer Specialists & Research Institute

DUBLIN--( BUSINESS WIRE )--The "HR Positive/ Her2 Negative Breast Cancer - Pipeline Insight, 2023" clinical trials has been added to ResearchAndMarkets.com's offering. This "HR Positive/ HER2 Negative Breast Cancer - Pipeline Insight, 2023" report provides comprehensive insights about 50+ companies and 53+ pipeline drugs in HR Positive/ HER2 Negative Breast Cancer pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Geography Covered Global coverage HR Positive/ HER2 Negative Breast Cancer: Overview Three common tests employed to test for HER2 levels are chromogenic in situ hybridization (CISH), immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH). Depending on the levels of HER2 or ERBB2 in the laboratory test breast cancer is classified as HER2 or ERBB2 positive or HER2 negative breast cancer. In HER2 or ERBB2 receptors in a normal breast maintains growth, division and repairing while in HER2 or ERBB2 positive breast cancer over-expression of HER2 or ERBB2 is seen. In case of HER2 negative breast cancer the levels of HER2 protein is in normal. The present goal of therapy for early HR+/HER2- breast cancer (BC) is to optimize disease-free survival (DFS) and overall survival (OS) rates with the currently available therapies while avoiding any relevant long-term sequalae. Local therapies have evolved toward less aggressive techniques (i.e. breast-preserving surgery, sentinel lymph node biopsy and intraoperative radiotherapy), which significantly reduce the long-term sequalae observed with more radical treatments. Endocrine therapy (ET) is still the cornerstone of adjuvant treatment because it significantly reduces BC relapse and mortality. Adjuvant chemotherapy is today recommended only for a particular subset of patients with a high risk of recurrence with ET alone, identified through genomic assays, age and/or disease stage. Bisphosphonates reduce the risk of bone metastasis and produce a slight although statistically significant improvement in survival in postmenopausal women. The CDK 4/6 inhibitor abemaciclib has been recently approved by the US FDA for patients at high risk of relapse. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the HR Positive/ HER2 Negative Breast Cancer pipeline landscape is provided which includes the disease overview and HR Positive/ HER2 Negative Breast Cancer treatment guidelines. The assessment part of the report embraces, in depth HR Positive/ HER2 Negative Breast Cancer commercial assessment and clinical assessment of the pipeline products under development. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence HR Positive/ HER2 Negative Breast Cancer R&D. The therapies under development are focused on novel approaches to treat/improve HR Positive/ HER2 Negative Breast Cancer. HR Positive/ HER2 Negative Breast Cancer Emerging Drugs Chapters This segment of the HR Positive/ HER2 Negative Breast Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. HR Positive/ HER2 Negative Breast Cancer Emerging Drugs Camizestrant: AstraZeneca Camizestrant is a potent, next-generation oral SERD and pure ER? antagonist, that has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. The asset has been shown to promising anti-tumour profile when administered alone or in combination with palbociclib and thus, the company is running a Phase III trial for the same. Dato-DXd: Daiichi Sankyo, Inc. Datopotamab deruxtecan (Dato-DXd) is an investigational currently in Phase III for HR-positive, HER2- negative breast cancer. It is a TROP2 directed antibody drug conjugate (ADC) designed using Daiichi Sankyo's proprietary DXd ADC technology, datopotamab deruxtecan is one of the three lead ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca's ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads, an exatecan derivative, via tetrapeptide-based cleavable linkers. CX-2009: CytomX Therapeutics CX-2009 is a Probody drug conjugate that consists of a humanized anti-CD166 monoclonal antibody conjugated to DM4, a potent microtubule inhibitor known to be active against multiple cancer types. It is currently being tested in Phase II trial in Advanced HR-Positive/HER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination with Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer. RGT-419B: Regor Therapeutics RGT-419B is a new generation of CDK inhibitor with an optimized kinase activity spectrum. The clinical development program of RGT-419B is designed to address the unmet medical needs of patients who are refractory or have relapsed after previous treatment, providing new opportunities to improve survival and quality of life for patients with advanced/metastatic breast cancer. It is currently being tested in Phase I trial in in subjects with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer. HR Positive/ HER2 Negative Breast Cancer: Therapeutic Assessment This segment of the report provides insights about the different HR Positive/ HER2 Negative Breast Cancer drugs segregated based on following parameters that define the scope of the report, such as: Major Players in HR Positive/ HER2 Negative Breast Cancer There are approx. 50+ key companies which are developing the therapies for HR Positive/ HER2 Negative Breast Cancer. The companies which have their HR Positive/ HER2 Negative Breast Cancer drug candidates in the most advanced stage, i.e. phase III include, AstraZeneca. Phases The report covers around 53+ products under different phases of clinical development like Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration HR Positive/ HER2 Negative Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intra-articular Intraocular Intrathecal Intravenous Ophthalmic Oral Parenteral Subcutaneous Topical Transdermal Molecule Type Products have been categorized under various Molecule types such as Oligonucleotide Peptide Small molecule Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. HR Positive/ HER2 Negative Breast Cancer: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses HR Positive/ HER2 Negative Breast Cancer therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging HR Positive/ HER2 Negative Breast Cancer drugs. HR Positive/ HER2 Negative Breast Cancer Report Insights HR Positive/ HER2 Negative Breast Cancer Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs HR Positive/ HER2 Negative Breast Cancer Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Questions Answered Current Treatment Scenario and Emerging Therapies: How many companies are developing HR Positive/ HER2 Negative Breast Cancer drugs? How many HR Positive/ HER2 Negative Breast Cancer drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of HR Positive/ HER2 Negative Breast Cancer? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the HR Positive/ HER2 Negative Breast Cancer therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for HR Positive/ HER2 Negative Breast Cancer and their status? What are the key designations that have been granted to the emerging drugs? Key Players Regor Therapeuics Seagen Inc. CytomX Therapeutics Taizhou EOC Pharma Chia Tai Tianqing Pharmaceutical Group AstraZeneca Daiichi Sankyo, Inc. Tyme, Inc. Seagen Inc. Context Therapeutics Eisai Inc. Shanghai Hengrui Pharmaceutical Co., Ltd. Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals Merus N.V. Atossa Therapeutics Roche Ellipses Pharma Key Products RGT-419B SGN-B7H4V CX-2009 EOC202 TQB3616 Camizestrant Dato-DXd SM-88 SGN-B7H4V Onapristone Giredestrant H3B-6545 Z-endoxifen MCLA-128 EP0062 HRS8807 SCR-6852 AND019 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/g7co1l About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.