Duvelisib hydrate

Nov. 06, 2024 -- Secura Bio, Inc. (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, today announced a poster presentation highlighting new data on the investigational use of COPIKTRA® (duvelisib) both as a single agent and in combination therapy for the treatment of Peripheral T-cell Lymphoma (PTCL) and advanced hematologic malignancies at the upcoming 2024 American Society of Hematology (ASH) Annual Meeting taking place on December 7-10, 2024 in San Diego, CA. The poster, entitled: Duvelisib in Patients with Relapsed/Refractory Peripheral T-cell Lymphoma: Final Results from the Phase 2 PRIMO Trial highlights the outcomes of 123 patients in the PRIMO dose expansion phase of the PRIMO clinical trial and will be presented by Dr. Neha Mehta-Shah, Washington University School of Medicine, on Sunday, December 8, 2024, from 6:00 PM to 8:00 PM (PST) in the San Diego Convention Center, Halls G-H. The abstract is now available here. The PRIMO clinical trial was a global, multicenter, open-label, parallel cohort, Phase 2 study sponsored by Secura Bio, Inc., that evaluated COPIKTRA for the treatment of adult patients with relapsed or refractory (R/R) Peripheral T-cell Lymphoma (PTCL). Based on the dose optimization phase results, an expansion group of 123 patients was added in which COPIKTRA was dosed at 75 mg twice daily for two cycles, followed by 25 mg twice daily. COPIKTRA will also be highlighted in a number of other poster presentations evaluating combination therapy, including: Dr Alison Moskowitz, Memorial Sloan Kettering Cancer Center, will be presenting an oral presentation entitled Dual-targeted therapy with ruxolitinib plus duvelisib for T-cell lymphoma. Dr Moskowitz will be presenting on Sunday, December 8, 2024, from 9:30 AM - 11:00 AM (PST) in the San Diego Convention Center, Ballroom 20CD Dr Jennifer Crombie, Dana-Farber Cancer Institute, will be presenting a poster entitled A Phase 2 Study of Duvelisib and Venetoclax in Patients with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Richter’s Syndrome (RS) on Monday, December 9, 2024, from 6:00 PM - 8:00 PM (PST) in the San Diego Convention Center, Halls G-H Dr Hayder Saeed, Moffitt Cancer Center, will be presenting a poster entitled A Phase I Study Of Duvelisib In Combination With Oral Azacitidine (BMS-986345) In Lymphoid Malignancy on Sunday, December 8, 2024, from 6:00 PM - 8:00 PM (PST) in the San Diego Convention Center, Halls G-H Dr Josie Ford, Massachusetts General Hospital, will be presenting a poster entitled Real-World Evidence for Duvelisib and Romidepsin Combination in Patients with Relapsed/Refractory Peripheral T-Cell Lymphomas on Monday, December 9, 2024, from 6:00 PM - 8:00 PM (PST) in the San Diego Convention Center, Halls G-H Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma that develops in mature white blood cells that circulate through the bloodstream and lymphatic system. PTCL accounts for between 10-15% of all non-Hodgkin lymphomas and generally affects people aged 60 years and older. Although there are many different subtypes of peripheral T-cell lymphoma, they often present in a similar way, with widespread, enlarged, typically painless lymph nodes in the neck, armpit, and/or groin. There are currently no well-established standards of care for patients with relapsed or refractory disease. COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first United States FDA approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. COPIKTRA is also being investigated for the treatment of lymphomas, including peripheral T-cell lymphomas (PTCL). COPIKTRA has been given Fast Track status in the United States for the treatment of adult patients with PTCL who have received at least one prior therapy. Additionally, COPIKTRA has received an Orphan Drug Designation for use in the treatment of T-cell lymphomas. Treatment of T-cell lymphomas is a disease category for which COPIKTRA is not currently indicated. COPIKTRA is being investigated in combination with other agents across several types of solid and hematologic malignancies, through investigator-sponsored studies. For more information on COPIKTRA, please visit https://copiktra.com/. Information about duvelisib clinical trials can be found on https://www.clinicaltrials.gov/. Secura Bio is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of significant oncology therapies for physicians and their patients. Its product, COPIKTRA, is currently approved for the treatment of multiple B-cell malignancies and is also being investigated for the treatment of PTCL, for which it has received Fast Track status in the United States and is being investigated in combination with other agents through investigator-sponsored studies. For more information on Secura Bio, please visit https://www.securabio.com/. 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WALTHAM, Mass.--( BUSINESS WIRE )-- BostonGene , a leading provider of AI-based molecular and immune profiling solutions, and researchers from multiple cancer centers including, Memorial Sloan Kettering Cancer Center, Dana-Farber Cancer Institute, Weill Cornell Medicine and Washington University School of Medicine in St. Louis and others, today announced the online publication of the manuscript “ Deep Clinical Responses and Limited Inflammatory Toxicity in Patients with Relapsed/Refractory T-cell Lymphomas Receiving Duvelisib and Romidepsin ”* in Nature Medicine. The study highlights significant clinical responses and reduced inflammatory toxicity in patients with relapsed and refractory T-cell lymphomas treated with a combination of duvelisib and romidepsin. Historically, PI3K inhibitors have been associated with autoimmune and infectious toxicities, often leading to market withdrawals. Researchers from multiple leading cancer centers had previously demonstrated single-agent activity of the PI3K-γδ inhibitor duvelisib in T-cell lymphomas, although inflammatory adverse events were noted. Based on this preliminary work, a new phase 1b/2a clinical trial was launched to investigate the safety and efficacy of duvelisib in combination with either romidepsin or bortezomib in patients with relapsed/refractory T-cell lymphomas. Combining duvelisib and romidepsin significantly improved treatment outcomes in patients with peripheral T-cell lymphomas (PTCL). To explore tumor molecular features that may be linked to therapeutic response to this novel therapeutic combination, BostonGene performed DNA whole exome (WES) and RNA transcriptome (RNAseq) sequencing on both pre-treatment and on-treatment biopsies. BostonGene then performed integrated multi-omic molecular analyses, including cellular deconvolution, mutational landscape analyses, longitudinal genetic reconstruction to study tumor evolution, and deciphering immune microenvironment dynamic changes. BostonGene uncovered that PTCL patients with a follicular helper T-cell subtype showed increased response rates to the combination and identified gene expression patterns potentially linked to therapeutic resistance. “ Our findings offer a promising new approach for treating patients with relapsed and refractory T-cell lymphomas, specifically those with the follicular helper T-cell subtype. We are excited about the potential of this combination therapy to improve patient outcomes and expand treatment options in this challenging disease,” said Nathan Fowler, MD, Chief Medical Officer at BostonGene. *Research conducted in collaboration with Memorial Sloan Kettering Cancer Center, Weill Cornell Medicine, Dana-Farber Cancer Institute, Washington University School of Medicine in St. Louis, Stanford University, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center Collaborative Innovation Center for Cancer Medicine, Merck and Co. About BostonGene Corporation BostonGene is a software-driven biotechnology company at the intersection of technology and biology, dedicated to advancing and personalizing cancer medicine. Founded in 2015, BostonGene has continuously pushed the boundaries of innovation to improve patient care and accelerate drug development. Our AI-powered multiomics platform decodes cancer patients' molecular profiles, including their immune system and tumor microenvironment, to uncover key disease drivers, identify novel drug targets and recommend the most effective treatments. With advanced bioanalytics, an indication-specific cancer library and a next-generation CLIA-certified, CAP-accredited high-complexity laboratory, we deliver precise, clinically validated insights that propel precision medicine and advance oncology research. For more information, visit www.BostonGene.com .