Venetoclax

ImmunoGen Presents Findings from Newly Diagnosed Acute Myeloid Leukemia Cohorts in Phase 1b/2 Study of Pivekimab Sunirine in Combination with Azacitidine and Venetoclax at ASH

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星期日, 十二月 10, 2023
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Molecular Pharmacology, Fever, Associate, Azacitidine, Hypotension, Safety, CCR, Spacecraft, Pneumonia, ASH, University, Cytopenia, Disease, Cellular, Constipation, Fatigue, Mortality, Penile ultrasonography, Patient, IMGN, DNA, MRD, Medical Affairs Bureau, Pharmacokinetics, Peripheral edema, Flow cytometry, Capillary leak syndrome, MD, Diarrhea, Cancer, Nausea, Survival, Drug resistance, Transplant, AML, Apoptosis, MD Anderson Cancer Center, Society, ImmunoGen, Hypokalemia, Hypophosphatemia, Venetoclax, Rare-earth element, Pharmaceutical industry, Birth control, Vaccine, Medicinal plants, Research

These findings will be presented in a poster session at the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, California.

Key Points: 
  • These findings will be presented in a poster session at the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, California.
  • “The MRD negativity rates, which are indicative of a deep remission, are particularly promising in the treated patient population.
  • Response rates and MRD negativity were numerically comparable between cohorts 1 and 2, despite differences in the venetoclax schedule.
  • We look forward to continuing to expand our cohort of newly diagnosed unfit patients to inform the development path for pivekimab in AML.”
    ImmunoGen is also presenting two preclinical posters at ASH.

GlycoMimetics Announces Independent Presentations on Uproleselan at American Society of Hematology Annual Meeting including New Clinical Data in Treated Secondary Acute Myeloid Leukemia

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星期日, 十二月 10, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Acute myeloid leukemia, LDAC, Safety, National Cancer Institute, ASH, Leukemia, Cellular, IIT, Cytogenetics, HCT, Pedal, Patient, Inflammation, Male, Cytarabine, Biobank, University, Transplant, AML, MD Anderson Cancer Center, Cancer, Society, Myelodysplastic syndrome, Cladribine, Haematopoietic system, Venetoclax, Pharmaceutical industry, Glycomimetic

“These findings underscore the broad potential of uproleselan, if successfully developed in combination with existing therapies, to benefit people with heterogeneous forms of AML.

Key Points: 
  • “These findings underscore the broad potential of uproleselan, if successfully developed in combination with existing therapies, to benefit people with heterogeneous forms of AML.
  • Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II
    This Phase 1b/2 clinical trial evaluated safety, tolerability, and preliminary efficacy of uproleselan added to cladribine and LDAC in patients with ts-AML.
  • This rare, high-risk study population is defined by prior chemotherapy treatment of a previous hematologic disorder, such as myelodysplastic syndrome.
  • Study investigators concluded these data support this low-risk approach to marrow blast reduction and disease control in preparation for HCT.

Schrödinger Presents Data Supporting Advancement of SGR-1505 and SGR-2921 at American Society of Hematology 2023 Annual Meeting

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星期日, 十二月 10, 2023
Oncology, Health, Technology, Health Technology, Software, Pharmaceutical, Biotechnology, Webcast, Cytokine, Decitabine, Safety, CDC7, Lymphoid leukemia, ASH, Acute myeloid leukemia, Harmonic pitch class profiles, B-cell lymphoma, Patient, Abstract, NF, Pharmacokinetics, Therapy, Venetoclax, Chronic lymphocytic leukemia, Significance, Trial of the century, Human, MALT1, AML, Potent, Cancer, Society, Myelodysplastic syndrome, NHL, CLL, Pharmaceutical industry, Vaccine

The preclinical data reported show that both SGR-1505 and SGR-2921 have multiple favorable attributes and the potential for combination activity with standard-of-care agents.

Key Points: 
  • The preclinical data reported show that both SGR-1505 and SGR-2921 have multiple favorable attributes and the potential for combination activity with standard-of-care agents.
  • The company will report additional data from the healthy subject study at its Pipeline Day on December 14, 2023.
  • “The pharmacological data for SGR-1505 and SGR-2921 demonstrate that our development candidates have favorable, differentiated profiles with best-in-class potential,” stated Karen Akinsanya, Ph.D., president of R&D therapeutics at Schrödinger.
  • “Our progress within these programs further validates our computational approach to designing therapies with the potential to address the limitations of current treatments.

Syros Announces Encouraging Initial Data from Randomized SELECT-AML-1 Phase 2 Clinical Trial Evaluating Tamibarotene in Combination with Venetoclax and Azacitidine

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星期三, 十二月 6, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Webcast, Aplastic anemia, ID, Azacitidine, Safety, CRi, Aes, Acute myeloid leukemia, Russell R. Dohner, Patient, MRD, Hematology, ELN, Bone marrow, University, MD, RARA, Survival, AML, Doctor of Philosophy, Consistency, Șaeș, Retinoic acid receptor alpha, Venetoclax, Pharmaceutical industry, Nursing, Health insurance, Syros

“These data highlight the potential of tamibarotene to be a cornerstone therapy for newly diagnosed, unfit AML patients with RARA overexpression, further demonstrating its differentiated product profile and validating our biologically targeted approach,” said David A. Roth, M.D., Chief Medical Officer of Syros. “These results -- the first from a randomized, controlled study -- demonstrate the potential impact of adding tamibarotene to the standard-of-care, venetoclax and azacitidine and, importantly, are consistent with prior experience. Across multiple clinical trials, we have observed tamibarotene’s ability to rapidly deliver clinically relevant activity, with a well-tolerated safety profile, including in a combination setting. We look forward to advancing our comprehensive clinical development program for tamibarotene, with additional data from SELECT-AML-1 and pivotal complete response data from our SELECT-MDS-1 trial in higher-risk myelodysplastic syndrome with RARA overexpression expected next year, as we work to deliver profound benefit to patients with hematologic malignancies.”

Key Points: 
  • “These results -- the first from a randomized, controlled study -- demonstrate the potential impact of adding tamibarotene to the standard-of-care, venetoclax and azacitidine and, importantly, are consistent with prior experience.
  • Across multiple clinical trials, we have observed tamibarotene’s ability to rapidly deliver clinically relevant activity, with a well-tolerated safety profile, including in a combination setting.
  • The trial is also evaluating the triplet regimen as a salvage strategy in patients in the control arm who do not respond to venetoclax and azacitidine.
  • Syros is also evaluating tamibarotene in combination with azacitidine in the SELECT-MDS-1 Phase 3 clinical trial in newly diagnosed higher-risk myelodysplastic syndrome patients with RARA gene overexpression.

MEI Pharma Reports First Quarter Fiscal Year 2024 Results and Operational Highlights

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星期四, 十一月 9, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Bevacizumab, MEI, Glycolysis, Colorectal cancer, Acute myeloid leukemia, Lymphoid leukemia, ASH, Cohort, Investment, Patient, Research, CDK9, Calendar, Wind, VEGF, Exposition, Cancer, AML, Society, Neoplasm, OXPHOS, Venetoclax, Kyowa Kirin, Pharmaceutical industry, Cryptocurrency

The Company anticipates announcing safety and efficacy data from the first cohort of 20 patients in the first half of 2024.

Key Points: 
  • The Company anticipates announcing safety and efficacy data from the first cohort of 20 patients in the first half of 2024.
  • For the quarter ended September 30, 2023, cash used in operations was $18.5 million, compared to $14.8 million during the quarter ended September 30, 2022.
  • Research and development expenses were $3.5 million for the quarter ended September 30, 2023, compared to $19.5 million for the quarter ended September 30, 2022.
  • MEI recognized revenue of $65.3 million for the quarter ended September 30, 2023, compared to $8.7 million for the quarter ended September 30, 2022.

Investigators from John Byrd's Lab at University of Cincinnati Presented Non-Clinical Summary Data for The Best-in-Class Selective BCL2 Inhibitor Clinical Candidate Developed by Eilean Therapeutics in Collaboration with ChemDiv

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星期三, 十二月 13, 2023
BCL2, SAN, Expert system, Chemical Diversity, CYP3A, Eilean Donan, Pharmacology, University, Cancer, Safety, University of Cincinnati, Venetoclax, Pharmaceutical industry

"A Novel Selective BCL2 Inhibitor with Limited Immune Suppression and Improved Safety Compared to Venetoclax" was presented by collaborators from University of Cincinnati (Ohio), Molsoft LLC, Expert Systems Inc of San Diego California, and Eilean Therapeutics LLC of Dover, Delaware.

Key Points: 
  • "A Novel Selective BCL2 Inhibitor with Limited Immune Suppression and Improved Safety Compared to Venetoclax" was presented by collaborators from University of Cincinnati (Ohio), Molsoft LLC, Expert Systems Inc of San Diego California, and Eilean Therapeutics LLC of Dover, Delaware.
  • The presentation highlighted best-in-class potency and selectivity against BCL2, a key pro-survival protein that is overexpressed in many cancers.
  • This clinical candidate demonstrated an equivalent in vivo anti-tumor efficacy as venetoclax in both B cell and myeloid malignancy cell lines and in vivo models.
  • Compared to venetoclax, the candidate exhibits significantly less suppression of non-malignant immune cell populations, a result that signals superior selectivity and improved safety profile.

Updated Data from the BRUIN Phase 1/2 Study of Pirtobrutinib in Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma Presented at the 2023 ASH Annual Meeting

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星期二, 十二月 12, 2023
Medicine, Drug, Safety, NYSE, Arrhythmia, BTK, CTCAE, MCL, Lymphoid leukemia, Progression-free survival, ASH, Cytopenia, Dana–Farber Cancer Institute, Lymphocytosis, Bleeding, Clinical trial, Fatigue, Non-Hodgkin lymphoma, Rituximab, Patient, Abstract, Mantle cell lymphoma, PFS, SLL, Lymphoma, Infection, FDA, DOR, LLY, Exposition, Neutropenia, PVR, ORR, Lilly, Eli Lilly and Company, Chronic lymphocytic leukemia, Nausea, Diarrhea, Pulmonary toxicity, IRC, Chills, Society, OS, NHL, PV, HIV disease progression rates, Venetoclax, Pharmaceutical industry, Dietary supplement, CLL

These data, which were presented in oral and poster presentations at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, continue to support the role of pirtobrutinib in the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL).

Key Points: 
  • These data, which were presented in oral and poster presentations at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, continue to support the role of pirtobrutinib in the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL).
  • The labeling for pirtobrutinib contains warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, and embryo-fetal toxicity.
  • The BRUIN Phase 1/2 clinical trial is evaluating pirtobrutinib in patients previously treated for MCL, CLL/SLL, or other non-Hodgkin lymphomas (NHL).
  • All presentations of safety and efficacy data from the BRUIN Phase 1/2 trial utilized a cutoff date of May 5, 2023.

Studies Highlight Both Novel Treatments and Enduring Value of Older Approaches

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星期日, 十二月 10, 2023
Human, Woman, ASH, Patient, Research, Infection, Navitoclax, Venetoclax, Cancer, Doctor of Philosophy, Anemia, Mutation, Bone marrow, Food, Progression-free survival, Acute myeloid leukemia, Leukemia, Male, AbbVie, Blood, Diarrhea, Bleeding, Family, Ruxolitinib, Society, San Diego Convention Center, Primary myelofibrosis, Spleen, SAN, Data, PFS, MD Anderson Cancer Center, University, Splenomegaly, Phase, Pain, Cell, B cell, JAK, FCR, Disease, Abdomen, Fatigue, MRD, Weakness, Chronic lymphocytic leukemia, Standard of care, MB, CLL, Lymphoma, Pharmaceutical industry, Medical imaging, Dentistry, Vaccine, Medical device, MD

SAN DIEGO, Dec. 10, 2023 /PRNewswire/ -- Research findings being presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition highlight new treatment approaches that are enabling patients to live longer or better, judicious uses of older treatment approaches, and how a powerful, relatively new prognostic tool is helping identify patients who are more or less likely to benefit from both older and newer treatments.

Key Points: 
  • Two other studies presented in this session spotlight ways in which a novel prognostic tool is demonstrating its value across a range of blood cancers.
  • The researchers used MRD to determine how long patients in the targeted-agents group should continue treatment.
  • These cells develop into specialized blood cells, such as red and white blood cells and platelets, that also carry the mutation.
  • By comparison, progression-free survival (PFS) for patients receiving the standard of care was 76.8% with a death rate of 7%.

Servier Data at ASH 2023 Furthers Leadership in Hard-to-Treat Hematologic Malignancies

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星期二, 十二月 5, 2023
Real-World Evidence, Azacitidine, Safety, PST, University, ASH, Acute myeloid leukemia, Comparison, Tablet, HMA, Hematology, Patient, Poster, MRD, FDA, Master of Science, Acute lymphoblastic leukemia, MDS, IDH, IDH1, Venetoclax, AML, Doctor of Philosophy, MD Anderson Cancer Center, Society, Mutation, Adolescence, ALL, Acute leukemia, Pharmaceutical industry, Nursing, Medical imaging, Ivosidenib, Medicine

BOSTON, Dec. 5, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, will present data in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego from December 9-12, 2023. The latest data underscores Servier's commitment to advancing scientific research, including gaining a more robust understanding of real-world treatment patterns for patients with difficult and hard-to-treat cancers.

Key Points: 
  • The latest data underscores Servier's commitment to advancing scientific research, including gaining a more robust understanding of real-world treatment patterns for patients with difficult and hard-to-treat cancers.
  • "ASH is a tremendous opportunity to connect with the broader hematologic community and share scientific advances with the power to improve the treatment landscape for patients in need of innovation," said David K. Lee, CEO, Servier Pharmaceuticals.
  • "Looking to the future, improving patient outcomes is going to be a collaborative effort across industry, academia and the community.
  • Servier is proud to serve as a bridge across these stakeholders in our goal of improving patient outcomes."

Montefiore Einstein Comprehensive Cancer Center Awarded FDA Grant for Clinical Trial on Experimental AML/MDS Treatment

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星期二, 十一月 28, 2023
Medicine, Apoptosis, B cell, Ionis Pharmaceuticals, Safety, Hematology, Food, Therapy, Syndrome, Clinical trial, Molecular biology, National Cancer Institute, Patient, Research, MD Anderson Cancer Center, Acute myeloid leukemia, FDA, MDS, STAT3, Prognosis, Survival, AML, Cancer, Knowledge, Venetoclax, Pharmaceutical industry

BRONX, N.Y., Nov. 28, 2023 /PRNewswire/ -- Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS)—two related blood diseases that disproportionally strike older adults—are notoriously difficult to treat and associated with high relapse rates. Although new therapies have improved survival, treatment options remain limited, and the prognosis for the 50% of people who experience disease relapse remains poor.

Key Points: 
  • Researchers at the National Cancer Institute-designated Montefiore Einstein Comprehensive Cancer Center (MECCC) were recently awarded a four-year, $2.6 million grant from the U.S. Food and Drug Administration (FDA) to conduct an innovative phase 1 clinical trial of a new drug for patients with relapsed and treatment-resistant forms of AML and MDS.
  • It is one of only 10 grants issued this year by the FDA through its Office of Orphan Products Development.
  • If the researchers find evidence that the experimental treatment has clinical activity, they will expand the study to a phase 2 trial to further assess the treatment's effectiveness.
  • The co-principal investigator of the clinical trial is Naval Daver, M.D., at the MD Anderson Cancer Center.