B-cell lymphoma

Verismo Therapeutics Announces Submission of IND Application to the FDA for SynKIR™-310 in Relapsed/Refractory B-cell NHL

Retrieved on: 
Wednesday, April 3, 2024
Malignancy, MCL, Patient, B-cell lymphoma, Standard of care, Follicular lymphoma, Trial of the century, NHL, IND, Verismo, Clinical trial, Investigational New Drug, Therapy, Mantle cell lymphoma, FDA, NK, DLBCL, B cell, CD19, Food, Bone marrow, Pharmaceutical industry

PHILADELPHIA, April 3, 2024 /PRNewswire/ -- Verismo Therapeutics, a clinical-stage CAR T company developing the novel KIR-CAR platform technology, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its Phase 1 clinical trial of SynKIR™-310, for the treatment of relapsed/refractory (r/r) B-cell Non-Hodgkin Lymphomas (B-cell NHL), including Diffuse Large B Cell lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL).

Key Points: 
  • Commercially approved CAR T cell therapies have shown impressively high initial response rates in blood cancers.
  • Over time, however, these therapies result in relapse in an estimated 40-50% of patients1.
  • There are currently very limited treatment options for patients with r/r DLBCL who relapse following treatment with commercial CAR T cell therapies.
  • Initiation of the clinical trial is the culmination of years of focused research and diligent work by the Verismo team."

GenFleet and BeiGene Enter into Trial Collaboration for a Potentially First-in-class Combination Therapy to Initiate Phase Ib/II Study of GFH009 (CDK9 inhibitor) and BRUKINSA® (zanubrutinib) Treating Diffuse Large B Cell Lymphoma

Retrieved on: 
Thursday, March 28, 2024
B-cell lymphoma, Plasma, Shanghai Cancer Center, Rituximab, Apoptosis, Leukemia, International Journal of Hematology, Patient, Hospital, Doxorubicin, Vincristine, Fudan University, CC3, Standard of care, Acute myeloid leukemia, Epidemiology, Biomedical Chromatography, Prednisone, Peripheral T-cell lymphoma, PARP, National Cancer Center, Therapy, MYC, BTK, Safety, BeiGene, CDK9, Cyclophosphamide, DLBCL, Canadian International Council, MCL1, Follicular lymphoma, Pharmaceutical industry

The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.

Key Points: 
  • The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.
  • This study will be the first combination trial conducted by a Chinese biotech to combine CDK9 inhibitor and BTK inhibitor targeting DLBCL.
  • The trials of GFH009 treating peripheral T-cell lymphoma and acute myeloid leukemia have entered into phase II stage in China and the U.S. respectively.
  • Epidemiology of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) in the United States and Western Europe: population-level projections for 2020–2025, Leukemia & Lymphoma, 2021
    3.

Novel research leverages AI to identify dogs at higher risk for cancer

Retrieved on: 
Tuesday, March 26, 2024
B-cell lymphoma, Intelligence, Partnership, Risk, Research, DNA, Golden, Cancer, University, Mammal, Morris Animal Foundation, Veterinarian, Human, Dog, Lymphoma, Comparative medicine, Lyra, Cat, Blood, Animal, DLBCL, Ageing

Findings may help identify dogs at higher risk for DLBCL.

Key Points: 
  • Findings may help identify dogs at higher risk for DLBCL.
  • The team plans to provide pet owners and veterinarians with intervention strategies to help lower the risk in identified dogs.
  • Beyond its direct impact on dogs, this research effort could influence numerous research avenues in other mammals, including cats, endangered species and even humans, Modiano added.
  • The approach may also provide insights into aging, cancer risk and chronic conditions, extending the study's significance beyond companion dogs.

Withdrawn application: Adcetris, 23/02/2024

Retrieved on: 
Wednesday, April 3, 2024
PTCL-NOS, Lymphoma, B-cell lymphoma, CHOP, Patient, PTCL, Doxorubicin, Vincristine, CHP, Cancer, Vinblastine, European Medicines Agency, CTCL, Prednisone, Lymphocyte, Agency, Clinical trial, Skin, Dacarbazine, CD30, Cyclophosphamide, Medicine

Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.

Key Points: 
  • Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.
  • The cytotoxic molecule then enters the cancer cells and prevents them from dividing, causing the cancer cells to die.
  • The application was withdrawn after the European Medicines Agency had evaluated the initial information from the company and had prepared questions for the company.
  • If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.

Nurix Therapeutics Announces U.S. FDA Lifts Partial Clinical Hold on NX-2127 Phase 1 Trial

Retrieved on: 
Monday, March 11, 2024
MCL, BTK, Head, SAN, B-cell lymphoma, NHL, Hematology, FDA, Food, Mantle cell lymphoma, Inflammation, Communication, Society, Therapy, Patient, Acceleration, Trial of the century, DLBCL, Cancer, Pharmaceutical industry

SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the U.S.

Key Points: 
  • SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the U.S.
  • Phase 1a/1b study evaluating NX-2127 in adults with relapsed/refractory B-cell malignancies.
  • The partial clinical hold on the study was announced by Nurix on November 1, 2023, following the company’s communication to the FDA of its intention to transition to an improved manufacturing process.
  • “We are pleased with the timely resolution of the partial clinical hold, which allows us to reinitiate enrollment in the NX-2127 Phase 1 study utilizing drug product from our new manufacturing process,” said Paula G. O’Connor, M.D., executive vice president and head of clinical development at Nurix.

Fate Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates

Retrieved on: 
Monday, February 26, 2024
Neoplasm, Regenerative medicine, CIRM, B-cell lymphoma, Graft-versus-host disease, Investment, TRAC, ADR, CD19, Cytokine release syndrome, Cell, Destiny, HER2, BCMA, Lupus, IPSC, Safety, GAAP, Therapy, Trastuzumab, Pharmacokinetics, Lymphoid leukemia, Patient, NK, Multiple myeloma, SLE, Immunotherapy, Research, CRS, Vaccine

SAN DIEGO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Total Operating Expenses: For the fourth quarter of 2023, GAAP operating expenses were $49.8 million, including research and development expenses of $31.8 million and general and administrative expenses of $17.9 million.
  • Shares Outstanding: Common shares outstanding were 98.6 million, and preferred shares outstanding were 2.8 million, as of December 31, 2023.
  • ET to review financial and operating results for the quarter and full year ended December 31, 2023.
  • The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.fatetherapeutics.com.

CERo Therapeutics, Inc. Announces Publication of Preclinical Research Supporting the Use of Its Clinical Candidate CER-1236 to Treat AML Patients

Retrieved on: 
Thursday, March 7, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Therapy, NSCLC, Investigational New Drug, Bone marrow, AML, RUNX1, Cancer, B-cell lymphoma, ASXL1, Clinical Cancer Research, Classification, Patient, CERO, IND, Cero, Vaccine

The results in the paper found that the target for CER-1236 is found in the large majority (83%) of leukemic cells extracted from the bone marrow from patients, and that more importantly CER-1236 effectively eliminated leukemic cells in the company’s experiments.

Key Points: 
  • The results in the paper found that the target for CER-1236 is found in the large majority (83%) of leukemic cells extracted from the bone marrow from patients, and that more importantly CER-1236 effectively eliminated leukemic cells in the company’s experiments.
  • Finally, the target for CER-1236 was found by CERo to be highly expressed and detectable across common AML genetic classification subtypes, including patient samples with adverse risk mutations in TP53, ASXL1 and RUNX1.
  • “We’re very pleased with this publication in Clinical Cancer Research supporting our near term plans to advance CER-1236 into the clinic.
  • As we have previously reported, CERo plans to file an Investigational New Drug (IND) application in the first half of 2024, and is targeting initial treatment of AML patients as well as B Cell lymphoma patients before the end of the year,” said Brian G Atwood, CERo’s Chairman and Chief Executive Officer.

Tampa General Hospital Brings New Hope for Patients with Advanced Blood Cancers

Retrieved on: 
Monday, March 4, 2024
Bone marrow, Blood pressure, Liver, Multiple myeloma, EVP, B-cell lymphoma, Immunotherapy, NHL, Borrello, Temperature, FDA, Physician, Food, Cancer, Hospital, Heart rate, Tampa General Hospital, Cell, Skin, Cancer Institute, B cell, BMT, Ear, Breast, Home, Safety, Bacteria, Johns Hopkins, APRN, Virus, TGH, Leukemia, Non-Hodgkin lymphoma, Patient, Lymphoma, Protein, Tampa, Florida, Medicine, Otorhinolaryngology, Nose, DLBCL, Immune system, Pharmaceutical industry

TAMPA, Fla., March 4, 2024 /PRNewswire/ -- As part of its commitment to harness innovative advances in cancer care, the Tampa General Hospital (TGH) Cancer Institute has added a novel approach to its therapeutic armamentarium for the treatment of patients with aggressive forms of B-cell non-Hodgkin lymphomas and other types of blood cancers.

Key Points: 
  • The field of immunotherapy has evolved from an academic research program to an essential pillar in the treatment of many cancers.
  • All are intended for the treatment of blood cancers, including lymphomas, some forms of leukemia and, most recently, multiple myeloma.
  • Following comprehensive planning and discussion, Tampa General's Hospital at Home program has started to be applied to CAR T patients meeting certain criteria.
  • Due the benefit of remote monitoring, the TGH Cancer Institute and Hospital at Home teams have been working on adapting Hospital at Home for oncology patients.

Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Provides a Corporate Update

Retrieved on: 
Thursday, February 15, 2024
Fast Track, BTK, MCL, Research, B-cell lymphoma, ASH, NHL, Inflammation, FDA, CLL, Calendar, Mantle cell lymphoma, Manuscript, Medicinal chemistry, Lymphocytosis, BCL2, Lymphoma, Society, Chronic lymphocytic leukemia, Therapy, Pharmacology, Accelerated approval (FDA), Rheumatoid arthritis, Lymphoid leukemia, Paclitaxel, Non-Hodgkin lymphoma, Patient, Journal, Clinical trial, Science, IND, Publication, Trial of the century, DLBCL, Cancer, Priority review, Pharmaceutical industry

NX-2127 exhibited dose-dependent PK, leading to robust and sustained degradation of BTK and biologically relevant degradation of IKZF1 (Ikaros).

Key Points: 
  • NX-2127 exhibited dose-dependent PK, leading to robust and sustained degradation of BTK and biologically relevant degradation of IKZF1 (Ikaros).
  • NX-2127 had a manageable safety profile that was consistent with previous reports for BTK-targeted and immunomodulatory therapies.
  • During the year ended November 30, 2023, Nurix achieved research milestones under its collaborations with Gilead and Sanofi totaling $12.5 million and $7.0 million, respectively.
  • Cash, cash equivalents and marketable securities was $295.3 million as of November 30, 2023, compared to $268.7 million as of August 31, 2023.

Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 6, 2024
Oncology, Health, Infectious Diseases, Hospitals, COVID-19, Pharmaceutical, Biotechnology, EPS, IPR, Compugen, Immunotherapy, Food and Drug Administration, ETR, Dow Jones Sustainability Indices, Progression-free survival, Obeldesivir, FDA, Virology, FTC, Hematology, ALL, HDV, Society, Neurotoxicity, Acquisition, HCV, Cell therapy, Acute lymphoblastic leukemia, MYR, Research, HIV, Patient, Tenofovir alafenamide, Food, Infection, Multiple myeloma, Standard of care, OS, Lymphoma, B-cell lymphoma, Table, GAAP, Docetaxel, Lung cancer, Science, Earnings per share, Investment, Liver disease, Risk, ASH, Pharmaceutical industry

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2023.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2023.
  • During the fourth quarter 2023, Gilead paid cash dividends of $943 million and utilized $150 million to repurchase common stock.
  • The Liver Disease portfolio sales were $691 million in the fourth quarter 2023 and remained flat compared to the same period in 2022.
  • Cell Therapy product sales increased 11% to $466 million in the fourth quarter 2023 compared to the same period in 2022.