LBL

Phase 2 Findings Show Wugen’s Investigational Allogeneic CAR-T, WU-CART-007, Was Highly Effective and Surpassed Standard of Care in Treating Hard-to-Treat T-ALL/LBL; Data Presented Today at European Hematology Association (EHA) 2024 Hybrid Congress

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금요일, 6월 14, 2024
Patient, City, EHA, LBL, Mortality, SAN, Initiate, European Hematology Association, Clinical trial, MRD, Disease, DNA, Cancer, Society, CD7, Pharmaceutical industry

ST. LOUIS and SAN DIEGO, June 14, 2024 (GLOBE NEWSWIRE) -- Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, announces positive Phase 2 results for the company’s investigational anti-CD7 CAR-T therapy, WU-CART-007 (“W-T7”), in patients with relapsed/refractory (R/R) t-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL).

Key Points: 
  • “Relapsed and refractory T-ALL/LBL is a highly aggressive disease with high rates of relapse and mortality in both children and adults,” Dr. Aldoss said.
  • A substantial proportion of patients (38%) had progressed or relapsed after allogeneic stem cell transplant.
  • Outcomes following WU-CART-007 treatment in the study surpassed current standard of care1 for R/R T-ALL/LBL and included:
    Overall response rate of 91% (10/11; 2 partial response (PR) in patients with extramedullary disease, R/R T-LBL).
  • Researchers presented other new findings with WU-CART-007 and WU-NK 101 in these posters at EHA:

Wugen Announces RMAT and PRIME Designations for WU-CART-007 to Accelerate Regulatory Reviews and Plans to Present Positive Phase 2 Study Findings at European Hematology Association (EHA) 2024 in June

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월요일, 5월 20, 2024
NCT, Patient, LBL, FDA, SAN, EHA, EMA, Bone marrow, PRIME, Safety, T-ALL, European Hematology Association, European, City, Pharmaceutical industry

ST. LOUIS and SAN DIEGO, May 20, 2024 (GLOBE NEWSWIRE) -- Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, today announced receipt of two new regulatory designations for its investigational CAR-T cell therapy, WU-CART-007, that it anticipates will expedite regulatory reviews on two continents.

Key Points: 
  • Specifically, Wugen received Regenerative Medicine Advanced Therapy (RMAT) designation in the United States and PRIME (“Priority Medicines”) designation in the European Union for WU-CART-007 for the treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).
  • Both designations provide increased agency support to expedite the development and review of promising therapies for patients in need.
  • Regulators granted Wugen these designations following their reviews of data including results from the global Phase 1/2 clinical trial for the treatment of R/R T-ALL/LBL.
  • The newest data from the Phase 1/2 study will be presented by Ibrahim Aldoss, M.D., City of Hope, on June 14 during the European Hematology Association (EHA) 2024 Hybrid Congress in Madrid, Spain.

MaxCyte and Wugen Sign Strategic Platform License to Expedite Scale-Up of Clinical and Commercial Manufacturing of Wugen’s Investigational Allogeneic, Off-the-Shelf Cell Therapies for Cancers

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화요일, 1월 30, 2024
Partnership, Cell engineering, LBL, Orphan drug, Expert, NK, Patient, Transfection, Adolescence, NCT, MBA, Food, Cancer, CD7, Doctor of Philosophy, SPL, Pharmaceutical industry

Under the terms of the agreement, Wugen gains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform.

Key Points: 
  • Under the terms of the agreement, Wugen gains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform.
  • Wugen is developing the next generation of off-the-shelf memory natural killer (NK) and CAR-T cell therapies for cancer.
  • The company’s investigational cell therapies originate from healthy donors and are further engineered to enhance their function of eliminating cancer cells.
  • Wugen is MaxCyte’s 26th clinical/commercial partnership overall, each of which generates pre-commercial milestone revenue, the vast majority of which includes sales-based payments.

Human medicines European public assessment report (EPAR): Atriance, nelarabine, Date of authorisation: 22/08/2007, Revision: 27, Status: Authorised

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화요일, 1월 2, 2024
Marketing, INN, Risk, Constipation, Needle, Body surface area, Nausea, DNA, Cancer, T-ALL, Anatomy, Paresthesia, Cough, IIA, Hypoesthesia, Diarrhea, Fever, Fatigue, Infection, Bone marrow, ATC, Pain, Disease, Ageing, Somnolence, Periodic breathing, Cerebral edema, Edema, Enzyme, Safety, Anemia, Tumor lysis syndrome, Patient, Medical Subject Headings, Febrile neutropenia, Agency, Guanine, International, Paralysis, LBL, Neutropenia, Blood, Language, Myalgia, Dizziness, Thrombocytopenia, Nervous system, Thymus, Select, Vomiting, Peripheral neuropathy, Survival, Lymph, Extremities, System, Weakness, Headache, Brain, Swelling, European Medicines Agency, Convulsion, Growth, Cell, Lymphatic system, Medical device

Human medicines European public assessment report (EPAR): Atriance, nelarabine, Date of authorisation: 22/08/2007, Revision: 27, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Atriance, nelarabine, Date of authorisation: 22/08/2007, Revision: 27, Status: Authorised

Wugen Presents Latest Data from First-In-Human Phase 1/2 Trial of WU-CART-007 in Patients with Difficult-to-Treat Blood Cancers at American Society of Hematology Annual Meeting

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월요일, 12월 11, 2023
Patient, Quality of life, Division, Death, Relapse, Pancytopenia, Cytokine release syndrome, Disease, LBL, Blood, EMD, SAN, Gene, Graft-versus-host disease, EMRA, CRC, ASH, CD38, Oncology, M.D, CRS, T-ALL, Fungal infection, Cell, Medicine, Phenotype, Pharmaceutical industry

“For a disease that disproportionately affects younger individuals, the need to find better treatments feels especially urgent,” said Armin Ghobadi, M.D, associate professor of medicine and clinical director of Center for Gene and Cellular Immunotherapy (CGCI) in the Division of Medical Oncology at the Washington University School of Medicine in St. Louis. “It’s encouraging to see positive momentum -- with favorable tolerability and efficacy data continuing to be reported as the study has expanded to include more patients with such difficult-to-treat blood cancers.”

Key Points: 
  • An investigational allogeneic CAR-T cell therapy, WU-CART-007 is being studied for the treatment of patients with relapsed or refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL).
  • In the latest update, an additional 13 patients were treated with WU-CART-007, which showed clinically acceptable safety profiles and preliminary evidence of anti-leukemic activity, demonstrating a notable clinical improvement.
  • Positive and consistent data from the WU-CART-007 Phase 1/2 trial collectively underscore its potential to address unmet medical needs for difficult-to-treat blood cancers as it advances to the next crucial phase of development.
  • In evaluable patients at DL≥ 2 (18/22), the Composite Complete Remission Rate (CRc) in patients was 67%.

AM Best Downgrades Credit Ratings of Lincoln Benefit Life Company; Affirms Credit Ratings of United Life Insurance Company, Guaranty Income Life Insurance Company and Kuvare Life Re Ltd.

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목요일, 11월 16, 2023
Professional Services, Insurance, Finance, ERM, LBL, Credit, Allstate, AM Best, Growth, Good, News, FSR, ALL, Risk management

In addition, AM Best has affirmed the FSR of A- (Excellent) and the Long-Term ICR of “a-” (Excellent) of Guaranty Income Life Insurance Company (GILIC) (headquartered in Baton Rouge, LA) and United Life Insurance Company (ULIC) (Cedar Rapids, IA).

Key Points: 
  • In addition, AM Best has affirmed the FSR of A- (Excellent) and the Long-Term ICR of “a-” (Excellent) of Guaranty Income Life Insurance Company (GILIC) (headquartered in Baton Rouge, LA) and United Life Insurance Company (ULIC) (Cedar Rapids, IA).
  • Concurrently, AM Best has affirmed the FSR of A- (Excellent) and the Long-Term ICR of “a-” (Excellent) of Kuvare Life Re Ltd. (Kuvare Re) (Bermuda).
  • Additionally, Guaranty Income Life Insurance Group’s reserve book is heavily weighted in interest sensitive reserves with a concentrated product profile.
  • For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best's Credit Ratings .

Jazz Pharmaceuticals to Present New Data Highlighting Advancements in Solid Tumors and Rare Blood Cancers at Upcoming Oncology Meetings

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목요일, 11월 30, 2023
Bone marrow, Trae Elston, Research, Safety, ASH, NACLC, Fulvestrant, Acute leukemia, International Association, MD Anderson Cancer Center, LBL, Breast cancer, ESMO, Jazz Pharmaceuticals, Patient, ASCO, MBC, Acute lymphoblastic leukemia, Conference, NSAA, Abstract, HER2, Lung cancer, Jazz, Society, ALL, HR, Pharmaceutical industry

DUBLIN, Nov. 30, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Company and its partners will present two abstracts at the 2023 San Antonio Breast Cancer Symposium (SABCS) from December 5-9; 11 abstracts at the 65th Annual American Society of Hematology (ASH) Annual Meeting from December 9-12; and two abstracts at the International Association for the Study of Lung Cancer (IASLC) 2023 North America Conference on Lung Cancer (NACLC) from December 1-3. New data include updated findings from a Phase 2a trial of the investigational HER2-targeted bispecific antibody zanidatamab in combination with palbociclib and fulvestrant as a chemotherapy-free option for HER2+/ HR+ metastatic breast cancer (mBC).

Key Points: 
  • New data include updated findings from a Phase 2a trial of the investigational HER2-targeted bispecific antibody zanidatamab in combination with palbociclib and fulvestrant as a chemotherapy-free option for HER2+/ HR+ metastatic breast cancer (mBC).
  • "SABCS will also feature data from a trial of zanidatamab in neoadjuvant breast cancer.
  • An investigator-sponsored (MD Anderson Cancer Center) SABCS poster presentation featuring results of a Phase 1 trial evaluating neoadjuvant zanidatamab in patients with stage 1 node-negative HER2+ breast cancer as a single-agent chemotherapy-free option.
  • Treatment‐related adverse events (TRAEs) ≥ grade 3 occurred in 126/228 (55%) patients with no TRAEs that led to death.1
    The Jazz and partner-supported presentations at SABCS 2023 are:

Wugen to Present New Clinical Data for WU-CART-007 and Preclinical Data for WU-NK-101, Two Investigational Allogeneic Cell Therapies for Challenging Hematologic Cancers, at American Society of Hematology Annual Meeting & Exposition

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목요일, 11월 2, 2023
Marriott Marquis, Patient, University of Nottingham, Washington University in St. Louis, Lymphoma, Intel Extreme Masters, Society, ASH, LBL, San Diego Marriott Marquis & Marina, NK, Abstract, Cell therapy, Exposition, Safety, American Society for Investigative Pathology, AML, SAN, Pharmaceutical industry, Vaccine, Mobile phone, Leukemia

ST. LOUIS and SAN DIEGO, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, will be presenting four abstracts, now available online, at the American Society of Hematology (ASH) Annual Meeting and Exposition Dec. 9-12.

Key Points: 
  • The Wugen oral and poster presentation schedule at ASH is below.
  • The meeting will take place at the Marriott Marquis in San Diego and virtually.
  • Access the full schedule here .
  • Session: #704, Cellular Immunotherapies: Early Phase and Investigational Therapies: Novel Approaches to Enhance Cellular Therapies and Immune Responses in Leukemias and Lymphomas, 10:30 a.m.- 12 p.m. PT
    Session: #703, Cellular Immunotherapies: Basic and Translational: Novel Approaches for Next Generation Cellular Immunotherapies, 9:30-11 a.m. PT

Ligand’s Partner Jazz Pharmaceuticals Receives European Commission Approval for Enrylaze® (a recombinant Erwinia asparaginase or crisantaspase) for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

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금요일, 9월 22, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Hypersensitivity, Neutropenia, Contraindication, Maintenance, Lymphocyte, Acute leukemia, Pancreatitis, Febrile neutropenia, IV, Civil service commission, MWF, Diarrhea, ALL, Acute lymphoblastic leukemia, IM, COG, Appetite, Abdominal pain, European Commission, NSAA, Sepsis, LBL, Vomiting, Patient, European, Anemia, Nausea, Headache, EC, Jazz Pharmaceuticals, Thrombocytopenia, Safety, Fatigue, Vaccine, Ligand Pharmaceuticals, Fever

“We congratulate our partner Jazz on its receipt of approval for Enrylaze® from the European Commission, expanding the market opportunity for one of our key commercial-stage products,” said Todd Davis, CEO of Ligand Pharmaceuticals.

Key Points: 
  • “We congratulate our partner Jazz on its receipt of approval for Enrylaze® from the European Commission, expanding the market opportunity for one of our key commercial-stage products,” said Todd Davis, CEO of Ligand Pharmaceuticals.
  • The determination of efficacy was based on demonstration of the achievement and maintenance of nadir serum asparaginase activity (NSAA) levels ≥ 0.1 U/mL.
  • Overall, the safety profile of JZP458 was consistent with the reported safety information for patients with ALL/LBL receiving asparaginase with combination chemotherapy.
  • The European Commission approval extends to all European Union Member states, as well as Iceland, Norway, and Liechtenstein.

Wugen Presents Initial Data from First-in-Human Phase 1/2 Trial of WU-CART-007 at the European Hematology Association (EHA) 2023 Congress

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금요일, 6월 9, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Pancytopenia, Complete Response Letter, Graft-versus-host disease, Intraparenchymal hemorrhage, European Hematology Association, CRS, Relapse, Encephalopathy, DLT, EMD, Rhizomucor, Dexamethasone, LBL, Congress, AML, Hematological Cancer Research Investment and Education Act, Cytokine release syndrome, EHA, Symantec Endpoint Protection, Mortality, Partial-response maximum-likelihood, Tumor microenvironment, Natural killer T cell, Acute myeloid leukemia, ORR, Safety, Disease, Pharmaceutical industry, Vaccine, Patient

“We are very encouraged by these initial safety and efficacy data from our ongoing Phase 1/2 trial of WU-CART-007 in patients with R/R T-ALL/LBL,” said Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer of Wugen.

Key Points: 
  • “We are very encouraged by these initial safety and efficacy data from our ongoing Phase 1/2 trial of WU-CART-007 in patients with R/R T-ALL/LBL,” said Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer of Wugen.
  • Many children and adults relapse after first line therapy and are left with very limited treatment options thereafter, often leading to high mortality.
  • Prior to enrollment, all patients had been heavily pretreated, with a median of 5 prior lines of therapy.
  • No cases of Graft versus Host Disease (GvHD), prolonged T-cell aplasia, or pancytopenia in the absence of disease were reported.