T-ALL

Bionano’s Symposium 2024 Featured Presentations from its Global User Community Highlighting OGM as a Powerful Alternative to Classical Cytogenetics and Strong Complement to NGS

Retrieved on: 
Tuesday, January 30, 2024
SAN, Breast, University, International, MD Anderson Cancer Center, FACMG, FDA, VAF, Bone marrow, SVS, Cytogenetics, Genome, LRS, OGM, University of Toronto, TNBC, Pressure, Biomarker, PARP, Quality control, Karyotype, HRD, Saint John Regional Hospital, T-ALL, CRISPR, Curie Institute, Triple-negative breast cancer, In situ hybridization, FISH, Frog, Genomics, Hospital, HRP, Patient, Marfan syndrome, Fluorescence, NIST, DSM-IV codes, Doctor of Philosophy, Cancer, Multiple myeloma, Workflow, Gene editing, Research, KT, Cell, Down syndrome, NGS, Vaccine

During this four-day online event, presenters reported on their use of OGM for applications in cancer, genetic disease, and cell and gene therapy.

Key Points: 
  • During this four-day online event, presenters reported on their use of OGM for applications in cancer, genetic disease, and cell and gene therapy.
  • OGM is helping to unravel persistent, complex mysteries in genetic disease that impact people, even in more common disorders like Down syndrome and Marfan syndrome.
  • OGM has the potential to meet the key requirements of the cell and gene therapy community.
  • “I would encourage anyone who was unable to attend live to login, view these presentations and see how bright the future of cytogenetics is with OGM.”

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

Retrieved on: 
Tuesday, January 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

Retrieved on: 
Monday, December 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%.

Beam Therapeutics Announces Portfolio Prioritization and Strategic Restructuring Focused on Potential Near-term Value Drivers and Long-term Growth of Precision Genetic Medicines Pipeline

Retrieved on: 
Thursday, October 19, 2023
Stem cell, Science, Hematology, Biotechnology, Health, Workforce, Sickle cell disease, Research, Growth, Partnership, T-ALL, Investment, Patient, ESCAPE, Pharmaceutical industry, Vaccine, Beam

CAMBRIDGE, Mass., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced portfolio priorities and plans to streamline its business operations to support potential near-term value drivers and long-term growth. This plan includes cost reduction initiatives that align with the company’s near-term goals, and the anticipated cost savings are expected to extend its revised operating plan into 2026.

Key Points: 
  • This plan includes cost reduction initiatives that align with the company’s near-term goals, and the anticipated cost savings are expected to extend its revised operating plan into 2026.
  • “From the beginning, Beam’s strategy has been to develop base editing technology broadly across a diverse portfolio of programs and delivery modalities, and our science and pipeline continue to progress across the board.
  • “We are grateful for the dedication and innumerable contributions of our impacted colleagues.
  • The company’s hepatitis B virus program will be paused and designated for partnering given the requirement of specialized development and commercial capabilities.

The AIM-HI Accelerator Fund Recognizes, Honors, and Congratulates Its 2023 Women’s Venture Competition Top Winners

Retrieved on: 
Monday, October 16, 2023
Research, Women, Clinical Trials, Biotechnology, Health, Consumer, Other Science, Science, Oncology, T-cell acute lymphoblastic leukemia, MBA, TCL, Hope, Press club, T-ALL, RNA, United Nations Foundation, Distinction, Prize, National Foundation for Cancer Research, Baylor College of Medicine, CTC, Cancer, Winners, Therapy, MGD, Environment, Survivor, First Prize, Woman, Baylor University, Patient, National Press Club (United States), T-cell lymphoma, Pharmaceutical industry, Vaccine

Blue-ribbon judge committee members selected them from a pool of 71 female-led, early-stage oncology companies across 15 countries.

Key Points: 
  • Blue-ribbon judge committee members selected them from a pool of 71 female-led, early-stage oncology companies across 15 countries.
  • The Phase 1 clinical trial has demonstrated strong efficacy and safety signals, with multiple long-term survivors in remission years after treatment.
  • This recognition from AIM-HI is an acknowledgment of our hard work and an affirmation of our technology platform,” said Dr. Hein.
  • In addition to the first and second-place winners, Delee was selected as The 2023 People’s Choice for “Best Pitch” by a public audience voting for their favorite pitch presentation during the 2023 Women’s Venture Competition selection process.

Shorla Oncology & EVERSANA Announce Commercial Launch of Recent FDA-Approved Nelarabine Injection for the Treatment of T-cell Leukemia Across the United States

Retrieved on: 
Tuesday, May 16, 2023
CHOP, T-cell acute lymphoblastic leukemia, Pharmacovigilance, Children's Hospital of Philadelphia, Hospital, Patient, Boxed warning, Cancer, T-ALL, Ageing, Leukemia, FDA, T-cell leukemia, Disease, Vaccine, Nursing, Pharmaceutical industry

CAMBRIDGE, Mass. and CHICAGO, May 16, 2023 /PRNewswire/ -- Shorla Oncology ('Shorla'), a U.S.-Ireland pharmaceutical company, and EVERSANA®, a leading provider of commercialization services to the life science industry, today announced the commercial launch of the company's oncology drug, Nelarabine Injection, for the treatment of T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL) in adult and pediatric patients aged one year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

Key Points: 
  • Nelarabine Injection, which received FDA approval in March of 2023, is now available for order through major wholesalers and specialty distribution partners.
  • Shorla Oncology selected EVERSANA to support the commercialization launch for the therapy in 2021.
  • "What a milestone for the Shorla Oncology team to officially have this new treatment option available to the oncology community across the U.S.," said Jim Lang, CEO, EVERSANA.
  • Founded in Ireland, Shorla specializes in developing innovative oncology drugs, with a focus on orphan and pediatric cancers.

OSE Immunotherapeutics Presents Clinical and Preclinical Data from its Immuno-Oncology Portfolio

Retrieved on: 
Tuesday, April 18, 2023
Oncology, Health, Clinical Trials, Research, Science, Biotechnology, Myelocyte, Kiel University, Acute lymphoblastic leukemia, CD47, Partnership, AACR, Schleswig-Holstein, CD127, IL-7, ALL, University Medical Center, Myeloid-derived suppressor cell, Inflammation, Survival, Cancer, Phagocytosis, American Association for Cancer Research, University Medical Center Schleswig Holstein, Head, Prognosis, Biomarker, Immunotherapy, Neck, Cetuximab, Ulcerative colitis, Boehringer Ingelheim, CD8, Patient, Hematology, T-ALL, ISIN, Mnemos EP, OSE, Tumor microenvironment, Pharmaceutical industry, Vaccine, Medical imaging

In addition, preclinical characterization data on CLEC-1 (new myeloid immune checkpoint) binding mechanism will also be presented on April 19.

Key Points: 
  • In addition, preclinical characterization data on CLEC-1 (new myeloid immune checkpoint) binding mechanism will also be presented on April 19.
  • Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “We are very pleased to share our latest scientific advances with the leading international cancer scientific community.
  • The escalation Phase 1 clinical trial data on selective SIRPα antagonist BI 765063 showed preliminary clinical efficacy results in monotherapy and in combination with PD1 inhibitor ezabenlimab in patients with advanced solid tumors.
  • Two clinical studies are ongoing in inflammatory diseases: a phase 2a study conducted in primary Sjögren’s syndrome by Servier and a Phase 2 study conducted in ulcerative colitis by OSE Immunotherapeutics.

Shorla Oncology Announces U.S. FDA Approval of Nelarabine Injection for the Treatment of T-cell Leukemia

Retrieved on: 
Tuesday, March 7, 2023
Oncology, Health, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, MD, T-cell leukemia, Research, Leukemia, T-ALL, Division, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, T-cell acute lymphoblastic leukemia, Patient, Cancer, Food, Childhood cancer, FDA, U.S. FDA, Pharmaceutical industry

Shorla Oncology (‘Shorla’), a US-Ireland pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the company’s oncology drug, Nelarabine Injection, for the treatment of T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL).

Key Points: 
  • Shorla Oncology (‘Shorla’), a US-Ireland pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the company’s oncology drug, Nelarabine Injection, for the treatment of T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL).
  • Nelarabine Injection provides patients with an alternative to a product that has historically been in shortage.
  • “We are very proud to see our research in oncology innovation and dedication to patient care culminate in this U.S. FDA approval,” said Sharon Cunningham, CEO and Co-founder of Shorla Oncology.
  • “We are delighted to announce this first U.S. FDA approval for Shorla Oncology, and we look forward to a successful launch in the U.S.,” said Dennis Purcell, Chairman of the Board at Shorla.

ICHNOS SCIENCES PRESENTS DATA SUPPORTING THREE ONCOLOGY ASSETS AT ASH 2022 ANNUAL MEETING

Retrieved on: 
Monday, December 12, 2022
BCMA, Daratumumab, Mouse, Oncology, T-cell acute lymphoblastic leukemia, MD, Infection, IND, Poster, Doctor of Philosophy, Multiple myeloma, CD38, Society, Patient, ISB, Treatment, Trace fossil classification, Research, HIV disease progression rates, Medicine, RRMM, Superior, MM, Antibody, Health, AML, Clinical trial, T-ALL, Relapse, Multimedia, Acute myeloid leukemia, CTN, Half-life, CRS, ASH, Risk, Vaccine, Pharmaceutical industry, Online shopping, NEW YORK, B cell

NEW YORK, Dec. 12, 2022 /PRNewswire/ -- Ichnos Sciences Inc., a global clinical-stage biotechnology company developing innovative multispecific immune cell engager antibodies in oncology, shared data during an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition supporting the advancement of its first-in-class TREAT™1 trispecific antibody, ISB 2001, to a first-in-human clinical trial. Both IND and CTN filings are planned during the first quarter of calendar year 2023 and preparations for a Phase 1 clinical trial in relapsed/refractory multiple myeloma (RRMM) are under way.

Key Points: 
  • Dual targeting with ISB 2001 may overcome escape mechanisms associated with BCMA and CD38 therapeutic antibodies, including approved T cell engagers.
  • In addition to the oral presentation on trispecific antibody ISB 2001 described above, Ichnos was selected for three poster presentations of data on other pipeline assets:
    1.
  • More information about the three oncology assets highlighted at the meeting, and the rest of Ichnos' pipeline can be found at this link .
  • With its patented BEATtechnology platform and pioneering teams, Ichnos Sciences has a mission to provide breakthrough, curative therapies that will extend and improve lives, writing a new chapter in healthcare.

Prelude Therapeutics Announces Third Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 14, 2022
BRM, Clinical trial, Brain, T-ALL, MYC, Thrombocytopenia, Monocyte, CLL, Safety, Security (finance), Anemia, Research and development, BTK, Prelude, R, Administration, Constipation, Drug resistance, CDK9, SMARCA4, Biotechnology, G&A, Research, Vomiting, NHL, COVID-19, Public expenditure, Incidence, Uveal melanoma, Large-cell lung carcinoma, FDA, Pharmacology, Sarcoma, BH3, CDK, Mesothelioma, Lymphoid neoplasms with plasmablastic differentiation, Hematological Cancer Research Investment and Education Act, Cancer, Pharmacokinetics, IND, MCL1, Fatigue, CD14, Glioma, Breast cancer, PRMT5, Human, SMARCA2, Risk, Nausea, Head, Patient, Pharmaceutical industry, Medical device

WILMINGTON, Del., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported financial results for the third quarter ended September 30, 2022 and provided an update on recent clinical and development pipeline progress.

Key Points: 
  • I believe these programs offer the best chance to improve patient outcomes and I share our investigators excitement in our highly differentiated molecules.
  • Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and marketable securities as of September 30, 2022, were $224.0 million.
  • Prelude anticipates that its existing cash, cash equivalents and marketable securities will be sufficient to fund Preludes operations into the fourth quarter of 2024.
  • We expect our research and development expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.