Neurotoxicity

Century Therapeutics Presents Initial Data from CNTY-101 Phase 1 ELiPSE-1 Trial Supporting the Potential for a Multi-Dosing Strategy for CAR iNK Enabled by Allo-Evasion™ Edits

Retrieved on: 
Saturday, December 9, 2023
Exposition, Tumor microenvironment, Bone marrow, Dose, Cytokine release syndrome, IPSC, Tissue, Pharming, DNA, Society, Therapy, DdPCR, Follicular lymphoma, Serum, Interleukin 2, Event, ASH, Neurotoxicity, Poster, Century, Ink, Cell, Patient, Malignancy, Webcast, Allotransplantation, Lymphoma, Science, Pharmaceutical industry

PHILADELPHIA, Dec. 09, 2023 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced the presentation of initial clinical data from a single-patient case study which Century believes support the potential for a multi-dosing strategy for CAR iNK enabled by Allo-Evasion™ edits at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 9-12 in San Diego. The poster, titled, “Multiple Doses of CNTY-101, an iPSC-Derived Allogeneic CD19 Targeting CAR-NK Product, are Safe and Result in Tumor Microenvironment Changes Associated with Response: A Case Study”, is available on the Scientific Resources page of the Company’s website.

Key Points: 
  • “We are thrilled that the initial clinical evidence for CNTY-101 provides support for the potential for Allo-Evasion™ to enable a multi-dosing regimen without the need for continued lymphodepletion.
  • Cycles one and two included three days of lymphodepletion (LD), whereas cycles three through seven were given with no LD.
  • Importantly, tumor microenvironment initial analyses demonstrated a vigorous increase in T cells within 8 days of the 1st CNTY-101 cell infusion.
  • The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website.

Gracell Biotechnologies Announces FDA Clearance of IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Refractory Systemic Lupus Erythematosus

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Monday, November 27, 2023
Quality of life, Food, Autoimmune disease, Autoantibody, Immune system, IND, FDA, SLE, IIT, Tissue, BCMA, Society, Cancer, Pharmacokinetics, Standard of care, B cell, Neurotoxicity, NHL, RRMM, Patient, CD19, Safety, Vaccine

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared Gracell’s Investigational New Drug (IND) application, allowing the Company to initiate a Phase 1/2 clinical trial of FasTCAR-T GC012F in the United States for the treatment of refractory systemic lupus erythematosus (rSLE).

Key Points: 
  • “We are excited to expand the clinical development of our lead FasTCAR asset, GC012F, for treatment of rSLE in the United States,” said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell.
  • “This progress marks the second U.S. IND clearance for GC012F, a notable milestone.
  • Systemic lupus erythematosus (SLE) is a B-cell-mediated autoimmune disease, in which autoantibodies produced by the immune system attack the patient’s own tissues, causing multi-organ damage.
  • Further, in preclinical studies, GC012F has shown a more effective elimination of antibody secreting cells compared to CD19 single-targeted CAR-T therapy.

CellOrigin announced treatment of the first patient with CAR-M in China and reported the second generation of CAR-M for solid tumors

Retrieved on: 
Wednesday, December 20, 2023
Quality of life, C-reactive protein, Research group, Fever, Tumor microenvironment, National academy, Biotechnology, Research, DLT, Cytokine release syndrome, CMC, TIR, Trial of the century, Metabolism, Macrophage, Zhejiang University, Pharmacokinetics, Neurotoxicity, Common, Patient, Safety, PNAS, Pharmaceutical industry

The successful completion of the first patient dosing of SY001  demonstrates the advanced technology of the company's R&D platform and the maturity of the CMC platform.

Key Points: 
  • The successful completion of the first patient dosing of SY001  demonstrates the advanced technology of the company's R&D platform and the maturity of the CMC platform.
  • Only 2 grade 3 adverse events occurred; Common grade 1 - 2 adverse events included fever, elevated C-reactive protein, etc.
  • Based on M-CAR, a functionally enhanced second generation CAR-iMAC has been developed to enhance the effectiveness of the therapy for solid tumors.
  • The mechanism of antigen-dependent activation and polarization of the second generation CAR-iMAC and the mechanisms of solid tumor cell killing were also revealed.

Immatics Announces Third Quarter 2023 Financial Results and Business Update

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Tuesday, November 14, 2023
Senior, Entrepreneurship, CRS, Peptide, Regenerative Medicine Advanced Therapy, Patient, Triple-negative breast cancer, Cell, Research, Pharmacology, Therapy, Conference, ORR, Neurotoxicity, Infrared spectroscopy correlation table, Cytokine release syndrome, Uveal melanoma, Bristol Myers Squibb, Safety, Head, Cancer, Administration, CD4, PRAME, Uterine cancer, Lung cancer, Melanoma, Ovarian cancer, Half-life, Development, SAB, BRAF, CD8, MAGEA4, Cytopenia, TCR, Protein, FDA, DLT, Messenger, Cmax, Toxic epidermal necrolysis, Sarcoma, CMC, Neoplasm, Vaccine, Medical imaging, Pharmaceutical industry, Cryptocurrency, Fine chemical, Drug, Moderna, NSCLC

“Immatics has had a strong quarter and made steady progress both in terms of the advancement of our clinical programs and in business development.

Key Points: 
  • “Immatics has had a strong quarter and made steady progress both in terms of the advancement of our clinical programs and in business development.
  • An update on the clinical development plan is expected in the first quarter of 2024.
  • An update on the clinical development plan is expected in the first quarter of 2024.
  • On September 11, Immatics announced a strategic multi-platform collaboration with Moderna, combining Immatics’ target and TCR platforms with Moderna’s cutting-edge mRNA technology.

Abecma Delivers Sustained Progression-Free Survival Versus Standard Regimens in Earlier Lines of Therapy for Relapsed and Refractory Multiple Myeloma Based on Longer-Term Follow-up from KarMMa-3

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Tuesday, December 12, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Multiple myeloma, Bristol Myers Squibb, Oncology Drug Advisory Committee, NYSE, Safety, Research, Food, Bone marrow, European Medicines Agency, Progression-free survival, ASH, CRS, Cohort, Risk, Disease, Cytopenia, Patient, PFS, BMY, Doctor of Philosophy, Division, FDA, Cell therapy, ORR, ASCT, Death, Survival, Grade, Neurotoxicity, Society, BCMA, HIV disease progression rates, Cytokine release syndrome, Boxed warning, Pharmaceutical industry, Hematology, Swissmedic, Idecabtagene vicleucel, OS

With extended follow-up, treatment with Abecma (n=254) continued to demonstrate higher overall response rates (ORR) and a deepening of responses versus standard regimens.

Key Points: 
  • With extended follow-up, treatment with Abecma (n=254) continued to demonstrate higher overall response rates (ORR) and a deepening of responses versus standard regimens.
  • Due to the median PFS observed with standard regimens, more than half (56%) of patients in the standard regimens arm crossed over to receive Abecma as a subsequent therapy.
  • Historically, based on real-world evidence, median OS for patients with triple-class exposed relapsed and refractory multiple myeloma is approximately 13 months.
  • Regulatory applications for Abecma in earlier lines of therapy for triple-class exposed relapsed and refractory multiple myeloma are also under review with the European Medicines Agency and Swissmedic.

DoseMe Adds Cefepime to Its Model-informed Precision Dosing Platform

Retrieved on: 
Monday, December 4, 2023
Technology, Biotechnology, FDA, Health, Pharmaceutical, Other Science, University, Research, Software, Infectious Diseases, Education, Health Technology, Science, Data Management, Hospice and palliative medicine, Neutropenia, Genetically modified bacteria, Cefepime, BCPS, TDM, Pneumonia, Doctor of Pharmacy, Risk, Fungal infection, Serum, Patient, Infection, Midwestern University, Pharmacokinetics, University of Illinois Chicago, Kidney, Owen Scheetz, Bacteria, Creatinine, Neurotoxicity, EGFR, Bias, Postgraduate education, Skin, Therapeutic drug monitoring, Pharmaceutical industry, Pharmacology, Dosem

DoseMe , a leading provider of precision dosing software for therapeutic drug monitoring (TDM) and creators of DoseMeRx and DoseMe Analytics, today announced the availability of its Cefepime model.

Key Points: 
  • DoseMe , a leading provider of precision dosing software for therapeutic drug monitoring (TDM) and creators of DoseMeRx and DoseMe Analytics, today announced the availability of its Cefepime model.
  • His research continues to highlight three keys to infectious disease monitoring - real time beta lactam monitoring, therapeutic drug monitoring and precision dosing.
  • “Similar to many beta lactam treatments, Cefepime displays a large amount of variability between patients and having DoseMeRx enables precision dosing,” stated Scheetz.
  • Greater recognition of the benefits of Model-informed Precision Dosing (MIPD) software for enhancing TDM and dosing precision necessitates thorough validation of models and reassessment of current workflows.

Atara Biotherapeutics To Present Positive New Tab-cel® Clinical Data During Oral Session at ESMO Immuno-Oncology Annual Congress 2023

Retrieved on: 
Wednesday, November 29, 2023
Oncology, Health, Stem Cells, Clinical Trials, Research, Science, Biotechnology, CNS, ATRA, Epstein–Barr virus, Safety, Partial-response maximum-likelihood, PST, Disease, Northwest Biotherapeutics, ESMO, HCT, Patient, CET, ORR, SOT, Cancer, Symantec Endpoint Protection, PTLD, Neurotoxicity, Congress, Central nervous system, EBV, TTR, OS, PR, Vaccine, Pharmaceutical industry

These results will be presented as an oral session at the European Society for Medical Oncology Immuno-Oncology (ESMO I‑O) Annual Congress taking place December 6-8, 2023, in Geneva, Switzerland.

Key Points: 
  • These results will be presented as an oral session at the European Society for Medical Oncology Immuno-Oncology (ESMO I‑O) Annual Congress taking place December 6-8, 2023, in Geneva, Switzerland.
  • “We’re pleased to share new multicenter data, including the first results from our ongoing multicohort EBVision trial and first clinical trial report of treatment with tab-cel in the first line setting.
  • The estimated one-year overall survival (OS) rate was 70.6% (95% CI: 43.0, 86.6) for all patients.
  • Date & Time: December 7, 2023, at 2:15 - 3:45 p.m. CET / 5:15 - 6:45 a.m. PST

Global CD19 Antibody Market and Clinical Pipeline Outlook 2023-2028: A $10 Billion+ Market by 2028 - ResearchAndMarkets.com

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Wednesday, November 22, 2023
Health, Pharmaceutical, Research, Antibody, Immune system, Non-Hodgkin lymphoma, Therapy, Lymphoid leukemia, Loncastuximab tesirine, Scleroderma, CRS, JW, IND, Tafasitamab, Tisagenlecleucel, B-cell lymphoma, Patient, Systemic scleroderma, CD19, Blinatumomab, FDA, Lupus, Acute leukemia, SLE, Chronic lymphocytic leukemia, Novartis, Sjögren syndrome, Neurotoxicity, Quality of life, NHL, Fast Track, ALL, Cytokine release syndrome, CLL, Vaccine, Pharmaceutical industry, Amgen

The "Global CD19 Antibody Market and Clinical Pipeline Outlook 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global CD19 Antibody Market and Clinical Pipeline Outlook 2028" report has been added to ResearchAndMarkets.com's offering.
  • This can be attributed to the rapid regulatory approvals, and the current pipeline of investigational CD19-targeting therapies shows potential for a further surge of this market cap.
  • CD19-targeting therapies have made a significant impact on the clinical landscape of cancer treatment.
  • Global CD19 Antibody Market and Clinical Pipeline Outlook 2028 Report Highlights:
    Global CD19 Antibody Market Opportunity: > USD 10 Billion By 2028
    Commercially Approved CD 19 Antibodies: 10 Antibodies
    Comprehensive Insights On CD19 Antibodies In Clinical Trials: > 190 Antibodies
    Global CD19 Antibodies Clinical Trials By Company, Indication and Phase

Poseida Therapeutics Presents Positive Early Results from its Phase 1 Trial of Allogeneic CAR-T P-BCMA-ALLO1 in Relapsed-Refractory Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Sunday, December 10, 2023
Webcast, Multiple myeloma, Associate, Immunomodulatory imide drug, Safety, SAN, DNA, TSCM, Prodrug, Therapy, Gene, International, CRS, Tissue, Artificial intelligence, SCR, Cytogenetics, Patient, Conference call, Blood, Haemophilia, Conference, Graft-versus-host disease, ORR, TCE, Cancer, Transposase, Partnership, Roche, Malignancy, Antibody, Neurotoxicity, Kinetics, Haemophilia A, RRMM, Cyclophosphamide, BCMA, Physician, Investigator's brochure, Bone marrow, ITT, Vanderbilt-Ingram Cancer Center, Cytokine release syndrome, Vaccine, Pharmaceutical industry, Broadcasting, Hematology

The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM).

Key Points: 
  • The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM).
  • We are excited to have taken this first step with our early P-BCMA-ALLO1 clinical results.
  • They inspire us to further develop P-BCMA-ALLO1 in partnership with Roche, and to continue advancing our entire allogeneic TSCM cell-based CAR-T portfolio."
  • Title: Early Safety Results of P-BCMA-ALLO1, a Fully Allogeneic Chimeric Antigen Receptor T-Cell (CAR-T), in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)
    Session Title: 704.

Immatics Reports Interim Clinical Data from ACTengine® IMA203 and IMA203CD8 TCR-T Monotherapies Targeting PRAME in an Ongoing Phase 1 Trial

Retrieved on: 
Wednesday, November 8, 2023
Patient, FDA, Research, Pharmacology, Uveal melanoma, Regenerative Medicine Advanced Therapy, Uterine cancer, NSCLC, International Congress on Tuberculosis, Corr, Cmax, Ovarian cancer, Nivolumab, Infrared spectroscopy correlation table, TCR, Appendix, CMC, Neurotoxicity, Lung, SD, DLT, Cytokine release syndrome, Melanoma, ORR, Cell therapy, Triple-negative breast cancer, CET, PRAME, Safety, CRS, Society, Melanoma Research, Diagnosis, Today, Cytopenia, BRAF, Pharmaceutical industry, Vaccine, Medical imaging, MD

The update is focused on IMA203 GEN1 in melanoma at the recently defined recommended Phase 2 dose (RP2D) and the first clinical data for IMA203CD8 GEN2.

Key Points: 
  • The update is focused on IMA203 GEN1 in melanoma at the recently defined recommended Phase 2 dose (RP2D) and the first clinical data for IMA203CD8 GEN2.
  • In line with previous results, IMA203 GEN1 monotherapy was well tolerated at total doses up to 10x109 TCR-T cells infused.
  • The presentation is available on Immatics’ website – covering the complete data set including Phase 1a, Phase 1b Cohort A and the deprioritized Cohort B (IMA203 GEN1 combined with nivolumab).
  • Discussions with FDA to align on patient populations, trial design and CMC aspects concerning the planned Phase 2 trial are ongoing.