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FDA clinical trial pauses are increasing year by year, and advanced cell and gene therapy clinical pauses require more transparency
Time of Update: 2023-02-01
According to a recent Wall Street Journal review of the FDA Review of clinical pause data, as biotech companies pursue more cutting-edge cell and gene therapy approaches, the FDA has issued more clinical trial pauses than ever before.
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"Select TIL" cell therapy has been approved by the FDA for clinical trials, and is committed to breaking through the limitations of existing TIL products
Time of Update: 2022-11-15
544px;background-color: rgb(255, 255, 255);text-align: center;box-sizing: border-box !important;overflow-wrap: break-word !important;margin-bottom: 0px;">——List of recent popular events——November 8, HCP residual risk and controlOn November 9, nucleic acid drug process development new technologyNovember 3, 2022 /eMedClub News/--Turnstone Biologics, an immunotherapy company for solid tumors, announced that the FDA has approved its IND application for TIDAL therapy TIDAL-01 for the treatment of advanced solid tumors.
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Universal CD20 CAR-γδ T cell therapy has been granted Fast Track designation by the US FDA. What are the advantages of γδ T cells?
Time of Update: 2022-06-12
▲ Adicet’s γδ T cell-based cell therapy process (Image source: Adicet’s official website) In addition, Adicet has demonstrated that it can target by generating and validating high-affinity and high-specificity T cell receptor-like monoclonal antibodies (TCRLs) The intracellular proteome, these TCRLs against disease-specific antigens presented on the cell surface by MHC class I complexes, could be exploited to arm γδ T cells, as T cell linkers, and as ADCs .
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Express T cell therapy has been recognized by the FDA as an advanced therapy for regenerative
Time of Update: 2022-06-06
▎WuXi AppTec Content Team Editor Recently, AlloVir announced that its multi-virus-specific T cell therapy posoleucel has received FDA Regenerative Medicine Advanced Therapy Designation (RMAT) for high-risk adults after allogeneic hematopoietic cell transplantation (allo-HCT).
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FDA Fast Track Designation for Innovative Cell Therapy for HPV16-Positive Solid Tumors
Time of Update: 2022-05-11
S. Food and Drug Administration (FDA) granted Fast Track designation to its lead cell therapy candidate SQZ-PBMC-HPV for the treatment of patients with human papillomavirus (HPV) 16-positive advanced or metastatic solid tumors .
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FDA issues draft guidance on development considerations for CAR-T cell therapy
Time of Update: 2022-04-30
In the draft guidance, the FDA provides specific recommendations for CAR-T cells on chemistry, manufacturing and control (CMC), pharmacology and toxicology, and clinical study design .
Therefore, control of the manufacturing process and proper interim and batch release testing are critical to ensure the safety, quality, and batch-to-batch consistency of CAR-T cells .
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US FDA approves world's first T-cell receptor (TCR) therapy Kimmtrak (tebentafusp)
Time of Update: 2022-04-27
In the final analysis of the trial, the study met its primary efficacy endpoint: tebentafusp monotherapy compared with investigator-selected regimens (82% Keytruda, 12% Yervoy, 6% dacarbazine) in clinical and Statistically significant survival advantage was demonstrated: significantly prolonged overall survival (OS) and reduced risk of death by 49% (HR = 0.
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CAR-T cell therapy Yescarta wins FDA approval for early-stage lymphoma treatment
Time of Update: 2022-04-24
lymphomaGilead Sciences announced today that the FDA has expanded the approval of Yescarta (axicabtagene ciloleucel) to include patients with large B-cell lymphoma (LBCL) who are refractory to first-line chemoimmunotherapy or who have relapsed within 12 months of first-line chemoimmunotherapy .
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FDA Approves Legend Bio's First CAR-T Cell Therapy Product, CARVYKTI® (Cedaki Orenza)
Time of Update: 2022-04-22
CARTITUDE-1 is an ongoing Phase 1b/2, open-label, single-arm, multicenter study evaluating the safety and efficacy of CARVYKTI® in adult patients with relapsed or refractory multiple myeloma who are Patients received at least 3 lines of prior therapy, including proteasome inhibitors (PIs), immunomodulators (IMiDs), and anti-CD38 monoclonal antibodies .
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Two T-cell therapies of Eureke Biotech received FDA orphan drug designation for express treatment of hepatocellular carcinoma
Time of Update: 2022-03-09
Both T cell product candidates are developed based on its proprietary ARTEMIS technology platform, targeting specific liver cancer antigens .
It is currently being evaluated in a Phase 1/2 clinical trial for the treatment of adult patients with GPC3-positive HCC .
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Genetically engineered NK cell therapy receives FDA Fast Track designation, combined
Time of Update: 2022-02-22
com/celularity-receives-fast-track-designation-from-us-fda-for-its-nk-cell-therapy-cynk-101/https://celularity.
com/celularity -receives-fast-track-designation-from-us-fda-for-its-nk-cell-therapy-cynk-001-in-development-for-the-treatment-of-aml/Bioworld plans to launch " "NK cell therapy" column, which interprets and introduces the latest research progress and reviews of NK cell therapy every week, as well as reports and interviews of related startups .
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Genetically engineered NK cell therapy receives FDA Fast Track designation, combined
Time of Update: 2022-02-18
It is reported that this is Celularity's third NK cell therapy to receive FDA Fast Track qualification in the past year.
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SIBIMAN’s CD19/CD20 CAR-T cell therapy has been granted RMAT and Fast Track dual qualifications by the FDA
Time of Update: 2022-01-24
S. Food and Drug Administration (FDA) awarded the Company Cellular Therapeutic product C-CAR039 (a novel autologous bispecific CAR-T therapy targeting CD19 and CD20 antigens) regenerative medicine advanced therapy (RMAT) qualification and fast track (FT) qualification for the treatment of relapsed or refractory and diffuse large B-cell lymphoma (r/r DLBCL) .
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Express for the treatment of leukemia, the FDA granted the "ready-to-use" placental-derived NK cell therapy fast track qualification
Time of Update: 2022-01-10
S. FDA has granted fast-track qualification for natural killer (NK) cell therapy CYNK-001 for the treatment of acute myeloid leukemia (AML) .
"Reference: [1] Celularity Receives Fast Track Designation from US FDA for its NK Cell Therapy CYNK-001 in Development for the Treatment of AML .
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Express AbbVie's ADC therapy is recognized by the FDA as a breakthrough therapy for the treatment of non-small cell lung cancer
Time of Update: 2022-01-08
It is used to treat patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild-type non-squamous non-small cell lung cancer (NSCLC) who have disease progression and c-Met overexpression during or after platinum drug treatment .