CD19

Century Therapeutics Presents New Preclinical Data Highlighting iPSC-derived Cell Therapy Platform Technology at the 2024 American Association for Cancer Research (AACR) Annual Meeting

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월요일, 4월 8, 2024
Computational biology, Malignancy, Canadian Aviation Regulations, Gene editing, Bone disease, Cell, Hook effect, CXCR4, Enfortumab vedotin, Synthetic biology, Patient, Neoplasm, Epitope, Differentiable function, Ink, PBMC, Protein engineering, HLA, Science, Cytotoxicity, AACR, Phenotype, Therapy, IPSC, Skin, Inflammation, Prognosis, Carcinogenesis, Rejection, CD22, VHH, Poster, NK, Century, Autoimmunity, Bone marrow, Engineering, CD19, Vaccine

PHILADELPHIA, April 08, 2024 (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 that preclinical data from the Company’s iPSC-derived cell therapy platform was presented at the AACR Annual Meeting 2024.

Key Points: 
  • PHILADELPHIA, April 08, 2024 (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 that preclinical data from the Company’s iPSC-derived cell therapy platform was presented at the AACR Annual Meeting 2024.
  • This novel CAR was engineered and tested in iPSC-derived gamma-delta T cells, showing in vitro tumor cell cytotoxicity.
  • These findings support the continued examination of a CD19xCD22 bispecific CAR for off-the-shelf allogeneic cell therapy to expand patient access beyond CD19 CAR-T cell therapies.
  • In these preclinical studies, Century identified novel single-domain antibodies (VHH) that bind to multiple epitopes on the NECTIN4 extracellular domain.

Caribou Biosciences Expands Clinical Development of CB-010 with FDA Clearance of IND in Lupus

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목요일, 4월 4, 2024
Logic, LN, Transplant, Medical College of Wisconsin, Rachel Haurwitz, Infection, Lupus, Risk, Medical college, Patient, Inflammation, Tissue, Autoimmune disease, Standard of care, Doctor of Philosophy, MD, Autoantibody, IND, Congress, HLA, Reindeer, Antibody, CRISPR, Safety, Immune system, Fatigue, FDA, Lupus nephritis, Autoimmunity, Bone marrow, ERL, Medicine, CD19, Food, PD-1, Pharmaceutical industry

BERKELEY, Calif., April 04, 2024 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that it received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024.

Key Points: 
  • The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024.
  • CB-010 targets CD19, a protein on the surface of B cells, and has a PD-1 knockout (KO) that reduces CAR-T cell exhaustion.
  • CB-010 holds the potential for deep depletion of disease-causing B cells which could reset the immune system, leading to sustained drug-free remission.
  • Instead, the chRDNA technology allows for precise insertion of the CAR at an intended location within the T cell genome.

Galapagos showcases innovative approach in hematological cancer care with clinical and translational data presentations at EBMT congress 2024

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목요일, 4월 4, 2024
Symantec Endpoint Protection, CLL, Safety, RT, Patient, EBMT, NHL, Euronext, Efficacy, Abstract, CD19, Pharmaceutical industry

ATALANTA-1 and EUPLAGIA-1 are ongoing Phase 1/2 open-label, multi-center studies designed to assess the safety, efficacy and feasibility of point-of-care manufactured GLPG5101 and GLPG5201 in patients with relapsed/refractory NHL, and relapsed/refractory CLL and RT, respectively.

Key Points: 
  • ATALANTA-1 and EUPLAGIA-1 are ongoing Phase 1/2 open-label, multi-center studies designed to assess the safety, efficacy and feasibility of point-of-care manufactured GLPG5101 and GLPG5201 in patients with relapsed/refractory NHL, and relapsed/refractory CLL and RT, respectively.
  • The primary objective of the Phase 1 part of the studies is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study.
  • GLPG5101 and GLPG5201 are second generation anti-CD19/4-1BB CAR-T product candidates, administered as a single fixed intravenous dose.
  • “We are committed to accelerating breakthrough innovations to extend the reach of CAR-T therapies to patients with rapidly progressing cancers,” said Dr. Jeevan Shetty, M.D., Head of Clinical Development Oncology at Galapagos.

Marker Therapeutics Reports Year-End 2023 Corporate and Financial Results

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월요일, 3월 25, 2024
ODD, Research, Food and Drug Administration, U.S. FDA, Drug discovery, AML, International, Patient, Committee, SBIR, Female, Acute myeloid leukemia, Sale, INN, Marker, EMA, OTS, NIH, IND, Myelodysplastic syndrome, European Medicines Agency, Counsel, Therapy, MRD, Bone marrow, USAN, MDS, APOLLO, FDA, DLBCL, Press release, CD19, Pharmaceutical industry

Marker also executed a comprehensive non-dilutive agreement with Cell Ready which included a sale of select cell manufacturing assets from Marker for approximately $19 million in cash.

Key Points: 
  • Marker also executed a comprehensive non-dilutive agreement with Cell Ready which included a sale of select cell manufacturing assets from Marker for approximately $19 million in cash.
  • Granted ODD from the Committee for Orphan Medicinal Products of the EMA for the treatment of patients with AML in 2023.
  • On June 26, 2023, Marker completed a non-dilutive transaction with Cell Ready, under which Cell Ready purchased certain cell manufacturing assets from Marker for approximately $19 million in cash.
  • Cash Position and Guidance: At December 31, 2023, Marker had cash and cash equivalents of $15.1 million.

CARGO Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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목요일, 3월 21, 2024
Research, B-cell lymphoma, Disease, Patient, SAN, G&A, Cancer, IPO, Stanford University, Trial of the century, Therapy, Safety, CD19, Pharmaceutical industry

SAN MATEO, Calif., March 21, 2024 (GLOBE NEWSWIRE) -- CARGO Therapeutics, Inc. (Nasdaq: CRGX), a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients, today provided a business update and reported financial results for the quarter and year ending December 31, 2023.

Key Points: 
  • CARGO had $405.7 million in cash and cash equivalents as of December 31, 2023, which it expects will fund operations through 2025.
  • Research and development (R&D) expenses were $27.1 million for the fourth quarter of 2023, which includes $0.7 million of non-cash stock-based compensation expense.
  • General and administrative (G&A) expenses were $7.9 million for the fourth quarter of 2023, which includes $1.0 million of non-cash stock-based compensation expense.
  • For 2023, net loss was $98.1 million, or $16.53 per share, including non-cash stock-based compensation and depreciation expenses of $3.3 million and $1.5 million, respectively.

Cabaletta Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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목요일, 3월 21, 2024
Research, MPV, IIM, MuSK protein, Toxicity, Conference, Disease, Dermatomyositis, Juvenile dermatomyositis, Federation, Patient, NOL, Observation, CRS, SLE, Health Canada, IND, Immunoglobulin therapy, Pemphigus, Investment, Investigational New Drug, Myopathy, Systemic scleroderma, Marketing, FDA, Clinical trial, Cytokine release syndrome, Cyclophosphamide, CD19, Food, Autoimmune disease, Pharmaceutical industry

In October 2023, Cabaletta received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) for the Phase 1/2 RESET-SSc trial.

Key Points: 
  • In October 2023, Cabaletta received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) for the Phase 1/2 RESET-SSc trial.
  • In November 2023, Cabaletta announced that its IND application for CABA-201 was allowed to proceed by the FDA for the Phase 1/2 RESET-MG trial.
  • Cabaletta anticipates reporting initial clinical data from the Phase 1/2 RESET-MG trial in the second half of 2024.
  • As of December 31, 2023, Cabaletta had cash, cash equivalents and short-term investments of $241.2 million, compared to $106.5 million as of December 31, 2022.

Allogene Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Update

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목요일, 3월 14, 2024
Research, Kite Pharma, PIN, CLL, Disease, AID, Patient, EFS, Observation, Pivotal, Cancer, Renal cell carcinoma, Bank statement, News, RCC, Therapy, CRISPR, Projection, MRD, GAAP, Autoimmune disease, Cyclophosphamide, CD19, Pharmaceutical industry

These restated financial statements have no impact on the Company’s cash, cash equivalents and marketable investments, cash runway or business operations.

Key Points: 
  • These restated financial statements have no impact on the Company’s cash, cash equivalents and marketable investments, cash runway or business operations.
  • Research and development expenses were $54.7 million for the fourth quarter of 2023, which includes $7.0 million of non-cash stock-based compensation expense.
  • General and administrative expenses were $17.2 million for the fourth quarter of 2023, which includes $8.2 million of non-cash stock-based compensation expense.
  • Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update.

Autolus Therapeutics Reports Full Year 2023 Financial Results and Business Updates

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목요일, 3월 14, 2024
Nucleus, Bone marrow, BCMA, BioNTech, B-ALL, Patient, ALL, SLE, Engineering, Minocycline, European Medicines Agency, Therapy, Research, Canadian Aviation Regulations, Flow cytometry, ASH, General counsel, Immunotherapy, SVP, EMA, Legal Affairs, Trial of the century, GMP, SME, BLA, Nature Communications, Development, UCL, Biologics license application, Multiple myeloma, MIA, University College London, Senior, TRBC, GD2, ASCO, FDA, CD19, Conference call, Conference, MAA, EHA, ADS, MHRA, T cell, ACS Chemical Biology, PDUFA, Autoimmune disease, Pharmaceutical industry

“For now, we remain fully focused on preparing for a potential obe-cel launch and successfully transitioning Autolus to a commercial stage company.

Key Points: 
  • “For now, we remain fully focused on preparing for a potential obe-cel launch and successfully transitioning Autolus to a commercial stage company.
  • In February 2024, Autolus promoted Dr. Chris Williams to Chief Business Officer and Alex Driggs to Senior Vice President, Legal Affairs and General Counsel.
  • Dr. Leiderman brings extensive transactional and financial expertise, and Mr. Azelby brings more than 30 years of biopharmaceutical leadership and commercial experience to Autolus’ Board.
  • Financial Results for the Year Ended December 31, 2023

Cullinan Oncology Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results

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목요일, 3월 14, 2024
Research, EGFR, NSCLC, Disease, AML, Cullinan, Patient, Tissue, Sale, Multiple myeloma, G&A, CMC, Enrollment, IND, Lymph, Investment, MDS, FDA, Lymphoma, Spleen, CD19, CGEM, Pharmaceutical industry

CAMBRIDGE, Mass., March 14, 2024 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted oncology therapies, today reported on recent and upcoming business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2023. The company also announced that Chief Financial Officer Jeff Trigilio will depart the company effective March 29. Following his departure, Jeff has agreed to support the company through a transition period.

Key Points: 
  • R&D Expenses: Research and development (R&D) expenses were $34.8 million for the fourth quarter of 2023, compared to $33.8 million for the third quarter of 2023.
  • R&D expenses for the fourth and third quarters of 2023 included $2.7 million and $3.2 million of equity-based compensation expenses, respectively.
  • G&A Expenses: General and administrative (G&A) expenses were $10.6 million for the fourth quarter of 2023, compared to $11.0 million for the third quarter of 2023.
  • Net Loss: Net loss (before items attributable to noncontrolling interest) for the fourth quarter of 2023 was $25.6 million, compared with net loss of $39.2 million for the third quarter of 2023.

Xcell Biosciences Strengthens Cell and Gene Therapy Collaboration With Labcorp

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월요일, 4월 1, 2024
Software, Research, General Health, Pharmaceutical, Oncology, Medical Devices, Technology, Artificial Intelligence, Genetics, Clinical Trials, Science, Health, TME, Patient, CGMP, AACR, Phenotype, Labcorp, AVATAR, Poster, CD19

Xcell Biosciences Inc. (Xcellbio), an instrumentation company focused on cell and gene therapy applications, today announced it has added new elements to its research collaboration agreement with Labcorp, a global leader of innovative and comprehensive laboratory services.

Key Points: 
  • Xcell Biosciences Inc. (Xcellbio), an instrumentation company focused on cell and gene therapy applications, today announced it has added new elements to its research collaboration agreement with Labcorp, a global leader of innovative and comprehensive laboratory services.
  • The companies will be jointly presenting results from their existing cell and gene therapy collaboration at the upcoming annual meeting of the American Association for Cancer Research (AACR).
  • Xcellbio has developed the AVATAR incubator system for cell therapy research and development.
  • Its latest platform, the AVATAR Foundry system, is a cGMP cell therapy manufacturing platform that delivers novel capabilities for improving the potency of cell therapies.