CAR

Atara Biotherapeutics Announces First Quarter 2024 Financial Results and Operational Progress

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星期四, 五月 9, 2024
Stem Cells, Biotechnology, Health, General Health, Pharmaceutical, Oncology, Research, Infectious Diseases, Genetics, Science, Clinical Trials, Mantle cell lymphoma, Cancer, International Society, Investment, Cell, Phenotype, Safety, Risk, Pharmacokinetics, Poster, Lymphoproliferative disorders, Depreciation, Cytokine, Partnership, Lymphoma, Biologics license application, ATRA, Follicular lymphoma, CD19, ASH, Epstein–Barr virus, Patient, NHL, LD, Toxicity, BLA, Memory, Workforce, EBV, Biomarker, SLE, Tabelecleucel, Pharmaceutical industry

Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the first quarter 2024, recent business highlights, and key upcoming milestones for 2024.

Key Points: 
  • Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the first quarter 2024, recent business highlights, and key upcoming milestones for 2024.
  • “This is anticipated to provide multiple near-term clinical milestones for ATA3219, including initial non-Hodgkin’s lymphoma data expected in the fourth quarter 2024, and initial lupus nephritis data in the first half of 2025, with plans to expand into a new SLE cohort without lymphodepletion.
  • Subjects will receive lymphodepletion treatment followed by ATA3219 at a dose of 40, 80, or 160 x 106 CAR+ T cells.
  • Subjects will receive LD treatment followed by ATA3219 at a dose of 40, 80, 240, or 480 x 106 CAR+ T cells.

Fate Therapeutics Reports First Quarter 2024 Financial Results and Business Updates

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星期四, 五月 9, 2024
FDA, Investment, Risk, Destiny, IND, Autoimmune disease, Enrollment, Death, Hospital, GAAP, NK, GEJ, Multiple myeloma, CRS, HER2, Pharmacokinetics, Graft-versus-host disease, Food, Lupus, Data, ADR, BCL, Histology, Therapy, BCMA, Autoimmunity, Safety, Trastuzumab, Research, TRAC, Incidence, IPSC, Chronic lymphocytic leukemia, Acute leukemia, Investigational New Drug, Cancer, Cell, Cmax, Patient, Gene, Society, B-cell lymphoma, BCM, Cytokine release syndrome, Immune system, SLE, Vaccine

SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today reported business highlights and financial results for the first quarter ended March 31, 2024.

Key Points: 
  • The patient was discharged after a three-day hospital stay without any notable adverse events.
  • The Company will conduct a conference call today, Thursday, May 9, 2024 at 5:00 p.m.
  • ET to review financial and operating results for the quarter and full year ended March 31, 2024.
  • The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.fatetherapeutics.com.

Century Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates

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星期四, 五月 9, 2024
Cancer, Investment, Cell, Research, Gene editing, Research and development, Ink, Computational biology, Myasthenia gravis, CRS, Science, Protein engineering, Administration, Rejection, IPSC, CD19, Autoimmune disease, Bristol Myers Squibb, Patient, Acquisition, Pharming, NHL, Century, Malignancy, BMS, AACR, SLE, Therapy, Lymphoid leukemia, GAAP, BCMA, NK, Pharmaceutical industry

Century’s core Allo-Evasion™ edits are designed to overcome the three major pathways of host versus graft rejection: CD8+ T cells, CD4+ T cells and NK cells.

Key Points: 
  • Century’s core Allo-Evasion™ edits are designed to overcome the three major pathways of host versus graft rejection: CD8+ T cells, CD4+ T cells and NK cells.
  • In April 2024, the Company announced plans to expand clinical development of CNTY-101 into additional autoimmune disease indications beyond SLE.
  • In the second half of 2024, Century intends to submit additional regulatory filings for CNTY-101 in autoimmune disease indications with limited current treatment options and high unmet need.
  • Century plans to share additional data from its Phase 1 ELiPSE-1 trial in R/R non-Hodgkin lymphoma (NHL) at the upcoming ASCO Annual Meeting, being held May 31-June 4, 2024, in Chicago, IL.

Fate Therapeutics Announces First Lupus Patient Treated in Phase 1 Autoimmunity Study of Off-the-shelf FT819 CAR T-cell Program

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星期四, 五月 9, 2024
FDA, University, Cancer, Periphery, Phenotype, Safety, CXCR4, Pharmacokinetics, Risk, Food, Destiny, Cell, B cell, Lupus, Nebraska Medicine, IND, Autoimmunity, Investigational New Drug, CD19, ADR, Patient, Principal, Gene, Society, IPSC, BCL, BCM, Memory, Hospital, Immune system, SLE, Therapy, Lymphoid leukemia, B-cell lymphoma, Vaccine

SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today announced that the first patient with systemic lupus erythematosus (SLE) has been treated in the Phase 1 autoimmunity study of FT819, the Company’s off-the-shelf, CD19-targeted chimeric antigen receptor (CAR) T-cell program. In addition, at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting, the Company today presented translational data from the Phase 1 study of FT819 in relapsed / refractory B-cell malignancies (BCM) and initial clinical observations from the Phase 1 study of its FT522 off-the-shelf, CD19-targeted CAR NK cell program in relapsed / refractory B-cell lymphoma (BCL). Data from these programs highlight the scientific rationale and demonstrate key therapeutic mechanisms of activity for the treatment of B cell-mediated autoimmune disease.

Key Points: 
  • Data from these programs highlight the scientific rationale and demonstrate key therapeutic mechanisms of activity for the treatment of B cell-mediated autoimmune disease.
  • The multi-center, Phase 1 autoimmunity study of FT819 is designed to assess safety, pharmacokinetics, and anti-B cell activity for patients with moderate-to-severe SLE (NCT06308978).
  • The first patient, a 27 year-old woman diagnosed with SLE over ten years ago who has refractory disease despite having been treated with multiple standard-of-care therapies, received conditioning chemotherapy followed by a single dose of FT819 at 360 million cells.
  • The patient was discharged after a three-day hospital stay without any notable adverse events.

MeiraGTx Reports First Quarter 2024 Financial and Operational Results

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星期四, 五月 9, 2024
FDA, Research, UCL Business, Weight loss, IND, Oxyntomodulin, Visual acuity, RIX, Oral medicine, American Academy, Brain, STN, Facial muscles, Technology transfer, Janssen Pharmaceuticals, Appetite, BLA, MHRA, Messenger, Subthalamic nucleus, Safety, Diabetes, Insurance, RNA, AAOM, AAV, Dopamine, Obesity, DNA, Autoimmune disease, Motor cortex, Treatment, Pros, GMP, GIP, Clinical trial, File, PSMA, Sale, Radiation, Neurodegenerative disease, DSM-IV codes, Saliva, Health care, Xerostomia, Patient, Riboswitch, Gene, Peptide, Head, PYY, Pharmaceutical industry

LONDON and NEW YORK, May 09, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial and operational results for the first quarter ended March 31, 2024, and provided a corporate update.

Key Points: 
  • MeiraGTx anticipates receiving an additional $15 million in near-term milestone payments later in 2024.
  • As of March 31, 2024, MeiraGTx had cash and cash equivalents of approximately $119.2 million and in April 2024, the Company collected $19.7 million in receivables which were due in the first quarter of 2024, effectively increasing the cash balance to $138.9 million.
  • The increase of $0.6 million was due to higher interest rates and cash balances during 2024.
  • Interest expense was $3.3 million for the three months ended March 31, 2024, compared to $3.1 million for the three months ended March 31, 2023.

Oncternal Therapeutics Provides Business Update and Announces First Quarter 2024 Financial Results

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星期四, 五月 9, 2024
Patient, Investment, Research, Prostate cancer, CD19, Therapy, SAN, Pharmaceutical industry

Our grant revenue was $0.6 million for the first quarter ended March 31, 2024.

Key Points: 
  • Our grant revenue was $0.6 million for the first quarter ended March 31, 2024.
  • Our total operating expenses for the first quarter ended March 31, 2024 were $9.3 million, including $1.4 million in non-cash stock-based compensation expense.
  • Research and development expenses for the quarter totaled $6.0 million, and general and administrative expenses for the quarter totaled $3.3 million.
  • These funds are expected to be sufficient to fund our operations into the first quarter of 2025.

CRISPR Therapeutics Provides Business Update and Reports First Quarter 2024 Financial Results

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星期三, 五月 8, 2024
Sickle cell disease, T1D, SHR, Cell, CRISPR, Partnership, CD19, CRISPR Therapeutics, Biomarker, Autoimmunity, SCD, LNP, Lupus, Kingdom, Porphobilinogen, ADC, Eye, ANGPTL3, RAAS, PBG, Therapy, Lymphoid leukemia, Vertex Pharmaceuticals, Type 1 diabetes, Pain, Cas9, AHP, Diabetes, Research, ALA, BP, CD70, AGT, Clinical trial, Government, G&A, TDT, Sale, CRSP, ALAS1, European, Disease, Patient, Liver, Gene, Society, Stem cell, Cardiovascular disease, SLE, Pharmaceutical industry

CASGEVY is the first therapy to emerge from a strategic partnership between CRISPR Therapeutics and Vertex Pharmaceuticals established in 2015.

Key Points: 
  • CASGEVY is the first therapy to emerge from a strategic partnership between CRISPR Therapeutics and Vertex Pharmaceuticals established in 2015.
  • CRISPR Therapeutics has two next-generation approaches with the potential to significantly expand the addressable population with SCD and TDT.
  • G&A Expenses: General and administrative expenses were $18.0 million for the first quarter of 2024, compared to $22.4 million for the first quarter of 2023.
  • Collaboration Expense: Collaboration expense, net, was $47.0 million for the first quarter of 2024, compared to $42.2 million for the first quarter of 2023.

Sana Biotechnology Reports First Quarter 2024 Financial Results and Business Updates

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星期三, 五月 8, 2024
CTA, CD22, HIP, Contingency, Cell Stem Cell, CD47, Lupus nephritis, Cell, Insulin, Safety, ANCA, Organoid, Research, Survival, Immunosuppression, Research and development, B cell, Development, VIVID, GLEAM, Administration, Autoimmunity, Exercise, Biotechnology, CD19, Patent, Sana, Patient, Regeneration, NHP, Diabetes, Cancer, Lymphoid leukemia, GAAP, Organization, Escape Room, Vaccine

Enrollment in this study continues, and Sana expects to share more data in 2024.

Key Points: 
  • Enrollment in this study continues, and Sana expects to share more data in 2024.
  • The trial has begun enrollment, and Sana expects to share initial data in 2024.
  • The trial has begun enrollment, and Sana expects to share initial data in 2024.
  • The Clinical Trial Application (CTA) cleared in 4Q 2023, and Sana expects to share initial data in the first half of 2024.

Allogene Therapeutics to Report First Quarter Financial Results and Provide Business Update

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星期一, 五月 6, 2024
News, Cancer, Kite Pharma, Autoimmune disease, Therapy, SAN, PIN, Call

ET

Key Points: 
  • ET
    SOUTH SAN FRANCISCO, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that it will report first quarter 2024 financial results and provide a business update on May 13, 2024, after the close of the market.
  • The announcement will be followed by a live audio webcast and conference call at 2:00 p.m. PT/5:00 p.m.
  • The listen-only webcast will be made available on the Company's website at www.allogene.com under the Investors tab in the News and Events section.
  • If you would like the option to ask a question on the conference call, please use this link to register.

Lyell Immunopharma Reports Business Highlights and Financial Results for the First Quarter 2024

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星期一, 五月 6, 2024
Lyell, Triple-negative breast cancer, Colorectal cancer, Research, IND, TIL, Patient, NR4A3, Workforce, Memory, AACR, NSCLC, TNBC, GAAP, G&A, Lung cancer, Pharmaceutical industry

Initial data from at least 20 patients from the Phase 1 clinical trial of LYL797 are expected this quarter.

Key Points: 
  • Initial data from at least 20 patients from the Phase 1 clinical trial of LYL797 are expected this quarter.
  • Initial clinical and translational data from the Phase 1 trial of LYL845 are expected in the second half of 2024.
  • Research and development (R&D) expenses were $43.2 million for the first quarter ended March 31, 2024, compared to $44.6 million for the same period in 2023.
  • The decrease in first quarter 2024 non-GAAP R&D expenses was primarily driven by a decrease in personnel-related expenses.