CD20

Fate Therapeutics Announces Termination of Collaboration Agreement with Janssen, Pipeline Prioritization, Next-Generation Programs, and Key 2023 Initiatives

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星期四, 一月 5, 2023
Cancer, ONO, IPSC, Annual general meeting, Society, SITC, Workforce, Mab, CD20, Patient, Lymphatic system, BCMA, CXCR2, Preclinical development, Treatment, Degenerative disease, Cichocki, FDA, IND, ADR, HER2, B-cell lymphoma, Ono Pharmaceutical, Pharmacokinetics, ASH, Society for Immunotherapy of Cancer, Nature Communications, Food, Therapy, Regulation of tobacco by the U.S. Food and Drug Administration, Destiny, NHL, Acute myeloid leukemia, NK, CD38, Immunotherapy, Investigational New Drug, MM, Risk, Disease, CAR, Tumor microenvironment, B cell, Multiple myeloma, Multiplexing, Vaccine, Pharmaceutical industry, Janssen, Safety

In addition, we look forward this year to the further emergence of our iPSC-derived CAR T-cell programs for the treatment of hematologic malignancies and solid tumors.

Key Points: 
  • In addition, we look forward this year to the further emergence of our iPSC-derived CAR T-cell programs for the treatment of hematologic malignancies and solid tumors.
  • Ongoing Phase 1 Study of FT576 BCMA-targeted CAR NK Cell Program to Accrue Higher-dose, Multi-dose Treatment Cohorts.
  • The Company ended the fourth quarter of 2022 with unaudited cash, cash equivalents, and receivables totaling approximately $475 million.
  • Based on its current operating plan, the Company expects to have sufficient financial resources to fund operations through 2025.

TG Therapeutics Announces FDA Approval of BRIUMVI™ (ublituximab-xiiy)

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星期三, 十二月 28, 2022
The New England Journal of Medicine, Multiple sclerosis, Advocacy, Central nervous system, FAAN, Food, Therapy, MD, MS, Research, News, Neurology, Ublituximab, CD20, HIV disease progression rates, ARR, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, TG, Patient, Family, RMS, Pediatrics, Consortium, MSN, Multiple sclerosis research, Stanford University, Physician, FDA, II, CMSC, History, Pharmaceutical industry, NEW YORK

Results from the ULTIMATE I & II trials were recently published in August 2022 in The New England Journal of Medicine.

Key Points: 
  • Results from the ULTIMATE I & II trials were recently published in August 2022 in The New England Journal of Medicine.
  • Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, "Today’s FDA approval marks an exciting day for everyone touched by MS and everyone that has worked on the development of BRIUMVI.
  • June Halper, MSN, APN-C, MSCN, FAAN, Chief Executive Officer of the Consortium of Multiple Sclerosis Centers has stated, “The approval of BRIUMVI is wonderful news.
  • Congratulations to TG Therapeutics from the CMSC and our leadership.”

Biogen Reaches Agreement with Genentech to Receive Royalties on the Potential Commercialization of a Late-Stage Bispecific Antibody as Part of Anti-CD20 Collaboration

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星期一, 十二月 19, 2022
BIIB, Hoffmann-La Roche, Economics, Food, European Medicines Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Genentech, Lymphatic system, Mantle cell lymphoma, CD3, Patient, Biogen, Antibody, Phase, CD20, EMA, Roche, Fine chemical, Vaccine, DLBCL

Under the terms of the agreement, Biogen will have no payment obligations and will receive tiered royalties on potential net sales of glofitamab within the United States as part of the companies long-standing collaboration on antibodies targeting CD20.

Key Points: 
  • Under the terms of the agreement, Biogen will have no payment obligations and will receive tiered royalties on potential net sales of glofitamab within the United States as part of the companies long-standing collaboration on antibodies targeting CD20.
  • Glofitamab is an investigational CD20xCD3 T-cell engaging bispecific antibody being developed by Roche for the treatment of B-cell non-Hodgkin’s lymphomas, including diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, and other blood cancers1.
  • If approved, glofitamab has the potential to be a first-in-class fixed-duration CD20xCD3 T-cell engaging bispecific antibody in DLBCL.
  • The companies have had a collaboration on antibodies targeting CD20 since 1995.

Mustang Bio Provides CAR T Cell Therapy Portfolio Updates and 2023 Anticipated Milestones

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星期一, 十二月 19, 2022
Dana–Farber Cancer Institute, Fred Hutchinson Cancer Research Center, Clinical trial, GBM, BPDCN, Cancer, Investigational New Drug, Infection, Glioblastoma, Translation, Food, SRT, Drug discovery, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research, American Association for Cancer Research, MD Anderson Cancer Center, City, Birmingham, Malignancy, Leukemia, CAR, Patient, Lymphatic system, Duke University, Chronic lymphocytic leukemia, Mayo, Waldenström, Degenerative disease, Mayo Clinic, Mustang, City of Hope, Safety, Investigator, A Call for Unity, WM, University, IND, Hematological Cancer Research Investment and Education Act, Toxic epidermal necrolysis, CD20, Clinical professor, CR, Cell, Pharmaceutical industry

WORCESTER, Mass., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced recent CAR T cell therapy portfolio updates and provided anticipated milestones for 2023.

Key Points: 
  • WORCESTER, Mass., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced recent CAR T cell therapy portfolio updates and provided anticipated milestones for 2023.
  • Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “In 2022, Mustang successfully advanced our CAR T cell therapy portfolio which has laid the foundation for us to achieve multiple milestones in the coming year.
  • The combination leverages MB-108 to make cold tumors “hot,” thereby improving the efficacy of MB-101 CAR T cell therapy.
  • Additionally, Mustang plans to file an IND application for a multicenter Phase 1 clinical trial once a lead CAR construct has been identified.

City of Hope-led trial leads to U.S. Food and Drug Administration's approval of a first of its kind bispecific antibody

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星期四, 一月 5, 2023
Yee, Cancer, Budde, Rash, Hoffmann-La Roche, B-cell lymphoma, Fever, Haematopoietic system, Follicular lymphoma, Food, National Cancer Institute, Genentech, City, Science, HIV disease progression rates, Non-Hodgkin lymphoma, Immunotherapy, LOS, Disease, CAR, CD3, Patient, Cytokine release syndrome, Lymphatic system, The Hope Division, Weight loss, FDA, Therapy, Fatigue, Prognosis, Headache, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CD20, Hematology, Diagnosis, Pharmaceutical industry, Vaccine, Health insurance, Lymphoma, Hope

LOS ANGELES, Jan. 5, 2023 /PRNewswire/ -- A trial led by City of Hope, one of the largest cancer research and treatment organizations in the nation, contributed to the U.S. Food and Drug Administration's approval of mosunetuzumab (commercial name: Lunsumio), the first bispecific antibody to treat people with relapsed or difficult to treat follicular lymphoma (FL), a type of non-Hodgkin lymphoma, after they have received two or more standard therapies.

Key Points: 
  • Instead of concentrating on a singular target, bispecific antibodies are therapeutics that act on two cellular targets simultaneously.
  • "At City of Hope, the integration of scientific research and clinical trials allows us to deliver groundbreaking science and treatments from laboratory to patient.
  • Mosunetuzumab is a first in class T cell engaging bispecific antibody and could change the way advanced follicular lymphoma is treated."
  • Ninety patients with follicular lymphoma, who ranged in age from 29 to 90 years old, were enrolled in the multicenter international trial.

IGM Biosciences Presents Data from T cell Engager Portfolio for Hematologic Malignancies at 2022 American Society of Hematology Annual Meeting

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星期日, 十二月 11, 2022
Sanofi, Immunoglobulin M, Investigational New Drug, Intellectual property, Patient, Neoplasm, Clinical trial, Inflammation, CD3, Security (finance), Antibody, Immunoglobulin G, Safety, Cancer, Biomarker, Multiple myeloma, Toxic shock syndrome, ASH, CD38, CDC, AML, IL-6, Acute myeloid leukemia, CD123, Infection, Society, Autoimmunity, IND, IGM, CD20, Risk, TDCC, COVID-19, Therapy, Aquaculture, Vaccine

Additionally, IGM-2644 achieved potent T cell dependent cellular cytotoxicity (TDCC) killing of daratumumab-resistant cell lines with minimal cytokine release as well as potent TDCC killing of myeloma patient samples.

Key Points: 
  • Additionally, IGM-2644 achieved potent T cell dependent cellular cytotoxicity (TDCC) killing of daratumumab-resistant cell lines with minimal cytokine release as well as potent TDCC killing of myeloma patient samples.
  • IGM-2644 was also shown to inhibit CD38+ tumor growth in humanized xenograft models, but it avoids killing immune effector cells as compared to an IgG bispecific T cell engager.
  • IGM-2537 also showed significantly reduced cytokine release, exemplified by IFN-γ, TNF-α and IL-6, as compared to an IgG T cell engager molecule.
  • IGM also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets.

Xencor Presents Data from Phase 1 Study of Plamotamab in Relapsed or Refractory Non-Hodgkin Lymphoma at the American Society of Hematology Annual Meeting

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星期一, 十二月 12, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Cytokine, CD3, Society, NHL, Cancer, Anemia, B-cell lymphoma, Safety, AE, Lymphoma, Patient, IL-6, COVID-19, DLBCL, Form 10-K, Cytokine release syndrome, Lymphocytopenia, Trial of the century, Clinical trial, Annual report, CST, Security (finance), Probability, III, Neutropenia, Non-Hodgkin lymphoma, Aggressive lymphoma, CD20, CD28, ITT, ASH, Therapy, ORR, Lenalidomide, CR, Follicular lymphoma, Degenerative disease, Incidence, Histology, Antibody, Engineering, CRS, AES, Janssen, Vaccine, Pharmaceutical industry, Cmax

In the Phase 1 monotherapy study of plamotamab, the recommended intravenous dose was well tolerated, and we are encouraged by the responses observed in the study.

Key Points: 
  • In the Phase 1 monotherapy study of plamotamab, the recommended intravenous dose was well tolerated, and we are encouraged by the responses observed in the study.
  • Xencors first combination study, evaluating plamotamab with tafasitamab plus lenalidomide, is enrolling patients with advanced, aggressive lymphoma.
  • Additionally, patients enrolling to the ongoing Phase 1 monotherapy study will now receive subcutaneous doses of plamotamab.
  • Plamotamab is also being evaluated in a Phase 2 study, in combination with tafasitamab plus lenalidomide, in patients with relapsed or refractory diffuse large B-cell lymphoma.

Mustang Bio Reports Third Quarter 2022 Financial Results and Recent Corporate Highlights

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星期一, 十一月 14, 2022
Fortress Biotech, CR, CD19, ORR, Food, CLL, IND Culver Line, Safety, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Follicular lymphoma, CD20, Regulation, Drug Quality and Security Act, Hematological Cancer Research Investment and Education Act, Annual report, Phase 1, Research, CAR, Orphan, Patent, Waldenström's macroglobulinemia, Fred Hutchinson Cancer Research Center, Cytokine release syndrome, Chronic lymphocytic leukemia, International Workshop on Lung Health, Mustang, Waldenström, Translation, Atlas Shrugged: Part I, Clinical trial, ODD, FDA, WM, Pharmaceutical industry

WORCESTER, Mass., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (Mustang) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating todays medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2022.

Key Points: 
  • WORCESTER, Mass., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (Mustang) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating todays medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2022.
  • We anticipate announcing early results from the Mustang-sponsored Phase 1 trial in December 2022.
  • Research and development expenses were $15.5 million for the third quarter of 2022, compared to $14.7 million for the third quarter of 2021.
  • General and administrative expenses were $3.4 million for the third quarter of 2022, compared to $2.4 million for the third quarter of 2021.

Genmab Announces U.S. Food and Drug Administration Accepts for Priority Review Biologics License Application (BLA) for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma (LBCL)

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星期一, 十一月 21, 2022
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Priority review, Environment, Lymph, Cancer, European Medicines Agency, Safety, B-cell lymphoma, Antibody, Biologics license application, MAA, NCT, DOI, Biotechnology, ORR, CD3, Diffusion, CD20, DLBCL, Marketing, PDUFA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Lymphoid leukemia, NHL, Risk management, FDA, Follicular lymphoma, Prescription Drug User Fee Act, Cell, Progression-free survival, Annual report, The New England Journal of Medicine, Food, Modulation, Priority, Risk, AbbVie, BLA, Lymphatic system, European Hematology Association, Patient, Mantle cell lymphoma, Pharmaceutical industry, Vaccine, Wood drying, Lancet, Genmab

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 21, 2023.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 21, 2023.
  • Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.
  • The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.
  • The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-NHL, including LBCL and DLBCL.

Xencor Reports Third Quarter 2022 Financial Results

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星期一, 十一月 7, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, AES, Atopic dermatitis, Society, Company, GSK, Immunotherapy, Income, Private Securities Litigation Reform Act, Degenerative disease, MCRPC, U.S. Securities and Exchange Commission, Vir, Autoimmune disease, Annual report, AE, Janssen, Monoclonal antibody, CD3, Investor, Antibody, NK, Biotechnology, Follicular lymphoma, G&A, Hematology, SITC, Forward-looking statement, COVID-19, Psoriasis, Genentech, Protein engineering, Biology, Form 10-K, Cytokine, Annual general meeting, Lenalidomide, NASDAQ, Novartis, IgG4-related disease, Lymphoma, CD25, Research, R, Sale, Safety, Technology, Review, PARP, CD20, Patient, Cancer, DLBCL, Prostate cancer, Hoffmann-La Roche, Investment, Marketing, Therapy, CD28, Security (finance), Vaccine, Pharmaceutical industry, Renewable energy, Life insurance, Regulatory T cell, MorphoSys, Alexion, Astellas Pharma

XmAb564 (IL2-Fc): Today, Xencor announced initial results from its single-dose Phase 1a study of XmAb564, administered subcutaneously in healthy volunteers.

Key Points: 
  • XmAb564 (IL2-Fc): Today, Xencor announced initial results from its single-dose Phase 1a study of XmAb564, administered subcutaneously in healthy volunteers.
  • Vir Biotechnology, Inc.: In the third quarter of 2022, Xencor reported $17.8 million in royalty revenue under the Companys agreement with Vir.
  • Financial Results for the Third Quarter Ended September 30, 2022
    Cash, cash equivalents, receivables and marketable debt securities totaled $654.6 million as of September 30, 2022, compared to $664.1 million on December 31, 2021.
  • ET (1:30 p.m. PT) to discuss the third quarter 2022 financial results, provide a corporate update and present results from the Phase 1a study of XmAb564.