CD20

Latest Odronextamab Data in Relapsed/Refractory Follicular Lymphoma Showed Compelling Responses and Overall Maintenance of Patient-Reported Outcomes

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星期一, 十二月 11, 2023
Telephone, Regeneron Pharmaceuticals, Quality of life, Food, Quality of life (healthcare), Treatment, Fever, DLBCL, EMA, FDA, CD20, Cytokine release syndrome, Dor, Anemia, Neutropenia, Pros, Orphan, Society, Research, B-cell lymphoma, ASH, Neuropsychological test, ICR, COVID-19, European Medicines Agency, ID, Fast track (FDA), University of Nantes, CRS, Webcast, Patient, Safety, Medicine, PFS, Pharmaceutical industry

TARRYTOWN, N.Y., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive data for odronextamab in patients with relapsed/refractory (R/R) follicular lymphoma (FL) from a pivotal Phase 2 trial (ELM-2). These data – which include updated efficacy, safety and patient-reported outcomes (PROs) – were presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition from December 9 to 12 in San Diego, CA. Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

Key Points: 
  • Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.
  • “As clinicians, our focus must remain patients’ wellbeing, along with favorable outcomes.
  • For odronextamab, it is particularly encouraging to see the unprecedented clinical results complemented by patient-reported outcomes that show quality of life and functional measures are maintained overall.
  • A replay of the conference call and webcast will be archived on the company's website for at least 30 days.

Updated Odronextamab Data from Relapsed/Refractory Diffuse Large B-cell Lymphoma Pivotal Trial Showed Deep and Durable Responses and the Potential of ctDNA To Predict Long-term Outcomes

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星期日, 十二月 10, 2023
DLBCL, IPI, Cytokine release syndrome, CD20, Anemia, International, Dor, Neutropenia, City, Society, B-cell lymphoma, ASH, ICR, CRS, Patient, Phase II, Regeneron Pharmaceuticals

TARRYTOWN, N.Y., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data for odronextamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The data from the pivotal Phase 2 trial (ELM-2) and Phase 1 trial (ELM-1) were shared in several presentations – including two orals – at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition from December 9 to 12 in San Diego, CA. Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

Key Points: 
  • TARRYTOWN, N.Y., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data for odronextamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
  • “Diffuse large B-cell lymphoma has a high risk of relapse, which is why it is so critical to demonstrate continued disease control over the long term.
  • “The primary analysis from the pivotal trial of odronextamab demonstrated impressive response rates, including in certain high-risk subgroups.
  • A replay of the conference call and webcast will be archived on the company's website for at least 30 days.

IGM Biosciences Announces Strategic Pipeline Prioritization and Cash Runway Extension

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星期二, 十二月 5, 2023
Workforce, DR5, Sanofi, IND, Antibody, FDA, Colorectal cancer, FOLFIRI, CD20, SLE, IGM, Clinical trial, Rheumatoid arthritis, Inflammation, Investigational New Drug, Lupus, CD38, Bevacizumab, Myopathy, Myositis, Patient, Immunoglobulin M, Vaccine

In conjunction with this strategic refocusing, the Company will be reducing its workforce by approximately 22 percent.

Key Points: 
  • In conjunction with this strategic refocusing, the Company will be reducing its workforce by approximately 22 percent.
  • As a result of these actions, IGM expects to extend its cash runway into the second quarter of 2026.
  • “IGM continues to have a tremendous opportunity to transform a variety of disease areas using an entirely new class of antibody medicines,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences.
  • As a part of this strategic refocusing, the Company will halt the following clinical development activities:

Gamida Cell Reports Third Quarter 2023 Financial Results and Provides Company Update

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星期二, 十一月 14, 2023
Annual general meeting, Bone marrow, Phenotype, ASH, Patient, Cell, Research, NF, Marketing, Therapy, CMS, Diagnosis, Safety, Rituximab, Myelocyte, SITC, CD20, ATM, Kinetics, UCLA Health, Society, Health, Courage, Corporation, Pivotal, UCB, Fibroblast, Whole blood, Immune reconstitution inflammatory syndrome, Partnership, NAM, Ronald Reagan, Medicare, Policy, FDA, Immunotherapy, Survival, Toxic epidermal necrolysis, Cancer immunotherapy, Lymphoma, Mesa, Video game, Pharmaceutical industry, Dentistry, Vaccine, Mobile phone, Transplant, NK

BOSTON, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today reported financial results for the quarter ended September 30, 2023, and provided a business update.

Key Points: 
  • (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today reported financial results for the quarter ended September 30, 2023, and provided a business update.
  • “The third quarter marked the first patients receiving Omisirge following FDA approval and the point at which Gamida Cell truly transitioned to a commercial-stage company with our first revenue reported,” said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell.
  • The company reported revenue for the delivery of two units of Omisirge in the third quarter of 2023 and projects revenue from a total of four to six units for full year 2023.
  • Annual shareholders meeting: Gamida Cell held its Annual General Meeting of Shareholders in New York City on October 19.

IGM Biosciences Announces Third Quarter 2023 Financial Results

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星期一, 十一月 13, 2023
Myositis, CD38, Safety, Food, Treatment, Progression-free survival, Colorectal cancer, Acute myeloid leukemia, Myopathy, Bevacizumab, IND, Investment, Immunoglobulin G, Clinical trial, Net, Administration, Patient, Research, Lupus, Rheumatoid arthritis, FDA, Autoimmune disease, American College, G&A, Bispecific monoclonal antibody, FOLFIRI, SLE, Immunoglobulin M, GAAP, CD20, R, Antibody, Research and development, IGM, Azacitidine, Pharmaceutical industry, Vaccine, Sanofi

MOUNTAIN VIEW, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the quarter ended September 30, 2023.

Key Points: 
  • MOUNTAIN VIEW, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the quarter ended September 30, 2023.
  • “During the third quarter, we continued to execute across our clinical development pipeline,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences.
  • Collaboration Revenue: For the third quarter of 2023, collaboration revenues were $0.5 million, compared to $0.3 million for the same period in 2022.
  • Research and Development (R&D) Expenses: For the third quarter of 2023, R&D expenses were $54.8 million, compared to $48.2 million for the same period in 2022.

New Analyses Presented at ASH 2023 Support the Potential Long-Term Response and Safety of Kite’s Tecartus® in Patients With Aggressive Blood Cancers

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星期二, 十二月 12, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Hospitals, Clinical Trials, Hackensack University Medical Center, Safety, Cytokine release syndrome, Senior, City, ASH, Aes, CRS, Haematopoietic system, Sepsis, Patient, Abstract, Thrombocytopenia, Blinatumomab, The James Cancer Hospital, Division, SCT, Acute lymphoblastic leukemia, Neutropenia, ORR, Encephalopathy, B-ALL, Infection, Survival, Death, CD20, Doctor of Philosophy, Society, Abstract (summary), OS, Confidence interval, TP53, LD, Cytopenia, Pharmaceutical industry, Nursing, Hematology, Brexucabtagene autoleucel, Lymphoma, MD

“The clinical results and real-world evidence presented at ASH clearly support the potential for long-term response and safety of Tecartus in aggressive blood cancers for which patients have limited treatment options,” said Frank Neumann, MD, PhD, Senior Vice President, Global Head of Clinical Development, Kite.

Key Points: 
  • “The clinical results and real-world evidence presented at ASH clearly support the potential for long-term response and safety of Tecartus in aggressive blood cancers for which patients have limited treatment options,” said Frank Neumann, MD, PhD, Senior Vice President, Global Head of Clinical Development, Kite.
  • The median OS for patients with complete response (CR) (n=46) was 58.7 months.
  • Efficacy and safety outcomes for 23 patients with R/R MCL enrolled in ZUMA-18, a multicenter, open-label, expanded-access study of Tecartus, were also presented.
  • An analysis of a CIBMTR observational database of R/R MCL patients receiving Tecartus from 84 U.S. centers was presented.

Atara Biotherapeutics Presents Positive Preclinical Data on ATA3431, A Next-Generation Allogeneic CD20/CD19-Targeted CAR, at the 65th ASH Annual Meeting

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星期一, 十二月 11, 2023
Biotechnology, Pharmaceutical, Health, ATRA, Epstein–Barr virus, TCR, Gene editing, Phenotype, Lymphoid leukemia, ASH, IND, Risk, Northwest Biotherapeutics, B-cell lymphoma, HCT, Head, Patient, CD19, Autoimmune disease, Acute lymphoblastic leukemia, HLA, Cancer, Survival, CD20, EBV, Society, Cell, Vaccine, Atara

Findings support ATA3431 advancement into clinical testing, initially focused on the treatment of B-cell malignancies.

Key Points: 
  • Findings support ATA3431 advancement into clinical testing, initially focused on the treatment of B-cell malignancies.
  • The data will be presented in a poster presentation at the 65th American Society of Hematology (ASH) Annual Meeting taking place December 9-12, 2023, in San Diego.
  • ATA3431 also incorporates the clinically validated 1XX costimulatory domain that enhances stemness and modulates exhaustion to extend functional persistence.
  • Compared to an autologous CD20/CD19 CAR-T benchmark, the ATA3431 preclinical data demonstrate potent antitumor activity, long-term persistence, and superior tumor growth inhibition.

AbelZeta Presents Data from Two Clinical Studies Relating to its Immuno-Oncology Drug Development at the 65th ASH Annual Meeting

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星期二, 十二月 12, 2023
American Society of Hematology, Annual general meeting, Johnson & Johnson, Safety, ASH, B-cell lymphoma, Patient, CD19, Partnership, CD20, Bone marrow, Janssen, Society, Pharmaceutical industry, Medical device, Hematology

"We are thrilled to share the long-term follow-up results from our clinical studies of C-CAR039 and C-CAR066 at the Annual Meeting of ASH, said Tony (Bizuo) Liu, Chairman and CEO of the Company.

Key Points: 
  • "We are thrilled to share the long-term follow-up results from our clinical studies of C-CAR039 and C-CAR066 at the Annual Meeting of ASH, said Tony (Bizuo) Liu, Chairman and CEO of the Company.
  • "The positive outcomes underscore the potential of these novel therapies in advancing the treatment landscape for patients with r/r B-NHL.
  • "We are proud of our collaboration and license agreement with Janssen to facilitate the global development and accessibility of C-CAR039 and C-CAR066.
  • This strategic partnership aligns with our mission to bring innovative and life-changing therapies to patients worldwide."

Gene Splicing Reduces Effectiveness of CD20-Targeting Monoclonal Antibodies Designed to Treat Variety of Blood Cancers and Disorders

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星期五, 十一月 17, 2023
DOI, DRS, Malignancy, CHOP, Research, University, Bone marrow, Leukemia, Blood, Hospital, Protein, Jim Valvano, Patient, Lymphoma, Division, Follicular lymphoma, Messenger, Child, Medical laboratory, Virus, Burkitt lymphoma, Antibody, Exon, Children's Hospital of Philadelphia, Doctor of Philosophy, Emerson Collective, MS4A1, Alternative splicing, Bangladesh Technical Education Board, Cell, RNA, Vaccine, Pathology, CD20

PHILADELPHIA, Nov. 17, 2023 /PRNewswire/ -- Immunotherapies that target the CD20 antigen have revolutionized how patients with a variety of blood cancers and hematologic disorders have been treated. However, many patients develop resistance to these treatments due to a loss of the antigen that's being targeted. Now, a new study from researchers at Children's Hospital of Philadelphia (CHOP) and the Perelman School of Medicine at the University of Pennsylvania (Penn) has found that gene splicing occurring within these cells can cause significant changes in CD20 protein levels that render the therapies ineffective.

Key Points: 
  • PHILADELPHIA, Nov. 17, 2023 /PRNewswire/ -- Immunotherapies that target the CD20 antigen have revolutionized how patients with a variety of blood cancers and hematologic disorders have been treated.
  • These findings may lead to more appropriate choices for therapy that maximize benefits to patients affected by a variety of blood cancers.
  • CD20 is a cell-surface protein involved in the fine-tuning of B cell responses to foreign agents like viruses.
  • Prior research had shown that a loss of CD20 reduced the effectiveness of these immunotherapies, since it would remove their intended target.

Adicet Reports Third Quarter 2023 Financial Results and Provides Business Updates

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星期三, 十一月 8, 2023
Science, Stem Cells, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, CAR, Trial of the century, IND, Food, Bio, CD70, Renal cell carcinoma, International Conference on Afghanistan, London (2010), CD20, Society for Immunotherapy of Cancer, Tropism, TGF, Conference, CDMO, Regulation of tobacco by the U.S. Food and Drug Administration, Prostate cancer, R, Engineering, Poster, Goodwill, SITC, Immunotherapy, MCL, Research and development, Annual general meeting, Probability, ACET, Tumor microenvironment, Epitope, NHL, Society, Cancer, PSMA, Patient, Administration, Prognosis, Prostate, CD27, Pharmaceutical industry, Cryptocurrency

Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today reported financial results and operational highlights for the third quarter ended September 30, 2023.

Key Points: 
  • Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today reported financial results and operational highlights for the third quarter ended September 30, 2023.
  • In October 2023, Adicet presented new preclinical data building on the potential of Adicet’s allogeneic gamma delta platform as a promising approach to target prostate cancer.
  • Financial Results for Third Quarter 2023:
    Research and Development (R&D) Expenses: R&D expenses were $26.2 million for the three months ended September 30, 2023, compared to $16.6 million during the same period in 2022.
  • Cash Position: Cash and cash equivalents were $183.3 million as of September 30, 2023, compared to $257.7 million as of December 31, 2022.