CD20

Artiva Biotherapeutics Receives Immunology Innovation of the Year in the 2023 BioTech Breakthrough Awards Program

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星期三, 十一月 8, 2023
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, SLE, Lupus nephritis, IND, CD16, CD20, Northwest Biotherapeutics, GVHD, Neurotoxicity, ADCC, NK, Cancer, Cytokine release syndrome, Rituximab, Immunotherapy, Autoimmune disease, Safety, Hospital, Patient, Lupus, Vaccine

This year’s program attracted more than 1,500 nominations from over 12 different countries throughout the world.

Key Points: 
  • This year’s program attracted more than 1,500 nominations from over 12 different countries throughout the world.
  • Seminal clinical data with autologous CAR-T cells suggests that deep B cell depletion can induce complete and long-lasting responses in patients with lupus nephritis.
  • “The use of autologous CAR-T cells requires apheresis, likely hospitalization, and the potential for serious side effects.
  • “We’re pleased to recognize Artiva with ‘Immunology Innovation of the Year’ for their pipeline of off-the-shelf, allogeneic NK cell therapies that have the potential to be safe and immediately accessible to patients in need,” said Bryan Vaughn, Managing Director of BioTech Breakthrough Awards.

Regeneron Reports Third Quarter 2023 Financial and Operating Results

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星期四, 十一月 2, 2023
CSU, DLBCL, Bispecific monoclonal antibody, FDA, Adolescence, American College, Ageing, CD3, ESMO, Food, Multiple myeloma, CD20, Fast Track, ACG, Congress, European Society for Medical Oncology, DME, Symantec Endpoint Protection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, American College of Gastroenterology, The Lancet, Ministry, Ministry of Health (Kuwait), CRL, MHLW, Ministry of Health, Labour and Welfare, Oncology, Sanofi, Safety, Atopic dermatitis, CSCC, European, Patient, BCMA, Chronic obstructive pulmonary disease, COPD, Dupilumab, BLA, Pharmaceutical industry, Medical device, Vaccine, C5, Regeneron Pharmaceuticals, Health, EU

"Our third quarter financial results reflect robust execution across the enterprise, including notable pipeline advances and strong commercial performance," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron.

Key Points: 
  • "Our third quarter financial results reflect robust execution across the enterprise, including notable pipeline advances and strong commercial performance," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron.
  • These results were also presented at the 23rd EURETINA Congress in October 2023.
  • The Company announced that Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron, will retire in February 2024.
  • Christopher Fenimore, current Senior Vice President, Head of Accounting and Controller at Regeneron, will succeed Mr. Landry as Chief Financial Officer upon his retirement.

Atara Biotherapeutics Announces Expanded Global Tab-cel® Partnership with Pierre Fabre Laboratories and Third Quarter 2023 Financial Results

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星期三, 十一月 1, 2023
Biotechnology, Health, Stem Cells, Pharmaceutical, Oncology, Media, ATRA, Research, CAR, Epstein–Barr virus, EDT, CD20, CD19, Northwest Biotherapeutics, PJT Partners, Workforce, Society, ASH, LLP, Partnership, Depreciation, USD, Cancer, EBV, Investment, Patient, BLA, Hart–Scott–Rodino Antitrust Improvements Act, American Society of Hematology, Vaccine, Pharmaceutical industry, Cryptocurrency, Video game, Tabelecleucel

“We are proud to expand our global tab-cel partnership with Pierre Fabre Laboratories, who is committed to delivering this first-of-its-kind treatment to patients in need across the globe,” said Pascal Touchon, President and Chief Executive Officer of Atara.

Key Points: 
  • “We are proud to expand our global tab-cel partnership with Pierre Fabre Laboratories, who is committed to delivering this first-of-its-kind treatment to patients in need across the globe,” said Pascal Touchon, President and Chief Executive Officer of Atara.
  • In addition, Pierre Fabre Laboratories has agreed to reimburse Atara for expected tab-cel global development costs through Biologics License Application (BLA) transfer, and purchase current and future tab-cel inventory through the BLA transfer date.
  • PJT Partners served as the exclusive financial advisor to Atara and Fenwick & West LLP served as legal counsel to Atara.
  • Concurrent with the execution of the global tab-cel partnership, Atara is undertaking a strategic restructuring and is reducing its current workforce by approximately 30 percent.

Coeptis Therapeutics Announces Research Demonstrating the Potential of SNAP-CAR T-cells to Reduce Tumor Burden and Growth in HER2 and CD20 Expressing Cancers Will be Presented at SITC 2023

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星期二, 十月 31, 2023
EGFR, Society for Immunotherapy of Cancer, Neoplasm, CAR, Ovarian cancer, Assistant, CD20, HER2, University, Research, CD69, Mouse, SNAP, SITC, Immunotherapy, Poster, Division, San Diego Convention Center, Cancer, University of Pittsburgh, LAMP1, Leukemia, NSG, Epitope, Society, Therapy, Immunology, Toxic shock syndrome toxin-1, Mobile phone, Vaccine

WEXFORD, Pa., Oct. 31, 2023 /PRNewswire/ -- Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, today announced that research demonstrating the potential of the SNAP-CAR T-cell platform to target multiple antigens, including HER2 and CD20, through combinatorial use of different adaptors will be the subject of a poster presentation at the Society for Immunotherapy of Cancer's 38th Annual Meeting (SITC 2023). SITC 2023 is being held Nov. 1–5, 2023, at San Diego Convention Center in San Diego. 

Key Points: 
  • SITC 2023 is being held Nov. 1–5, 2023, at San Diego Convention Center in San Diego.
  • Further, in another leukemia model targeting the CD20 antigen, SNAP-CAR T cells showed significant inhibition of tumor growth.
  • "While still early in its development, we continue to see vast potential for the SNAP-CAR platform for treating both liquid and solid tumor malignancies."
  • "The data being presented at SITC 2023 encapsulates the groundbreaking research being conducted at the University of Pittsburgh, which demonstrates the potential of SNAP-CAR T-cells to reduce tumor burden and tumor growth in numerous cancers, including HER2-expressing and CD20-expressing cancers," said Dave Mehalick, President and CEO of Coeptis Therapeutics.

Gamida Cell Reports Preliminary Data from Phase 1 Study of Natural Killer (NK) Cell Therapy Candidate GDA-201

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星期一, 十月 16, 2023
Research, FDA, Genetics, Clinical Trials, Stem Cells, Biotechnology, Pharmaceutical, Health, Science, Oncology, Multimedia, Tumor microenvironment, Mantle cell lymphoma, NAM, Cell, MD, Therapy, Toxic epidermal necrolysis, CD20, Cytokine release syndrome, Rituximab, Safety, University, Lymphoma, Malignancy, Neutropenia, Neoplasm, NK, Phenotype, Follicular lymphoma, Science Translational Medicine, Patient, Oxidative stress, Pharmaceutical industry, Vaccine

(Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced new early data in 10 patients with CD20 positive non-Hodgkin lymphoma enrolled in the first three cohorts in an ongoing multicenter Phase 1 study of natural killer (NK) cell therapy candidate GDA-201.

Key Points: 
  • (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced new early data in 10 patients with CD20 positive non-Hodgkin lymphoma enrolled in the first three cohorts in an ongoing multicenter Phase 1 study of natural killer (NK) cell therapy candidate GDA-201.
  • View the full release here: https://www.businesswire.com/news/home/20231016887701/en/
    Enrolled patients were heavily pretreated with a median of six prior lines of therapy, including CAR-T cell therapy (six patients) and hematopoietic stem cell transplant (four patients).
  • The fourth and final cohort of the study, at the target dose level of 2x108 cells/kg, is currently enrolling.
  • GDA-201 exhibited a promising efficacy profile, with an overall response rate of 74% and a complete response rate of 68%.

Odronextamab BLA for Treatment of Relapsed/Refractory Follicular Lymphoma (FL) and Diffuse Large B-cell Lymphoma (DLBCL) Accepted for FDA Priority Review

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星期五, 九月 29, 2023
Biologics license application, Hematology, CD20, DLBCL, European Medicines Agency, Bone marrow, Marketing, Regeneron Pharmaceuticals, Patient, Priority, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Society, Food, Safety, Pharmaceutical industry

TARRYTOWN, N.Y., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies. The target action date for the FDA decision is March 31, 2024. 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.
  • The BLA was supported by data from a Phase 1 and pivotal Phase 2 trial (ELM-1 and ELM-2).
  • The FDA previously granted odronextamab Orphan Drug Designation and Fast Track Designation for FL and DLBCL.
  • Odronextamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

Umoja Biopharma’s VivoVec Platform Presents Encouraging Proof-of-Concept Data in Ongoing Non-Human Primate Study at the 8th CAR-TCR Summit

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星期五, 九月 1, 2023
CD20, Cell, CAR, Discovery, Hematological Cancer Research Investment and Education Act, Animal, Patient, Cancer, NHP, MDF, Vaccine, Umoja

SEATTLE, Sept. 01, 2023 (GLOBE NEWSWIRE) -- Umoja Biopharma, Inc., a transformative immuno-oncology company creating off-the-shelf treatments for solid and hematologic cancers, today announced new data from an ongoing non-human primate (NHP) study demonstrating effective, durable, and well tolerated in vivo chimeric antigen receptor (CAR) T cell generation using the Company’s VivoVec™ platform technology at the 8th CAR-TCR Summit taking place in Boston, MA, August 29 - September 1, 2023.

Key Points: 
  • The data include results from the first four NHPs treated in an ongoing study and demonstrate rapid and efficient in vivo generation of anti-CD20-targeting CAR T cells following a single infusion of Umoja’s multidomain fusion (MDF) VivoVec particles without the administration of pre-conditioning lymphodepleting chemotherapy.
  • Additionally, these data suggest that the CAR T cells generated in vivo demonstrated on-target activity and persistent T cell memory.
  • “These data highlight the incredible progress Umoja has made and the potential of our unique delivery platform to effectively generate CAR T cells in vivo.
  • Beyond the generation of CAR T cells, we are observing on-target CAR activity and durable cell survival, which could potentially translate to significant clinical benefits for patients.

Odronextamab Receives EMA Filing Acceptance for Treatment of Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma

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星期四, 八月 17, 2023
Lymphoma, Regeneron Pharmaceuticals, Hematology, CD20, DLBCL, European Medicines Agency, Bone marrow, Marketing, EMA, Patient, MAA, Society, Safety, Pharmaceutical industry

The EMA previously granted odronextamab Orphan Drug Designation for FL and DLBCL.

Key Points: 
  • The EMA previously granted odronextamab Orphan Drug Designation for FL and DLBCL.
  • 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.
  • DLBCL is an aggressive subtype, with up to 50% of high-risk patients experiencing progression after first-line treatment (e.g., relapsing or refractory to treatment).
  • Odronextamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

Mustang Bio Reports Second Quarter 2023 Financial Results and Recent Corporate Highlights

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星期一, 八月 14, 2023
Waldenström macroglobulinemia, Partnership, Mayo Clinic, Arm, CD19, Chronic lymphocytic leukemia, Follicular lymphoma, CRS, Fred Hutchinson Cancer Research Center, CD20, European Hematology Association, Clinical trial, Lymphoma, Research, History, Translation, WM, CAR, Waldenström, Acquisition, International Conference on Afghanistan, London (2010), Cytokine release syndrome, Patient, Cancer, CR, Clinical professor, Immunoglobulin M, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mustang, Conference, ORR, DSM-IV codes, Food, Safety, Disease, Pharmaceutical industry, Cryptocurrency, Video game

WORCESTER, Mass., Aug. 14, 2023 (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 difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the second quarter ended June 30, 2023.

Key Points: 
  • WORCESTER, Mass., Aug. 14, 2023 (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 difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the second quarter ended June 30, 2023.
  • Research and development expenses were $10.8 million for the second quarter of 2023, compared to $15.2 million for the second quarter of 2022.
  • Non-cash, stock-based expenses included in research and development were $(0.1) million for the second quarter of 2023, compared to $0.4 million for the second quarter of 2022.
  • General and administrative expenses were $3.1 million for the second quarter of 2023, compared to $3.1 million for the second quarter of 2022.

Poseida Therapeutics Announces Strategic Investment by Astellas and Provides Business Update

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星期一, 八月 7, 2023
Antigen, Partnership, Genetic engineering, CD19, Astellas Pharma, Lymphoid leukemia, CD20, Cell therapy, Epithelium, Roche, Cancer, Breast, Cell, CAR, Patient, SAN, OTC, Rare, FDA, Therapy, IND, Pharmaceutical industry, Vaccine, Takeda

SAN DIEGO, Aug. 7, 2023 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced a $50 million strategic investment by Astellas, which is comprised of the purchase of 8,333,333 shares of common stock at $3.00 per share for an aggregate purchase price of $25 million and an additional $25 million one-time payment for certain strategic rights, and provided a business update.

Key Points: 
  • "We are excited to announce a strategic investment by Astellas, a premier global pharmaceutical company that shares our strategic vision for the future of genetic engineering and cell and gene therapies.
  • This investment further validates our technology and approach and also reflects our broad strategic options in progressing the business," said Mark Gergen, Poseida's Chief Executive Officer.
  • "Based on this investment and cost control measures implemented in the business, we are extending our cash runway guidance as we remain focused on being good stewards of capital.
  • "The strategic investment by Astellas, together with our disciplined capital expenditure, cost control initiatives and expected payments and milestones from the Roche collaboration, put us on a firm financial foundation," said Johanna Mylet, Chief Financial Officer of Poseida.