Anti-CD19 immunotoxin

Celyad Oncology reports third quarter 2023 financial results and recent business highlights

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Jeudi, novembre 9, 2023
CD95, CAR, NKG2D, 2023 International Conference on Climate Resilient Pakistan, RNA, Graft-versus-host disease, Public expenditure, CD19, ICLE, Conference, PD-1, Autophagy, Research, Mont-Saint-Guibert, Nucleic acid, SITC, Immunotherapy, Intrinsic termination, MicroRNA, Fortification, Dumont, B-ALL, Gene, Society, Anti-CD19 immunotoxin, PSMA, Patient, BCMA, Lymphocyte, Vaccine, Bank, Medical device, Euronext

“Celyad Oncology team is resolutely dedicated to harnessing our expertise, extensive know-how, and valuable intellectual property portfolio to address the existing challenges within CAR T-cell therapies.

Key Points: 
  • “Celyad Oncology team is resolutely dedicated to harnessing our expertise, extensive know-how, and valuable intellectual property portfolio to address the existing challenges within CAR T-cell therapies.
  • Celyad Oncology has relocated from September 25, 2023 into a new research facility which fits better its current needs after the strategic shift.
  • The Company remains headquartered at the Axis Parc, Mont-Saint-Guibert, Belgium but with its new business location at Dumont 9.
  • Net cash burn during the third quarter of 2023 amounted to €2.7 million, in line with expectations.

Allogene Therapeutics Presents Preclinical Data on Next Generation Cloak™ and Dagger™ Technologies at the Society for Immunotherapy of Cancer Annual Meeting

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Vendredi, novembre 3, 2023
Neoplasm, Survival, CAR, Kite Pharma, RFX5, CD70, Society for Immunotherapy of Cancer, CD19, Cell, B-cell lymphoma, Research and development, RCC, Development, SITC, Immunotherapy, NK, Annual general meeting, CD58, Society, Cancer, Anti-CD19 immunotoxin, Therapy, Patient, Escape Room, HLA, Vaccine

The development of “off-the-shelf” CAR T products that utilize cells from healthy donors has the potential to make CAR T therapies scalable and accessible to more patients.

Key Points: 
  • The development of “off-the-shelf” CAR T products that utilize cells from healthy donors has the potential to make CAR T therapies scalable and accessible to more patients.
  • However, the effectiveness of allogeneic CAR T cells requires controlling rejection of the allogeneic CAR T cells by the patient’s immune system.
  • Allogene’s proprietary Cloak and Dagger technologies are two novel strategies the Company is investigating to help control immune rejection and enhance expansion, persistence, and performance of AlloCAR T cells with the use of standard lymphodepletion regimens.
  • In the study, the survival of “cloaked” cells was assessed in mixed lymphocyte reaction assays with T cells and NK cells.

Allogene Therapeutics Reports Third Quarter 2023 Financial Results and Business Update

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Jeudi, novembre 2, 2023
Research, Society for Hematology and Stem Cells, PIN, Second Half, PFS, Investment, News, SITC, Annual general meeting, Kinetics, ICML, Infection, CAR, International Conference on Afghanistan, London (2010), CD70, Society for Immunotherapy of Cancer, GAAP, Licensure, ORR, University, Cancer, Anti-CD19 immunotoxin, Therapy, Patient, Lymphoma, ASCO, B-cell lymphoma, Congress, Conference, Cytopenia, ASH, Immunotherapy, Dor, Cytokine release syndrome, Follicular lymphoma, Society, MD Anderson Cancer Center, Investigational New Drug, Kite Pharma, AACR, IND, Incidence, FC, American Society of Clinical Oncology, RCC, Poster, General counsel, Vaccine, Pharmaceutical industry

Following the close of the third quarter, the Company announced Geoffrey Parker as Executive Vice President, Chief Financial Officer, overseeing the Company’s financial operations and business development activities.

Key Points: 
  • Following the close of the third quarter, the Company announced Geoffrey Parker as Executive Vice President, Chief Financial Officer, overseeing the Company’s financial operations and business development activities.
  • Research and development expenses were $46.0 million for the third quarter of 2023, which includes $6.7 million of non-cash stock-based compensation expense.
  • General and administrative expenses were $17.0 million for the third quarter of 2023, which includes $8.6 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.

Kyverna Therapeutics and Oxford Biomedica Sign License and Supply Agreement for LentiVector® Platform

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Mercredi, septembre 20, 2023
LSE, Partnership, Oxford Biomedica, CD19, Anti-CD19 immunotoxin, OXB, Development, CAR, CDMO, Patient, Engineering, Lupus nephritis, Vaccine

EMERYVILLE, Calif., Sept. 20, 2023 /PRNewswire/ -- Kyverna Therapeutics ("Kyverna"), a clinical-stage cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, today announced a non-exclusive, multi-year license and supply agreement with Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica"), a quality and innovation-led viral vector Contract and Development Manufacturing Organization (CDMO), enabling the use of LentiVector® with any Kyverna product.

Key Points: 
  • EMERYVILLE, Calif., Sept. 20, 2023 /PRNewswire/ -- Kyverna Therapeutics ("Kyverna"), a clinical-stage cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, today announced a non-exclusive, multi-year license and supply agreement with Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica"), a quality and innovation-led viral vector Contract and Development Manufacturing Organization (CDMO), enabling the use of LentiVector® with any Kyverna product.
  • The LentiVector® platform is the first commercially approved lentiviral-based gene delivery system.
  • The platform enables the successful development of breakthrough gene and cell-based medicines.
  • "We are delighted to be working with Oxford Biomedica, a recognized leader in reliable, quality vector supply.

Celyad Oncology Reports First Half 2023 Financial Results and Recent Business Highlights

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Lundi, septembre 4, 2023
Intellectual property, Business development, Fragment crystallizable region, Society, Mont-Saint-Guibert, Fortification, CD19, Intrinsic termination, CD95, International Teletraffic Congress, ICLE, Gene editing, American depositary receipt, Anti-CD19 immunotoxin, CIITA, Immunotherapy, SITC, Research, T cell, CAR, Congress, Society for Immunotherapy of Cancer, Euronext Paris, International Conference on Nuclear Disarmament, Oslo, 2008, NKG2D, Patient, Brussels Stock Exchange, Cytokine, Dumont, PD-1, Lancet, MicroRNA, Gene, Lymphocyte, Conference, Management, Vaccine, Rare-earth element, Medical device, Pharmaceutical industry, Euronext

First Half 2023 and recent corporate highlights:

Key Points: 
  • First Half 2023 and recent corporate highlights:
    Georges Rawadi was appointed Chief Executive Officer of the Company as from April 27, 2023.
  • Georges Rawadi is a seasoned executive with over 20 years of experience in pharma/biotech, as research director, business developer, CEO, and board member.
  • He also has insightful knowledge of both the company and the CAR-T space as he spent four years at Celyad Oncology (2014-2018) as Vice-President Business Development & Intellectual Property (“BD & IP”).
  • Key financial figures for the first half of 2023, compared with the first half of 2022 and full year 2022, are summarized below:

Verismo Therapeutics and University of Pennsylvania Discover Two Novel Binders Targeting CD19; Enter Licensing Agreement

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Mardi, août 22, 2023
Partnership, University, CD19, Anti-CD19 immunotoxin, Bone marrow, Research, Immunotherapy, Doctor of Philosophy, Penn, CAR, MD, Patient, Medicine, Therapy, IND, Pharmaceutical industry, Verismo

PHILADELPHIA, Aug. 22, 2023 /PRNewswire/ -- Verismo Therapeutics, a clinical-stage CAR T company, Penn spinout, and pioneer of the novel KIR-CAR platform technology, today announced that it had entered into a licensing agreement with the University of Pennsylvania for worldwide exclusive rights for two newly discovered anti-CD19 binders.

Key Points: 
  • The newly discovered binders are a result of the s ponsored research agreement between Verismo and the University of Pennsylvania that was executed in 2022.
  • Donald Siegel, MD, PhD's lab utilized his state-of-the-art phage display technique to discover two anti-CD19 binders with high activity.
  • "Our team at Verismo is thrilled to announce the discovery of these two groundbreaking anti-CD19 binders," said Dr. Laura Johnson, Chief Scientific Officer at Verismo.
  • "We are thrilled to unveil the groundbreaking discovery of two novel CD19 binders," said Dr. Bryan Kim, CEO of Verismo.

Allogene Therapeutics Reports Second Quarter 2023 Financial Results and Business Update

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Mercredi, août 2, 2023
European Medicines Agency, AACR, B-cell lymphoma, Kite Pharma, CD19, Investment, CD70, RCC, ICML, Multiple myeloma, Infection, American Society of Clinical Oncology, Lymphoma, Anti-CD19 immunotoxin, Cancer, Licensure, CTA, GAAP, FC, Cytopenia, Equity, PFS, UNIVERSAL, EMA, ASCO, Hematological Cancer Research Investment and Education Act, CAR, Incidence, ATM, PIN, 2023 International Conference on Climate Resilient Pakistan, Dor, Cytokine release syndrome, Patient, IVD, Research, American Association for Cancer Research, Therapy, Society, Conference, ORR, News, BCMA, Life insurance, Pharmaceutical industry, Medical imaging, Vaccine

Research and development expenses were $62.0 million for the second quarter of 2023, which includes $6.9 million of non-cash stock-based compensation expense.

Key Points: 
  • Research and development expenses were $62.0 million for the second quarter of 2023, which includes $6.9 million of non-cash stock-based compensation expense.
  • General and administrative expenses were $18.5 million for the second quarter of 2023, which includes $9.7 million of non-cash stock-based compensation expense.
  • Net loss for the second quarter of 2023 was $78.0 million, or $0.53 per share, including non-cash stock-based compensation expense of $16.6 million.
  • 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.

Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in Lupus Nephritis

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Jeudi, juin 1, 2023
Priority review, Therapy, Paul Ehrlich Institute, Clinical trial, Anti-CD19 immunotoxin, CTA, Fast Track, Lupus, Lupus nephritis, Accelerated approval (FDA), CAR, Patient, PEI, Engineering, Autoimmune disease, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, EU, LN

EMERYVILLE, Calif., June 1, 2023 /PRNewswire/ -- Kyverna Therapeutics ("Kyverna"), a cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KYV-101 for the treatment of patients with refractory lupus nephritis (LN). KYV-101 is a novel anti-CD19 chimeric antigen receptor T-cell (CAR T) therapy designed to deplete B cells, including autoreactive B cells, in autoimmune disease patients. 

Key Points: 
  • KYV-101 is a novel anti-CD19 chimeric antigen receptor T-cell (CAR T) therapy designed to deplete B cells, including autoreactive B cells, in autoimmune disease patients.
  • "The FDA granting us Fast Track designation for KYV-101 means we can move more quickly toward bringing this potentially transformative and life-saving medicine to patients with lupus," said Peter Maag, Ph.D., chief executive officer (CEO) of Kyverna.
  • Fast Track designation is designed to facilitate the development and expedite the review of new therapeutics intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs, thus enabling drugs to reach patients sooner.
  • Therapies granted Fast Track designation are given the opportunity for more frequent interactions with the FDA and may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

Kyverna Therapeutics to Present New Data of KYV-101 in Lupus at European Congress of Rheumatology

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Mercredi, mai 24, 2023
Lupus, Anti-CD19 immunotoxin, SLE, CAR, Congress, Patient, European, Engineering, Autoimmune disease, Lupus nephritis, Cytokine, EULAR, Rheumatoid arthritis, Vaccine, Rheumatology

EMERYVILLE, Calif., May 24, 2023 /PRNewswire/ -- Kyverna Therapeutics ("Kyverna"), a cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, today announced it will present new preclinical findings on KYV-101. KYV-101 is a novel anti-CD19 chimeric antigen receptor T-cell (CAR T) therapy designed to deplete B cells, including autoreactive B cells in autoimmune disease patients. The data will be presented at a poster session and at an industry-sponsored symposium at the 2023 European Congress of Rheumatology (EULAR), being held May 31-June 2, 2023, in Milan, Italy.

Key Points: 
  • KYV-101 is a novel anti-CD19 chimeric antigen receptor T-cell (CAR T) therapy designed to deplete B cells, including autoreactive B cells in autoimmune disease patients.
  • The data will be presented at a poster session and at an industry-sponsored symposium at the 2023 European Congress of Rheumatology (EULAR), being held May 31-June 2, 2023, in Milan, Italy.
  • "These data demonstrated strong CAR-mediated activity in vitro of KYV-101 CAR T cells derived from patients with lupus, a key prerequisite for positive outcomes," said Peter Maag, Ph.D., chief executive officer (CEO) of Kyverna.
  • KYV-101, A Fully Human CD19 CAR T cell Generated from Autoimmune Patient Lymphocytes, Demonstrates CAR-Mediated and CD19-Dependent Activity Against Autologous B cells

Precision BioSciences Reports First Quarter 2023 Financial Results and Provides Business Update

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Mardi, mai 9, 2023
Research, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Sequence, Insurance, Intellectual property, Hepatitis B, HBsAg, Development, Chromosomal translocation, Patient, Cell, Eli Lilly and Company, Infant, CccDNA, Patent, Cash, University, Duchenne muscular dystrophy, Therapy, Gene, Gene editing, NK, Precision, IND, Precision BioSciences, Non-Hodgkin lymphoma, Anti-CD19 immunotoxin, Hepatitis B virus, IP, AAV, Hepatocyte, CAR, Administration, HBV, Central nervous system, Molecular Partners, NHL, CTA, State Administrative Expenses, DMD, Novartis, Vivo, OTC, Annual general meeting, Sickle cell disease, NHP, Society, Pharmaceutical industry, Vaccine, Lilly

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS®-based ex vivo allogeneic CAR T and in vivo gene editing therapies, today announced financial results for the first quarter ended March 31, 2023 and provided a business update.

Key Points: 
  • Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS®-based ex vivo allogeneic CAR T and in vivo gene editing therapies, today announced financial results for the first quarter ended March 31, 2023 and provided a business update.
  • Precision plans to provide an update on the expansion cohort as well as additional long-term follow up from the previously presented azer-cel cohorts in May 2023.
  • The Company also expects to provide a program update on seven patients treated at Dose Level 2 in May 2023.
  • Cash and Cash Equivalents: As of March 31, 2023, Precision had approximately $158 million in cash and cash equivalents.