GD2

Autolus Therapeutics Reports Full Year 2023 Financial Results and Business Updates

Retrieved on: 
Thursday, March 14, 2024
Nucleus, Bone marrow, BCMA, BioNTech, B-ALL, Patient, ALL, SLE, Engineering, Minocycline, European Medicines Agency, Therapy, Research, Canadian Aviation Regulations, Flow cytometry, ASH, General counsel, Immunotherapy, SVP, EMA, Legal Affairs, Trial of the century, GMP, SME, BLA, Nature Communications, Development, UCL, Biologics license application, Multiple myeloma, MIA, University College London, Senior, TRBC, GD2, ASCO, FDA, CD19, Conference call, Conference, MAA, EHA, ADS, MHRA, T cell, ACS Chemical Biology, PDUFA, Autoimmune disease, Pharmaceutical industry

“For now, we remain fully focused on preparing for a potential obe-cel launch and successfully transitioning Autolus to a commercial stage company.

Key Points: 
  • “For now, we remain fully focused on preparing for a potential obe-cel launch and successfully transitioning Autolus to a commercial stage company.
  • In February 2024, Autolus promoted Dr. Chris Williams to Chief Business Officer and Alex Driggs to Senior Vice President, Legal Affairs and General Counsel.
  • Dr. Leiderman brings extensive transactional and financial expertise, and Mr. Azelby brings more than 30 years of biopharmaceutical leadership and commercial experience to Autolus’ Board.
  • Financial Results for the Year Ended December 31, 2023

Autolus Therapeutics Reports Third Quarter 2023 Financial Results and Business Updates

Retrieved on: 
Thursday, November 2, 2023
SLE, Patient, FDA, EBMT, Medical Affairs Bureau, Trial of the century, Research, CAR, Multiple myeloma, Financial result, CD19, European Medicines Agency, Conference, UCL, Society, Program management, ASH, Senior, MHRA, MRD, Canadian Aviation Regulations, EMA, Nucleus, Autoimmune disease, Hand, European Society of Clinical Microbiology and Infectious Diseases, Conference call, Therapy, BCMA, Blackstone, ALL, BLA, Nature Medicine, GD2, Construction, Pharmaceutical industry, Nursing, Vaccine, Payment card, Cryptocurrency, EU, Blood

Patients continue to be enrolled and initial data will be presented at ASH in December 2023.

Key Points: 
  • Patients continue to be enrolled and initial data will be presented at ASH in December 2023.
  • Financial Results for the Third Quarter Ended September 30, 2023
    Cash and cash equivalents at September 30, 2023, totaled $256.4 million, as compared to $382.4 million at December 31, 2022.
  • Autolus estimates that its current cash and cash equivalents on hand and anticipated future milestone payment from Blackstone will extend the Company’s cash runway into 2025.
  • Unaudited Financial Results for the Third Quarter Ended September 30, 2023

Renaissance Pharma launches today and announces the in-licensing of Hu14.18K322A (Hu14.18) from St. Jude Children’s Research Hospital for the treatment of High-Risk Neuroblastoma

Retrieved on: 
Tuesday, August 1, 2023
Neuroblastoma, Maintenance, Pharma, Journal of Clinical Oncology, Survival, OS, Cancer, Record, Regulatory Agencies, Haematopoietic system, EMA, Senior, Radiation, Journal, Patient, GD2, Physician, Mab, European Journal of Oncology Nursing, EFS, Hospital, Phase, FDA, Partial-response maximum-likelihood, Pharmaceutical industry, Vaccine, Jude the Apostle, MD, Renaissance

Jude”) for Hu14.18, a humanised antibody in development by St. Jude for the treatment of newly diagnosed high-risk neuroblastoma.

Key Points: 
  • Jude”) for Hu14.18, a humanised antibody in development by St. Jude for the treatment of newly diagnosed high-risk neuroblastoma.
  • 50% of neuroblastoma patients have high-risk (HRNB) disease which has an overall survival of ~50% over 5 years3.
  • Lee Morley, Executive Chairman of Renaissance Pharma, said: “We couldn’t be more motivated by the prospect of bringing Hu14.18 to patients.
  • Renaissance Pharma now has its full attention on bringing this humanised antibody to market as expeditiously as possible.

Renaissance Pharma launches today and announces the in-licensing of Hu14.18K322A (Hu14.18) from St. Jude Children’s Research Hospital for the treatment of High-Risk Neuroblastoma

Retrieved on: 
Tuesday, August 1, 2023
Neuroblastoma, Maintenance, Pharma, Journal of Clinical Oncology, Survival, OS, Cancer, Record, Regulatory Agencies, Haematopoietic system, EMA, Senior, Radiation, Journal, Patient, GD2, Physician, Mab, European Journal of Oncology Nursing, EFS, Hospital, Phase, FDA, Partial-response maximum-likelihood, Pharmaceutical industry, Vaccine, Jude the Apostle, MD, Renaissance

Jude”) for Hu14.18, a humanised antibody in development by St. Jude for the treatment of newly diagnosed high-risk neuroblastoma.

Key Points: 
  • Jude”) for Hu14.18, a humanised antibody in development by St. Jude for the treatment of newly diagnosed high-risk neuroblastoma.
  • 50% of neuroblastoma patients have high-risk (HRNB) disease which has an overall survival of ~50% over 5 years3.
  • Lee Morley, Executive Chairman of Renaissance Pharma, said: “We couldn’t be more motivated by the prospect of bringing Hu14.18 to patients.
  • Renaissance Pharma now has its full attention on bringing this humanised antibody to market as expeditiously as possible.

Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma approved in Brazil

Retrieved on: 
Tuesday, May 23, 2023
Neuroblastoma, Interim, Adium, Sarcoma, Cancer, Patient, GD2, Memorial Sloan Kettering Cancer Center, MSK, Brazilian Health Regulatory Agency, Therapy, Pharmaceutical industry, Vaccine

DANYELZA will be marketed in Brazil by Y-mAbs’ partner Adium Pharma S.A. (“Adium”).

Key Points: 
  • DANYELZA will be marketed in Brazil by Y-mAbs’ partner Adium Pharma S.A. (“Adium”).
  • DANYELZA is administered to patients three times in a week and the treatment is repeated every four weeks.
  • “Today is an important day for children living with refractory/relapsed high-risk neuroblastoma in Brazil.
  • It’s very exciting to see this treatment approved, creating access to DANYELZA in Brazil from the joint efforts by our partner Adium and the development team at Y-mAbs.

Y-mAbs Announces Presentation of Naxitamab data at AACR

Retrieved on: 
Tuesday, April 18, 2023
BCSC, TNBC, Triple-negative breast cancer, ADCC, Cancer, EST, NK, GD2, Memorial Sloan Kettering Cancer Center, MSK, MD Anderson Cancer Center, Growth, Poster, Therapy, Breast cancer, ISS, Naxitamab, Vaccine, Pharmaceutical industry

The disialoganglioside GD2 has been shown to be upregulated in triple-negative breast cancer (“TNBC”) and its high expression is associated with a poor prognosis.

Key Points: 
  • The disialoganglioside GD2 has been shown to be upregulated in triple-negative breast cancer (“TNBC”) and its high expression is associated with a poor prognosis.
  • Y-mAbs provided naxitamab (DANYELZA) to this pre-clinical investigator sponsored study (“ISS”) at M.D.
  • Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs.
  • MSK has institutional financial interests related to the compound and Y-mAbs.

Ginkgo Bioworks and WARF Announce Partnership to Discover Next Generation GD2 CAR T-Cell Therapies

Retrieved on: 
Thursday, April 13, 2023
Neuroblastoma, DNA, CRISPR, Partnership, University, Therapy, Engineering, Wisconsin Alumni Research Foundation, Clinical trial, Bone marrow, Immunotherapy, ICD, Research, University of Wisconsin–Madison, CAR, Journal, Ginkgo, GD2, Cell engineering, Health, FDA, NYSE, WARF, Pharmaceutical industry, Vaccine, Cancer

MADISON, Wis. and BOSTON, April 13, 2023 /PRNewswire/ -- The Wisconsin Alumni Research Foundation (WARF), which has a mission of supporting research at the University of Wisconsin-Madison, and Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, today announced a partnership to leverage Ginkgo's proprietary high-throughput combinatorial CAR discovery and screening platform with the aim of discovering next generation GD2 CAR T-cell therapies with improved persistence, proliferation, fitness, and other functional properties to improve efficacy for the treatment of solid tumors.

Key Points: 
  • Through this partnership, Ginkgo will collaborate with the University of Wisconsin-Madison researchers Professor Krishanu Saha, Ph.D., as principal investigator (PI) and Dr. Christian Capitini, M.D.
  • Under this collaboration, Ginkgo will use its pooled CAR screening platform to design and characterize novel intracellular signaling domains that prevent the exhaustion of T-cells in the GD2 solid tumor context.
  • In addition, Ginkgo and WARF plan to collaborate on the development of a pooled in vivo screening platform to advance novel CAR discovery further.
  • WARF and Ginkgo hope to work towards solving this challenge by utilizing Ginkgo's high-throughput combinatorial CAR discovery platform.

Y-mAbs Reports Fourth Quarter and Full-Year 2022 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, March 30, 2023
Interim, Survival, Cancer, EST, Research, Sale, Trial of the century, Patient, Sarcoma, GD2, Carcinoma, Memorial Sloan Kettering Cancer Center, MSK, Yoy, Growth, FDA, Therapy, BLA, Cryptocurrency, Pharmaceutical industry, Video game, Melanoma

“The fourth quarter of 2022 marked another period of significant progress for DANYELZA and set up 2023 to be a very productive year,” said Thomas Gad, President and Interim Chief Executive Officer.

Key Points: 
  • “The fourth quarter of 2022 marked another period of significant progress for DANYELZA and set up 2023 to be a very productive year,” said Thomas Gad, President and Interim Chief Executive Officer.
  • “We are thrilled to report record DANYELZA net revenues of $16.4 million in the fourth quarter of 2022, a 31% sequential increase compared to the previous quarter.
  • The increase was primarily driven by an increase in the number of new U.S. patients in treatment during the fourth quarter of 2022.
  • As of December 31, 2022, Y-mAbs has delivered DANYELZA to 48 centers across the United States, corresponding to an increase of 12% in the number of centers since the third quarter of 2022.

Autolus Therapeutics Reports Full Year 2022 Financial Results and Operational Progress

Retrieved on: 
Tuesday, March 7, 2023
NHL, Follicular lymphoma, Therapy, GMP, CMC, Canadian Aviation Regulations, Multiple myeloma, Non-Hodgkin lymphoma, Patient, Good, EHA, European Hematology Association, B-ALL, CRS, MCL, MRD, Good manufacturing practice, Hand, Vii, Conference, Depreciation, Capital market, Employment, DLBCL, UCL, Exercise, Society, Information technology, Information, Conference call, Blackstone, CNS, CD19, ALL, Cancer, Research, Chronic lymphocytic leukemia, B-cell lymphoma, BLA, IDMC, CLL, Chemistry, Mantle cell lymphoma, ASH, GD2, FDA, Safety, CAR, Clinical trial, Data, BCMA, Nursing, Pharmaceutical industry, Cryptocurrency, Rare-earth element, Vaccine

Further details of the event will be provided in due course

Key Points: 
  • Further details of the event will be provided in due course
    LONDON, March 07, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced its operational and financial results for the full year ended December 31, 2022.
  • The Company is evaluating patients across the entire range of disease burden, including patients with minimal residual disease (MRD).
  • Data presented at the European Hematology Association (EHA) meeting in June 2022 demonstrated first activity in primary CNS lymphoma.
  • Financial Results for the Year Ended December 31, 2022
    Cash and cash equivalents and restricted cash at December 31, 2022, totaled $382.8 million, as compared to $310.7 million at December 31, 2021.

Y-mAbs Announces Partnership Regarding Early Access Program for DANYELZA (naxitamab-gqgk) in Europe

Retrieved on: 
Wednesday, December 21, 2022
Cancer, Bone marrow, Central nervous system, Therapy, WEP, MSK, Interim, GD2, Patient, Injection, FDA, Granulocyte-macrophage colony-stimulating factor, Memorial Sloan Kettering Cancer Center, Peripheral nervous system, Cell, Pharmaceutical industry

DANYELZA is a humanized, monoclonal antibody that binds to the glycolipid GD2.

Key Points: 
  • DANYELZA is a humanized, monoclonal antibody that binds to the glycolipid GD2.
  • GD2 is a disialoganglioside that is overexpressed on neuroblastoma cells and other cells of neuroectodermal origin, including the central nervous system and peripheral nerves.
  • DANYELZA is administered on days 1, 3, and 5 of each treatment cycle as an intravenous infusion after dilution.
  • “We are excited to be able to give European patients access to DANYELZA through this early access program with WEP,” said Thomas Gad, founder, President and Interim CEO.