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Wednesday, December 18, 2024

GT BIOPHARMA, INC.: GT Biopharma Announces Updated Positive Safety Data From Phase 1 GTB-3550 Monotherapy Trike™ Trial an Investigational Immunotherapy for Refractory Cancers to be Presented at ESMO Congress 2021

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GT Biopharma, Inc. issued the following announcement on Sept. 15. 

GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE protein biologic technology platform, today announced that Jeffrey Miller, MD, University of Minnesota Medical School, Professor of Medicine, Division of Hematology, Oncology and Transportation will present a mini-oral presentation at the European Society for Medical Oncology (ESMO) Congress 2021 to be held virtually September 16-21.

The mini-oral presentation will present updated positive Phase 1 safety data, progress, and preclinical data going beyond hematologic malignancies to solid tumors of a Phase 1 GTB-3550 TriKE trial. The Tri-Specific Killer Engager TriKE program is currently in pre-clinical and clinical development for the treatment of relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS) with solid tumor TriKE commercial manufacturing and IND enabling studies in progress.

Mini-oral Poster Presentation Details:

Title: GTB-3550 TriKE safely activates and delivers IL-15 to NK cells, but not T cells, in immune suppressed patients with advanced myeloid malignancies, a novel paradigm exportable to solid tumors expressing Her2 or B7H3 (Abstract #4068)

Speaker: Jeffrey Miller, MD

Mini-oral Session: Investigational Immunotherapy (Channel 2)

Presentation Time: September 17 at 6:10 PM EST

Mini-oral Presentation Number: 965MO

The abstract is currently available on the ESMO website at www.esmo.org. At the start of the mini-oral session the presentation will be available in the "Presentations" section of the Company's website at https://www.gtbiopharma.com.

Recent Announcement

The Company recently announced the advancement of GTB-3650 into IND-enabling studies, with which it plans to supplant the ongoing Phase 1 program with GTB-3550. GTB-3650 is a novel molecule based on camelid single-domain camelid antibody technology with advantages that build upon the strong proof-of-concept data from the Company's first generation TriKE program, GTB-3550.

Therapeutic and commercial advantages of GTB-3650 compared to GTB-3550 include:

  • Based on second generation camelid single-domain antibody technology that holds several advantages over traditional IgG monoclonal antibodies
  • Improved potency and enhanced binding affinity
  • Similar preclinical safety profile
  • Commercial manufacturing capabilities through arrangement with Cytovance
  • Proprietary patented molecule, which unlike GTB-3550, is wholly owned by GT Biopharma
Original source can be found here.

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