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     553  0 Kommentare GT Biopharma Issues Open Letter to Shareholders Detailing Recent Activities

    BRISBANE, CALIFORNIA, Feb. 02, 2023 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company” or “GTB”) (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 platform, issued an open letter from the CEO to shareholders, detailing the Company’s recent activities. The full letter is published below:

    Dear GT Biopharma Shareholders,

    I am proud to say that we have made significant progress towards fulfilling our corporate mission. It remains our goal to bring to market, a novel camelid nanobody technology platform, with target-directed immunotherapy in the fight against cancers. At the moment, we have more than 6 promising pipeline assets in active preclinical development, targeting both solid tumors and hematological malignancies. On the corporate development side our board and executives continue to manage the task of taking GT Biopharma’s promising assets into the clinic. Earlier in the year, Manu Ohri, joined the executive leadership team as our chief financial officer to lead the Company’s finance team and I was appointed interim CEO in addition to my existing role as Executive Chairman.

    Operationally, we reached an exciting milestone in our development lifecycle and signed an agreement with Cytovance Biologics Inc. in the third quarter of fiscal 2022. The agreement covers all work required to facilitate the registration of an investigational new drug (IND) filing with the U.S. Food and Drug Administration for our lead investigational asset GTB-3650. GTB-3650, a second generation TriKE will move forward in its development and we expect to file an IND submission in the first half of 2023. An IND submission for GTB-5550 in solid tumors is expected to follow thereafter. We are proud of the work that the team has performed in order to reach this juncture.

    As previously noted, GTB-3650 is in place of GTB-3550, the Company’s first generation, first-in-human TriKE. The pivoting to GTB-3650 continues to be underpinned by the safety data that was carried forward from GTB-3550’s Phase 1 safety study. The therapeutic and commercial advantages of GTB-3650 as compared to GTB-3550 however are many and include:

    • Traditional IgG monoclonal antibodies based on second generation camelid single-domain antibody technology;
    • Improved potency and enhanced binding affinity;
    • Similar preclinical safety profile; and
    • Commercial manufacturing capabilities through arrangement with Cytovance.

    While the biotech capital markets continue to remain volatile, we remain well capitalized and expect our current cash runway to fund operations into 2023. Additionally, we remain actively engaged with the capital markets at large and have presented at numerous investment conferences throughout the year. On the scientific front, we continue to be an active participant in order to bring awareness of our technology and have presented at many of the important annual oncology medical meetings that have taken place thus far. Most recently, Dr. Jeff Miller presented a study at the American Society of Hematology's 64th Annual Meeting. The presentation highlighted the potential of a novel dual antigen targeting approach for the treatment of acute myeloid leukemia (AML), combining GT Biopharma’s Tri-specific Killer Engager (TriKE) with the induced pluripotent stem cell (iPSC) product platform of Fate Therapeutics, Inc. (NASDAQ:FATE).

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    GT Biopharma Issues Open Letter to Shareholders Detailing Recent Activities BRISBANE, CALIFORNIA, Feb. 02, 2023 (GLOBE NEWSWIRE) - GT Biopharma, Inc. (the “Company” or “GTB”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural …

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