GT Biopharma Poster Presentation and Mini Oral Session at

• GTB-5550 generates a strong and NK cell particular proliferation sign in comparison with IL-15 alone
• GTB-5550 particularly targets B7-H3+ cells
• GTB-5550 successfully induced NK cell degranulation and interferon gamma manufacturing in response to numerous prostate, mind tumor (atypical rhabdoid/teratoid), HNSCC, a number of myeloma, sarcoma, ovarian, and myeloid malignancies
• GTB-5550 TriKE In vivo exercise in xenogeneic fashions of human tumor is underway and already validating in vitro research

BRISBANE, Calif., Sept. 12, 2022 (GLOBE NEWSWIRE) —  GT Biopharma, Inc. (the “Company” or “GTB”) (NASDAQ: GTBP), a scientific stage immuno-oncology firm targeted on creating progressive therapeutics based mostly on the Company’s proprietary pure killer (NK) cell engager, TriKE® platform, as we speak introduced highlights of an accepted summary titled, “B7H3-Targeted Tri-specific Killer Engagers deliver IL-15 to NK cells but not T cells, and specifically targets solid tumors as a pan-tumor antigen strategy mediated through NK cells,” for poster presentation each nearly at the European Society for Medical Oncology (“ESMO”) Congress 2022 being held at the Paris Expo Porte de Versailles from September 9-13, in Paris, France.

GTB-5550 product candidate is in improvement for the therapy of B7H3 constructive stable tumor cancers and a number of myeloma. GTB-5550 TriKE is a tri-specific molecule composed of a twin camelid nanobody that binds the CD16 receptor on NK cells, the one chain variable fragment (scFv) of an anti-B7H3 antibody, and human IL-15.

Highlights of the summary poster and mini-oral session embrace:

• GTB-5550 offers a strong and NK cell particular proliferation sign in comparison with IL-15 alone
• GTB-5550 particularly targets B7-H3+ cells
• GTB-5550 successfully induced NK cell degranulation and interferon gamma manufacturing in response to numerous prostate, mind tumor (atypical rhabdoid/teratoid), HNSCC, a number of myeloma, sarcoma, ovarian, and myeloid malignancies
• GTB-5550 TriKE In vivo exercise in xenogeneic fashions of human tumor is underway and already validating in vitro research

“GT Biopharma’s TriKE platform harnesses the natural killing power of NK cells with protein therapeutics, not NK cell therapy. Our approach induces activation of NK cells via CD16 and IL-15 while targeting well-known tumor antigens, offering a potentially safer alternative to T-cell related immunotherapy without cytokine release syndrome and neurotoxicity and we expect to submit an Investigational New Drug (IND) application in 2023 in solid tumors,” stated Michael Breen, Executive Chairman and Interim CEO of GT Biopharma.”

About the Study

Background
IL-15, the homeostatic issue for NK cells is being clinically developed but it surely has little anti-tumor exercise alone. GT Biopharma hypothesized that focused supply of IL-15 to NK cells together with Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) would impart NK cells with specificity to tumor antigens. As proof of idea, a scientific trial of GTB-3550 (a CD33- focused Tri-specific Killer Engager (TriKE) in AML) induced endogenous NK cell growth and activation in refractory AML sufferers. GTB-5550 (a B7H3 TriKE) was developed as a novel twin camelid (cam) TriKE containing wild sort IL-15 and comprised of two cam engagers: focusing on CD16 on NK cells and B7H3 on a number of stable tumors.

Method
The IL-15 exercise of the B7H3 TriKE was measured in proliferation assays. Tumors have been incubated with NK cells with or with out B7H3 TriKE. In some tumors, CRISPR tech was used to knockout B7H3 to function a specificity management in addition to B7H3 detrimental hematologic tumors. NK cell perform was measured by stream cytometry and in stay tumor imaging assays.

Results
B7H3 TriKE was titrated onto lymphocytes leading to a dose- dependent proliferation of NK cells however not T cells. This was in marked distinction to rhIL-15, that stimulated each, suggesting completely different biologic exercise of IL-15 when delivered via the camCD16 engager. camB7H3 was broadly expressed on prostate, head and neck, ovarian and glioblastoma cancers in addition to a number of myeloma. We noticed a B7H3 TriKE dose-dependent improve in CD107a degranulation and inflammatory cytokines to all B7H3 constructive targets that was extremely particular, with no response seen with B7H3 detrimental hematologic targets and management traces created with a CRISPR knockout of B7H3. Compared to rhIL-15, GTB-5550 given at molar equal dosing induced B7H3 killing in in a dose-dependent method above that seen with rhIL-15 induced pure cytotoxicity. In vivo exercise in xenogeneic fashions of human tumor is underway and already validating our in vitro research.

ESMO Congress 2022 presentation particulars:
Poster Presentation Display (#755P) Title: “B7H3-Targeted Tri-specific Killer Engagers Deliver IL-15 to NK Cells But Not T Cells, And Specifically Targets Solid Tumors As a Pan-Tumor Antigen Strategy Mediated Through NK Cells”
Session: Investigational Immunotherapy
Speaker: Dr. Jeffrey S. Miller
Location: 7.3.O – Orléans Auditorium
Date and Time: Saturday, September 10, 2022 at 14:45 – 16:15 (CEST)

ESMO Congress 2022 has printed full abstracts on their web site. GT Biopharma will publish its poster on the corporate’s web site within the “Presentations” part in the course of the convention.

For summary and occasion particulars please go to: https://www.esmo.org/meetings/esmo-congress-2022.

About GT Biopharma, Inc.
GT Biopharma, Inc. is a scientific stage biopharmaceutical firm targeted on the event and commercialization of immuno-oncology therapeutic merchandise based mostly on our proprietary TriKE® NK cell engager platform. Our TriKE® platform is designed to harness and improve the most cancers killing talents of a affected person’s immune system’s pure killer cells. GT Biopharma has an unique worldwide license settlement with the University of Minnesota to additional develop and commercialize therapies utilizing TriKE® expertise. For extra data, please go to gtbiopharma.com.

Forward-Looking Statements
Certain statements on this press launch could represent “forward-looking statements” concerning future occasions and our future outcomes. All statements apart from statements of historic information are statements that could possibly be deemed to be forward-looking statements. These statements are based mostly on present expectations, estimates, forecasts, and projections in regards to the markets wherein we function and the beliefs and assumptions of our administration. Words equivalent to “expects,” “anticipates,” “targets,” “goals,” “projects”, “intends,” “plans,” “believes,” “seeks,” “estimates,” “endeavors,” “strives,” “may,” or variations of such phrases, and related expressions are supposed to establish such forward-looking statements. Readers are cautioned that these forward-looking statements are topic to a lot of dangers, uncertainties and assumptions which can be tough to foretell, estimate or confirm. Therefore, precise outcomes could differ materially and adversely from these expressed in any forward-looking statements. Such dangers and uncertainties embrace these components described in our most up-to-date annual report on Form 10-Okay, as such could also be amended or supplemented by subsequent quarterly reviews on Form 10-Q, or different reviews filed with the Securities and Exchange Commission. Readers are cautioned to not place undue reliance on these forward-looking statements. The forward-looking statements are made solely as of the date hereof, and we undertake no obligation to publicly launch the results of any revisions to those forward-looking statements. For extra data, please discuss with our filings with the Securities and Exchange Commission.

TriKE® is a registered trademark owned by GT Biopharma, Inc.

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