BEVERLY Hills, Calif., May 18, 2021 /PRNewswire/ — GT Biopharma, Inc. (NASDAQ: GTBP) a clinical stage biopharmaceutical company focused on the development and commercialization of disruptive, target-directed Natural Killer (NK) cell engager immunotherapy protein biologic platform technology, TriKE™, for the treatment of cancer and infectious diseases, today announced that it will be hosting a call with Dr. Jeffrey S. Miller and GT Biopharma on Wednesday, May 19th at 4:00 PM Eastern Time.
Interim GTB-3550 TriKE™ Data
Updated Interim Results from First-in-Human GTB-3550 TriKE™ Phase I/II Clinical Trial for the Treatment of High-Risk Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute Myeloid Leukemia (AML): Results demonstrated up to 63.7% reduction in bone marrow blast levels, and restoration of endogenous NK cell function, proliferation and immune surveillance without combination ex vivo supplemental NK cell therapy. All patients treated displayed no signs of any grade of cytokine release syndrome (CRS) across all dose cohorts. GTB-3550 TriKE™ is currently being administered to patients at doses significantly higher than the reported maximum tolerated dose (MTD) for continuous infusion of recombinant human interleukin-15 (IL-15).
Enrollment in Phase I Portion of GTB-3550 TriKE™ Phase I/II Clinical Trial in MDS and AML Continues: GTB-3550 TriKE™ Phase I/II Clinical Trial in high-risk MDS and AML patients continues to enroll patients. Patient 11 began treatment dosed at 150mcg/kg/day.
New Findings Supporting GTB-3550 TriKE™ Monotherapy: GTB-3550 TriKE™ monotherapy is able to rescue the patient’s otherwise exhausted/inhibited/non-functional endogenous NK cell population, and target direct killing of the patient’s AML and MDS cancer cells without the need for the co-administration addition of supplemental progenitor-derived or autologous/allogenic engineered NK cells.
Preliminary Phase II Clinical Trial Design: The Phase II expansion part of the current GTB-3550 clinical trial intends to enroll patients with CD33 expression ≥50% in independent cohorts (higher-risk MDS and AML); treat patients with two cycles of GTB-3550 therapy with a rest period between cycles as opposed to the single-cycle used during Phase 1; enroll patients with fewer prior treatment lines; and, evaluate the potential use of minimal residual disease (MRD) based endpoints that may allow for accelerated approval.
A live webcast of the presentation may be accessed by visiting https://www.webcaster4.com/Webcast/Page/4/41418 as well as from the Investors section of the GT Biopharma website at https://ir.gtbiopharma .com/.
Those who wish to dial in for the audio portion only of the event an audio only may do so at:
PARTICIPANT DIAL-IN (TOLL FREE): – 1-877-870-4263
PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-0790
Canada Toll Free: 1-855-669-9657
Please ask to be joined into the GT Biopharma call.
An archived replay of the webcast will be available on the Company’s website by visiting:
Replay Access Code: 10156826
About GTB-3550 TriKE™
GTB-3550 TriKE™ is a first-in-class immuno-oncology therapeutic being evaluated in patients age 18 and older in a Phase I/II clinical trial (NCT03214666) having CD33+ malignancies (primary induction failure or relapsed AML with failure of one reinduction attempt or high-risk MDS progressed on two lines of therapy). Interim results demonstrated GTB-3550 TriKE™ reduces bone marrow blast levels in AML and MDS patients, and improved NK cell function and proliferation.
About GT Biopharma, Inc.
GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based our proprietary TriKE™ NK cell engager platform. Our TriKE™ platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system natural killer cells (NK cells). GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE™ technology.
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For more information, please visit www.gtbiopharma .com.
Stern Investor Relations, Inc.
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SOURCE GT Biopharma, Inc.
Pursuant to an agreement between Midam Ventures LLC and GT Biopharma (GTBP) Midam has been paid $150,000 for a period from March 1, 2021, to April 1, 2021. This compensation is payment 1 of 12 as part of a 12-month agreement between Midam Ventures LLC & GT Biopharma (GTBP), for a period from March 1, 2021, to February 28, 2022. Midam Ventures LLC expects to be paid $150,000 per month for a total of 12 months by GT Biopharma (GTBP). Midam has been paid an additional $150,000 for a period from April 2, 2021, to May 1, 2021. This compensation is payment 2 of 12 as part of the Agreement. Midam has been paid an additional $150,000 for a period from May 2, 2021, to June 1, 2021. This compensation is payment 3 of 12 as part of the Agreement. Midam has been paid an additional $150,000 for a period from June 2, 2021, to July 1, 2021. This compensation is payment 4 of 12 as part of the Agreement. Midam has been paid an additional $200,000 for a period from July 2, 2021, to July 29, 2021. This compensation is payment 5 of 12 as part of the Agreement. Midam has been paid an additional $200,000 for a period from July 29, 2021, to September 2, 2021. This compensation is payment 6 of 12 as part of the Agreement. We may buy or sell additional shares of GT Biopharma (GTBP) in the open market at any time, including before, during, or after the Website and Information, to provide public dissemination of favorable Information about GT Biopharma (GTBP).