Benzinga | May 18, 2021 09:51AM EDT

GT Biopharma To Host Interim GTB-3550 TriKE Data Review Call With Dr. Jeffrey Miller On May 19 At 4 p.m. EDT

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(tm), 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(tm) Data

Clinical Highlights

* Updated Interim Results from First-in-Human GTB-3550 TriKE(tm) 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(tm) 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(tm) Phase I/II Clinical Trial in MDS and AML Continues: GTB-3550 TriKE(tm) 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(tm) Monotherapy: GTB-3550 TriKE(tm) 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:

https://services.choruscall.com/ccforms/replay.html

Replay Access Code: 10156826

About GTB-3550 TriKE(tm)

GTB-3550 TriKE(tm) 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(tm) reduces bone marrow blast levels in AML and MDS patients, and improved NK cell function and proliferation.