On August 13, 2021 GT Biopharma, Inc. ("GT Biopharma" or 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, reported a general business update of events in the second quarter ending June 30, 2021 (Press release, GT Biopharma, AUG 13, 2021, View Source [SID1234586568]).
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"I am pleased with the corporate and clinical development milestones that GT Biopharma continues to achieve throughout the first half of 2021," said Anthony J. Cataldo, GT Biopharma’s Chairman and Chief Executive Officer. "The Company continues to demonstrate that our proprietary TriKE platform technology is both safe and efficacious, demonstrated through our recent positive, interim data announcement of our ongoing Phase I/II dose expansion clinical trial of GTB-3550 TriKE. The TriKE platform is robust, focusing not only on hematologic cancers but also on solid tumor cancers such as lung, prostate, breast and ovarian cancers. The TriKE platform includes our B7H3, PD-L1 and HER2 TriKE product candidates. Our breadth of indications and the utility of TriKE as a therapeutic agent reduces the risk profile of our therapeutic platform and pipeline. Our collaborative efforts were strengthened through the Company’s research agreement with Dr. Jeffrey S. Miller and the University of Minnesota, and signifies that we are continuing to hit important strides in the clinic. These positive milestones reinforce GT Biopharma’s need to continue developing this first-in-human treatment for patients living with AML, MDS and other CD33+ hematologic cancers."
Clinical Highlights
Reported Positive, Interim Data Results from First-in-Human GTB-3550 TriKE Phase I Clinical Trial for the Treatment of Refractory/Relapsed Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS): In June 2021, GT Biopharma and Dr. Jeffrey S. Miller presented positive, interim results from the Phase I dose-escalation portion of the Phase I/II dose expansion clinical trial of GTB-3550 TriKE at the 2021 Raymond James Human Health Innovation Conference. Results demonstrated that 57% of patients achieved significant reduction in AML/MDS cancer cell burden, with one patient reaching up to 63.7% reduction in bone marrow blast levels. Across all patients, treatment of GTB-3550 TriKE was well tolerated and no signs of cytokine release syndrome (CRS) were detected. This portion of the Phase I/II dose expansion trial is focused on determining the recommended Phase II dose, the maximum tolerated dose (MTD), optimal dose schedule, safety and tolerability of GTB-3550 TriKE administration. The Phase I safety study is expected to complete later this fall and the Company has scheduled an interim data publication for September 16-21, 2021 at the European Society for Medical Oncology Conference to be held in Paris, France.
Corporate Highlights
Announced Strategic Research Agreement with Dr. Jeffrey S. Miller of the University of Minnesota: In July 2021, GT Biopharma announced that it has entered a research agreement with Dr. Jeffrey S. Miller, associated with the University of Minnesota to further develop the Company’s proprietary TriKE technology. This agreement reinforces the clinical success that TriKE continues to demonstrate in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
Inclusion in the Russell 2000 Index: In June 2021, GT Biopharma was added to the Russel 2000 Index, signifying corporate and clinical development milestones that the Company continues to achieve. This listing enhances GT Biopharma’s visibility to a broader investment community, and increases long-term growth potential as the Company continues to achieve important clinical milestones associated with both their robust preclinical and clinical pipelines.
Announced $16M Cash Increase from Warrant Exercise Proceeds: In July 2021, the Company announced a $16M increase in cash from exercised warrant proceeds that were a part of the recent $27M financing completed in February of this year. This capital will be used to further develop the TriKE technology in both preclinical and clinical pipelines.
Conference Call
The Company will host a conference call at 8:30 a.m. EST today to provide a general business update. To join the call U.S. callers should dial 1-877-870-4263 and international callers should dial 1-412-317-0790. All participants should ask to be connected to the GT Biopharma conference call.
A live webcast of the event will be available by visiting the "Presentations" page in the Investors section of GT Biopharma’s website at www.gtbiopharma.com/news-media/presentations. A replay of the webcast will be archived for 30 days following the presentation.
About GTB-3550 TriKE
GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment of acute myeloid leukemia (AML), myelodysplastic syndromes (MDS) and other CD33+ hematologic cancers. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of Interleukin 15 (IL-15). The natural killer (NK) cell-stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as AML, MDS and other CD33+ hematopoietic malignancies.