GT Biopharma develops clinical-stage immuno-oncology therapeutics based on its proprietary TriKE® natural killer cell engager platform. News around GTBP focuses on candidate-specific development updates for GTB-3650, a TriKE® program for relapsed or refractory CD33-expressing hematologic malignancies, and GTB-5550, a B7-H3-targeted TriKE® program for solid tumors known to express B7-H3.
Company updates also cover FDA investigational new drug activity, Phase 1 trial enrollment and safety-review disclosures, R&D spending, liquidity commentary and periodic financial results. GT Biopharma also issues investor-conference announcements as it presents its NK cell engager strategy and clinical pipeline to the capital markets.
GT Biopharma, Inc. (OTCQB:GTBP) announced that its abstract regarding GTB-3550 TriKE for treating high-risk myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) has been selected for oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting on December 5, 2020. The abstract highlights NK cell proliferation at initial dose cohorts. The results will also be published in the November supplemental issue of the journal Blood. GTB-3550 is currently under evaluation in a Phase I/II clinical trial targeting CD33 positive leukemias.
GT Biopharma announced the addition of Dr. Samir Taneja and Dr. Philip Werthman to its Scientific and Medical Advisory Board. Dr. Taneja, a urologic oncology expert from NYU, brings extensive knowledge in cancer treatment. Dr. Werthman, noted for his contributions in reproductive medicine, offers valuable experience in translating research into commercial success. CEO Anthony Cataldo expressed optimism about how their expertise will enhance GT Biopharma's mission to expand its TriKE technology applications.
GT Biopharma has entered a partnership with Cytovance Biologics for exclusive GMP manufacturing of three TriKETM therapeutic candidates. The deal allows for a $6 million payment in cash or shares, contingent on milestone achievements within 12 months. Cytovance's KeystoneTM systems promise enhanced production yields. GT Biopharma's TriKETM platform targets NK cell engagement to treat cancers, with its first product candidate, GTB-3550, in Phase I/II trials for AML. This partnership highlights GT Biopharma's commitment to expanding clinical opportunities.
GT Biopharma announced the treatment completion of its first patient in the GTB-3550 TriKE Phase I/II clinical trial, achieving a reduction in acute myeloid leukemia (AML) blast levels from 18% to 12%. The patient displayed enhanced NK cell activity, attributed to the IL-15 component, without adverse reactions. This trial aims to evaluate the safety, tolerability, and efficacy of GTB-3550 in high-risk hematologic malignancies. The company expresses hope for continued positive outcomes as it escalates dosing in future treatments.