Benzinga | Apr 12, 2021 08:06AM EDT

GT Biopharma Announces Interim Results From GTB-3550 TriKE Monotherapy

GT Biopharma, Inc. (NASDAQ:GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary NK cell engager (TriKE(tm)) protein biologic technology platform, announced today additional interim results from its GTB-3550 TriKE(tm) first-in-human Phase I/II clinical trial for the treatment of high-risk myelodysplastic syndromes (MDS) and refractory/relapsed acute myeloid leukemia (AML).

Additional results show 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.

GTB-3550 TriKE(tm) monotherapy has demonstrated clinical benefit in very hard to treat relapsed/refractory AML and high-risk MDS cancer patients by significantly reducing cancer cell (blast) levels and, in some cases, ending transfusion dependency with patients becoming eligible for bone marrow transplant.

The ability to use GTB-3550 in a monotherapy setting is a significant competitive and therapeutic advantage, and a major cost savings compared to the co-administration of drug/cell therapy combination regimens. GTB-3550 TriKE(tm) therapy requires no patient pre-treatment regimens such as myeloablative chemotherapy, and is well tolerated with no signs of cytokine release syndrome (CRS) or other toxicities suggesting GTB-3550 could be used to treat patients earlier in the disease process, whereas complicated and expensive combination drug/cell therapy regimens are expected to be used as late-stage or salvage therapies after all other therapeutic options have been exhausted.

Highlights from the first nine patients treated with GTB-3550 TriKE(tm) include:

* Up to 63.7% Reduction in Bone Marrow Blast Levels Resulting in Clinical Benefit

* Restores Patient's Endogenous NK Cell Function, Proliferation and Immune Surveillance

* No Progenitor-derived or Autologous/Allogenic Cell Therapy Required

* No Cytokine Release Syndrome Observed

* 3 out of the last 5 Patients Treated Respond (25mcg/kg/day to 100mcg/kg/day therapeutic dose range)

"We believe GTB-3550 TriKE(tm) sets a new standard for NK cell engager therapies due to the incorporation of Interleukin 15 (IL-15) directly in the protein backbone. The flexibility and versatility of our TriKE(tm) platform allows us to change the cancer cell targeting moiety of TriKE(tm) to attack different cancers while maintaining the core NK cell activation, proliferation and persistence attributes of the molecule," said Anthony J. Cataldo, GT Biopharma's Chairman and Chief Executive Officer. "The TriKE(tm) is a true monotherapy, unlike all other NK cell technologies in development. The novel TriKE(tm) uniquely does not need any outside NK cell manufacturing or combination drugs, to supplement or assist. Further, the TriKE(tm) does not require pre-conditioning of the patient's immune system. These supplemental requirements of competitive technologies add tremendous cost to an already costly therapeutic approach. Everything the TriKE(tm) does happens with no outside assistance whatsoever. We believe the TriKE's clinical data is demonstrating exactly that, opening the door to a significantly more cost-effective off-the-shelf therapeutic."