Benzinga | Aug 3, 2021 07:10AM EDT

GT Biopharma Announces Preclinical Results For GTB-5550 B7H3 TriKE

GT Biopharma, Inc. (NASDAQ:GTBP), a clinical stage biopharmaceutical company focused on developing target-directed, tri-specific Natural Killer (NK) cell engager therapies (TriKE(tm)) incorporating interleukin 15 (IL-15) for the treatment of cancer, announced preclinical results for GTB-5550, its B7H3 TriKE(tm) product candidate as a prospective therapy for the treatment of several different types of cancers.

GTB-5550 TriKE(tm) was evaluated in several preclinical models overexpressing B7H3, and was found to be effective at promoting NK cell killing of multiple cancer cell types. B7H3 is over-expressed on several cancer types including non-small cell lung cancer, squamous cell carcinoma, and breast, renal, pancreatic, ovarian, liver and colorectal cancers. GTB-5550 TriKE(tm) is presently undergoing GMP manufacturing scale-up in preparation for filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for evaluation in humans.

B7H3 is a member of the B7 family of immune checkpoint inhibitors which includes PD-1/PD-L1 and CTLA-4/CD80. Merck's Keytruda(r) (pembrolizumab) and Bristol-Myer Squibb's YERVOY(r) (ipilimumab) targeting the PD-1/PD-L1 and CTLA-4/CD-80 checkpoints, respectively, have demonstrated significant survival benefit and are blockbuster immune-oncology therapeutics.

B7H3 expression on cancer cells is highly associated with undesirable treatment outcomes and survival time. Targeting B7H3 on cancer cells with TriKE(tm) and redirecting NK cells to attack and kill cancer cells expressing B7H3, could result in a therapeutic treatment that limits the metastatic potential and invasiveness of certain solid tumor cancers.

Anthony J. Cataldo, GT Biopharma's Chairman and Chief Executive Officer, commented: "We are pleased to report our GTB-5550 TriKE(tm) has passed this important development milestone, and demonstrated effectiveness in promoting redirected and target-specific killing by NK cells."