GT Biopharma, a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the company’s proprietary natural killer (NK) cell engager, TriKE platform, entered into a settlement and investment agreement with its contract manufacturing partner, Cytovance Biologics. The agreement covers all work required to facilitate the registration of an investigational new drug (IND) filing with the U.S. FDA of its lead investigational asset GTB-3650.

GTB-3650 is the company’s lead second-generation Tri-Specific Killer Engager (TriKE) program currently in preclinical development for the treatment of relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The company previously announced that its second generation TriKE, GTB-3650, will supplant GTB-3550. The MSA with Cytovance covers all changes to scope of work in order to advance GTB-3650 forward. In consideration for this scope of work payments to Cytovance will be in the form of cash and stock but limited to no more than 4.9% of GTB’s total shares outstanding.

The company now expects to file its IND application with the FDA for its GTB-3650 product no later than March 31, 2023, and to file its IND application with the FDA for its GTB-5550 product no later than June 30, 2023.

Therapeutic and commercial advantages of GTB-3650 compared to GTB-3550 include:

• GTB-3650 is based on second generation camelid single-domain antibody technology that holds several advantages over traditional IgG monoclonal antibodies;
• Improved potency and enhanced binding affinity; and
• Similar preclinical safety profile proprietary patented molecule, which unlike GTB-3550, is wholly owned by GT Biopharma.