GT Biopharma (GTBP) FY Conference Transcript

Summary of GT Biopharma Conference Call Company Overview - Company Name: GT Biopharma - Ticker: GTBP - Industry: Biotechnology, specifically focused on oncology and immunotherapy - Current Stage: Clinical-stage company conducting Phase 1 trials for blood cancer and acute myeloid leukemia [2][3] Core Technology and Pipeline - Technology: Trispecific killer cell engager camelid nanobodies designed to target cancer and HIV - Pipeline: Over six candidates in development, with plans to file an IND for solid tumors by the end of the calendar year [3] - Key Focus: Solid tumor oncology market, which is significantly larger than the blood cancer market [3] Clinical Trials and Findings - GTB-3550: First-generation TriKE® targeting CD33 for myeloid leukemia; well-tolerated with no safety issues reported [9][10] - NK Cell Expansion: The therapy demonstrated the ability to increase NK cell counts in patients, which is crucial for effective cancer treatment [10] - GTB-3650: Second-generation camelid TriKE® currently in trials, showing early signs of sustained immune activation and no dose-limiting toxicity [13][14] Advantages of Trispecific Engagers - Unique Mechanism: Combines IL-15 with NK cell engagement, enhancing the proliferation and activity of NK cells compared to other engagers that do not include IL-15 [19][20] - Clinical Activity: Preliminary data indicates potential clinical activity with reductions in leukemia blast cells observed in treated patients [11] Targeting B7H3 - B7H3 TriKE®: Developed to target a pan-tumor antigen, showing increased potency in preclinical models compared to first-generation engagers [12][16] - Solid Tumor Trials: Plans to conduct outpatient therapy with subcutaneous injections, aiming for a more manageable treatment regimen [18] Future Directions - Basket Trials: Seven cohorts planned to identify clinical activity across various diseases, which will inform the FDA approval pathway [19] - Exploration of CD19 Targeting: Investigating the potential of CD19 TriKE® for treating autoimmune diseases, with promising preclinical data [21][22] Conclusion - GT Biopharma is positioned to leverage its innovative trispecific engager technology to address significant unmet needs in oncology, with a focus on both blood cancers and solid tumors, while also exploring applications in autoimmune diseases. The company aims to advance its clinical trials and seek FDA approval in the coming years [2][19]