Business
Forte Biosciences, Inc. Announces Second Quarter 2024 Results and Provides Business Update
DALLAS--(BUSINESS WIRE)-- Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and
About this update from Forte Biosciences, Inc.
[{"type":"text","content":" DALLAS--(BUSINESS WIRE)--\nForte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced second quarter 2024 results and provided a business update.\n\n\nSecond Quarter 2024 Business Highlights\n\n\n“Forte continues to make excellent progress with FB102, our anti-CD122 monoclonal antibody therapeutic candidate. The SAD/MAD phase 1 healthy volunteer study has successfully completed and FB102 has demonstrated a good safety profile,” said Paul Wagner, Ph.D., Chairman and Chief Executive Officer of Forte Biosciences. “Based on the successful completion of the phase 1 healthy volunteer cohorts, Forte is initiating a patient study in celiac disease with data expected by the second quarter of 2025. Based on the biology of celiac disease and the mechanism of action of FB102 we are excited about the potential in celiac disease, an indication with a significant unmet need. We believe the data to date supports the significant potential for FB102 across a variety of autoimmune and autoimmune-related diseases with large addressable markets and we look forward to pursuing these opportunities as we continue to advance the FB102 program.”\n\n\nR&D and Clinical Development Updates\n\n\nIn FB102 mechanistic in-vitro studies, human donor T and NK cells were stimulated with either IL2 or IL15 in the presence or absence of FB102. FB102 significantly inhibited proliferation and activation at levels comparable to unstimulated cells. Human donor regulatory T cell (Treg) studies stimulated with IL2 demonstrated comparable proliferation both in the presence and absence of FB102.\n\n\nIn the 4 and 13 week nonhuman primate (NHP) studies, after a single dose, FB102 demonstrated significant reductions in the NK cell pharmacodynamic marker. Additionally, after multiple doses at exposures comparable to human therapeutic doses, Treg levels in the FB102 dosing arm was comparable to vehicle. These observations suggest that FB102 is demonstrating selectivity with respect to inhibiting the intermediate vs high affinity IL2 receptor.\n\n\nThe phase 1 healthy volunteer SAD/MAD cohorts have successfully completed. The FB102 phase 1 healthy volunteer study demonstrated a good safety profile. Of note, in this study FB102 reported a significant reduction in t...