About the company Nexgene Biotech is advancing SD-619, an IND-enabling oncology biologic designed to enable therapeutic response in immunotherapy-resistant tumors through modulation of tumor microenvironment (TME) biology. The program has demonstrated strong in vivo efficacy (p < 0.001) across resistant tumor models, along with a favorable safety profile, supporting its progression toward clinical translation. The company is currently focused on IND-enabling development, with ongoing workstreams in PK characterization, CMC de-risking, and regulatory strategy. Lead Asset: SD-619 * Significant tumor growth inhibition in syngeneic models (LLC1, CT26) * Activity observed in both IO-resistant and IO-responsive settings * Favorable safety profile with high-dose tolerability * Injectable formulation established for translational development Positioning: A TME-modulating biologic with potential as a combination-enabling agent in resistant tumor settings. Development Status * IND-enabling stage * CMC framework established with batch comparability approach * Initial reproducibility demonstrated across multiple batches * PK studies underway, with initial data expected from 2026 Strategy Focused on advancing SD-619 as a lead oncology asset, with potential expansion into additional indications following clinical validation.
| Website | http://www.nexgene.com |
| Employees | View employees |
| Founded | 2023 |
| Industry | Biotechnology Research |
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