Fulgent Genetics, Inc. announced data from a Phase 1/1b clinical study of FID-007 in treating various solid tumors was presented in a poster session at the American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on June 3, 2023. Of 40 evaluable patients with weekly dose levels from 15 mg/m2 to 160 mg/m2, 7 (18%) had a partial response by RECIST 1.1 (pancreatic, biliary tract, and HNSCC) and 14 (35%) had stable disease. Three out of 4 HNSCC patients with PR had previously been treated with taxane.

The duration of follow-up (months), median (range) is 12.0 (0.4 - 38.9). No high-grade neuropathy has been noted to date. FID-007 demonstrates preliminary evidence of anti-tumor activity in heavily pre-treated patients across various tumor types.

Based on overall tolerability, pharmacokinetics, and efficacy, 125mg/m2 has been chosen as the recommended Phase 2 dose (RP2D). FID-007 consists of paclitaxel encapsulated in a polyethyloxazoline (PEOX) polymer excipient designed to enhance PK, biodistribution, and tolerability. In addition to allowing the drug to remain in solution until it can enter a cancer cell, the PEOX nanoparticle is designed to preferentially deliver paclitaxel to the tumor through the leaky hyperpermeable vasculature.