On June 3, 2024 Fulgent Pharma, a subsidiary of Fulgent Genetics, Inc. (NASDAQ: FLGT) and a leading nanobiotechnology company specializing in innovative cancer therapeutics, reported that Phase 1 clinical data on its lead therapeutic development candidate, FID-007, to treat Head and Neck cancer, was presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 2, 2024 in Chicago, Illinois (Press release, Fulgent Pharma, JUN 3, 2024, View Source [SID1234644064]).

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Of eleven head and neck squamous cell carcinoma (HNSCC) evaluable patients with weekly dose levels from 15 mg/m2 to 160 mg/m2, five (45%) had a partial response and three (27%) had stable disease by RECIST. Three out of five HNSCC patients with PR had previously been treated with taxane. The duration of follow-up (months), median (range) is 4.0 (1.0 – 15.0). No high-grade neuropathy has been noted to date. FID-007 demonstrates preliminary evidence of anti-tumor activity in heavily pre-treated HNSCC patients across different primary tumor sites, with an overall response rate of 45%. Phase 2 study of FID-007 combination with cetuximab in patients with HNSCC has begun enrollment.

Commenting on the data, Ming Hsieh, Chairman of the Board and Chief Executive Officer, said, "We are very encouraged by the data from these Head and Neck cancer patients, in particular the preliminary evidence of relatively lower toxicity and improved treatment tolerance with FID-007 compared to prior therapies. These data support the Phase 2 clinical study we recently began in head and neck squamous cell carcinoma, and we look forward to bringing FID-007 to more patients as we continue enrollment."

The poster is available on the News & Events section of the company’s Investor Relations website at View Source

About FID-007

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.