Fulgent Data at ASCO 2024 Showcases FID-007's Antitumor Activity in Head and Neck Cancer

Fulgent Pharma, a subsidiary of Fulgent Genetics, Inc. and a pioneering company in nanobiotechnology cancer treatments, recently shared promising Phase 1 clinical trial data for its primary therapeutic candidate, FID-007, aimed at treating Head and Neck cancer. This data was unveiled at the American Society for Clinical Oncology (ASCO) Annual Meeting held on June 2, 2024, in Chicago, Illinois.

In this Phase 1 trial, eleven patients suffering from head and neck squamous cell carcinoma (HNSCC) received weekly doses of FID-007, ranging from 15 mg/m2 to 160 mg/m2. Among these patients, five showed a partial response, and three maintained stable disease according to RECIST criteria. Notably, three of the five patients who exhibited partial responses had been previously treated with taxane. The median duration of follow-up for these patients was 4 months, with a range from 1 to 15 months. Importantly, no severe cases of neuropathy have been reported so far. The preliminary results indicate that FID-007 may have significant anti-tumor activity in HNSCC patients who have undergone extensive prior treatments, with an overall response rate of 45%.

The Phase 2 study involving a combination of FID-007 and cetuximab for HNSCC patients has already commenced enrollment. Ming Hsieh, Chairman of the Board and CEO of Fulgent Pharma, expressed optimism about these findings, particularly emphasizing the lower toxicity and better treatment tolerance seen with FID-007 compared to previous therapies. Hsieh stated, "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."

FID-007 is a formulation of paclitaxel encapsulated in a polyethyloxazoline (PEOX) polymer excipient, designed to enhance pharmacokinetics, biodistribution, and tolerability. This innovative design allows the drug to remain in solution until it reaches cancer cells, with the PEOX nanoparticle preferentially delivering paclitaxel to tumors through their leaky vasculature.

Fulgent Pharma originated as part of Fulgent LLC in Temple City, California, in June 2011. As the company evolved, it ventured into precision medicine and clinical genetic and genomic testing. In 2016, Fulgent LLC split into two independent entities, Fulgent Pharma and Fulgent Genetics, to better pursue their distinct goals. In 2022, Fulgent Pharma was re-acquired by Fulgent Genetics, facilitating advancements in personalized cancer genomics and precision oncology therapeutics. Today, Fulgent Pharma is dedicated to developing drug candidates for various cancers, collaborating with institutions like the University of Southern California, Moffitt Cancer Center, and ANP Technologies.

Fulgent Genetics is a technology-driven company with a solid clinical diagnostic business, offering molecular diagnostic testing services, comprehensive genetic testing, and high-quality anatomic pathology laboratory services. These services provide physicians and patients with actionable diagnostic information to enhance patient care. The company is also focused on developing cancer treatment drugs using a novel nanoencapsulation and targeted therapy platform, aiming to transform from a genomic diagnostic business into a fully integrated precision medicine company.