Fulgent Data at ASCO 2023 Highlights Progress for Its Lead Therapeutic Oncology Candidate, FID-007, in Various Cancers

Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the “Company”), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, today 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).

Commenting on the data, Ming Hsieh, Chairman of the Board and Chief Executive Officer, said, “We are pleased with the progress we are making with the clinical program for FID-007 and this encouraging data, that FID-007 may potentially address a number of unmet needs in various cancers. We look forward to next steps with this program, including initiation of a Phase 2 clinical study for the treatment of head and neck cancer later this year or early next year.”

The poster is available on the News & Events section of the company’s Investor Relations website at https://ir.fulgentgenetics.com/.

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.

About Fulgent Pharma

Fulgent Pharma has developed and possesses a novel nanoencapsulation technology which includes over 40 patents and a targeted therapy platform designed to improve the therapeutic window and pharmacokinetic profile of both new and existing cancer drugs. Fulgent Pharma began as Fulgent Therapeutics in Temple City, California, in June 2011. As the company progressed into the sphere of personalized medicine, it also started delving into clinical genetic testing—a natural complement. In 2016, Fulgent Therapeutics split into two separate entities—Fulgent Pharma and Fulgent Genetics—in order to better pursue their independent objectives. Today, Fulgent Pharma is fully focused on perfecting drug candidates for treating a broad range of cancers. Its partners in this endeavor include the University of Southern California, Moffitt Cancer Center, and ANP Technologies.