Fulgent Data at ASCO 2024 Highlights Antitumor Activity from Lead Therapeutic Oncology Candidate, FID-007, in Head and Neck Cancer

Rhea-AI Summary

Fulgent Pharma, a subsidiary of Fulgent Genetics (NASDAQ: FLGT), presented Phase 1 clinical data on FID-007, its lead therapeutic oncology candidate, at the ASCO Annual Meeting on June 2, 2024. The study involved 11 patients with head and neck squamous cell carcinoma (HNSCC). Results showed a 45% partial response (PR) rate and a 27% stable disease (SD) rate. Three out of five patients with PR had previously been treated with taxane. The follow-up duration ranged from 1 to 15 months, and no high-grade neuropathy was observed. FID-007 demonstrated preliminary antitumor activity and lower toxicity. Fulgent has initiated a Phase 2 study of FID-007 in combination with cetuximab for HNSCC patients.

Positive

• 45% partial response rate and 27% stable disease rate in Phase 1 study.
• No high-grade neuropathy observed among patients.
• Initiation of Phase 2 study with FID-007 in combination with cetuximab.
• Preliminary data suggest lower toxicity and improved treatment tolerance.

Negative

• follow-up duration with a median of 4.0 months.
• Small sample size of only 11 patients in the Phase 1 study.

Oncology Doctor

From an oncology perspective, the preliminary Phase 1 data on FID-007 presented at ASCO 2024 shows promising antitumor activity in heavily pre-treated head and neck squamous cell carcinoma (HNSCC) patients. Partial responses in 45% of the evaluable patients and stable disease in 27% suggest that FID-007 could offer a meaningful clinical benefit. Particularly notable is the reported lack of high-grade neuropathy, a common and severe side effect associated with many cancer treatments. This suggests that FID-007 might offer a better tolerability profile, which is a significant advantage for patients who have already endured aggressive treatments.

However, it is essential to approach these results with caution as they are from a Phase 1 trial, primarily designed to assess safety rather than efficacy. The ongoing Phase 2 trials will provide more robust data on FID-007's effectiveness and further clarify its safety profile. Still, the early results are encouraging and worth monitoring closely as they could significantly impact treatment options for HNSCC patients.

Financial Analyst

From a financial standpoint, the announcement of Phase 1 clinical data for FID-007 at the ASCO 2024 meeting is a positive development for Fulgent Genetics, Inc. The data indicates a 45% overall response rate, which is promising for a drug in such an early stage of development. The initiation of Phase 2 trials shows progression in the pipeline, potentially increasing investor confidence. However, it's vital to note that early-phase clinical trials carry significant risks and the translation of Phase 1 success to subsequent phases is not guaranteed.

With Fulgent Pharma aiming at a niche segment within oncology, the results will likely boost investor sentiment in the short term. Nevertheless, long-term sustainability hinges on continued positive outcomes, regulatory approvals and eventual market adoption. Investors should monitor future updates closely, especially those concerning the Phase 2 trial's results, as these will be important for Fulgent's valuation and potential revenue growth from FID-007.

Medical Research Analyst

As a medical research analyst, it’s important to contextualize the data presented for FID-007. The fact that three out of five partial responders had prior taxane treatment suggests that FID-007 might offer an effective option for patients who have limited choices after standard treatments fail. The durability of responses, with a median follow-up of 4 months, also adds a layer of credibility to these results, though longer follow-up is needed to assess sustained efficacy.

The lack of high-grade neuropathy reported so far is a positive sign, potentially translating into better quality of life for patients undergoing treatment. As the Phase 2 study progresses, it will be important to monitor any emerging side effects, as larger populations often reveal less common adverse events. The combination with cetuximab is particularly interesting, as it could open up combination therapies that might further enhance efficacy.

EL MONTE, Calif.--(BUSINESS WIRE)-- Fulgent Pharma, a subsidiary of Fulgent Genetics, Inc. (NASDAQ: FLGT) and a leading nanobiotechnology company specializing in innovative cancer therapeutics, today announced 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) Annual Meeting on June 2, 2024 in Chicago, Illinois.

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 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 began as part of Fulgent LLC in Temple City, California, established in June 2011. As the company progressed into the sphere of precision medicine, it also started delving into clinical genetic and genomic testing - a natural complement. In 2016, Fulgent LLC split into two separate entities - Fulgent Pharma and Fulgent Genetics - in order to better pursue their independent objectives. In 2022, Fulgent Pharma was acquired by Fulgent Genetics to synergistically advance personalized cancer genomics and precision oncology therapeutics. 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. For more information visit FulgentGenetics.com.

About Fulgent Genetics

Fulgent is a technology-based company with a well-established clinical diagnostic business and a therapeutic development business. Fulgent’s clinical diagnostic business offers molecular diagnostic testing services, comprehensive genetic testing, and high-quality anatomic pathology laboratory services designed to provide physicians and patients with clinically actionable diagnostic information to improve the quality of patient care. Fulgent’s therapeutic development business is focused on developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform designed to improve the therapeutic window and pharmacokinetic profile of new and existing cancer drugs. The Company aims to transform from a genomic diagnostic business into a fully integrated precision medicine company.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include statements about, among other things: future performance; Fulgent Pharma’s research and development efforts, including any implications that the results of earlier clinical trials will be representative or consistent with later clinical trials, the expected timing of enrollment and regulatory filings for these trials and the availability of data or results of these trials, including any implication that interim or preliminary data will be representative of final results. Forward-looking statements are statements other than historical facts and relate to future events or circumstances or Fulgent Pharma’s future performance, and they are based on management’s current assumptions, expectations, and beliefs concerning future developments and their potential effect on Fulgent Pharma’s business. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the success of Fulgent Pharma’s development efforts, including its ability to progress its candidates through clinical trials on the timelines expected; its compliance with the various evolving and complex laws and regulations applicable to its business and its industry; and its ability to protect its proprietary technology and intellectual property. As a result of these risks and uncertainties, forward-looking statements should not be relied on or viewed as predictions of future events.

The forward-looking statements made in this press release speak only as of the date of this press release, and Fulgent Pharma and Fulgent Genetics assume no obligation to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required by law.

Fulgent Genetics, Inc.’s reports filed with the U.S. Securities and Exchange Commission, or the SEC, including its annual report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 28, 2024, and the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, are made available on the Fulgent Genetics’ website upon their filing with the SEC. These reports contain more information about Fulgent Genetics and Fulgent Pharma, their business and the risks affecting their business.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240603406357/en/

Investor Relations Contact

The Blueshirt Group

Melanie Solomon, melanie@blueshirtgroup.com

Source: Fulgent Pharma

FAQ

What is the stock symbol for Fulgent Pharma?

The stock symbol for Fulgent Pharma's parent company, Fulgent Genetics, is FLGT.

What were the results of the Phase 1 study of FID-007 presented at ASCO 2024?

The Phase 1 study showed a 45% partial response rate and a 27% stable disease rate among HNSCC patients, with no high-grade neuropathy observed.

When and where was the FID-007 study data presented?

The data was presented at the ASCO Annual Meeting on June 2, 2024, in Chicago, Illinois.

Has Fulgent Pharma started a Phase 2 study for FID-007?

Yes, Fulgent Pharma has begun enrollment for a Phase 2 study of FID-007 in combination with cetuximab for HNSCC patients.

What is the overall response rate of FID-007 in the Phase 1 study?

FID-007 showed an overall response rate of 45% in heavily pre-treated HNSCC patients.

What type of cancer is FID-007 being tested for?

FID-007 is being tested for head and neck squamous cell carcinoma (HNSCC).