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 two poster presentations being
presented tomorrow, November 4, 2023, at the Society for
Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego,
CA.
“These data support our mission to build a holistic platform to
provide comprehensive solutions and services across the cancer care
continuum, including early detection, diagnostics, and monitoring,
as well as drug discovery and development,” said Ming Hsieh,
Chairman and CEO of Fulgent Genetics and co-founder of Fulgent
Therapeutics. “We see strong momentum in our precision diagnostics
business as a driver of core revenue, and we are encouraged by the
steady progress of our therapeutic development for FID-007 in
oncology indications.”
The poster titled, “Critical clinical evaluation of plasma to
tumor tissue concordance by cancer type using Illumina’s cell-free
ctTSO500 commercial liquid biopsy assay,” explores the critical
role of comparing ctDNA variants detected in plasma with those
found in tissue, shedding light on the practical implementation of
liquid biopsy technology. The research presents a meticulous
analysis of plasma-to-tissue concordance across various cancer
types, offering valuable insights into the considerations for
validation, using Illumina's cutting-edge ctTSO500 commercial
liquid biopsy assay. The clinical research findings, based on a
comprehensive examination of 124 cases across different cancers,
reveal significant concordance variations, often linked to the
cancer stage and the timing of biopsy and blood sample collection.
In uterine cancers, the researchers detected 65.9% of the SNV/indel
variants in plasma that were also in FFPE, 47% in colon cancer, 67%
in gastric cancer, 56% in bladder cancer, 51% in larynx cancer, and
41% in prostate. The study calls for the involvement of certified
labs, highlighting the need for stringent quality management and
regulatory alignment. The research ultimately underscores the
reproducibility, sensitivity, and practical importance of
Illumina's ctTSO500 liquid biopsy, particularly for patients who
either cannot or prefer not to undergo traditional solid biopsies
for cancer screening.
The poster titled, “FID-007: Nanoencapsulated Paclitaxel Derived
from a Novel Nano-Drug Delivery Platform,” highlights progress for
Fulgent Pharma’s lead therapeutic oncology candidate, FID-007, in
various cancers. Similar to data presented at the ASCO Annual
Meeting in June, of 40 evaluable patients with weekly dose levels
from 15 mg/m2 to 160 mg/m2, 7 (18%) had a partial response (PR) 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. Preliminary clinical data
suggests FID-007 may have anti-tumor activity in heavily
pre-treated patients across various tumor types. Based on the lack
of adverse events, pharmacokinetics, and early indications of
treatment effect, 125 mg/m2 has been chosen as the recommended
Phase 2 dose. In addition, subgroup analysis based on 7 patients
for Head and Neck cancer and 4 patients for Ampullary/Pancreatic
cancer showed 57% and 50% objective response rate,
respectively.
The posters will be available on the Investor Relations section
of the company’s website at
https://ir.fulgentgenetics.com/presentations.
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.
About Fulgent
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;
guidance regarding expected quarterly and annual financial results,
core revenues, GAAP loss, and non-GAAP loss; evaluations and
judgments regarding the stability of certain revenue sources,
momentum, vision, future opportunities and future growth the
Company’s testing services and technologies and expansion; the
Company’s identification and evaluation of opportunities and its
ability to capitalize on opportunities, capture market share, or
expand its presence in certain markets; and the Company’s ability
to continue to grow its business.
Forward-looking statements are statements other than historical
facts and relate to future events or circumstances or the Company’s
future performance, and they are based on management’s current
assumptions, expectations, and beliefs concerning future
developments and their potential effect on the Company’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 market potential
for, and the rate and degree of market adoption of, the Company’s
tests, including its Beacon787 panel; its ability to maintain
turnaround times and otherwise keep pace with rapidly changing
technology; the Company’s ability to maintain the low internal
costs of its business model; the Company’s ability to maintain an
acceptable margin; risks related to volatility in the Company’s
results, which can fluctuate significantly from period to period;
risks associated with the composition of the Company’s customer
base, which can fluctuate from period to period and can be
comprised of a small number of customers that account for a
significant portion of the Company’s revenue; the Company’s level
of success in obtaining coverage and adequate reimbursement and
collectability levels from third-party payors for its tests and
testing services; the Company’s level of success in establishing
and obtaining the intended benefits from partnerships, strategic
investments, joint ventures, acquisitions, or other relationships;
the success of the Company’s development efforts, including the
Company’s ability to progress its candidates through clinical
trials on the timelines expected; the Company’s compliance with the
various evolving and complex laws and regulations applicable to its
business and its industry; and the Company’s 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 the Company assumes
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.
The Company’s reports filed with the U.S. Securities and
Exchange Commission, or the SEC, including its annual report on
Form 10-K for the year ended December 31, 2022, filed with the SEC
on February 28, 2023, and the other reports it files from time to
time, including subsequently filed annual, quarterly and current
reports, are made available on the Company’s website upon their
filing with the SEC. These reports contain more information about
the Company, its business and the risks affecting its business, as
well as its results of operations for the periods covered by the
financial results included in this press release.
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version on businesswire.com: https://www.businesswire.com/news/home/20231103002198/en/
Investor Relations Contact The Blueshirt Group Melanie
Solomon, melanie@blueshirtgroup.com
Fulgent Genetics (NASDAQ:FLGT)
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