Fulgent Data at ASCO 2023 Highlights Progress for Its Lead Therapeutic Oncology Candidate, FID-007, in Various Cancers
05 Juin 2023 - 2:30PM
Business Wire
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.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230605005253/en/
Investor Relations The Blueshirt Group Melanie Solomon,
melanie@blueshirtgroup.com
Fulgent Genetics (NASDAQ:FLGT)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Fulgent Genetics (NASDAQ:FLGT)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024