GigaGen Inc., a biotechnology company advancing transformative
antibody drugs for immunodeficiencies, infectious diseases and
checkpoint resistant cancers, and a subsidiary of Grifols,
announced today that the United States Food and Drug Administration
(FDA) has cleared its Investigational New Drug (IND) application to
initiate a Phase 1 trial to evaluate the company’s first
recombinant polyclonal drug for the treatment of hepatitis B virus
(HBV) infection, GIGA-2339.
"FDA clearance of our IND application marks a significant
milestone as part of Grifols’ commitment to develop transformative
antibody drugs for infectious diseases," said Carter Keller, senior
vice president of Grifols and head of GigaGen. "Patients
experiencing chronic HBV live with ongoing complications and
commonly progress to hepatocellular carcinoma and cirrhosis. With
over 1,000 different HBV-targeted antibodies in the mixture,
GIGA-2339 is unlike any therapy currently in development. We look
forward to initiating our trial in late 2024 and showcasing the
clinical potential of our recombinant polyclonal antibody platform,
starting with HBV."
Despite currently available therapies and vaccines, HBV affects
more than 296 million people worldwide, resulting in more than
800,000 deaths each year.1 Currently there is no cure, as existing
drugs can halt viral replication but only minimally reduce the
levels of viral protein.
Developed using GigaGen’s next-generation platform, GIGA-2339
consists of more than 1,000 anti-HBV antibodies developed in the
laboratory by capturing and then reproducing the natural antibody
response from donors who have been vaccinated against HBV.
GIGA-2339 is over 2,000 times more potent than plasma-derived HBV
drugs and covers the large diversity of circulating HBV variants.
In mouse models, GIGA-2339 neutralized and cleared HBV's viral DNA
along with its antigens. Through this unique mechanism of action,
GIGA-2339 has the potential to clear viral particles and activate
the immune response to provide functional cure for people living
with HBV.
The Phase 1 dose escalation clinical trial is designed to assess
the safety and tolerability of GIGA-2339 in patients with confirmed
HBV infection.
1WHO
(https://www.who.int/news-room/fact-sheets/detail/hepatitis-b)
About GigaGen’s platformGigaGen’s
next-generation hyperimmune platform offers a novel way to develop
recombinant polyclonal antibody therapeutics in the laboratory
which are potentially more powerful than what a natural immune
response can provide. Using high-throughput, single-cell genomic
and protein engineering technology, GigaGen creates cell lines that
express recombinant human antibodies against a diversity of
infectious disease antigens, including HBV. The polyclonal cell
bank can then be used to continuously manufacture hyperimmune
products against the pathogen of interest at existing manufacturing
facilities.
About GrifolsGrifols is a global healthcare
company founded in Barcelona in 1909 committed to improving the
health and well-being of people around the world. A leader in
essential plasma-derived medicines and transfusion medicine, the
company develops, produces, and provides innovative healthcare
services and solutions in more than 110 countries.
Patient needs and Grifols’ ever-growing knowledge of many
chronic, rare and prevalent conditions, at times life-threatening,
drive the company’s innovation in both plasma and other
biopharmaceuticals. The company is focused on treating conditions
across a broad range of therapeutic areas: immunology, hepatology
and intensive care, pulmonology, hematology, neurology, and
infectious diseases.
A pioneer in the plasma industry, Grifols continues to grow its
network of donation centers, the world’s largest with over 390
across North America, Europe, Africa and the Middle East, and
China.
As a recognized leader in transfusion medicine, Grifols offers a
comprehensive portfolio of solutions designed to enhance safety
from donation to transfusion, in addition to clinical diagnostic
technologies. It provides high quality biological supplies for
life-science research, clinical trials, and for manufacturing
pharmaceutical and diagnostic products. The company also supplies
tools, information and services that enable hospitals, pharmacies
and healthcare professionals to efficiently deliver expert medical
care.
Grifols, with more than 24,000 employees in more than 30
countries and regions, is committed to a sustainable business model
that sets the standard for continuous innovation, quality, safety,
and ethical leadership.
The company’s class A shares are listed on the Spanish Stock
Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols
non-voting class B shares are listed on the Mercado Continuo
(MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).
GigaGen is advancing transformative antibody drugs for
immunodeficiencies, infectious diseases and checkpoint resistant
cancers by leveraging industry-leading, single-cell technologies.
Its novel technology platforms uniquely capture and recreate
complete immune repertoires as functional antibody libraries. This
approach has enabled the creation of first-in-class recombinant
polyclonal antibody therapies for the treatment of infectious
diseases. In addition, GigaGen’s lead oncology asset, GIGA-564, is
an anti-CTLA-4 monoclonal antibody that has demonstrated improved
anti-tumor efficacy and reduced toxicities in preclinical models
through a unique mechanism of action.
For more information, please
visit www.grifols.com or www.gigagen.com.
Media Contacts:Monica Rouco Molina, Ph.D.
LifeSci Communicationsmroucomolina@lifescicomms.com Tel:
+1-929-469-3850
Grifols Press Officemedia@grifols.comTel. +34
93 571 00 02
LEGAL DISCLAIMERThe facts and
figures contained in this report that do not refer to historical
data are “future projections and assumptions”. Words and
expressions such as “believe”, “hope”, “anticipate”, “predict”,
“expect”, “intend”, “should”, “will seek to achieve”, “it is
estimated”, “future” and similar expressions, in so far as they
relate to the Grifols group, are used to identify future
projections and assumptions. These expressions reflect the
assumptions, hypotheses, expectations and predictions of the
management team at the time of writing this report, and these are
subject to a number of factors that mean that the actual results
may be materially different. The future results of the Grifols
group could be affected by events relating to its own activities,
such as a shortage of supplies of raw materials for the manufacture
of its products, the appearance of competitor products on the
market, or changes to the regulatory framework of the markets in
which it operates, among others. At the date of compiling this
report, the Grifols group has adopted the necessary measures to
mitigate the potential impact of these events. Grifols, S.A. does
not accept any obligation to publicly report, revise or update
future projections or assumptions to adapt them to events or
circumstances subsequent to the date of writing this report, except
where expressly required by the applicable legislation. This
document does not constitute an offer or invitation to buy or
subscribe shares in accordance with the provisions of the following
Spanish legislation: Royal Legislative Decree 4/2015, of 23
October, approving recast text of Securities Market Law; Royal
Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4
November, and any regulations developing this legislation. In
addition, this document does not constitute an offer of purchase,
sale or exchange, or a request for an offer of purchase, sale or
exchange of securities, or a request for any vote or approval in
any other jurisdiction. The information included in this document
has not been verified nor reviewed by the external auditors of the
Grifols group.
Eagle Capital Growth (AMEX:GRF)
Historical Stock Chart
From Sep 2024 to Oct 2024
Eagle Capital Growth (AMEX:GRF)
Historical Stock Chart
From Oct 2023 to Oct 2024