GigaGen Inc., a biotechnology company advancing
transformative antibody drugs for immune deficiencies, infectious
diseases and checkpoint resistant cancers, and a subsidiary of
Grifols, announced today that it has signed an agreement with the
National Cancer Institute (NCI), part of the National Institutes of
Health, to advance development of the company’s differentiated
anti-CTLA-4 antibody drug candidate for cancer treatment, GIGA-564.
This Cooperative Research and Development Agreement enables
further preclinical and clinical studies to assess GIGA-564's
potential across various tumor types, including the first in-human
Phase 1 clinical trial for the drug candidate in advanced solid
tumors.
“We are proud to receive the NCI’s support and partner with
their esteemed clinical research team to drive the GIGA-564 program
forward,” said Carter Keller, senior vice president of Grifols and
head of GigaGen. “GIGA-564 represents a new approach to designing
anti-CTLA-4 agents with potential not only to enhance anti-tumor
activity but also to mitigate immune-related toxicities typically
associated with first generation anti-CTLA-4 therapies. We look
forward to continuing to demonstrate its potential in a clinical
setting as we plan to file the IND application for our first Phase
1 clinical trial in advanced solid tumors before the end of
2023.”
This agreement signifies a milestone for GigaGen, as GIGA-564
could be the company's first oncology candidate to reach clinical
stage.
GIGA-564, a fully human monoclonal antibody, distinguishes
itself from currently available anti-CTLA-4 drugs. Previous
anti-CTLA-4 drugs were designed to strongly block CTLA-4's
interaction with its ligands, thereby enhancing T cell
co-stimulation. However, this approach has been associated with
heightened immune-related side effects.
Moreover, recent insights reveal that previous anti-CTLA-4 drugs
contribute to an increased proliferation of T regulatory cells
(Tregs), which may dampen their intended effect of activating
cytotoxic T cells that are vital for attacking tumors. In
comparison, GIGA-564's uniqueness stems from its minimal CTLA-4
blockade and its ability to deplete intratumoral Tregs within the
tumor microenvironment. This distinctive mode of action has
translated into superior anti-tumor performance and reduced
immune-related toxicity in preclinical models, distinguishing it
from commercially available anti-CTLA-4 drugs.
The initiative will be spearheaded by distinguished NCI
researchers James L. Gulley, M.D., Ph.D. and Jeffrey Schlom, Ph.D.,
in close partnership with GigaGen’s team. The program will draw
upon the extensive infrastructure and established scientific and
clinical expertise in oncology drug development from the Center for
Immuno-Oncology of the NCI Center for Cancer Research. As part of
the agreement, the NCI will conduct the Phase 1 clinical study of
GIGA-564 in advanced solid tumors. GigaGen will be the IND sponsor
and will provide the clinical-grade GIGA-564 material. The NCI will
conduct additional preclinical studies and potential clinical
studies of GIGA-564 as a monotherapy or in combination with other
therapies.
GigaGen and NCI will present IND-enabling data and the clinical
trial plan for GIGA-564 at the 2023 SITC Annual Meeting, to be held
in San Diego, Calif., on November 1-5, 2023. Presentation details
are below:
Title: Non-clinical results and design of
First-in-Human study for GIGA-564, a third-generation anti-CTLA-4
monoclonal antibodyPoster #: 1380
Presenter: Erica L. Stone, Ph.D.
Date: Saturday, Nov. 4, 2023
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 to enhance quality of life. Grifols 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.
In 2022, Grifols’ economic impact in its core countries of
operation was EUR 9.6 billion. The company also generated 193,000
jobs, including indirect and induced.
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 immune deficiency, 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,
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any other jurisdiction. The information included in this document
has not been verified nor reviewed by the external auditors of the
Grifols group.
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