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 the first patient has been dosed in a
Phase 1 clinical trial evaluating the safety and tolerability of
its anti-CTLA-4 oncology drug, GIGA-564, for the treatment of
metastatic or locally advanced solid tumors.
“The initiation of this Phase 1 trial with
GIGA-564 marks a significant milestone as it is GigaGen’s first
oncology asset to enter the clinic,” said Carter Keller, senior
vice president of Grifols and head of GigaGen. “We look forward to
potentially translating the superior anti-tumor performance and
reduced immune-related toxicity observed with GIGA-564 in
pre-clinical studies into the clinical setting. There is a pressing
need for innovative therapies for solid tumors and we believe
GIGA-564 has the potential to improve outcomes for patients.”
The trial is being conducted by researchers at
the National Cancer Institute (NCI), part of the National
Institutes of Health, in close partnership
with GigaGen. For more information about the trial, refer
to clinicaltrials.gov identifier: NCT06258304. For
patients interested in enrolling in this clinical trial, please
call NCI’s toll-free number: 1-800-4-Cancer (1-800-422-6237) (TTY:
1-800-332-8615); visit the website: https://trials.cancer.gov;
and/or email: NCIMO_referrals@mail.nih.gov.
About GIGA-564
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.
About Grifols
Grifols 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 23,000 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 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:Mollie Godbout
LifeSci Communicationsmgodbout@lifescicomms.com
Grifols Press
Officemedia@grifols.comTel. +34 93 571 00 02
LEGAL DISCLAIMER
The 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.