GigaGen Granted Expansion of Contract with US Department of Defense to Develop Synthetic Human Antibody Treatments for Botulinum Neurotoxins

Modified agreement expands total grant value to $11.8M to advance development activities including manufacturing and investigational new drug (IND)-enabling studies

SOUTH SAN FRANCISCO, Calif., Oct. 19, 2023 (GLOBE NEWSWIRE) -- 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 the company has been granted an expansion of its contract with the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to develop synthetic human antibody treatments for botulinum neurotoxins.

The modification, awarded through Army Contracting Command, will expand the value of the agreement to $11.8M. The expanded contract will leverage GigaGen’s novel platform capabilities to rapidly create synthetic human antibodies to protect the warfighter against botulinum neurotoxins (BoNT) A and B and will support advanced development activities including manufacturing and IND-enabling studies to demonstrate improved potency and military utility.

“We are very happy to have received this expansion of our initial contract, which affirms DOD’s confidence in our technology and approach and its commitment to support the development of the BoNT hyperimmune product through clinical development,” said Carter Keller, a senior vice president at Grifols and head of GigaGen. “We are proud of this partnership which will further support the development of our pipeline and platform capabilities and will contribute to the development of key therapeutics against high-priority pathogens.”

GigaGen’s next-generation hyperimmune platform offers a novel way to develop recombinant (synthetic) 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 will create cell lines that express recombinant human antibodies against BoNT A and B. The polyclonal cell bank can then be used to continuously manufacture the BoNT A & B hyperimmune product at existing manufacturing facilities.

This effort will demonstrate an accelerated, target-specific therapeutic manufacturing platform’s ability to rapidly create and express polyclonal antibody cell banks against BoNT A and B. It will also confirm if rapid manufacturing timelines will support the JPEO-CBRND’s preparedness goals and ability to deliver timely capabilities against a known or emerging threat.

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 more than 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 in vivo 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 Communications
mroucomolina@lifescicomms.com
Tel: +1-929-469-3850

Grifols Press Office:
media@grifols.com
Tel. +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.


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