SIGA Announces Preclinical Oncology Research Collaboration with Bioarchitech

NEW YORK, Jan. 25, 2022 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that it entered into a collaboration with Bioarchitech, a United Kingdom-based biotech company developing immunotherapy for the treatment of cancer. The research collaboration will investigate TPOXX^® (tecovirimat) in combination with Bioarchitech’s proprietary vaccinia-based immunotherapy platform in preclinical studies. This platform utilizes engineered antibodies and other proteins expressed within the genome of an oncolytic virus. Cancer cells infected by the vaccinia virus release these potent immunotherapy molecules into the tumor where they orchestrate the destruction of malignant cells using the patient’s own immune system.

“TPOXX has potential as a powerful tool to better enable success of vaccinia-based immunotherapies,” said Dr. Phil Gomez, CEO of SIGA. “TPOXX, a potent antiviral drug to vaccinia, could potentially increase the immunotherapeutic effect of such therapies by allowing the safe use of higher doses of vaccinia vectors. We are pleased to enter into this collaboration with Bioarchitech, an innovator of next generation cancer immunotherapies.”

“The vision of definitive treatment for cancer by harnessing the power of the immune system is gradually coming into view through the combination of oncolytic viruses with immune mediators,” said Prof Geoff Hale, Managing Director of Bioarchitech. “Vaccinia virus offers unique advantages because of its ability to carry a large payload and target a wide variety of tumor types. We are excited about the prospect of using TPOXX to enable delivery of larger doses which is critical for the effective use of new oncolytic therapies.”

On July 13, 2018, the U.S. Food and Drug Administration (FDA) approved oral TPOXX for the treatment of smallpox to mitigate the impact of a potential outbreak or bioterror attack. In preclinical studies, TPOXX has been shown to be active against most orthopoxviruses, including vaccinia (published in NEJM, 2018). The unique mechanism of action of TPOXX coupled with published efficacy in animal studies, make it an important addition to development programs focused on vaccinia-based cancer therapies. In 2020, SIGA entered into a collaboration with Turnstone Biologics to supply TPOXX to support Turnstone’s proprietary oncolytic vaccinia immunotherapy clinical programs.

ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®

SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX is a novel small-molecule drug and the US maintains a supply of TPOXX under Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018. The full label is available by clicking here. Oral tecovirimat received approval from the European Medicines Agency (EMA) in 2022. The EMA approval includes labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox. The full label is available by clicking here. In September 2018, SIGA signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, for additional procurement and development related to both oral and intravenous formulations of TPOXX. For more information about SIGA, please visit www.siga.com.

ABOUT BIOARCHITECH LTD.

Bioarchitech is developing innovative oncolytic viruses and co-therapies to overcome the challenges of using immunotherapy to treat common cancers. It is doing this by developing potent transgenes encoded within vaccinia virus designed to prime anti-tumor immune responses. Bioarchitech is backed by a syndicate of private investors and has collaborations underway with innovative biotechnology companies to meet the challenges of cancer. Bioarchitech is a preclinical stage research and development company based within the University of Oxford’s BioEscalator at the heart of the research campus in Oxford, UK. For more information, visit www.bioarchitech.com.

About Smallpox

Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years. Naturally-occurring smallpox was eradicated worldwide by 1980, the result of an unprecedented global immunization campaign. Samples of smallpox virus have been kept for research purposes. This has led to concerns that smallpox could someday be used as a biological warfare agent. A vaccine can prevent smallpox, but the risk of the current vaccine's side effects is too high to justify routine vaccination for people at low risk of exposure to the smallpox virus.

FORWARD-LOOKING STATEMENTS

This press release contains certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. More detailed information about SIGA and risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this press release, is set forth in SIGA's filings with the Securities and Exchange Commission, including SIGA's Annual Report on Form 10-K for the fiscal year ended December 31, 2020, and in other documents that SIGA has filed with the SEC. SIGA urges investors and security holders to read those documents free of charge at the SEC's web site at http://www.sec.gov. Interested parties may also obtain those documents free of charge from SIGA. Forward-looking statements are current only as of the date on which such statements were made, and except for our ongoing obligations under the United States of America federal securities laws, we undertake no obligation to update publicly any forward-looking statements whether as a result of new information, future events, or otherwise.

The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.

Contacts:

Investor Contact
Laine Yonker, Edison Group
lyonker@edisongroup.com

Michael Crawford, Edison Group
mcrawford@edisongroup.com

Bioarchitech Ltd.
Kevin Maskell, Bioarchitech Limited
Kevin.maskell@bioarchitech.com