Kineta Initiates First-in-Human Clinical Trial of LHF-535 a Novel Therapy for Lassa Fever

Phase 1 study to assess the safety, tolerability and pharmacokinetic profile of LHF-535 in healthy volunteers

No therapy or vaccine currently approved for use in Lassa fever

Seattle, WA, September 5, 2018 – Kineta, Inc., an emerging biotechnology company focused on the development of novel immunotherapies and antiviral drugs announced today the initiation of a first-in-human, Phase 1a clinical trial of its antiviral drug LHF-535 to treat Lassa hemorrhagic fever. Lassa fever is an acute, viral illness endemic in West Africa that causes an estimated 100,000-300,000 infections and up to 5,000 deaths annually.¹

The main objectives of the Phase 1a clinical study are to assess the safety, tolerability and pharmacokinetic profile of LHF-535 in healthy subjects. This single-ascending dose (SAD) study will be conducted in up to 56 healthy subjects randomized into 5-7 cohorts of 8 subjects each.  Results of the SAD clinical study are expected in the first quarter of 2019.  A Phase 1b multiple-ascending dose (MAD) clinical study is planned to commence in 2019 following the completion of the Phase 1a study.

“We are very excited to initiate the first-in-human study of our lead drug candidate LHF-535, a first-in-class antiviral for Lassa fever”, said Kineta CEO, Shawn Iadonato.  “The recent outbreaks of Ebola and Zika viruses remind us of the critical need to develop new therapies for neglected tropical diseases and biodefense threats like Lassa fever. We were also pleased that the FDA recently added Lassa fever to the Tropical Disease Priority Review Voucher Program, further validating the need for an effective therapy”.²

LHF-535 is an oral antiviral with potent activity against Lassa fever and other arenaviruses, as demonstrated in preclinical studies. Its mechanism of action involves inhibiting virus entry into target host cells and suppressing viral replication. LHF-535 was well-tolerated in preclinical studies and reduced virus titers and enhanced survival in animal models of Lassa fever.

Kineta received a Wellcome Trust Translation Fund Award of up to $7.2 M in 2016 to advance the development of LHF-535 to treat Lassa fever though Phase 1 clinical studies.

References:

1. US CDC. Lassa fever: fact sheet (09/04/2018)

https://www.cdc.gov/vhf/lassa/pdf/factsheet.pdf

2. FDA addition of Lassa fever to Tropical Disease Priority Review Voucher Program https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm534162.htm

Kineta, Inc. is an emerging biotechnology company that is focused on the translational development of first-in-class therapies from discovery to proof of concept.  Kineta is developing a focused pipeline of novel drug candidates that address critical unmet patient needs in neuroscience, immuno-oncology and biodefense. We actively collaborate with a broad array of private, government, biodefense and industry partners to advance our innovative research. Development of LHF-535 for Lassa fever is through Kineta Inc.’s subsidiary Kineta Viral Hemorrhagic Fever, LLC. For more information on Kineta, Inc. visit our website, www.kinetabio.com.

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NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Kineta’s plans for pre-clinical and clinical studies, regulatory filings, and anticipated drug effects in human subjects. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Kineta’s business which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and Kineta undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

Contact Jacques Bouchy

jbouchy@kineta.us

(206) 378-0400