SAN DIEGO, December 3, 2020 – Qpex Biopharma, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of innovative anti-infective therapies, announced today that it has initiated a Phase 1 clinical study of QPX7728, its novel ultra-broad-spectrum beta-lactamase inhibitor.

“Today marks another important milestone for Qpex as we begin advancing 3 novel product candidates into clinical trials during the coming months”, said Michael Dudley, Pharm.D., President and CEO of Qpex Biopharma. “We believe that QPX7728 has demonstrated a preclinical profile that exceeds that of recently marketed beta-lactamase inhibitors as well as those in ongoing clinical trials. Our team, consisting of scientists and clinicians that rapidly brought the first agent from the cyclic boronic acid class from discovery to patients during the last decade, is poised to rapidly advance QPX7728 in the clinic with the continued support of our partners”.

The Phase 1 study will investigate the safety and pharmacokinetics of QPX7728 alone following single and multiple intravenous doses, and in combination with a beta-lactam antibiotic in healthy adult subjects.

About QPX7728

QPX7728 is an ultra-broad-spectrum beta-lactamase inhibitor discovered by Qpex scientists.  Beta-lactamases are bacterial enzymes that destroy beta-lactam antibiotics and are the major mechanism of resistance to these drugs in gram-negative bacteria.  Unlike other inhibitors, QPX7728 inhibits serine- and metallo-beta lactamases of Classes A, B, C, and D in Acinetobacter spp., Pseudomonas aeruginosa, and Enterobacteriaceae. QPX7728 is also active against beta-lactamases that are resistant to inhibition by avibactam. This spectrum of inhibition, coupled with a low sensitivity of QPX7728 to multi-drug resistance mechanisms like efflux and permeability as compared to other agents, allows QPX7728 to restore the potency of multiple beta-lactam antibiotics against drug-resistant Acinetobacter spp., Pseudomonas aeruginosa, and Enterobacteriaceae.  QPX7728 can be delivered by oral or intravenous administration.

QPX7728 is an integral part of a portfolio of products being developed to comprehensively address patient needs associated with drug-resistant gram-negative infections and currently enables two product candidates in the Qpex pipeline:

·       OMNIvance^?: an IV-administered QPX7728-based product with best-in-class coverage of key pathogens, including carbapenem-resistant Acinetobacter, Enterobacteriaceae and Pseudomonas.

·       ORAvance^?: an orally-administered combination product based on QPX7728 to treat infections that occur in the outpatient and community setting caused by drug-resistant gram-negative bacteria, including extended-spectrum beta-lactamase (ESBL)- and carbapenemase-producing Enterobacteriaceae.

About Biomedical Advanced Research and Development Authority (BARDA) Partnership

Qpex scientists and clinicians have an extensive track-record of successfully working with public-private partnerships, including partnerships with BARDA that led to the first approved antimicrobial drug product under that program in 2017.  The advancement of QPX7728 into the clinic is part of Qpex’s current partnership with BARDA that is focused on advancing a portfolio of novel antibiotics, including the QPX7728-based products OMNIvance and ORAvance. The development of the products in this portfolio is funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under OTA number HHSO100201600026C. The agreement provides for up to $132 million in support for the development of a portfolio of new antibiotics to fight drug-resistant gram-negative infections.

About Brii Biosciences Partnership

Qpex Biopharma and Brii Biosciences have entered into a strategic collaboration to develop and commercialize three of Qpex’s investigational products, including QPX7728-based products,  to treat a range of multi-drug resistant gram-negative infections in greater China.  Under the terms of the agreement, Brii obtained a license to develop, manufacture, and commercialize these products in greater China, which includes Taiwan, Hong Kong, Macau and the People’s Republic of China. Qpex retained all other rights globally, including the U.S. and Europe.  In addition to the initial upfront payment, Brii will make success-based development, regulatory and commercial milestone payments, and share in the costs of a global development program.  Qpex will also receive tiered royalties on sales in the Brii territory.

About Antimicrobial Resistance (AMR)

In 2019, the US Center for Disease Control and Prevention (CDC) estimated that over 2.8 million antibiotic-resistant infections occur every year.  Among the most serious and difficult to treat infections are those caused by drug-resistant gram-negative bacteria, which are considered by the CDC to be serious-to-urgent resistance threats.  The Qpex pipeline is designed to target these most serious and urgent resistance threat pathogens, including ESBL- and carbapenemase-producing Enterobacteriaceae (CRE) which are found in the community as well as hospital setting, and carbapenem-resistant strains of Acinetobacter, and Pseudomonas.

About Qpex Biopharma

Qpex Biopharma, Inc. is a clinical-stage biopharmaceutical company with a pipeline of best-in-class agents addressing critical needs for treatment of infectious diseases in both the inpatient and outpatient settings. The company’s lead program is based upon QPX7728, a novel ultra-broad-spectrum beta-lactamase inhibitor discovered by Qpex scientists.  Qpex was launched in 2018 with investments from New Enterprise Associates, Adams Street Partners, LYZZ Capital, Hatteras Venture Partners, and Stanford University Draper Fund as well as funding provided through an agreement with the Biomedical Advanced Research and Development Authority (BARDA). Qpex has a multi-product collaboration with Brii Biosciences for the development and commercialization of three of its products in greater China. For more information, please visit www.qpexbio.com.