Total award of up to $318M for development
and procurement of novel antibiotic cefepime-taniborbactam for the
treatment of melioidosis and multi-drug resistant
infections
Venatorx Pharmaceuticals, a private, late-stage clinical
pharmaceutical company focused on improving health outcomes for
patients with multidrug-resistant bacterial infections and
hard-to-treat viral infections, today announced the Biomedical
Advanced Research and Development Authority (BARDA), part of the
Administration for Strategic Preparedness and Response within the
U.S. Department of Health and Human Services (HHS), has awarded the
company a contract to support the development of
cefepime-taniborbactam for the treatment of melioidosis. The
contract also includes options to procure cefepime-taniborbactam
for national preparedness efforts.
The contract with BARDA leverages the 2004 Project BioShield
Act, that enabled acceleration of the research, development,
purchase, and availability of effective medical products against
chemical, biological, radiological, or nuclear agents.
“We thank BARDA, ASPR, and HHS for their dedication to
scientific innovation and commitment to this private-public
partnership. The contract supports Venatorx’s mission to address
the devasting impact on patient lives from the growing
multidrug-resistant bacterial infections in the U.S.,” said
Christopher J. Burns, Ph.D., President and CEO of Venatorx.
“Venatorx and cefepime-taniborbactam can play an important role in
helping to enhance the biodefense preparedness of our country, save
lives and protect Americans. We are confident that
cefepime-taniborbactam is extremely well-positioned to help address
potential public health emergencies as increasing antibiotic
multi-drug resistant infections continue to represent a global
threat.”
Terms of the Award
This project has been funded in whole or in part with Federal
funds from the Administration for Strategic Preparedness and
Response, Biomedical Advanced Research and Development Authority,
under contract number 75A50122C00080. Under the terms of the
agreement, Venatorx may receive up to $318M in development funding
and potential product procurement. BARDA will initially award
approximately $72M for the development of cefepime-taniborbactam,
including completion of a clinical study in HABP/VABP, CMC
development, post-marketing commitments, nonclinical studies, and
submission of a pre-EUA package to FDA for melioidosis. Based on
milestone achievements, Venatorx may receive additional funding of
up to approximately $67M for further development of
cefepime-taniborbactam, including a melioidosis clinical study, and
up to $179M for product procurement.
About Cefepime-Taniborbactam
Cefepime, a fourth-generation cephalosporin, is a widely
used beta-lactam (BL) antibiotic with more than two decades of
proven safety and clinical utility against susceptible
gram-negative and gram-positive bacteria. Taniborbactam is a
beta-lactamase inhibitor (BLI) with broad coverage of both serine-
and metallo-beta-lactamases. In combination with cefepime,
taniborbactam may offer a new treatment option for patients with
serious bacterial infections caused by difficult-to-treat drug
resistant gram-negative bacteria, most notably carbapenem-resistant
Enterobacterales (CRE) and carbapenem-resistant or multi-drug
resistant Pseudomonas aeruginosa (CRPA/MDR-PA), and other severe or
rare infections.
Cefepime-taniborbactam recently completed a Phase 3 study
(CERTAIN-1) in adults with complicated urinary tract infections
(cUTI), including pyelonephritis. In this study,
cefepime-taniborbactam met the primary noninferiority efficacy
endpoint at Test-of-Cure visit and furthermore demonstrated
statistical superiority to the comparator, meropenem. In addition,
cefepime-taniborbactam was well-tolerated with a similar safety
profile to meropenem. Based on positive results from the CERTAIN-1
clinical trial, Venatorx expects to submit a New Drug Application
to the FDA for cefepime-taniborbactam in the first half of 2023.
Cefepime-taniborbactam has been granted Qualified Infectious
Disease Product (QIDP) and Fast Track designation by the U.S. Food
and Drug Administration (FDA).
Funding Partners and Collaborators for
Cefepime-Taniborbactam
This project has been funded in part with federal funds from the
National Institute of Allergy and Infectious Diseases, National
Institutes of Health, Department of Health and Human Services,
under contract number HHSN272201300019C, and Wellcome Trust under
Award No. 360G-Wellcome-101999/Z/13/Z, and has continued with
federal funds from the Department of Health and Human Services;
Administration for Strategic Preparedness and Response, Biomedical
Advanced Research and Development Authority, under contract number
HHSO100201900007C.
In September 2018, Venatorx entered into an exclusive license
agreement with Everest Medicines to support the development,
registration, and commercialization of cefepime-taniborbactam in
Greater China, South Korea, and select countries in Southeast Asia.
Everest will be solely responsible for the commercialization of
cefepime-taniborbactam in its territory and Venatorx will be
eligible to receive royalties on net sales.
In April 2020, Venatorx and GARDP announced a collaboration to
accelerate the development of, and access to,
cefepime-taniborbactam for adult and pediatric populations.
Venatorx has granted GARDP exclusive rights to distribute and
sub-distribute cefepime-taniborbactam, once it is approved for
clinical use, in low- and lower-middle-income countries.
About Venatorx Pharmaceuticals
Venatorx is a private, late-stage clinical pharmaceutical
company focused on improving health outcomes for patients with
multidrug-resistant bacterial infections and hard-to-treat viral
infections. Venatorx’s lead program, cefepime-taniborbactam, is a
clinical-stage antibiotic that completed a Phase 3 study in adults
with complicated urinary tract infections, including
pyelonephritis. Based on positive results from the CERTAIN-1 Phase
3 clinical trial, the Company expects to submit a New Drug
Application with the U.S. Food and Drug Administration for
cefepime-taniborbactam in the first half of 2023. Venatorx is also
developing an oral antibacterial, ceftibuten/ledaborbactam
(formerly known as VNRX-7145), for the treatment of cUTI, including
pyelonephritis, caused by certain bacteria in adult patients with
limited treatment options; this product is nearing completion of
Phase 1. For more information about Venatorx and its
anti-infectives portfolio, please visit www.venatorx.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including without limitation statements
regarding the potential, safety, efficacy, and regulatory and
clinical development of Venatorx Pharmaceuticals’ product
candidates.
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