The Bill and Melinda Gates Foundation has awarded Achaogen $10.5 million in grant funding and is making a $10 million investment in the South San Francisco-based firm to support the identification of monoclonal antibodies (mAbs) against serious, multidrug-resistant (MDR) Gram-negative bacteria. The initial grant will fund Achaogen’s program to discover mAbs against Acinetobacter baumannii, which is the major cause of neonatal sepsis. If this project is successful, Achaogen may receive future grants from the Gates Foundation for additional antibody discovery and development programs.
Achaogen says the equity investment will accelerate the overall development of its mAb discovery platform, which it is applying to discover new treatments for infections that largely affect the poor.
“We are honored to partner with the Gates Foundation on this important work, which is aligned with our mission to discover and develop treatments to combat infections caused by Gram-negative pathogens,” said Kenneth Hillan, M.B., Ch.B., Achaogen's CEO. “This investment enables us to effectively pursue antibodies against neonatal sepsis while accelerating the development of our antibody platform.”
“Neonatal sepsis remains one of the deadliest conditions afflicting newborns globally,” added Trevor Mundel, Ph.D., president of Global Health at the Gates Foundation. “The successful development of simple and sustainable prophylactics and therapeutics would make a tremendous impact toward decreasing neonatal mortality in developing countries. Achaogen’s expertise in Gram-negative infections combined with their understanding of mAb development will be important for the success of this approach, and we look forward to a sustained partnership.”
Achaogen's lead candidate plazomicin is an aminoglycoside antibiotic that has been evaluated in two Phase III trials, EPIC and CARE, for treating serious bacterial infections caused by MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE). Positive data from the studies was reported in December 2016. Achaogen aims to submit an NDA to FDA for plazomicin during the second half of 2017, and projects submitting a Marketing Authorization Application to the European Medicines Agency during 2018. The plazomicin program has been part funded through a contract from the Biomedical Advanced Research and Development Authority (BARDA), valued at up to $123.8 million.
Achaogen has been working with Thermo Fisher since 2015 to develop a commercial assay for measuring plazomicin drug levels, to aid in therapeutic drug management. The firms aim to have the assay ready if and when the drug is lauched commercially.
Achaogen aims to start clinical development with a second clinical candidate, C-Scape, an oral beta-lactam/beta-lactamase inhibitor combination, during the second quarter of 2017. C-Scape is in development for treating complicated urinary tract infections (cUTI) caused by MDR pathogens, including extended spectrum beta-lactamase (ESBL)-producing Escherichia coli and Klebsiella pneumoniae. A pivotal Phase III study for the cUTI indication could feasibly start during the first half of 2018, the firm suggest.
Both plazomicin and C-Scape have been granted Qualified Infectious Disease Product (QIPD) status by the FDA.