Cidara Therapeutics, Inc., a biotechnology company developing novel anti-infectives including immunotherapies, today announced that the company has received a grant for up to $6.9 million from CARB-X (Combating Antibiotic Resistant Bacteria Accelerator) to advance the development of its antibiotic immunotherapy, CD201, for the treatment of life-threatening multi-drug resistant (MDR) Gram-negative bacterial infections. CD201 is the first development candidate to be generated by Cidara’s novel Cloudbreak™ immunotherapy discovery platform, designed specifically to create compounds that direct a patient’s immune cells to attack and eliminate bacterial, fungal or viral pathogens.

carbapenem-resistant Klebsiella pneumoniae (CRKP) /CDC
carbapenem-resistant Klebsiella pneumoniae (CRKP) /CDC

CD201 is a first-in-class, bispecific antibiotic immunotherapy being developed for the treatment of multi-drug resistant bacterial infections, including those caused by MCR-1-producing pathogens. CD201 works by binding to a target present on a wide range of Gram-negative bacteria, including MCR-1-positive strains, while simultaneously recruiting immune components to an infection site to coordinate localized host-mediated infection clearance. CD201 has demonstrated potent antibacterial activity in vitro against a number of clinically significant Gram-negative bacteria, including Klebsiella, Acinetobacter, Pseudomonas and Enterobacter spp. and resistant pathogens (including bacteria resistant to carbapenems and colistin), as well as pathogens harboring the mcr-1 plasmid. CD201 also has demonstrated preliminary efficacy and safety in a number of animal models of infection.

CARB-X is the world’s largest public-private partnership focused on antibacterials, created by the U.S. Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID). CARB-X is funded by BARDA and the London-based Wellcome Trust, a global charitable foundation, and administered by the Boston University School of Law.

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“This grant from CARB-X validates the progress we’ve made to date with our Cloudbreak platform,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “We believe that the Cloudbreak immunotherapy approach has the potential to transform the way infectious diseases are treated, similar to the way immunotherapy has transformed cancer treatment. With this valuable support from CARB-X, we look forward to accelerating the development of CD201 through the critical early stages, including continuing our IND-enabling studies.”

Following a competitive review process, CARB-X selected Cidara’s CD201 product candidate for its first phase of funding awarded to companies with pre-clinical development projects in the area of antibiotic-resistant infections, a serious global health threat. Under the grant, CARB-X will provide up to $3.9 million in base funding and up to $3.0 million in additional funding through Phase 1, linked to the successful progression of the project through milestones established by CARB-X.
 
To be considered, the clinical project must target one of the deadly antibiotic-resistant bacteria on the Serious or Urgent Threat List prepared by the U.S. Centers for Disease Control and Prevention (CDC) or appear on the Priority Pathogens list published by the World Health Organization (WHO). The first projects selected for the Powered by CARB-X portfolio focus on Gram-negative bacteria, which are responsible for half of all healthcare associated infections many of which are resistant to multiple drugs.
 
The rise in drug-resistant bacteria is a growing public health concern. In the U.S. alone, the CDC estimates that 23,000 people die each year from drug-resistant infections, with related healthcare costs of approximately $20 to $25 billion. In addition, a recent CDC report highlighted the urgent need for novel antibacterials that are effective against Gram-negative bacteria.