Cidara Selects First Development Candidate From Its Cloudbreak Immunotherapy Discovery Platform

CD201 Demonstrates Potential to Treat Life-Threatening Multi-Drug Resistant Gram-negative Bacterial Infections

SAN DIEGO--(BUSINESS WIRE)--Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that the company has selected the first development candidate from its proprietary immunotherapy discovery platform, Cloudbreak™. Cloudbreak is the first platform of its kind designed specifically to create compounds that direct a patient's immune cells to attack and eliminate bacterial, fungal or viral microbial pathogens. The selected candidate, CD201, is a novel, bispecific antimicrobial immunotherapy being developed for the treatment of multi-drug resistant (MDR) bacterial infections, including those caused by MCR-1 resistant pathogens.

“CD201 validates the Cloudbreak platform and demonstrates its tremendous potential to help address dangerous infections, including those caused by the growing number of drug-resistant pathogens. Based on our planned IND-enabling studies, we expect to file an IND next year to initiate the clinical development of CD201.”

“Our Cloudbreak platform represents an entirely new approach to infectious diseases and has the potential to transform the treatment of these diseases in the same way that immunotherapy has transformed the treatment of cancer,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “CD201 validates the Cloudbreak platform and demonstrates its tremendous potential to help address dangerous infections, including those caused by the growing number of drug-resistant pathogens. Based on our planned IND-enabling studies, we expect to file an IND next year to initiate the clinical development of CD201.”

The emergence of MDR Gram-negative bacteria, including the recently discovered “superbug” MCR-1 resistant bacteria, raises the possibility of a return to a pre-antibiotic era for some patients. Existing therapies for MDR pathogens do not cover all strains of pathogens such as Pseudomonas or exhibit poor activity against Acinetobacter. Using the Cloudbreak platform, Cidara designed CD201 to circumvent existing bacterial resistance mechanisms and introduce a new mechanism of immune-mediated killing, potentially providing a novel tool for fighting MDR pathogens. These include pathogens resistant to carbapenems, a staple, standard-of-care therapy for Gram-negative infections, as well as colistin, an antibiotic used as last-resort therapy.

CD201 works by binding to a target present on a wide range of Gram-negative bacteria, including MCR-1, 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, Acenitobacter, 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.

“Harnessing the immune system to fight harmful bacteria such as Gram-negative and resistant pathogens has the potential to significantly improve outcomes in patients with life-threatening infections,” said Cornelius J. (Neil) Clancy, M.D., University of Pittsburgh. “The approach taken with CD201 could fundamentally change the way we treat serious Gram-negative infections across multiple patient populations.”

Cidara plans to continue ongoing investigations with Cloudbreak, with the intention of advancing multiple development candidates across different indications and therapeutic areas.

About Multi-Drug Resistant Bacteria

Many strains of bacteria have mutated over time and have developed resistance to existing antibiotics resulting in limited therapeutic options for patients and a growing public health crisis. Antibiotic resistance is seen in both community- and hospital-acquired infections and is of most concern for patients with bacterial infections that are resistant to a number of antibiotic classes. These bacteria are referred to as multi-drug resistant (MDR). MDR Gram-negative bacteria include strains of Acinetobacter, Pseudomonas and Klebsiella, which can lead to serious, life-threatening infections in the absence of effective new treatments.

About Cidara Therapeutics

Cidara is a clinical-stage biotechnology company focused on developing new anti-infectives that have the potential to transform the standard of care and save or improve patients’ lives. The company is currently advancing its novel echinocandin antifungal, CD101, through Phase 2 studies in two indications and developing CD201, its bispecific antimicrobial immunotherapy, for the treatment of multi-drug resistant bacterial infections. CD101 IV has enhanced potency and is the only once-weekly therapy intended for the treatment and prevention of life-threatening invasive fungal infections. CD101 topical is the first and only agent of its class being studied for the treatment and prevention of vulvovaginal candidiasis (VVC), a prevalent mucosal infection. CD201 is the first drug candidate selected from Cidara’s novel Cloudbreak™ platform, the first immunotherapy discovery platform designed specifically to create compounds that direct a patient's immune cells to attack and eliminate bacterial, fungal or viral pathogens. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the company’s plans for CD201, including IND-enabling studies, the potential for the company to file an IND for CD201 in 2017, the potential for CD201 to successfully treat bacterial infections and the potential for CD201 and the Cloudbreak program to transform the treatment of infectious diseases. Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Cidara’s preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; changes in Cidara’s plans to develop and commercialize its product candidates; Cidara’s ability to obtain additional financing; Cidara’s ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Cidara’s Form 10-Q most recently filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cidara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.