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Cidara Therapeutics Selects First Development Candidate from its CloudbreakTM Immunotherapy Discovery Platform

By September 21, 2016No Comments

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

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

“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

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

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

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.

Westwicke Partners, LLC
Robert H.
Uhl, 858-356-5932
Managing Director

Sam Brown Inc.
Mike Beyer, 312-961-2502