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Cidara Therapeutics and Rutgers University Awarded $5.5 Million Grant from NIH to Support Development of Novel Immunotherapy Agents Targeting Multi-drug Resistant Gram-negative Bacterial Infections

By May 21, 2018No Comments

New Partnership to Jointly Conduct Preclinical Development of
Cidara’s Cloudbreak Antibody-Drug Conjugates

Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company
developing novel anti-infectives including immunotherapies, today
announced that it and Rutgers University have been awarded a five-year,
$5.5 million partnership grant from the U.S. National Institute of
Allergy and Infectious Diseases (NIAID) of the National Institutes of
Health (NIH), an agency of the United States Department of Health and
Human Services.

The grant will fund the continued research and development of Cidara’s
innovative Cloudbreak™ antibody-drug conjugate (ADC) platform to
identify novel immunotherapy agents for the treatment and prevention of
serious and life-threatening multi-drug resistant (MDR) Gram-negative
bacterial infections in high-risk patient populations. The Cloudbreak
immunotherapy platform is a fundamentally new approach for the treatment
of infectious disease that, in a single molecule, pairs potent
antimicrobials with agents that redirect the immune system to destroy
fungal, bacterial and viral pathogens.

“Treatment options for Gram-negative bacterial infections have become
increasingly limited due to the rapid emergence of multi-drug resistance
to existing and newly approved antimicrobial agents,” said Jeffrey
Stein, Ph.D., president and chief executive officer of Cidara. “An agent
designed to treat and prevent Gram-negative infections in high-risk
populations by engaging the immune system would provide an alternative
strategy for addressing a critical public health need. We are pleased to
collaborate with the NIH and Rutgers to further evaluate potential use
of our Cloudbreak ADCs as countermeasures against Gram-negative

The initial preclinical development activities covered by the grant will
be conducted at the Public Health Research Institute (PHRI) of New
Jersey Medical School, Rutgers University, located in Newark, New
Jersey. David S. Perlin, Ph.D., executive director and professor at
PHRI, will lead the research phase of the grant and serves as principal

“Preliminary studies have identified promising ADCs that possess both
intrinsic and immune-mediated bactericidal activity against clinically
important Gram-negative pathogens including MDR isolates,” said Dr.
Perlin. “I believe that a novel ADC agent could be a much-needed and
welcome addition to the Gram-negative therapeutic arsenal. I look
forward to advancing Cidara’s ADC Cloudbreak program as part of this
NIH/NIAID partnership grant.”

About Gram-negative Bacterial Infections

Gram-negative pathogens are responsible for half of all healthcare
associated infections (HAIs) and the primary cause of HAIs in intensive
care units (ICU). The Centers for Disease Control and Prevention (CDC)
estimates that there were 1.7 million total HAIs in the United States
and the estimated number of death associated with HAIs were 99,000,
costing the U.S. health care system $20 billion per year. While
mortality due to these infections is already high, infections caused by
MDR strains result in significantly higher mortality and hospital length
of stay when compared to those caused by susceptible strains.

About NIAID and NIH

The National Institute of Allergy and Infectious Diseases (NIAID)
conducts and supports basic and applied research to better understand,
treat, and ultimately prevent infectious, immunologic, and allergic
diseases. For more than 60 years, NIAID research has led to new
therapies, vaccines, diagnostic tests, and other technologies that have
improved the health of millions of people in the United States and
around the world. NIAID is one of the 27 Institutes and Centers of the
National Institutes of Health (NIH). For more information, visit

The National Institutes of Health (NIH) – the nation’s medical research
agency – includes 27 Institutes and Centers and is a component of the
U.S. Department of Health and Human Services. NIH is the primary federal
agency for conducting and supporting basic, clinical and translational
medical research, and investigates the causes, treatments and cures for
both common and rare diseases. For more information about NIH and its
programs, visit

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, rezafungin acetate,
formerly known as CD101 IV, through clinical trials. Rezafungin has
improved pharmacokinetics compared to existing echinocandins and the
potential for expanded utility across patient settings. It is the only
once-weekly product candidate in development for the treatment and
prevention of life-threatening invasive fungal infections. The company’s
Phase 2 STRIVE clinical trial of rezafungin met its primary safety and
efficacy objectives, and Cidara plans to initiate Phase 3 pivotal trials
in the treatment of candidemia and invasive candidiasis and the
prophylaxis of invasive fungal infections in 2018. Cidara also is
leveraging its novel Cloudbreak™ platform to develop antibody-drug
conjugates for the treatment of multi-drug resistant Gram-negative
bacterial infections. Cloudbreak is the first immunotherapy discovery
platform designed specifically to create compounds that directly kill
pathogens and also 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

About Rutgers University and New Jersey Medical School

Rutgers, The State University of New Jersey, is a leading national
research university and the state of New Jersey’s preeminent,
comprehensive public institution of higher education. Established in
1766, the university is the eighth oldest higher education institution
in the United States. More than 69,000 students and 22,500 full- and
part-time faculty and staff learn, work, and serve the public at Rutgers
locations across New Jersey and around the world. The mission of New
Jersey Medical School is to educate students, physicians, and scientists
to meet society’s current and future healthcare needs through
patient-centered education; pioneering research; innovative clinical,
rehabilitative and preventive care; and collaborative community outreach.

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, the potential for the full grant proceeds to be received and used by
Cidara and Rutgers University, and the potential for Cidara’s ADCs to be
successfully developed and be safe and effective in treating and
preventing bacterial infections. 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.

Research reported in this publication was supported by the National
Institute of Allergy And Infectious Diseases of the National Institutes
of Health under Award Number R01AI138986. The content is solely the
responsibility of the authors and does not necessarily represent the
official views of the National Institutes of Health.

Cidara Therapeutics, Inc.
Partners, LLC
Robert H. Uhl
Managing Director

Sam Brown Inc.
Christy Curran
The State University of New Jersey
Patti Verbanas
News & Media Relations