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Cidara Therapeutics Selects First Clinical Development Candidate from its Cloudbreak Influenza (Antiviral) Program

By April 15, 2019No Comments

CB-012 demonstrates potent antiviral activity against influenza A
and B viruses

Cidara presenting preclinical results today at ECCMID 2019

Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company
developing novel anti-infectives including immunotherapies, today
announced that the company has selected the antiviral conjugate (AVC)
CB-012 as its first clinical development candidate from the company’s
Cloudbreak® influenza (antiviral) program. Data supporting
the selection will be presented today in an oral session at the 29th
European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID). CB-012 is a novel conjugate of a highly potent antiviral agent
linked to a human antibody fragment.

“The data clearly demonstrate the potential for CB-012 as either a
long-acting preventative or fast-acting therapy with potent activity
against seasonal and pandemic strains of influenza. A single molecule
which links a potent antiviral drug with a long-acting immune system
engager has the potential for important advantages over traditional
vaccines and therapies,” said Jeffrey Stein, Ph.D., president and chief
executive officer of Cidara. “We are committed to advancing our
portfolio of promising development candidates, including CB-012, and are
progressing IND-enabling studies this year.”

Applying the principles of oncology immunotherapy, Cidara’s Cloudbreak
AVCs attack influenza through a dual mechanism: The antiviral agent
neutralizes the influenza virus directly, while the human antibody
fragment engages a patient’s immune system to accelerate elimination of
the pathogen. The approach is designed to improve on, and combine, the
preventive effects of vaccination with an antiviral drug’s capability to
treat flu illness. Cidara’s vision is that a single dose of an AVC could
prevent influenza for an entire flu season, with or without concurrent
vaccine administration, cover strains that are missed by vaccines in any
given year, and be effective even in people with decreased immune

Today’s ECCMID presentation describes results from nonclinical studies,
which evaluated the potential of CB-012 for the treatment and prevention
of seasonal and pandemic influenza A as well as influenza B infections.
Key findings suggest CB-012 offers:

  • Superior in vitro activity compared to standard-of-care
    antivirals and coverage of both influenza A and B viruses
  • Full protection from, or treatment of, H1N1, H3N2, and Tamiflu-
    (oseltamivir) resistant H1N1-related infections with a single dose of
    CB-012 in preclinical efficacy models
  • Long half-life in multiple preclinical species
  • Efficacy in multiple dosing formulations including intravenous,
    subcutaneous and intramuscular
  • Expanded treatment window in preclinical models to 72 hours
    post-infection versus Tamiflu (oseltamivir), which loses its ability
    to protect when administered beyond 24 hours post-infection

“The data being presented today at ECCMID suggest CB-012 could provide
longer, effective protection for patients from the influenza virus as
compared to current standards of care,” said Les Tari, Ph.D., senior
vice president of research for Cidara, and presenter of the CB-012 data
at ECCMID. “We believe Cloudbreak AVCs offer an exciting new approach in
the global fight against seasonal and pandemic influenza.”

About Influenza Virus

Influenza, or flu, is a respiratory infection caused by influenza
viruses. The flu virus can cause mild to severe illness and, at times,
can lead to death. Young children, the elderly (people aged 65 years and
older), pregnant women and immunocompromised patients are more prone to
infection, but even healthy people are at risk of infection with
seasonal flu. While influenza vaccines are critical to global health,
they have limited efficacy and must be redesigned every year as
scientists attempt to predict the next season’s dominant circulating

On average, vaccines are only 40 percent effective, with lower rates in
young children and the elderly. The U.S. Centers for Disease Control and
Prevention (CDC) estimates that as many as 646,000 people may die from
influenza each year worldwide. According to CDC estimates for the United
States, approximately 50 million people became ill from the flu and
almost 80,000 people died in the 2017-18 season alone.

About Cidara Therapeutics

Cidara is a clinical-stage biotechnology company focused on the
discovery, development and commercialization of novel anti-infectives
that have the potential to transform the standard of care and save or
improve patients’ lives. Cidara is currently advancing its novel
echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial
for the treatment of candidemia and invasive candidiasis, and continues
to discuss with regulatory authorities its plans for the design and the
initiation of a second Phase 3 trial in the prophylaxis of invasive
fungal infections in patients undergoing allogeneic blood and marrow
transplantation. Rezafungin is the only once-weekly product candidate in
development for the treatment and prevention of life-threatening
invasive fungal infections. Cidara also is leveraging its proprietary
Cloudbreak® platform to develop antiviral conjugates (AVCs)
for serious infections, including further investigation of the high
potency and long half-life observed in its AVCs for influenza. The
Cloudbreak platform is designed to discover compounds that both directly
kill pathogens and direct a patient’s immune system to attack and
eliminate 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 potential for CB-012 as a long-acting
preventative or fast-acting therapy and to provide potent activity
against seasonal and pandemic strains of influenza, and the potential
for CB-012 to treat and prevent influenza and represent an improvement
over current vaccines and therapies. In addition, such statements also
include the potential for in vitro results or results in animal
studies with CB-012 to provide similar clinical results in humans,
including the ability to provide the following in humans: full
protection from, or treatment of, H1N1, H3N2, and Tamiflu- (oseltamivir)
resistant H1N1-related infections, a long half-life, efficacy in
different dosing formulations, and an expanded influenza treatment
window to 72 hours post-infection. Such statements also include, but are
not limited to, the potential for rezafungin to successfully treat or
prevent invasive fungal infections and represent an improvement over
current approaches and Cidara’s ability to successfully develop
rezafungin. 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-K 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

Robert H. Uhl
Westwicke Partners, LLC
(858) 356-5932

Andrea Cohen
Sam Brown Inc.
(917) 209-7163