Company secures two oral and four poster presentations
Presentations include new data highlighting the antiviral effect
and immune system engagement of CB-012 for the prevention and treatment
of flu
SAN DIEGO –
Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company
developing novel anti-infectives including immunotherapies, today
announced that new data from studies of rezafungin, the company’s Phase
3 antifungal, and CB-012, its Cloudbreak® antiviral
Fc-conjugate (AVC) candidate for influenza, will be presented at the
American Society for Microbiology (ASM) Microbe 2019 annual meeting
taking place June 20-24 in San Francisco.
“Our presentations at ASM Microbe underscore our ongoing commitment to
developing new anti-infectives to address the urgent need for innovation
in this space,” said Jeffrey Stein, Ph.D., president and chief executive
officer of Cidara. “We are excited to present new data that further
reinforce the potential of rezafungin to address a range of serious,
life-threatening fungal infections, including azole-resistant invasive
aspergillosis, as well as new data highlighting CB-012’s unique
mechanism of action and novel approach to engage the immune system to
treat and prevent seasonal and pandemic flu.”
Rezafungin is a novel antifungal echinocandin being developed as a
once-weekly, high-exposure therapy for the treatment and prevention of
serious invasive fungal infections. CB-012 is the first AVC candidate
generated by Cidara’s Cloudbreak anti-infective immunotherapy platform.
A total of four Cidara abstracts have been accepted for presentations at
this year’s ASM meeting, including one selected for bonus presentation
during an oral symposium. Three posters will present studies of
rezafungin supporting its potential in the treatment of Candida
infections and invasive aspergillosis. The fourth poster will feature
new data from preclinical studies of CB-012 evaluating its antiviral
activity against seasonal and pandemic influenza A and influenza B
strains compared to oseltamivir. In addition, Cidara’s chief medical
officer, Taylor Sandison, M.D., will present on rezafungin during a
pipeline session dedicated to new and emerging antifungals.
Details of the ASM 2019 rezafungin and CB-012 presentations are as
follows:
Oral Presentations
Title: Population Pharmacokinetic (PPK) and
Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment Analyses for
Rezafungin (RZF) for Treatment of Candida Infections
Presenter:
C. Rubino
Date and time: Sunday, June 23, 8:30 a.m. – 10:30 a.m.
Pacific Time
Location: 203/204 South
Session S279: PK/PD for
My FDA Package? What Do I Need?
Presentation time: 9:15 a.m. – 9:30
a.m. Pacific Time
Title: Rezafungin (CD101)
Presenter: T. Sandison
Date and
time: Monday, June 24, 8:30 a.m. – 11:00 a.m. Pacific Time
Location:
201/202 South
Session S378: Antifungals New and Near
Presentation
time: 9:05 a.m. – 9:25 a.m. Pacific Time
Poster Presentations
Title: Disk Diffusion Testing of the Novel Echinocandin Rezafungin
against Candida spp. – Broth vs. Disk Correlation and
Quality Control
Presenter: A. Marra
Date and time: Friday,
June 21, 11:00 a.m. – 12:00 p.m. Pacific Time and 4:00 – 5:00 p.m.
Pacific Time
Location: Exhibit and Poster Hall
Session P435:
AAR03 – Antifungal Susceptibility Surveillance and Resistance
Title: Population Pharmacokinetic (PPK) and
Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment Analyses for
Rezafungin (RZF) for Treatment of Candida Infections
Presenter:
C. Rubino
Date and time: Saturday, June 22, 11:00 a.m. – 12:00 p.m.
Pacific Time and 4:00 – 5:00 p.m. Pacific Time
Location: Exhibit
and Poster Hall
Session P512: AAR07 – Clinical Antimicrobial
Pharmacokinetics and Pharmacodynamics
Title: Rezafungin is Efficacious against Invasive Aspergillosis Caused
by Azole-Resistant Aspergillus fumigatus Harboring the TR34/L98H
Mutation
Presenter: N. Wiederhold
Date and time: Sunday, June
23, 11:00 a.m. – 1:00 p.m. Pacific Time
Location: Exhibit and
Poster Hall
Session P583: AAR03 – Antifungal Agents and Resistance,
including New Agents
Title: CB-012 – A Novel Antiviral-fc Conjugate for Treatment and
Prevention of Influenza Virus
Presenter: L. Tari
Date and
time: Sunday, June 23, 11:00 a.m. – 1:00 p.m. Pacific Time
Location:
Exhibit and Poster Hall
Session P574: HMB18 – Anti-Pathogen
Strategies: Fighting Back at Pathogens
The abstracts can be accessed through the ASM Microbe website: www.asm.org.
Following the meeting, the presentation slides and posters will be
available on the Cidara website: www.cidara.com.
About Rezafungin
Rezafungin is a novel antifungal echinocandin being developed as a
once-weekly, high-exposure therapy for the treatment and prevention of
serious invasive fungal infections. Rezafungin has a unique
pharmacokinetic profile with a prolonged half-life and front-loaded
plasma exposure which, in contrast to all other echinocandins, allow for
once-weekly IV therapy for inpatient and outpatient use. Rezafungin is
being developed to address unmet needs in the treatment of candidemia
and invasive candidiasis as well as in prophylaxis (prevention) of
invasive fungal disease caused by Candida, Aspergillus,
and Pneumocystis spp. in patients undergoing allogeneic blood and
marrow transplantation.
About CB-012
CB-102 is an antiviral candidate from Cidara’s novel class of antiviral
Fc-conjugates (AVCs) being developed for the prevention and treatment of
influenza. CB-012 was designed using the company’s Cloudbreak
anti-infective immunotherapy platform. As an AVC, CB-012 is neither a
vaccine nor a typical antiviral drug or monoclonal antibody. AVCs are
potent, small-molecule antivirals conjugated to the Fc domain of a human
antibody (IgG1). This design allows AVCs to work in multiple ways. In
addition to directly targeting and inhibiting viral replication, AVCs
focus the immune system on the infection, similar to how certain cancer
immunotherapies engage the immune system to destroy cancer cells. With
this novel approach, Cidara believes its AVCs have the potential to
protect for an entire flu season with a single dose, with or without
concurrent vaccination, and to provide a highly potent treatment for
seasonal and pandemic influenza.
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 is seeking
funding to complete its rezafungin development plans including funding
necessary for completion of the first Phase 3 treatment trial and to
commence a second Phase 3 trial of prophylaxis against invasive fungal
infections in patients undergoing allogeneic blood and marrow
transplantation. Rezafungin is the only once-weekly drug 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 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, Cidara’s ability to develop new anti-infectives that are innovative
or address unmet needs, and 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. Such statements also include, but are not limited to,
statements regarding the potential for Cidara’s AVCs, including CB-012,
to treat and prevent influenza and represent an improvement over current
vaccines, and the ability of Cidara’s AVCs to provide protection for an
entire flu season with a single dose. 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 made.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190605005030/en/
INVESTOR CONTACT:
Robert H. Uhl
Westwicke Partners, LLC
Managing
Director
(858) 356-5932
robert.uhl@westwicke.com
MEDIA CONTACT:
Andrea Cohen
Sam Brown Inc.
(917)
209-7163
andreacohen@sambrown.com
