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Cidara Therapeutics to Present New Data on Rezafungin and its Cloudbreak Antiviral Candidate for Influenza at ASM Microbe 2019
June 5, 2019 at 8:00 AM EDT

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--(BUSINESS WIRE)--Jun. 5, 2019-- 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-012 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.

 

Source: Cidara Therapeutics, Inc.

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