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Cidara Therapeutics Presents New Preclinical Data on Novel Drug-Fc Conjugate CD388 at the 7th International Society for Influenza and Other Respiratory Virus Diseases Conference

2023-05-03

临床2期上市批准临床结果

SAN DIEGO, May 03, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to save lives and improve the standard of care for patients facing serious diseases, is delivering two oral presentations highlighting new preclinical data on its novel drug-Fc conjugate (DFC) candidate targeting influenza A and B, CD388, at the 7th International Society for Influenza and Other Respiratory Virus Diseases (ISIRV) conference in Seattle, Washington, May 3-5, 2023. “These encouraging CD388 preclinical data provide further support for the potential of our Cloudbreak® DFC programs,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “CD388 has shown potential activity against seasonal and pandemic influenza strains, as well as activity against influenza strains resistant to neuraminidase inhibitors, the current standard of care. We look forward to building on these promising data for the clinical advancement of CD388 and continuing to leverage our Cloudbreak platform to help develop targeted therapeutics designed to inhibit specific disease targets, including in influenza and cancer.” Presentation details and key highlights for the two oral presentations can be found below. Oral presentation details: Title: CD388, a Novel Drug Fc-Conjugate (DFC), Demonstrates Potent, Universal Activity Against Influenza A and B Session: Preclinical Development Presenter: James Levin, Ph.D., Senior Director of Preclinical Development at Cidara Date and Time: May 3, 2023, at 2:30 – 2:45 p.m. PT Key Highlights: CD388 has broad spectrum activity against seasonal and pandemic influenza A and B strains in vitro, including highly pathogenic and neuraminidase-resistant isolates. The in vitro potency of CD388 translated into a high level of protection in mouse survival and quantitative lung burden treatment models. Title: CD388 Demonstrates a High Barrier to Resistance and Retains Potent Activity Against NAIR Influenza A and B Variants Session: Antivirals, Monoclonal Antibodies and Combinations Presenter: Simon Doehrmann, Ph.D, Senior Scientist at Cidara Date and Time: May 4, 2023, at 11:35 - 11:50 a.m. PT Key Highlights: CD388 retained potency against neuraminidase inhibitor neuraminidase inhibitor-resistant variants and demonstrated a high barrier of resistance development in vitro. No CD388 specific resistance mechanisms were identified. Cidara is currently advancing its Cloudbreak DFC program in an ongoing Phase 2a trial being conducted in collaboration with Janssen Pharmaceuticals, Inc (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson that is evaluating the pre-exposure prophylactic activity of CD388 against the H3N2 influenza A virus strain. The Company recently announced promising interim efficacy and safety data from the Phase 2a study. Cidara is additionally advancing its first oncology DFC candidate, CD421, a first-in-class inhibitor of CD73, with an IND anticipated in 2024. About Cidara Therapeutics Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The company’s portfolio comprises new approaches aimed at transforming existing treatment and prevention paradigms, including drug-Fc conjugates (DFCs) from its proprietary Cloudbreak® platform targeting oncologic and viral diseases. In addition, Cidara recently received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit . Forward-Looking Statements This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “believe,” “could,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether the nonclinical data generated for CD388 will be predictive of therapeutic activity in humans, whether any Cloudbreak DFC candidate will be safe or effective, and whether we will submit an IND for CD421 in 2024r. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s preclinical or clinical trials, delays in action by regulatory authorities due to limitations on inspections and other COVID-19-related effects, and impacts of the COVID-19 pandemic or other obstacles on the enrollment of patients or other aspects of CD388 development. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. Investor Contact: Brian Ritchie LifeSci Advisors (212) 915-2578 britchie@lifesciadvisors.com Media Contact: Veronica Eames LifeSci Communications 646-970-4682 veames@lifescicomms.com