SAN DIEGO, Dec. 01, 2022 — Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 11,510,992, entitled Compositions and Methods for the Treatment of Viral Infections, for CD388, a highly potent, long-acting drug-Fc conjugate (DFC) designed to achieve universal prevention of seasonal and pandemic influenza.
The patent is the first issued for CD388, and includes claims directed to the composition of matter of CD388. The patent is projected to expire in 2039 plus any available patent term extension.
“We are pleased to receive the first U.S. patent for our lead flu DFC, CD388, as we establish robust IP protection for this new class of drug,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Achieving this milestone concludes a productive year for the CD388 program, including the ongoing Phase 1 first in human trial, as well as the Phase 2a human challenge study. We look forward to announcing results from these trials in the first half of 2023.”
The Phase 1 study (NCT05285137) is a randomized, double-blind, dose-escalation study to determine the safety, tolerability and pharmacokinetics of intramuscular and subcutaneous administration of CD388 in healthy subjects. The Phase 2a trial (NCT05523089) is a single-center, randomized, double-blind, placebo-controlled, proof-of-concept study to assess the prophylactic antiviral activity, safety, tolerability and pharmacokinetics of CD388 against influenza via a human viral challenge model, and to explore the impact of dose levels on efficacy. Both trials are being conducted under an exclusive worldwide license and collaboration agreement with Janssen.
CD388 is a DFC from Cidara’s Cloudbreak® platform, which stably couples highly potent small molecules or peptides to a proprietary composition of a human antibody fragment (Fc). For influenza, CD388 is designed to directly inhibit viral proliferation by targeting a conserved region on the viral envelope, potentially conferring universal prevention of Types A and B influenza with a single seasonal dose.
About Cloudbreak® DFCs
Cidara is developing a new generation of immunotherapeutic antivirals from its Cloudbreak platform that couple potent antivirals to a human antibody fragment (Fc). These highly potent, long-acting, drug-Fc conjugates (DFCs) directly inhibit viral proliferation while simultaneously engaging the immune system. In addition to the clinical-stage CD388 program for seasonal and pandemic influenza, Cidara is advancing DFC programs to target other life-threatening viruses, such as SARS-CoV-2, as well as immuno-oncology targets associated with multiple cancers.
Influenza (“the flu”) is a contagious viral infection that can cause mild to severe illness, sometimes resulting in death. It’s caused by influenza viruses that infect the nose, throat and lungs, and can put people, such as children, older people and people with certain health conditions, at higher risk for complications.1 While today’s flu vaccines are credited with significant public health benefits and currently offer the best defense against infection, vaccines have only been effective in about 14-40% of people over the past five years.2 Every year, there are an estimated 1 billion cases of influenza, resulting in 290,000 to 650,000 influenza-related respiratory deaths.3
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 is comprised of new approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
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,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to the potential for influenza DFCs, including CD388, to provide universal protection against all influenza strains for an entire season, whether Cidara will be able to complete the Phase 2a clinical trial for CD388, whether, and whether preliminary results of the ongoing trials will be reported in the first half of 2023. 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 most recent Quarterly Report on Form 10-Q 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.
- About Flu. Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/flu/about/index.html. Last accessed November 2022.
- Past Seasons’ Vaccine Effectiveness Estimates. Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/flu/vaccines-work/past-seasons-estimates.html. Last accessed November 2022.
- WHO launches new global influenza strategy. World Health Organization. Available at: https://www.who.int/news/item/11-03-2019-who-launches-new-global-influenza-strategy. Last accessed November 2022.