SAN DIEGO, Oct. 11, 2023 — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced new data on its drug-Fc conjugate (DFC) candidate, CD388, at IDWeek 2023. The conference is taking place both in-person at the Boston Convention and Exhibition Center in Boston, MA and virtually from October 11 – 15, 2023.
“It is important to highlight these new data demonstrating the safety, efficacy and tolerability of CD388 in preventing influenza A and B,” said Jeffrey Stein, Ph.D. president and chief executive officer of Cidara. “These data support the conclusions drawn from the Phase 2a study, additional data from which will be disclosed at an upcoming conference, that CD388 has the potential to offer true universal protection for patients regardless of their immune status. These data continue to support the unique approach of our Cloudbreak platform which aims to design DFCs that may safely and effectively prevent and treat serious diseases such as influenza and cancer.”
CD388 is being developed for the universal protection of influenza A and B under an exclusive worldwide collaboration agreement with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company. Janssen recently delivered its Election to Proceed Notice for CD388 with the intent to transfer its rights and obligations to another entity.
Presentation details are summarized below:
Title: In Vivo Efficacy of CD388, a Novel Drug Fc-Conjugate (DFC), Against Seasonal Subtypes of Influenza in Prophylaxis in Immune Competent Mice, and in a Severe Immunodeficient (SCID) Mouse Model
Presenter: James Levin, Ph.D., Cidara Therapeutics
Session Title: Experimental Therapeutics
Session Location: 102 AB
Date and Time: October 14, 2023, 10:30AM – 11:45 AM ET
Title: Single Ascending Dose Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular CD388, a Novel Long-acting Drug-Fc Conjugate for Universal Prevention of Seasonal and Pandemic Influenza
Presenter: Shawn Flanagan, Ph.D., Cidara Therapeutics
Session Title: New Antimicrobial Drug Development
Session Location: Hall B&C
Date and Time: October 14, 2023, 12:15- 1:30 PM ET
Title: Efficacy of CD388, a Novel Drug Fc-Conjugate (DFC), is Driven by the Small Molecule Neuraminidase Inhibitor (NAI)
Presenter: James Levin, Ph.D., Cidara Therapeutics
Session Title: Antimicrobial Novel Agents
Session Location: Hall B&C
Date and Time: October 14, 2023, 12:15PM – 1:30PM ET
About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara 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 www.cidara.com.
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 Janssen or an assignee will conduct additional clinical trials of CD388, and whether CD388 will ultimately be proven safe or effective for prevention of influenza infection or any indication. 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
