• First in class, multi-specific CD73/PD-1 inhibitor DFC, exhibited robust anti-tumor activity in humanized mouse models of colorectal cancer at low doses
  
• CD73/PD-1 DFC demonstrated superior anti-tumor activity to CD73 and PD-1 monotherapies

SAN DIEGO, Dec. 07, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak^® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the presentation of new preclinical data on its novel, multi-specific CD73/PD-1 targeting drug-Fc conjugate (DFC) candidate at the ESMO Immuno-Oncology (IO) Annual Congress. Cidara also presented new preclinical data on CBO421, its first-in-class CD73-targeting DFC. The conference is taking place December 6-8, 2023, virtually and in-person in Geneva, Switzerland.

“We are thrilled to be presenting promising preclinical data on our novel multi-specific DFC in colorectal cancer for the first time at ESMO-IO this year,” said Jeffrey Stein, Ph.D., president and chief executive officer at Cidara. “Dual inhibition of both CD73 and PD-1 checkpoint pathways with a single DFC contributed to significant tumor growth reduction, highlighting the potential clinical benefits of this first-in-class multi-specific inhibitor derived from our Cloudbreak platform.”

Presentation details are summarized below:

Title: Discovery of a Novel, Dual CD73 & PD-1 Targeting Multi-specific Drug Fc-Conjugate (DFC) for the Treatment of Cancer
Presenter: James Levin, Ph.D., Cidara Therapeutics
Date and Time: Thursday, December 7, 2023, 12:00-1:00 PM CET
Key highlights:

• CD73/PD-1 DFC is a potent inhibitor of hCD73 and hPD-1
• DFC reduced tumor growth by 56% at 1mg/kg and >70% at 3mg/kg doses
• DFC demonstrated superior activity to a pembrolizumab biosimilar antibody and a matched CD73 DFC at 1/3 the dose of the respective monotherapies

Title: Discovery of CBO421, a First-in-Class Drug Fc-Conjugate (DFC), Targeting CD73 in Cancer
Presenter: Simon Döhrmann, Ph.D., Cidara Therapeutics
Date and Time: Thursday, December 7, 2023, 12:00-1:00 PM CET
Key highlights:

• CBO421 is a potent, AMP-competitive inhibitor of CD73 that demonstrates a differentiated in vitro activity profile across several assays compared with small molecule and antibody inhibitors of CD73 in clinical development
• The in vitro potency, multiple mechanisms of action, and favorable pharmacokinetics profile of CBO421 translated to antitumor efficacy in monotherapy and in combination with PD-1 therapy

Cidara is currently advancing its dual CD73/PD-1 inhibitor DFC and CBO421 in preclinical studies. The company plans to file an investigational new drug (IND) application in mid-2024 for CBO421.

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 nonclinical data generated for CBO421 to date will be predictive of activity in humans, whether pharmacokinetics, toxicology, and other nonclinical data being generated for CBO421 will be adequate to support an IND filing with the FDA, and whether a combination CD73 and PD-1 DFC will progress to further nonclinical development. 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. 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.

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