SAN DIEGO, Jan. 04, 2023 — 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 it has selected its first oncology drug-Fc conjugate (DFC) candidate from the company’s Cloudbreak® platform: CBO-212, targeting CD73.
“We are excited to start the new year by announcing CBO-212 as our first oncology DFC, marking a significant inflection point for Cidara and our Cloudbreak platform,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “With our Cloudbreak oncology program we seek to develop a new generation of immunotherapies, and our CBO-212 DFC is a first-in-class CD73 inhibitor that combines the strengths of small molecules and monoclonal antibodies targeting CD73. We look forward to advancing CBO-212 through IND enabling studies and providing updates on its progress in leading conferences as we continue to generate more data.”
CBO-212 targets CD73, which contributes to immune evasion in solid cancers by flooding the microenvironment surrounding tumors with adenosine, a potent immune cell suppressor. CD73 is highly expressed on a variety of tumor and stromal cells as well as immunosuppressive cell populations such as regulatory T cells and myeloid-derived suppressor cells. CBO-212 is designed to address the potency, efficacy, pharmacokinetic and safety limitations of small molecule and monoclonal antibody candidates targeting CD73.
Cloudbreak DFCs stably couple highly potent small molecules or peptides to a proprietary variant of a human antibody fragment (Fc). As a result, DFCs are long-acting, and are designed to directly inhibit specific disease targets. DFCs can be tuned to engage the immune system or to be immune silent, expanding the breadth of indications that can be targeted. Immune active DFCs can attract an immune response against cancer cells to maximize disease eradicating activity, while immune silent DFCs allow for expansion into cancer indications where immune system engagement would result in host toxicity.
About Cloudbreak® DFCs
Cidara is developing a new generation of immunotherapeutic agents from its Cloudbreak platform that couple potent drugs to a human antibody fragment (Fc). These highly potent, long-acting drug-Fc conjugates (DFCs) are designed to inhibit specific disease targets while simultaneously engaging the immune system. In addition to multiple oncology programs, Cidara is advancing its antiviral DFC CD388 through Phase 1 and Phase 2a clinical trials in partnership with Janssen for the universal prevention and treatment of influenza. Cidara is also advancing DFC programs to target other life-threatening viruses, such as SARS-CoV-2.
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 whether CBO-212 will demonstrate sufficient safety in animal toxicology studies to support proceeding to submission of an IND for human clinical trials, whether CBO-212 can be formulated into a suitable product for administration to humans and can be manufactured in accordance with GMP requirements, and whether the characteristics of CBO-212 observed in laboratory studies will be predictive of its activity in human subjects or patients. 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.