Cidara Therapeutics and WuXi XDC Expand Collaboration for IND-enabling CMC Development to Advance Cidara’s CD73 Oncology DFC Program
Agreement builds upon the existing relationship with WuXi XDC for CMC development and GMP manufacturing of Cidara’s CD388 drug-Fc conjugate (DFC) for influenza to now include the oncology program
SAN DIEGO and SHANGHAI, China, Feb. 01, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, and WuXi XDC, a leading global CRDMO company dedicated to end-to-end bioconjugates services, today announced an expansion of their existing collaboration under which WuXi XDC will provide investigational new drug (IND)-enabling chemistry, manufacturing and controls (CMC) development services for Cidara’s CD73 oncology DFC program.
“WuXi XDC has been an excellent development and manufacturing partner for our ongoing CD388 influenza DFC program, and we are excited to expand this relationship by combining WuXi XDC’s core competencies in bioconjugates manufacturing with our expertise in DFCs to advance the manufacturing of our first-in-class CD73 oncology DFC,” said Jeff Stein, Ph.D., president and CEO of Cidara Therapeutics.
Cidara’s lead oncology candidate, renamed CD421, targets CD73 in the adenosine pathway, which contributes to immune evasion in solid cancers by flooding the tumor microenvironment 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. Cidara’s lead CD73 DFC 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 could result in host toxicity.
Dr. Jimmy Li, CEO of WuXi XDC, added, “We’re thrilled to expand our strategic collaboration with Cidara to further develop new bioconjugates solutions. This expanded partnership is a strong testament to our industry-leading capabilities and expertise. We’re committed to building an innovation ecosystem for bioconjugates by offering global open-access technology platforms with premier quality standards to support our partners worldwide as they build their innovative ideas into transformative new treatments for patients.”
Financial terms of the agreement were not disclosed.
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 its oncology program, 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.
About WuXi XDC
WuXi XDC, a joint venture between WuXi Biologics and WuXi STA, provides end-to-end contract research, development and manufacturing of bioconjugates, including antibody drug conjugates (ADCs). The company’s services cover antibodies and other biologics, chemical payloads and linkers, as well as bioconjugated drug substance and drug product. WuXi XDC has been successful in bringing multiple ADC projects to the Investigational New Drug (IND) filing stage in 15 months or less, nearly cutting in half the traditional development timeline. As of September 30, 2022, WuXi XDC is supporting 270 integrated client projects, including 29 in post-IND and 8 in late-phase stage. For more information about WuXi XDC, please visit: https://www.wuxibiologics.com/services-solutions/#XDC
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 a CD73 targeting DFC can be formulated into a suitable product for administration to humans and can be manufactured in accordance with GMP requirements. 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.