Update on Phase 2a data for JNJ-0953 (CD388) for universal prevention of seasonal influenza from Janssen Pharmaceuticals, Inc. leadership following Election to Proceed notification
Detailed overview of potential role of Drug-Fc Conjugates (DFCs) in oncology; Cidara to present clinical development strategy for DFCs, focusing on CD73, chemokine receptors, and multispecific DFCs targeting solid tumors
Formal Q&A session with KOL’s to follow presentations
SAN DIEGO, Sept. 07, 2023 — 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 it will host a virtual R&D Day on Thursday, September 21, 2023 at 12:00 PM ET. To register for the event, click here.
Penny Heaton, MD (Global Therapeutic Area Head, Infectious Diseases & Vaccines, Janssen Pharmaceuticals) and Jorge Villacian, MD (Compound Development Lead, Janssen Pharmaceuticals), will present an update of the Phase 2a data from the Janssen collaboration study of the JNJ-0953 (CD388) drug candidate in development for the universal prevention of seasonal influenza, and discuss potential opportunities for the clinical program.
Cidara leadership will provide an update on its Cloudbreak® pipeline using its oncology DFCs and will provide insight into clinical development considerations for DFCs, focusing on CD73, chemokine receptors, and multispecific DFCs targeting solid tumors.
Stephen Schoenberger, PhD (La Jolla Institute for Immunology) will discuss the unmet needs in cancer immunotherapy.
Ezra Cohen, MD (Chief Medical Officer, Tempus) will highlight the potential role of drug-Fc conjugates (DFCs) to transform the oncology therapeutic landscape.
A live question and answer session will follow the formal presentations.
About Penny Heaton, MD
Dr. Heaton is the Global Therapeutic Area Head, Infectious Diseases & Vaccines at Janssen Research & Development. In this role, she leads a global team focused on developing transformational prevention methods, vaccines and treatments for some of the world’s most threatening infectious diseases. Penny holds two decades of infectious diseases and vaccine research and development experience. Prior to this role, she served as the Chief Executive Officer for the Bill & Melinda Gates Medical Research Institute (Gates MRI), where she led the development of investigational products from pre clinical through late stage development against multiple diseases including TB, malaria and enteric diseases and also served as Director of Vaccine Development at the Gates Foundation, working to address additional infectious diseases including HIV, pneumonia and polio. She has also led vaccine clinical research and development for companies including Novartis and Merck, where she co developed a rotavirus vaccine that has been universally recommended by the World Health Organization for infants worldwide. A graduate of the University of Louisville School of Medicine in Kentucky, Penny is board certified in Pediatrics and Pediatric Infectious Diseases.
About Jorge Villacian, MD
Dr. Villacian is the Compound Development Leader for JNJ-0953 (CD388) at Janssen R&D, where he has led the Janssen team in collaboration with Cidara to move this compound forward. Jorge has held several positions since joining Johnson and Johnson in 2006, including Chief Medical Officer of the Janssen Diagnostics organization, where he and his team developed and managed global research and development collaborations for a variety of diagnostic and companion diagnostic programs in different Therapeutic Areas at Janssen. Before joining J&J, he led Phase 3 studies for anti-HIV treatments at Boehringer Ingelheim. Jorge has also served on steering and advisory committees concerning HIV and antimicrobial resistance and has led and participated in multiple EU-funded projects on rapid diagnostic test development and adoption, as well as pandemic preparedness. Prior to joining industry, he worked as a Consultant Physician in Micronesia and later in Singapore at the Communicable Diseases Center where he played a significant role in the management of the 2003 SARS outbreak. After receiving his M.D. from the National Autonomous University in Mexico City, he trained at Mount Sinai Medical Center in Miami and the Mayo Clinic in Rochester and is Board Certified in Internal Medicine and Infectious Diseases.
About Stephen Schoenberger, PhD
Dr. Schoenberger is a translational immunologist working in the area of precision cancer immunotherapy. Leveraging insights made over more than 30 years of fundamental studies on the immuno-biology of CD4+ and CD8+ T cells, he now guides an integrated research consortium involving research scientists, physicians, and bioinformaticians working to identify neoantigens (NeoAg) through a novel functional strategy based on validation, rather than prediction. Dr. Schoenberger is an investigator on 3 clinical trials involving personalized NeoAg-specific immunotherapy now underway at the UCSD Moores Cancer Center, with additional IIT’s scheduled for 2024. Dr. Schoenberger holds Professorships at the La Jolla Institute for Immunology and the UCSD Moores Cancer Center.
About Ezra Cohen, MD
Dr. Cohen is a leading medical oncologist and cancer researcher who brings a unique combination of extensive clinical and research experience to Tempus’ leadership team. He was most recently the Chief of the Division of Hematology-Oncology as well as the Associate Director of Clinical Science at UC San Diego (UCSD) Moores Cancer Center. Dr. Cohen also led the Precision Immunotherapy Clinic and co-directed the San Diego Center for Precision Immunotherapy at UCSD. Before UCSD, Dr. Cohen spent 15 years at the University of Chicago, where he was the co-director of the Head and Neck Cancer Program as well as Hematology/Oncology Fellowship Program Director.
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 or sublicensee will continue clinical development of CD388, whether oncology DFCs we have developed will be safe for testing in humans, whether we will be able to identify new DFCs directed to additional cancer targets, and whether any DFC will ever be demonstrated to be safe and effective for treatment of any oncology 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. 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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LifeSci Advisors
(212) 915-2578
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