Cardiff Oncology Formally Introduces Scientific Advisory Board

- SAB includes recognized leaders with expertise in oncology drug development, pharmaceutical industry dynamics and translational research –

- SAB will continue to provide insight and guidance on the strategy to advance onvansertib through later-stage clinical development -

SAN DIEGO, March 6, 2023 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, today formally introduced the full membership of its Scientific Advisory Board (SAB). The SAB is comprised of a distinguished group of academic and industry experts who bring depth and breadth of knowledge in oncology drug development, clinical trial design, translational science and clinical research. In most cases, these individuals have been advising the Company for several years and will now collectively serve a critical role as we advance the clinical development of onvansertib. The Company anticipates that over time the membership of the SAB may expand to add additional expertise in new indications or stages of clinical development.

"We are privileged to work with such accomplished oncology medical and scientific thought leaders who are providing strategic guidance to Cardiff Oncology," said Fairooz Kabbinavar, MD, chief medical officer of Cardiff Oncology. "Our advisory board of highly esteemed experts will contribute unique knowledge and experience to the advancement of onvansertib through later-stage clinical development."

The Cardiff Oncology Scientific Advisory Board includes:

• Scott Kopetz, MD, PhD, FACP (MD Anderson Cancer Center)
• Heinz-Josef Lenz, MD, FACP (University of Southern California Norris Comprehensive Cancer Center)
• Christoph Reinhard, PhD, MBA (Independent Consultant in oncology translational research)
• Adam Schayowitz, PhD, MBA (Pfizer Inc.)
• Josep Tabernero, MD, PhD (Vall d'Hebron University Hospital / University of Vic)
• Eric Van Cutsem, MD, PhD (University of Leuven / University Hospitals Gasthuisberg)

"I am honored to serve alongside some of the world's leading experts on this SAB in the development of a novel oncology therapy and the application of biomarkers for precision cancer medicine. The clinical data generated with onvansertib are impressive, as it has been shown to combine with FOLFIRI and bevacizumab to drive durable clinical responses in second-line mCRC patients with various KRAS mutations," said Dr. Heinz-Josef Lenz, associate director for clinical research and co-leader of the GI cancers program at the University of Southern California (USC) Norris Comprehensive Cancer Center, and member of the SAB. "We believe these results suggest onvansertib has the potential to fill a long-standing need to bring improved treatment options to these patients."

"PLK1 plays central roles in mitosis and DNA damage repair, and its overexpression is associated with poor prognosis in a variety of cancers," added Scott Kopetz, MD, PhD, FACP,  professor and deputy chair in the department of gastrointestinal medical oncology, MD Anderson Cancer Center, and member of the SAB. "Onvansertib's ability to potently and specifically inhibit PLK1 suggests it can combine synergistically with multiple oncology drug classes to overcome treatment resistance and offer superior clinical benefit in a range of cancers with high unmet need. Preclinical studies in mCRC evaluating onvansertib in combination with DNA damaging agents have generated compelling data in support of this hypothesis, and I am eager to work with Cardiff Oncology's management team as they build upon these results in the clinical setting."

More background on Cardiff Oncology Scientific Advisory Board Members

Scott Kopetz, MD, PhD, FACP (MD Anderson Cancer Center)

• Professor and deputy chair department of GI medical oncology
• Principal Investigator of several practice-changing clinical trials
• Chair of the NCI Colon Cancer Task Force

Scott Kopetz, MD, PhD, FACP, joined MD Anderson Cancer Center in 2006 and is professor and deputy chair in the department of gastrointestinal medical oncology. Dr. Kopetz is board-certified in internal medicine and in medical oncology. He has authored over 350 peer-reviewed articles in respected scientific journals such as New England Journal of Medicine, Journal of Clinical Oncology, Lancet, Lancet Oncology, JAMA, Cancer Discovery and Nature Medicine. He was the principal investigator of several practice changing clinical trials, including trials for patients with BRAF mutated colorectal cancer that led to new standards of care. Dr. Kopetz leads the MD Anderson Gastrointestinal Cancer Center Program and is chair of the NCI Colon Cancer Task Force.

Heinz-Josef Lenz, MD, FACP (University of Southern California Norris Comprehensive Cancer Center)

• Associate Director for clinical research
• Co-leader of the GI cancers program
• Co-Director of the Colorectal Center at the Keck School of Medicine (USC)

Heinz-Josef Lenz, MD, FACP, is the associate director for clinical research and co-leader of the GI cancers program at the University of Southern California (USC) Norris Comprehensive Cancer Center. He is professor of medicine and preventive medicine, section head of gastrointestinal oncology in the division of medical oncology and co-director of the Colorectal Center at the Keck School of Medicine of USC. An active researcher, Dr. Lenz focuses on topics including the regulation of gene expression involved in drug resistance, patients at high risk of developing colorectal cancer and determination of carcinogenesis, methods of early detection and better surveillance of these cancers. He is a member of professional societies such as the American Association for Cancer Research (AACR), the American Gastroenterology Association and the National Society of Genetic Counselors. He also serves as co-chair of the GI Committee and Correlative Science Committee for SWOG. He is a member of the National Cancer Institute (NCI) Task Force for Gastroesophageal Cancer, the NCI Steering Committee and the NCI Translational Science Committee.

Christoph Reinhard, PhD, MBA (Independent Consultant)

• Life Science Consultant
• Leader in oncology translational research

Christoph Reinhard, PhD, MBA, is a life science consultant, leader in oncology translational research and former senior director of translational sciences oncology at Eli Lilly and Company. His work is focused on oncology drug development at biotech and pharmaceutical companies with a special emphasis on target qualification and discovery of strategies enabling individualized treatment. Dr Reinhard's special interests evolved out of large scale genomic studies of gastrointestinal patient tumors that demonstrated the need for mechanism based target selection and biomarker guided drug development. He is currently engaged as chief scientific officer of CELLphenomics GmbH, which aims to enable individualized treatment of patients based on organoid cultures of their tumors. He also previously served as an associate director of oncology at Novartis Institutes for BioMedical Research.

Adam Schayowitz, PhD, MBA (Pfizer Inc.)

• Pfizer Oncology Global Development Head (Breast Cancer, Colorectal Cancer and Melanoma)

Adam Schayowitz, PhD, MBA, is the Development Head for Breast Cancer, Colorectal Cancer and Melanoma at Pfizer Oncology. He joined Pfizer in 2018 to lead the prostate cancer franchise, grounded in XTANDI. He then became responsible for the Precision Medicine Franchise (Colorectal and Melanoma) based on the Array acquisition and in 2021 added the breast cancer portfolio to his responsibilities. Adam's primary responsibility is to lead the teams responsible for the development and lifecycle management of BRAFTOVI, MEKTOVI, Ibrance, ARV-471 and the late stage pipeline medicines. Prior to joining Pfizer, Adam led the development of Zejula (niraparib) at Tesaro, including the pivotal phase 3 ovarian cancer program as well as other global studies in breast cancer, lung cancer, and prostate cancer in collaboration with Janssen.

Josep Tabernero, MD, PhD (Vall d'Hebron University Hospital / University of Vic)

• Head of medical oncology
• Pharmacodynamic studies and translational research

Josep Tabernero, MD, PhD is head of the medical oncology department at the Vall d'Hebron University Hospital, director of the Vall d'Hebron Institute of Oncology and professor of medicine at Universitat de Vic - Universitat Central de Catalunya (University of Vic). He has been principal investigator of several Phase 1 pharmacodynamic studies and translational projects with tumor-directed targeted therapies and immune-based therapies. His research aims at potentiating molecular therapies targeting specific oncoproteins and accelerating more effective personalized cancer medicines for patients displaying genetic lesions or pathway dysregulation. Dr. Tabernero serves on the Editorial Boards of various top tier journals including Annals of Oncology, ESMO Open, Cancer Discovery, Clinical Cancer Research, Cancer Treatment Reviews and Nature Reviews Clinical Oncology. He has authored approximately 500 peer-reviewed papers with an H-Index of 95. Dr. Tabernero was the president of ESMO and is also a member of AACR and ASCO. He has also been a member of the Educational and Scientific Committees of ESMO, ASCO, AACR, AACR/NCI/EORTC, ASCO GI, ESMO Targeted Anticancer Therapies (TAT) and ESMO-GI/World Congress on Gastrointestinal Cancer meetings.

Eric Van Cutsem, MD, PhD (University of Leuven / University Hospitals Gasthuisberg)

• Professor and Division Head of Digestive Oncology
• Drug development, identification of molecular markers and diagnostic tools for GI cancers

Eric Van Cutsem, MD, PhD, is full professor and division head of digestive oncology at University of Leuven (KUL) and University Hospitals Gasthuisberg, in Leuven, Belgium. He is a member of the Belgian Royal Academy of Medicine and president of the Belgian Foundation Against Cancer. Dr. Van Cutsem's research focuses on the development of new treatment strategies for gastrointestinal (GI) cancers, including drug development and identification of molecular markers and diagnostic tools. He co-founded ESMO GI/World Congress on Gastrointestinal Cancer and serves/served on the board or key committees of the European Society for Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO), European Neuroendocrine Tumor society (ENET), the European Organisation for Research and Treatment of Cancer (EORTC), European Society o Digestive Oncology (ESDO) and of the patient advocacy groups EuropaColon and Digestive Cancers Europe.

About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as KRAS/NRAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC), as well as in investigator-initiated trials in triple negative breast cancer (TNBC) and small cell lung cancer (SCLC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit https://www.cardiffoncology.com.

Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Cardiff Oncology Contact:
James Levine
Chief Financial Officer
858-952-7670
[email protected]  

Investor Contact:  
Kiki Patel, PharmD 
Gilmartin Group  
508 320-1110 
[email protected] 

Media Contact:  
Richa Kumari 
Taft Communications 
551 344-5592   
[email protected] 

SOURCE Cardiff Oncology, Inc.