On February 12, 2024 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported that it convened a Scientific Advisory Board (SAB) focusing the discussions on NT219’s indication in recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) (Press release, Purple Biotech, FEB 12, 2024, View Source [SID1234640039]).

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"This scientific advisory board of head and neck cancer key opinion leaders, who are oncologists, researchers, and investigators, provided us their insights on the therapeutic landscape of R/M SCCHN treatment and invaluable guidance on clinical studies for NT219 in combination with cetuximab as a second/third line treatment and potentially in combination with a PD1 inhibitor as a first line treatment," stated Purple Biotech CEO, Gil Efron. "Their recognition of the critical unmet need in recurrent and metastatic head and neck cancer provides further support and momentum to our development program. Now that we have determined the recommended Phase 2 dose, we are prepared to move to our next phase of development. We look forward to the head and neck cancer SAB’s continued guidance and support."

Head & Neck Cancer SAB Members Include:

Douglas Adkins, MD – Dr. Adkins is a Professor of Medicine and Director, Head and Neck and Thyroid Medical Oncology, at the Siteman Cancer Center, Washington University School of Medicine. He is a nationally recognized expert in head and neck cancer known for his commitment to advancing patient care through clinical research. With approximately 350 publications to his name, Dr. Adkins serves on committees including the National Cancer Institute: Head and Neck Steering Committee and Focus Group Member, Metastatic and Recurrent Head and Neck Cancer Task Force from 2015 to 2021.

Ezra Cohen, MD – Dr. Cohen is a Chief Medical Officer of oncology of Tempus AI. He was most recently the Chief of the Division of the Hematology-Oncology and Associate Director of Translational Science at Moores Cancer Center in San Diego, California, and Lead Principal Investigator of Purple Biotech’s Phase 1 /2 dose escalation study of NT219 in the treatment of R/M SCCHN. Dr. Cohen is a medical oncologist and an internationally recognized cancer researcher. He cares for patients with all types of head and neck cancers, including esophageal, thyroid and salivary gland cancers. As a physician-scientist, Dr. Cohen also leads a laboratory that studies novel cancer treatments, including immunotherapy, and has made major contributions in understanding how targeted cancer therapies work. A frequent speaker at national and international meetings, he has authored more than 170 peer-reviewed papers and has been the principal investigator of multiple clinical trials of new drugs for head and neck cancer and other solid tumors in all phases of development.

Antonio Jimeno, MD, PhD – Dr. Jimeno is a Professor at the University of Colorado School of Medicine, the Director of the Head and Neck Cancer (HNC) Program and the Communicating PI of the Colorado HNC SPORE. Clinically, he has an active portfolio of trials investigating relevant targets to modulate immunity and the microenvironment in HNC. Preclinically, his focus is studying how HNC regulates key immune ligands deploying humanized models of HNC to investigate susceptibility to immune modulation and immune evasion mechanisms. Overall, his work furthers understanding of cancer and microenvironment interactions and the development of increasingly powerful and complex models.

Lisa Licitra Francesca Linda, MD – Professor Licitra is a Scientific Director of CNAO, the Hadrontherapy facility in Pavia, Italy. Prof. Licitra served as Associate Professor, Department of Oncology and Hemato-Oncology and Chief of Head and Neck Cancer Medical Oncology Department at Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy. She is Co-founder and member of the European Head and Neck Cancer Society. Prof. Licitra has authored nearly 400 papers in peer-reviewed journals, written 20 book chapters, and approximately 150 scientific articles.

Ari Rosenberg, MD – Dr. Rosenberg is Assistant Professor of Medicine at the University of Chicago and an oncologist who specializes in using basic, translational, and clinical research to improve the lives of his patients. As a clinical investigator, Dr. Rosenberg develops and conducts clinical trials that incorporate novel tissue and blood-based biomarkers, and he has a particular focus on novel therapies and immunotherapeutic strategies, as well as developing multimodality treatment paradigms to reduce treatment-related toxicity.

About NT219

NT219 is a first-in-class, small molecule that promotes Insulin Receptor Substrates 1/2 (IRS) degradation and inhibits Signal Transducer and Activator of Transcription 3 (STAT3) phosphorylation, two major complementary signaling pathways that play a key role in the tumor and its microenvironment. IRS1/2 acts as scaffolds, organizing signaling complexes that mediate mitogenic, metastatic, angiogenic, and anti-apoptotic signals from IGF1R and other oncogenes, consisting of an important driver in multiple cancers and is highly involved in triggering drug resistance. STAT3 is a transcription factor that is broadly hyperactivated in many cancers, promoting proliferation, survival, angiogenesis, metastasis, and tumor immune evasion. Feedback activation of STAT3 plays a prominent role in mediating drug resistance to various anti-cancer therapies. As an inhibitor of both IRS1/2 and STAT3, NT219 has the potential to prevent the development of resistance to multiple approved therapies.