Renata Pasqualini, Ph.D.
Professor, Department of Internal Medicine
Chief, Division of Molecular Medicine
Health Sciences Center
The University of New Mexico
Dr. Pasqualini has disclosed three inventions to STC and has three UNM-affiliated pending patent applications for her new therapeutic drugs to treat prostate, lung and breast cancers.
In 2014, the National Cancer Institute estimated that there will be 233,000 new cases of prostate cancer in the U.S. and 29,480 prostate cancer related deaths. Prostate cancer is the most common malignancy in males. Although most prostate cancer patients have indolent disease progression, some have aggressive tumors that ultimately metastasize to bone and soft tissue, resulting in substantial morbidity and mortality. Tumor biomarkers are used to help detect, diagnose, and manage some types of cancer and with prostate cancer. Tumor suppressor genes will inevitably help in the treatment process for those that are or will find themselves suffering from this disease.
Dr. Pasqualini’s tumor suppressor gene for the treatment of prostate cancer have been identified and cloned through a novel regulatory mechanism that plays a functional role in prostate cancer growth and progression. This newly discovered protein-coding gene emphasizes the unique regulatory interplay of a human genetic transcriptional unit and reveals a molecular target for diagnostic and therapeutic intervention.
Antibody-drug conjugates (ADCs) are a new class of highly potent biopharmaceutical drugs designed as a targeted therapy for the treatment of patients with cancer. ADCs are complex molecules comprising an antibody or an antibody fragment linked via a stable linker to a biological active cytotoxic payload or drug. By combining the unique targeting capabilities of monoclonal antibodies with the cancer-killing ability of cytotoxic drugs, antibody-drug conjugates allow sensitive discrimination between healthy and diseased tissue.
Dr. Pasqualini’s tumor localizing antibodies are specific human monoclonal antibodies for treating cancer using a unique method of combining phage and yeast display selection in vitro with tumor xenograft selection in vivo. Antibody-drug conjugates suitable for therapeutic administration for breast and prostate cancer patients are expected to be excellent candidates for therapy with the compositions and methods of this technology.
Dr. Pasqualini and her husband and long-time research partner, Dr. Wadih Arap, both international experts in the discovery of new cancer drugs and the treatment of prostate and other advanced cancers, focus on the central working hypothesis that normal or diseased tissues show different protein expression in the human vascular endothelium, which offers the potential to develop novel diagnostic, imaging, and therapeutic strategies. Their research program uses combinatorial peptide- and antibody-based library selection to discover, validate, and exploit the biochemical diversity of endothelial cell surface receptors to generate novel vascular-targeted drugs for cancer.
Their work has led to the development of two human clinical trials. The Food and Drug Administration (FDA) granted “safe-to-proceed” status for the first vascular-targeted trial in 2009. The study with a cohort of metastatic prostate cancer patients is complete and the results are in press. The IND (investigative new drug) trial successfully met drug localization and activity end points based on analyses of patient bone metastasis at multiple dose levels. The filing of a second IND trial is now an active Phase I study to evaluate an anti-obesity drug in castrate-resistant prostate patients with no standard treatment options. Two other drugs are in pre-IND stage, and several others are in the pre-clinical laboratory phase. Long-term, the broader vision of their research is to generate a large-scale receptor map of the human vasculature.
PENDING PATENT APPLICATIONS
Methods for the Detection and Treatment of Prostate Cancer
Human Antibodies and Therapeutic Methods
Human Antibodies and Therapeutic Methods