Developmental Therapeutics in Oncology

Andrea Wang-Gillam, MD, PhD
Director

The Division of Oncology has a robust early phase clinical trial program that offers a broad range of cancer treatment options with novel therapeutic targets. In partnership with the National Cancer Institute, investigators here lead multiple safety and efficacy studies focused on a wide range of cancers, including breast, lung, lymphoma and melanoma, among others.

The Division's Developmental Therapeutics (DT) Program is exemplified by its rapid translation of innovative and groundbreaking basic research into the clinical setting. Washington University physician scientists, at the forefront of immunotherapy, have successfully developed personalized vaccine treatments based on specific tumor genetic characteristics. This customized vaccine strategy is currently being tested in patients with breast, lung and pancreatic cancers as well as glioblastoma.

 

DT Fast Track Option

DT Fast Track Option

The DT program has gained a reputation among pharmaceutical companies as a "clinical trial powerhouse" for rapid trial activation and robust patient enrollments. Early phase clinical trials can be activated within 8-9 weeks due to a Fast Track option embedded in the program. Because of our division's efficient clinical trials infrastructure, the DT program has launched multiple first-in-humans, first-in-class studies with some of the newest drugs in the oncology pipeline. At present, multiple classes of anti-cancer agents including targeted therapy, immunotherapy, antibody-drug conjugates, and epigenetic modifiers are being evaluated.

The program is a member of the prestigious Experimental Therapeutics Clinical Trials Network (ETCTN) via the NCI's Cancer Therapy Evaluation Program (CTEP). In collaboration with other large academic ETCTN institutions, Division faculty have opened 17 therapeutic trials with novel drugs; in particular, many trials focus on applying the precision approach of testing new agents in patients with tumors harboring specific mutations.

 

Highlighted DT Investigations

  • Phase 1B Randomized Clinical Trial to Evaluate the Safety and Immune Response to a Mammaglobin-A DNA Vaccine in Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy; Sponsor, Department of Defense (Institutional)
  • Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Personalized Polyepitope DNA Vaccine Strategy in Breast Cancer Patients with Persistent Triple- Negative Disease Following Neoadjuvant Chemotherapy; Sponsor, Susan G. Komen for the Cure (Institutional)
  • Phase I Clinical Trial of Evaluate the Safety and Immunogenicity of a Neoantigen DNA Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy; Sponsor, NCI Pancreatic Cancer Specialized Program of Research Excellence Program (Institutional)
  • Molecular Analysis for Therapy Choices (MATCH) study; Sponsor, NCI

 

DT Program at a Glance

DT Program at a Glance

 

Drug Development Program

Complementing the Developmental Therapeutics Program is a comprehensive effort to translate discoveries and therapies identified by Washington University School of Medicine researchers into new drugs optimized for oncology clinical trials.

The goal of the recently established Drug Development Program is to understand the disease mechanism being targeted and what, if any, drug molecules already have been reported related to that pathway or mechanism. Potent, novel analogues that have appropriate pharmacologic and physiochemical properties will then be designed to target those mechanisms. The optimization process is very results oriented, with the intent of rapidly identifying new drugs for human trials.

The Division has recruited a medicinal chemist to lead the program. Peter Ruminski, MS, has almost 40 years of expertise in drug discovery and development, both within the pharmaceutical industry (Searle, Pharmacia, Pfizer) and at a leading drug discovery center at an academic medical center.

Current projects include identifying novel drugs to treat graft vs. host disease and for peripheral hematopoietic stem cell mobilization. Since October 2017, several new collaborations with researchers in oncology have been established and are currently in the process of generating preliminary data with which to seek funding to advance these projects.

Oncology Clinical Trials

Oncology Clinical Trials