About Us

Istari Oncology, Inc. is a clinical-stage biotechnology company focused on novel immuno-oncology and immunotherapy platforms for the treatment of glioblastoma and a wide variety of tumors. The company was founded by Darell Bigner, MD, and Matthias Gromeier, MD, of Duke University Medical Center in 2016. Both are leaders in their respective research fields of virology, immunology, monoclonal development and clinical medicine, particularly in the treatment of brain tumors.

Our core technology assets are:

  • PVSRIPO, a prototypic oncolytic recombinant polio virus vaccine, in a Phase 2 study for recurrent glioblastoma (GBM)
  • A series of Antibody-Drug Conjugates (ADCs) comprising antibodies or antibody fragments to a variety of oncology targets – presently conjugated with PE-38 toxin to maximize the killing effect in a Phase 1 study

We believe that our technologies have applicability beyond glioblastoma with additional and accessible major solid tumor types as targets. Numerous solid tumors have shown a high level of expression of the CD155 receptor target for the polio virus. Pre-clinical work is underway at Duke to explore the viability of these targets, such as melanoma and prostate, lung, breast, pancreas and stomach cancer, for clinical development.

The research and clinical development of our immunotherapy technology platforms originated from The Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke University Medical Center. In 2016, Duke University licensed a broad range of patents and patent applications to Istari Oncology and provided access to additional intellectual property created at Duke to continue clinical and commercial development of these technologies.

An Exciting History. A Promising Future.

Although the idea of using viruses to target cancer cells dates back more than a century, advances in the genetic engineering of viruses now make it possible to safely test this immunotherapy against many types of cancer. One very promising type of genetically engineered virus is the PVSRIPO poliovirus.

Dr. Gromeier invented the PVSRIPO poliovirus more than 15 years ago, when he discovered that many cancer cells, including glioblastoma cells, produce the poliovirus receptor Necl-5/CD155. The vaccine works by killing tumor cells and initiating an anti-tumor secondary immune response. After years of pre-clinical safety studies to prove the vaccine would not infect patients with polio, the FDA granted investigational new drug (IND) status for PVSRIPO in 2011.

In 2012, Dr. Bigner launched a Phase 1 study of PVSRIPO with his colleagues Allan H. Friedman, MD; Henry S. Friedman, MD; Annick Desjardins, MD, FRCPC; and John H. Sampson, MD, PhD, at Duke University Medical Center. As of May 2017, out of 24 recurrent glioblastoma patients who were treated with PVSRIPO in the study, there were three long-term survivors (patients still alive 50+ months after treatment). Two patients experienced such great response to the therapy that they could be declared “disease free.” Further, 11 patients were doing well with the selected “optimal” dose with no disease progression, and one who had disease progression was still alive.

This early analysis demonstrates that patients receiving PVSRIPO are living longer than is typically expected for GBM patients, for whom prognoses are typically grim. Currently, the three-year survival rate with PVSRIPO treatment is 21%, compared to the 4% survival rate of historical controls.

Our second technology platform consists of a series of ADCs, which are select, highly specific monoclonal antibodies for a variety of oncology targets.

To learn more about Istari Oncology’s technology, visit Our Science.