Over the next several months, we will highlight innovations from the past decade at The Johns Hopkins University to illustrate the depth, breadth and impact of research from the university’s many divisions and disciplines.
The culmination of 25 years of work, Pylarify is an on-market imaging agent for prostate cancer detection based on technology from Martin Pomper, M.D., Johns Hopkins Professor of Radiology and Radiological Sciences from 1996 to 2023.
Pylarify was brought to market by Lantheus, a leader in radiopharmaceutical oncology, and approved by the FDA in 2021. It has since become the market leader for prostate cancer diagnostic imaging via PET scan. It is estimated to have been used in over 250,000 patient scans in 2024, and analysts project 2024 sales of at least $1 billion.
Prostate cancer is the second leading cause of cancer-related death in men, and one in eight men will receive a prostate cancer diagnosis. PyL, the imaging agent that Pomper and his team discovered, attaches to cells with elevated PSMA levels, allowing doctors to pinpoint the exact location or locations of the cancer without a biopsy or other procedures.
Pomper’s interest in imaging prostate cancer began in 1996 when he came across a journal article about an inhibitor of glutamate carboxypeptidase II (GCPII), a brain enzyme that generates glutamate — a chemical that nerve cells use to send signals to other cells. Excess glutamate has been found in people with various neurological diseases, and researchers have learned that blocking GCPII in animals can limit excess glutamate and provide therapeutic benefits. Imaging compounds for GCPII have difficulty penetrating the brain, however, hampering clinical development.
But GCPII is also found elsewhere in the body, where it is called a different name: PSMA. Pomper pivoted his research, theorizing that his compounds could image prostate cancer. He and his team started making various imaging agents and, over the years, slowly but steadily accumulated funding for their work.
JHTV obtained patent protection for PyL in 2014. Jeanine Pennington, JHTV’s director of licensing, joined Pomper to convince a company holding background intellectual property rights on the technology to co-develop the imaging agent.
“The moral of the story is perseverance,” Pomper says. “In addition to our team, I owe it to Johns Hopkins, which has provided me with the kind of freedom, collaborators and physical environment to do things like this.”
Pylarify Milestones:
- 1996: Pomper began his research on PSMA-based (prostate specific membrane antigen) imaging agents at Johns Hopkins. This marked the start of his research into developing small-molecule tracers for prostate cancer.
- Mid-2000s: The first PSMA-targeted PET imaging agents were tested in clinical trials. These early trials demonstrated the potential of PSMA-targeted imaging to detect prostate cancer more accurately than traditional methods.
- 2019: The OSPREY and CONDOR clinical trials were conducted, demonstrating Pylarify’s effectiveness in detecting prostate cancer metastases with high specificity and sensitivity. These trials were crucial in validating Pylarify’s clinical uses.
- 2021: The U.S. Food and Drug Administration (FDA) approved Pylarify for use in PET imaging of prostate cancer, marking the culmination of over two decades of research and development by Dr. Pomper and his team. Pylarify was launched commercially.
More about Pylarify and Pomper: