The experimental mesothelioma cell killer known as CRS-207 has received orphan drug status in Europe. This will help researchers speed up development of the Listeria monocytogenes-based immunotherapy.
Orphan drug status in Europe gives therapy developers there access to protocol assistance and invaluable scientific advice. It also gives the company involved in a drug’s development important financial incentives to keep working on the new product and get it ready for market.
CRS-207 is still in the early stages of testing on humans, but has already shown signs of its potential value for mesothelioma patients.
CRS-207 induces a potent immune-system response in the form of T-cell mediation. The company developing CRS-207 says the product has been engineered to find mesothelioma cells and make them sick.
It achieves this by exposing mesothelioma cells to Listeria monocytogenes. Listeria normally makes you violently ill, but this Listeria is lab-modified to only make mesothelioma cells violently ill.
When the mesothelioma cells turn ill, the immune system sends T cells to the rescue. But once the T cells arrive, they recognize the mesothelioma cells — not the Listeria germs — as the target to be attacked.
Mesothelioma Drug Qualifies for Orphan Drug Status Because it Is Rare
Orphan drug status was granted to CRS-207 by the European Medicines Agency (EMA). This is Europe’s version of our own U.S. Food and Drug Administration (FDA).
The FDA, by the way, also granted orphan drug status to CRS-207. But that occurred nearly a year ago.
To earn designation as an orphan drug in Europe, the new medication must be intended to treat a rare life-threatening or chronically debilitating ailment.
The EMA defines rare conditions as those that afflict no more than four people for every 10,000 residents of the European Union. Mesothelioma meets that criterion.
And it is for only the treatment of mesothelioma that the EMA has granted CRS-207 this status as an orphan drug — even though the drug also is showing promise as a treatment for other cancers.
Those other cancers include lung, ovarian, endometrial and gastric cancers. But, for now, the research focus will be on mesothelioma because of the mandate in the orphan drug status approval.
CRS-207 Drug Used in Malignant Pleural Mesothelioma Cases
At the moment, the developer of CRS-207 is proceeding with the second stage of a Phase 1 clinical trial of the drug. The goal is to determine safe doses for patients.
All of the patients participating in this clinical trial have malignant pleural mesothelioma that cannot be treated surgically.
Notably, the Phase 1 testing of CRS-207 is incorporating administration of the drug with standard chemotherapy to see how well the two work together.
The developer is so pleased with the results of testing so far that it wants to skip Phase II and go straight to Phase III after Phase I ends. The developer said it plans to do so in the early part of 2016.
The developer is a Berkeley, California, company by the name of Aduro Biotech, Inc. It describes itself as a clinical-stage immunotherapy company.
Aduro says it concentrates on discovering and bringing to market therapies for difficult diseases such as mesothelioma. The products it develops work by relying on the power of the human immune system.
Many of the new drugs developed by Aduro are based on the company’s proprietary live-attenuated, double-deleted Listeria monocytogenes.