Oncolytic Virus for Mesothelioma Receives Special FDA Designation

The U.S. Food and Drug Administration (FDA) granted orphan drug status to an oncolytic virus developed for mesothelioma. This special designation allows quicker review of the therapy and could expedite getting the treatment to patients with this rare and aggressive cancer.

The oncolytic virus is called MVdeltaC, which is designed for pleural mesothelioma. This type of mesothelioma begins in the lining of the lungs, also known as the pleura.

 

What Does Orphan Drug Designation Mean?

Orphan drug status is a label given to medications for rare diseases, such as mesothelioma. The goal of this designation is to inspire manufacturers to develop new therapies for these rare cancers, which do not have as many patients and therefore may not be as profitable for companies.

After receiving the designation, the drug sponsor and manufacturer receive incentives, such as tax credits for clinical testing. These incentives help manufacturers and sponsors test therapies and further develop them for patient use.

Orphan drug status is not a guarantee of FDA approval in the future. It also does not vouch for a therapy’s safety or effectiveness.

 

What Is MVdeltaC?

Oncolytic viruses are unique cancer therapies genetically engineered to infect cancer cells and ignore other, healthy, cells in the body. This cancer treatment is emerging for aggressive types of cancer that do not often respond well to chemotherapy – such as mesothelioma.

MVdeltaC is a genetically modified version of a measles virus. Genetic engineering of the virus directs it to only infect cells of mesothelioma tumors. The virus replicates within the tumor cells and causes them to die.

When the cells die, they release proteins that the patient’s immune system can register as foreign. This activates the immune system to look for the same cancerous proteins in other cells.

The dual mechanism of using a virus to kill cells and activating the immune system is the basis of oncolytic virus therapy and why many believe this treatment is a promising combination of virotherapy and immunotherapy.

 

Searching for a Cure for Mesothelioma

Mesothelioma is a rare cancer that forms in the lining of the lungs, abdominal cavity or heart. These linings are collectively called the mesothelium.

Mesothelioma is an aggressive cancer – the average survival is 1-2 years – and usually reaches nearby organs quickly after tumor cells start multiplying.

The top options for treatment are surgery, immunotherapy and chemotherapy. Most people with the cancer are age 60 or older and unfit for surgery. Chemotherapy and immunotherapy are approved by the FDA for mesothelioma, but they are far from cures and usually only give patients an extra year of life.

Scientists are looking for and testing new therapies for mesothelioma, hoping to destroy tumors to prolong patients’ lives or even eliminate all tumors and serve as a cure. Oncolytic viruses like MVdeltaC are one such therapy with immense potential.

 

How Has MVdeltaC Performed in Tests?

Drug manufacturer Oncovita presented preclinical data for MVdeltaC at the International Society for Vaccines Annual Congress.

According to OncLive.com, the results showed the oncolytic virus showcased up to 3-fold greater potency than the standard measles virus in human tumor cell samples. The therapy worked in more than 70% of samples spanning eight cancer types, one of which was mesothelioma.

MVdeltaC injection also triggered the release of tumor-associated antigens, which are the internal proteins in cancer cells. It also caused a promising response from the immune system.

The next step is a clinical trial for patients with solid tumors, specifically focusing on people with cancers resistant to a certain immunotherapy called checkpoint inhibitors.

“Receiving orphan drug designation from the FDA for MVdeltaC marks a major milestone for Oncovita and validates our approach of harnessing the potential of measles vaccine viruses to treat solid tumors, particularly rare and devastating cancers such as pleural mesothelioma,” Stéphane Altaba, chief executive officer of Oncovita, stated in a news release.