Exciting News: Special FDA Designation for Mesothelioma Vaccine

Exciting News: Special FDA Designation for Mesothelioma Vaccine

A company called Ultimovacs has achieved something big in the world of cancer treatment. They received a special title from the US Food and Drug Administration (FDA) for their vaccine called UV1. This vaccine is meant to help people with mesothelioma, which is a rare and tough-to-treat cancer.

Understanding UV1 and Its Goal

UV1 is not like regular vaccines that protect you from diseases. Instead, it’s a vaccine that tries to make your immune system fight cancer. It targets an enzyme in cancer cells called telomerase (hTERT), which is important in mesothelioma. This cancer is known for growing in the lining around your lungs due to asbestos exposure.

The UV1 vaccine is made of three special hTERT parts, chosen based on some scientific information. These parts have shown that they can help your immune system fight different types of cancer. So, there’s hope that this vaccine might be a good treatment.

Learning from the Research

To get this special title from the FDA, scientists studied UV1 in a Phase II NIPU study (NCT04300244). In this study, they tested UV1 on 118 patients with mesothelioma. They used UV1 after the patients had tried another cancer treatment called platinum chemotherapy. They also used it together with two medicines called Opdivo and Yervoy, made by Bristol-Myers Squibb.

Even though the study didn’t show everything the scientists hoped for, it did have some good news. People who got UV1 lived longer, which is really important when fighting cancer. We’ll soon learn more about how UV1 helps when they share the results at the ESMO Congress in Madrid this October.

What’s Next for UV1

Ultimovacs isn’t just focused on mesothelioma. They’re also studying UV1 in another Phase II INITIUM study (NCT04382664) to treat a type of skin cancer called malignant melanoma. Just like in mesothelioma, they are looking at UV1 along with Opdivo and Yervoy.

Initially, we expected to hear results from this study in the first half of 2023. But, things are going a bit slower than we thought. So, we’ll need to wait until the first half of 2024 to see what they find.

A Ray of Hope for Mesothelioma Patients

The CEO of Ultimovacs, Carlos de Sousa, is very happy about getting the FDA’s special title for UV1. He says it shows that UV1 has big potential and that we need new treatments for people with mesothelioma. Right now, mesothelioma is a rare cancer, and it’s tough to treat. People who have it often don’t live very long. But UV1 is bringing hope for better days ahead.


Ra, Justine. “Ultimovacs Bags Orphan Drug Tag for Mesothelioma Vaccine -.” Pharmaceutical Technology (blog), October 9, 2023. https://www.pharmaceutical-technology.com/news/ultimovacs-bags-orphan-drug-tag-for-mesothelioma-vaccine/.

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