Research and clinical trials
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The U.S. Food and Drug Administration this week granted fast-track designation for ONCOS-102, an immunotherapy vaccine that targets malignant mesothelioma and other hard-to-treat tumors.
This appointment is expected to expedite the regulatory approval process. The vaccine developer, Targovax, a small biotechnology company focused on oncolytic viruses, sees this as an early endorsement from the Food and Drug Administration.
“Yes, that opens the door for us,” Dr. Magnus Jaderberg, chief medical officer of Targovax, told Asbestos.com’s Mesothelioma Center. “It validates what the Food and Drug Administration believes is a potentially promising drug for this disease. This is important.”
Improving the prognosis of mesothelioma
This designation stems in part from interim results in February from an ongoing phase 2 clinical trial that showed increased survival for patients receiving the vaccine along with standard chemotherapy.
The median overall survival was 20.5 months, compared to 13.5 months for the control group who received only chemotherapy.
ONCOS-102 has demonstrated broad-spectrum activation of the immune system with appropriate tolerability and safety, according to the researchers. A follow-up to the trial will be announced in the coming months with an expected higher median survival in the composite group.
At the last update, half of the 20 patients in the experimental group were alive.
“It’s too early to say I’m confident [that this is the answer to mesothelioma]Gaderberg said. But when you are the most important organizer in the world [the FDA] It tells you that they will provide additional resources to help you through the organizational process, and that is helpful.”
In 2020, the US Food and Drug Administration approved – for the first time in 16 years – a new systemic treatment for mesothelioma. The immunotherapy combination of Opdivo and Yervoy was approved last May after showing an improved average survival of four months.
Access to resources for mesothelioma research
Fast-track designation includes more frequent interactions with the FDA, access to more FDA resources, and priority review status that can significantly shorten the regulatory process. It is used mostly for new medicines that are intended to meet unmet medical needs.
Mesothelioma, a rare cancer often associated with asbestos exposure, has no known cure. The most effective treatment has been aggressive surgery, but less than a third of people diagnosed with the disease qualify for the procedure.
ONCOS-102 has already received the Food and Drug Administration’s Orphan Drug Designation, which allows clinicians for early use in treating rare diseases.
ONCOS-102 Clinical Trial Opening Soon
Targovax, in partnership with Merck & Co., will open. , soon to be a clinical trial for mesothelioma combining ONCOS-102 and Keytruda, known generically as pembrolizumab.
Both companies believe that combining two different types of immunotherapy can produce effective synergies. The US Food and Drug Administration in 2020 granted approval for Keytruda, but only for a small percentage of mesothelioma patients who express high levels of a specific protein on the cell surface.
Keytruda alone has shown impressive results with mesothelioma, but only for a small percentage of these patients, and its viability was lacking. Jaderberg believes that ONCOS-102 could increase a tumor’s sensitivity to Keytruda.
“We could end up with a very powerful combination of immunotherapy,” Jaderberg said in 2020. ‘Standard of care [for mesothelioma] It will likely change in the next couple of years. There’s a good chance that ONCOS-102 will be a part of that.”
ONCOS-102 is the company’s flagship product. It is a genetically modified adenovirus designed to selectively infect cancer cells while activating a patient’s immune system. It is also being tested for use in colorectal and skin cancers.
The upcoming mesothelioma trial is expected to involve at least 10 cancer centers in the United States with more than 100 patients participating.
It will compare combination ONCOS-102, Keytruda and chemotherapy with Keytruda and chemotherapy only.
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