FDA grants Orphan Designation to MTG-20

FDA granted Orphan Drug Designation for MTG-201, a therapy targeting Dickkopf-3 gene defects in various cancers, for the treatment of malignant mesothelioma.

The Dickkopf-3 gene produces a protein called REIC (Reduced Expression in Immortalized Cells protein), which is a critical protein in the downstream mechanism of apoptosis and when absent cancer cells cannot die.

By expressing REIC protein from within cancer cells, MTG-201 induces selective apoptosis due to ER stress, directly killing the cancer and reducing cancer burden. MTG-201 also stimulates the production of activated T-cell lymphocytes that specifically target and destroy residual cancer cells.

MTG-201, developed by MTG Biotherapeutics, is currently in phase I clinical trials for the treatment of prostate cancer and mesothelioma. Preclinical programs are ongoing for the treatment of liver and bladder cancers. MTG-201 is also being evaluated for efficacy in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 antibodies.

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FDA grants Orphan Designation to MTG-20

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FDA grants Orphan Designation to MTG-20

YOU MAY BE INTERESTED IN

The Directors: Candace Johnson and Jonathan Friedberg on living through uncertainty at NCI, payment woesDirectors of two neighboring cancer centers in Upstate New York will face challenges, but “we’ll get through it”

Senators slam Bhattacharya for deflecting responsibility for NIH cuts, upheavalSusan Collins: Trump’s 40% cut is “so disturbing”

In first NCAB meeting since Trump’s inauguration, Lowy reflects on funding choices in lean times“In the NCI director’s office, we have a photograph of a stone bridge, and it asks the question, which stone holds up the bridge? And the answer is all of them.”

CRC patients with cannabis use disorder may have higher odds of death within five years of diagnosisObservational study suggests that clinicians should be cautious when recommending cannabis to manage cancer symptoms

Insights from ASCO 2025: Real-world evidence drives clinical decision-making

The Cancer Letter receives nine journalism, design awards

Never miss an issue!

Login

The Directors: Candace Johnson and Jonathan Friedberg on living through uncertainty at NCI, payment woes
Directors of two neighboring cancer centers in Upstate New York will face challenges, but “we’ll get through it”

Senators slam Bhattacharya for deflecting responsibility for NIH cuts, upheaval
Susan Collins: Trump’s 40% cut is “so disturbing”

In first NCAB meeting since Trump’s inauguration, Lowy reflects on funding choices in lean times
“In the NCI director’s office, we have a photograph of a stone bridge, and it asks the question, which stone holds up the bridge? And the answer is all of them.”

CRC patients with cannabis use disorder may have higher odds of death within five years of diagnosis
Observational study suggests that clinicians should be cautious when recommending cannabis to manage cancer symptoms