MTG Biotherapeutics Announces that MTG-201 was Granted Orphan Drug Designation by the US FDA for the Treatment of Malignant Mesothelioma

Aug 21, 2015, 18:00 ET from MTG Biotherapeutics

SAN DIEGO, Aug. 21, 2015 /PRNewswire/ -- MTG Biotherapeutics (MTG), an immuno-oncology company developing novel therapeutics for the treatment of cancer, today announced that the US Food and Drug Administration has granted Orphan Drug Designation for MTG-201, an advanced biologic 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.

Mesothelioma is a rare, aggressive cancer that most often affects the lining of the pleural cavity. Available treatments for mesothelioma are very limited, particularly for patients with advanced disease.  In particular, there is a great need to develop therapies such as MTG-201 that can directly attack the mesothelioma cancer cells and induce the immune system against the cancer, to put in combination with anti-CTLA-4 antibodies now in development for this disease.

"There is a significant need for new treatment options for patients with mesothelioma given this is one of the most aggressive and poorly treated cancers.  MTG-201 represents a very novel approach to treating this cancer by selectively inducing apoptosis and inducing an immunologic response against the cancer," said Richard Lowenthal, CEO and President of MTG.  "MTG has already demonstrated that ability of MTG-201 to induce selective apoptosis in Phase 1 studies for prostate cancer, another cancer immortalized by hypermethylation of the Dickkopf-3 gene.  Mesothelioma has been found to be the most sensitive cancer to this mechanism of action and as such we are moving MTG-201 into Phase 1 development for this indication."

The US Food and Drug Administration Orphan Drug Designation program provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the USA.

MTG-201 is part of a pipeline of immuno-oncology therapies based on REIC protein expression in cancers with hypermethylation of the Dickkopf-3 gene.  By expressing REIC protein from within cancer cells, MTG-201 induces selective apoptosis due to ER stress, thus directly killing the cancer and reducing cancer burden.  As a result of this selective apoptotic mechanism, MTG-201 also stimulates the production of activated T-cell lymphocytes that specifically target and destroy residual cancer cells.  Given this mechanism of action, MTG-201 has the potential to work with checkpoint inhibitors now in development in a highly synergistic manner. 

In addition to being investigated as a treatment for patients with mesothelioma, MTG-201 is currently in clinical development for the treatment of prostate cancer.  Preclinical programs are ongoing for the treatment of liver (HCC) and bladder cancers.

In the US, under the Orphan Drug Act, the FDA's Office of Orphan Products Development (OOPD) grants orphan drug status to a drug intended to treat a rare disease or condition, which is generally a disease that affects fewer than 200,000 individuals in the country. Upon approval, if received, the designation provides MTG-201 with certain benefits, including seven years of US market exclusivity in the specified indications if the sponsor complies with certain FDA requirements. Additional incentives for the sponsor include tax credits related to qualified clinical trial expenses and a possible exemption from FDA application fees.

About Mesothelioma
Mesothelioma is an aggressive form of cancer that occurs in the mesothelium, the thin layer of tissue that covers the lungs and other organs. Mesothelioma is associated with exposure to asbestos in most cases. According to the World Health Organization, there are a total of 59,000 cases of mesothelioma worldwide each year. Most mesotheliomas begin as one or more nodules that progressively grow to form a solid coating of tumor surrounding the lung leading to eventual suffocation and death. A high percentage of mesotheliomas contain cancer stem cells, which are generally resistant to the currently available treatment options for mesothelioma. Current treatment in the front line setting consists of 4-6 cycles of Alimta (pemetrexed) in combination with platinum-based therapy. Alimta is the only approved treatment for mesothelioma and there are no approved therapies for relapsed mesothelioma. Relapsed mesothelioma is highly aggressive with a median time to disease progression of only 6 weeks.

About MTG-201 Development Program
MTG-201 is a novel investigational biologic in Phase 1 clinical trials for the treatment of prostate cancer and mesothelioma. MTG-201 selectively induces apoptosis in cancer cells that are immortalized by hypermethylation of the Dickkopf-3 gene and thus are REIC protein deficient.  Secondary to induction of apoptosis, cancer specific activated T-cell Lymphocytes are induced and have been demonstrate to have effectiveness against secondary tumors and residual cancer.  MTG-201 is also be evaluated for efficacy in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 antibodies.

About MTG Biotherapeutics
MTG Biotherapeutics (MTG) is a privately held biopharmaceutical company located in San Diego, California. The company is a pioneer in the use of novel biologic technologies to selectively induce apoptosis in cancers that are immortalized through hypermethylation of the Dickkopf-3 gene.  MTG was licensed the technology for MTG-201 and MTG-202 as well as other potential line extensions from a Japan based Biotechnology Company, Momotaro-Gene Inc.  MTG-201 is based on discoveries at Okayama Medical Hospital.

Media Contact:

MTG Biotherapeutics Inc.

Richard Lowenthal, 858-335-1300

richard.lowenthal@mtg-bio.com

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SOURCE MTG Biotherapeutics