Mirata Therapeutics (MRTX), is a microcap oncology company with their lead inhibitor mocetinostat (MGCD0103), an oral spectrum-selective HDAC inhibitor for the treatment of myelodysplastic syndrome or lymphoma. The company has two other inhibitor products in early stages of testing but mocetinostat is the focus of this post because it is furthest along in the FDA approval process, with the initiation of a phase 3 trial scheduled for the second half of 2014. The company believes they could be the first HDAC inhibtor to the market for first line myelodyspaltic patients, a disease that affects 10,000 to 30,000 people in the US and that may have a global MDS market of $1.5 billion by 2017, based on research here Global MDS Market.
Quick facts:
13 million shares outstanding
220 million market cap
68 million in cash
Patent Exp: 2022 for (mocetinostat)
13 clinical trials and 437 patients have used (MGCD0103)
Competition: MEI Pharma (pracinostat) Patent Exp. 2028 for composition of matter.
Phase II Results (Presented at ASCO June 2013 Abstract 7116)
The subset analysis involved 28 MDS patients.
54% had bone marrow blast count >10%.
64% categorized as intermediate or high risk.
Median age was 72.
Pre-treated with one or more prior therapy: (50%) of patients.
Objective Response Rate:
(CR + CRi + Hl) 61%.
Disease Control Rate:
(CR + CRi + Hl + SD) 93%.
Grade 3 drug related adverse events:
Fatigue (23%), Nausea (22%), Diahrea (17%), and vomiting (9%).
The results above compare favorably to current standard of care and is leading to a phase 3 trial for MGDC0103 in first line MDS patients second half of 2014.
Bottom Line: The company plans to finalize discussions and obtain a special protocol assessment from the FDA for the design of a phase 3 trial for mocetinostat in patients with mylodysplastic syndrome in the first half of 2014. There is competition from other companies that use HDAC therapy for myelodysplatic syndrom (MDS), but Mirati's data looks better than the current standard of care. The company is about a year ahead of Mei Pharma's trials where the data looks equal in efficacy so far. The company can be first to market with an oral HDAC inhibitor in combination with AZA for patients in first line MDS.
Disclosure: We currently do not hold shares of MRTX.
Quick facts:
13 million shares outstanding
220 million market cap
68 million in cash
Patent Exp: 2022 for (mocetinostat)
13 clinical trials and 437 patients have used (MGCD0103)
Competition: MEI Pharma (pracinostat) Patent Exp. 2028 for composition of matter.
Phase II Results (Presented at ASCO June 2013 Abstract 7116)
The subset analysis involved 28 MDS patients.
54% had bone marrow blast count >10%.
64% categorized as intermediate or high risk.
Median age was 72.
Pre-treated with one or more prior therapy: (50%) of patients.
Objective Response Rate:
(CR + CRi + Hl) 61%.
Disease Control Rate:
(CR + CRi + Hl + SD) 93%.
Grade 3 drug related adverse events:
Fatigue (23%), Nausea (22%), Diahrea (17%), and vomiting (9%).
The results above compare favorably to current standard of care and is leading to a phase 3 trial for MGDC0103 in first line MDS patients second half of 2014.
Bottom Line: The company plans to finalize discussions and obtain a special protocol assessment from the FDA for the design of a phase 3 trial for mocetinostat in patients with mylodysplastic syndrome in the first half of 2014. There is competition from other companies that use HDAC therapy for myelodysplatic syndrom (MDS), but Mirati's data looks better than the current standard of care. The company is about a year ahead of Mei Pharma's trials where the data looks equal in efficacy so far. The company can be first to market with an oral HDAC inhibitor in combination with AZA for patients in first line MDS.
Disclosure: We currently do not hold shares of MRTX.
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