On January 15, 2021 Greenfire Bio, LLC reported that its subsidiary, Green3Bio Inc., initiated a Phase 1 clinical trial of GRN-300, a first-in-class, orally bioavailable small molecule inhibitor of the Salt Inducible Kinases 2 and 3 (SIK2, SIK3), at the University of Texas MD Anderson Cancer Center (Press release, Greenfire, JAN 15, 2021, View Source [SID1234577710]). This study will examine the safety and tolerability of GRN-300 and determine the dose to be used in initial efficacy studies. Patients will receive GRN-300 alone or in combination with paclitaxel.
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GRN-300 is the first clinical candidate sponsored by Green3Bio to reach the clinical stage. "We are delighted to see GRN-300 transition to helping serious refractory cancer patients," said Ajit Gill, CEO of Greenfire Bio. "Our mission is to accelerate differentiated therapies and we are especially privileged to be able to work with MD Anderson on this clinical program."
"We are genuinely excited to be bringing a new therapeutic tool to care for these very challenging patients," said Dr. Steve Morris, the Chief Medical Officer of Greenfire Bio. "Based on its unique mechanism of action, we believe this therapy will distinguish itself particularly when combined with paclitaxel." The study plans to begin enrolling patients immediately.
This study is registered at ClinicalTrials.gov Identifier: NCT04711161.
About Ovarian Cancer
According to the American Cancer Society, ovarian cancer ranks fifth in cancer deaths among women. In 2018, there were nearly 68,000 new cases of ovarian cancer diagnosed in Europe and around 45,000 deaths. This year, an estimated 21,000 women will be diagnosed with ovarian cancer and 14,000 will die from the disease in the US alone. Ovarian cancer is difficult to detect in an early, more treatable stage; therefore, the high death rate is the result of the current lack of salvage treatment for the vast majority of women who experience a recurrence, resulting in a 5-year survival rate of less than 30%.
About GRN-300
GRN-300 is an orally bioavailable small molecule dual inhibitor of the salt-inducible kinase 2 and 3 (SIK2, SIK3). The SIK2 kinase is overexpressed in 30% of ovarian cancer specimens suggesting a clinical mechanism of treating ovarian cancer by blocking SIK2 kinase activity. SIK2 and SIK3 are prevalent in several other tumor types, including prostate cancer, breast cancer, diffuse large B-cell lymphoma, and melanoma. Higher levels of expression of SIK2 have been shown to be significantly correlated with poor progression-free survival in patients with high-grade serous ovarian cancers. GRN-300 demonstrated activity in animal models as a single agent for the treatment of ovarian carcinoma and in combination with paclitaxel and has a strong safety profile.