What we have

Treatment Candidate for advanced non-small cell lung cancer

T12 / FST12
Indication: Advanced NSCLC
Target: HMW GPBP and EMT

FST12 is the Company’s lead drug candidate being developed for advanced lung cancer. The company’s objective is to advance FST12 into clinical studies up to and including Phase 2a studies, with the objective of demonstrating safety and biological activity in slowing the growth and spread of lung cancer. FST12 is a proprietary, patent-protected, drug candidate that selectively inhibits high molecular weight (HMW) GPBP kinase activity which is prevalent in the extracellular compartment of drug resistant metastatic tumors. HMW GPBP regulates the assembly and organization of the extracellular collagen IV network stabilizing tumor cells upon epithelial-to-mesenchymal transition (EMT), a principal cause of the emergence of drug resistance and invasiveness. None of the currently approved treatments for lung cancer target the epithelial-to-mesenchymal transition of the tumor. Consistent with its unique specificity toward HMW GPBP, FST12 has exhibited a robust treatment effect and low toxicity in animal studies. FST12 has displayed preferential efficacy on mesenchymal lung and breast cancer models. FST12 is expected to exhibit synergistic anti-cancer activity when combined with cytotoxic agents and delay the emergence of recurrent cancer and drug resistance. FST12 is also expected to reduce metastasis formation from tumors that no longer respond to therapies.

FST12

Treatment Candidates for idiopathic pulmonary fibrosis

GPBP-Mab / FSM26
Indication: IPF
Target: HMW GPBP and EMT

Idiopathic pulmonary fibrosis (IPF) is a life-threatening lung disease that often leads to respiratory failure and other cardiopulmonary complications. Only a few treatments have been approved for this disease, and although patients show some improvement, the disease continues to progress. There is a serious medical need for treatments that target the root cause of IPF, that is fibroblast activation and expansion. FibroStatin’s proprietary treatment candidates target the HMW GPBP kinase and inhibit the epithelial-to-mesenchymal transition (EMT), a primary source of fibroblast expansion and consequential fibrosis. The Company has evaluated GPBP specific Mabs and SMEs in a number of animal models of IPF. These treatments substantially reduced organ fibrosis and extend animal survival. The Company has also completed several studies for its proprietary treatment candidates which demonstrated efficacy in animal models for disorders that have been associated with inflammatory fibrosis including lupus nephritis, rheumatoid arthritis, and diabetes.

Proprietary Companion Dx ELISA to detect GPBP levels in plasma

The Company has developed a proprietary GPBP ELISA test system that detects GPBP levels in the plasma. Initial studies show that GPBP plasma levels rise prior to the appearance of metastases. Thus, the test has the potential of predicting tumor metastases before they occur! GPBP plasma levels also elevate in animal models of idiopathic pulmonary fibrosis. This test will be evaluated as a companion diagnostic to determine if lung cancer patients with elevated plasma GPBP levels are more responsive to FST12 therapy, and to determine if IPF patients with elevated GPBP levels are more responsive to FSM26 therapy.

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