Drug repurposing for Cancer. The company anticipates that its metastasis control technology will revolutionize cancer therapy by providing the first important drug for preventing and treating metastasis in prostate, breast and other cancers, and a companion test to identify those patients who will respond to it – anticipated to be around 50% of prostate and breast cancer cases, resulting in an unusually broad market. Since this metastasis technology and IP are based on blocking the CCR5 receptor, an accelerated path to FDA approval and the market may available through out-licensing the repurposing of tested/approved HIV drugs that target the receptor.
Preclinical Testing Platform. ProstaGene has developed a platform of prostate cancer cell lines that metastasize relaibaly to bone and brain in immune competent mice. This unique plaform provides a more reliable pre clinical testing ground, as the immune system is important in the onset and progression of human prostate cancer. The prostate cancer cell line platform developed by Prostagene more faithfully resembles human prostate adenocarcinoma. Each line has a tailored pathway activation for testing pathway inhibitors.
The prostate cancer cell lines developed by Porstagene resemble human prostate cancer subtypes both genetically and at the epigenetic level.
Previous preclinical testing models for novel therapeutics has been xenografts in immune-deficient mice (1). The immune system plays a critical role in the onset and progression of human cancer in particular prostate cancer. Despite the known importance of the immune system in tumor progression, xenograft testing in immune deficient mice has been the historic gold standard. Metastatic disease, is the cause of the majority of human cancer deaths, yet preclinical testing models that recapitulate the molecular complexity of human cancer, and metastasize reliably to distant sites, including bone, in immune competent mice, remained to be identified. Inadequate pre-clinical testing models has likely contributed to the high false positive rate, and subsequent clinical failure of many oncology products.
ProstaGene has developed through sophisticated molecular engineering, proprietary models that reliably recapitulate human metastatic cancer, in the immune competent state. The models reflect the complexity of human cancer at the gene expression and gene structure level. This proprietary platform has been used to identify, through preclinical studies gene signatures for prognostication.
Diagnostic marker identification
Through sophisticated algorithm development ProstaGene has developed biomarker signatures for prognostication and therapeutic substratification. Two large retrospective clinical studies have been completed.
Diagnostic Tests. The “ProstaGene Diagnostic Tests” are a gene signature that distinguishes normal prostate from tumor with approximately 98- 99% predictive value.
Prognostic Test. The “ProstaGene Prognosticator Test” has been shown to distinguish patients with poor vs good outcome for their disease.
ProstaGene’s proprietary platform of tumor models have been used to identify novel therapeutics to treat metastases to lung and bone (3,4). The preclincal studies demonstrate a dramatic reduction in metastases.
ProstaGene’s proprietary platform of tumor models has been used to identify novel targets for tumor metastasis. ProstaGene is engaging in partnerships with leading pharmaceutical and biotechnology companies to create new value and new therapies for patients around the globe.
Jiao, X., Velasco-Velázquez, M., Li, Z., Xu,S., Sicoli , D., Mu,Z., Cristofanilli, M., Rui, H., Den, RB., Fatatis, A., Pestell, RG. CCR5 governs breast cancer stem cell expansion and DNA damage repair. Cancer Res. 2018. 2018 Apr 1;78(7):1657-1671. doi: 10.1158/0008-5472.CAN-17-0915. Epub 2018 Jan 22.PMID:29358169>
1. Ju X, Ertel A, Casimiro C, Yu Z, Meng H, McCue P, Walters R, Fortina P, Lisanti M, Pestell RG. Novel Oncogene Inducted Metastatic Prostate Cancer Cell Lines Define Human Prostate Cancer Progression Signatures. Cancer Res. 2013 Jan 15;73(2):978-89. . Epub 2012 Nov 30.
2 Ertel A, Casimiro MC, Gomella LG, Ju X, Pestell RG. Novel Oncogene Driven Gene Signatures as Diagnostic and Prognostic Tools in Human Prostate Cancer. UroToday. 2013 (Epub 2013 Dec 13. ISSN 1944-4810).
3 Velasco-Velázquez M, Jiao X, de la Fuente M, Pestell TG, Ertel A, Lisanti MP, Pestell RG. CCR5 antagonist blocks metastasis of basal breast cancer cells. Cancer Res. 2012 Aug 1;72(15):3839-50. Epub 2012 May 25.
4 Velasco-Velázquez M, Pestell RG. The CCL5/CCR5 Axis Promotes Metastasis in Basal Breast Cancer. OncoImmunology. 2013 Apr 1;2(4):e23660.