APIS Assay Technologies Ltd. has entered into a Research & Development agreement with the Laboratory of Elsa Flores, Ph.D., and Marco Napoli, Ph.D. characterising the suitability of TROLL-2 and TROLL-3 as predictive biomarkers of cancer progression with the goal to assess the role of TROLLs as markers of response to chemotherapy.

Cancer is a multi-pathway disease, whereby it is now clear that personalised genomic medicine is required in the diagnosis and stratification of treatment, and in the prediction and prevention of the disease. There is a real clinical need for validated biomarkers that can demonstrate clinical impact in the decisions made for cancer treatment pathways.

The most frequent genetic alterations across multiple human cancers are mutations in TP53 and the activation of the PI3K/AKT pathway, two events crucial for cancer progression

The laboratory of Dr. Elsa R. Flores has recently demonstrated that the crosstalk between p53 mutations and the AKT pathway is mediated by two long non-coding RNAs (lncRNAs), called TROLL-2 and TROLL-3, which promote tumor formation and progression in several orthotopic models of human cancers. (Nat Commun. 2020 Oct 14;11(1):5156. doi: 10.1038/s41467-020-18973-w)

The published and patented data provide preclinical rationale for the implementation of these lncRNAs and WDR26 as novel therapeutic targets for the treatment of human tumors dependent upon mutant TP53 and/or the PI3K/AKT pathway.

The first target of the R&D collaboration will be Triple-negative breast cancers. TNBCs are among the most therapeutically challenging human cancers and are frequently characterized by the hyperactivation of the PI3K/AKT pathway and the gain-of-function mutation of the tumor suppressor TP53.

TNBCs have higher levels of both lncRNAs compared to non-TNBC cases. A pan-cancer analysis of TCGA datasets and human cancer tissue microarrays showed that these two lncRNAs are prognostic in breast cancer and that they are novel biomarkers of cancer progression in at least 6 different tumor types, underlying the relevance of TROLL-2 and TROLL-3 across multiple human tumors.

The aim of the research collaboration between APIS and Moffitt will be to determine the feasibility of these lncRNAs as a diagnostic tool for the prediction of efficacy of treatment pathways and prognosis of treatment outcome in chemoresistant TNBCs and further analysing NSCLC and melanoma as potential diagnostic targets for the TROLL Biomarkers.

“The collaboration with Dr. Flores and the Moffitt team expands the APIS Biomarker portfolio by targeting the p53 family pathway, with potential companion diagnostics applications,” said Dr. Ian Kavanagh, COO, APIS Technologies Ltd.

Dr. Flores is Chair and Senior Member of the Department of Molecular Oncology and Leader of the Cancer Biology and Evolution Program at Moffitt Cancer Center in Tampa, FL. She has more than 20 years of experience in cancer biology, the p53 pathway, RNA biology and mouse models of human cancer.

Dr Flores added, “The R&D collaboration with APIS will provide a clear and realistic path to provide new diagnostic applications to the patients.”

APIS CEO, Dr. Schorr pointed out that in Spring 2020 APIS has obtained a worldwide exclusive license for the commercial developments of TROLL-2 and TROLL-3 from Moffitt, building the ground for a commercial IVD development of those biomarkers.

About APIS Assay Technologies Ltd
APIS Assay Technologies Ltd, a company combining outstanding In Vitro Diagnostics (IVD) experience with integrated AI to develop biomarker-based diagnostic assays. APIS develops new tests for the prediction, prevention, and diagnosis of disease from discovery to regulatory approval. The company’s business model is based on three pillars: biomarker diagnostics development, molecular diagnostic contract development, and applied bioinformatics.