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Hamilton, Bermuda, July 6, 2021 – Auris Medical Holding Ltd. (NASDAQ:EARS), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced the selection of mutant KRAS-driven colorectal cancer as the first therapeutic indication for its OligoPhore™ oligonucleotide delivery platform. The Company intends to develop the treatment under project code AM-401 with submission of an IND targeted for the end of 2022.
Addressing high unmet medical need
Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer and the second leading cause of cancer death in the US.1 In 2021, there will be an estimated 149,500 new cases of CRC in the US, and 52,980 deaths from CRC.2 Approximately 40 to 50% of patients with CRC harbor mutations of the KRAS gene,3 which are known to contribute to the development, invasion and metastasis of CRC. KRAS encodes the Ras protein which controls - like an "on / off switch" – cell growth, cell maturation, and cell death. Through the mutations, the Ras proteins can be rendered persistently active, causing cancer cells to grow and spread in the body.
Beside CRC, KRAS mutations are frequently observed in pancreatic cancer and lung cancer. Approximately 19% of patients with cancer harbor Ras mutations, equivalent to approximately 3.4 million new cases per year worldwide.4 Mutations in KRAS alone account for approximately one million deaths per year worldwide.5 Although the role of KRAS mutations in cancer has been known for decades, they have remained a challenging target for therapeutic interventions. Only recently two small molecule inhibitors of single KRAS mutations were approved in a breakthrough by the Food and Drug Administration (FDA) for use in the treatment of non-small cell lung cancer (NSCLC).
Compelling results in KRAS-driven models of colorectal and pancreatic cancer
The selection of CRC as the first therapeutic indication for the OligoPhore™ technology was made based on the high unmet medical need, compelling outcomes from studies with OligoPhore™ enabled KRAS silencing, and a well-defined regulatory and development pathway. In vitro and in vivo experiments conducted jointly by research teams from Washington University, St. Louis MO and the University of South Florida, Tampa FL, demonstrated efficient uptake of OligoPhore™ nanoparticles with KRAS-targeted siRNA in colorectal and pancreatic cancer cells, strong inhibition of KRAS expression, reduced viability of tumor cells and significant reduction in tumor growth and volume.6 Importantly, a murine model demonstrated the capacity of the OligoPhore™ platform to drive targeted delivery of the nanoparticles specifically to tumor cells.
"In our preclinical studies with OligoPhore enabled siRNA delivery, we have demonstrated potent knock down of KRAS in a highly targeted and effective fashion, which inhibited a key driver of cancer cell proliferation and metastases", commented Samuel Wickline, MD, Auris Medical's Chief Scientific Officer. "Based on these compelling data and the results from our extensive review of strategic development options, we look forward to advancing OligoPhore first in colorectal cancer before applying the technology also to other therapeutic indications. Thanks to its flexibility and specificity, OligoPhore can be used to simultaneously deliver different siRNA payloads for broad target inhibition, which opens exciting novel therapeutic options."
Posted In: EARS
