AUM Biosciences has dosed the first patient in a Phase II clinical trial of its mRNA translation inhibitor AUM001 to treat metastatic colorectal cancer (MSS CRC).
The first patient received the dose at Pindara Private Hospital in Queensland, Australia.
The open-label and randomised study is being conducted in partnership with Merck, as part of a clinical trial collaboration and supply agreement for KEYTRUDA (pembrolizumab), an anti-PD-1 therapy.
It will assess AUM001’s tolerability, safety, and effectiveness as a monotherapy or along with KEYTRUDA in the microsatellite stable (MSS) subset of patients with MSS CRC.
It includes two modules, Module 1 being a dose escalation run-in module and Module 2 comprising a cohort expansion.
Module 1 will identify the maximum tolerable dose (MTD) and the recommended Phase 2 dose (RP2D) while Module 2 will evaluate the safety and clinical activity of AUM001.
Patients will be administered AUM001 orally as monotherapy and along with intravenous pembrolizumab or irinotecan.
The first patient was given AUM001 orally once every other day in Arm A of Module 1, which has multiple dose-finding cohorts for the monotherapy.
Module 1 intends to enrol up to 48 patients with a top-line readout expected in the fourth quarter of this year.
AUM Biosciences chairman and CEO Vishal Doshi said: “Dosing the first patient in AUM001’s Phase II trial is a major milestone in advancing our mission to build an industry-leading portfolio of innovative therapies designed to reverse cancer resistance.
“While colorectal cancer is the third most common cancer globally, there are limited therapeutic options due to the resistance associated with current treatments.
“AUM is leveraging multi-faceted strategies, technologies, and targets to develop a diversified pipeline of candidates that have distinct mechanisms of action to overcome cancer drug resistance.”
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