Singapore-based AUM Biosciences has entered into a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ, USA, a premier global research-intensive biopharmaceutical company, to evaluate AUM001 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a global Phase 2 trial in patients with microsatellite stable colorectal cancer (MSS CRC).

The Phase 2 trial is designed to evaluate safety, tolerability, and efficacy of AUM001, as a monotherapy and in combination with KEYTRUDA. Enrollment is planned to commence in the second half of 2022, pending positive outcome of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) and a Clinical Trial Notification (CTN) with the Australian Therapeutics Goods Administration (TGA).

As a monotherapy, AUM001 demonstrated encouraging safety, tolerability and target engagement in two Phase 1 studies. In a multiple ascending dose Phase 1 trial completed in March 2021, AUM001 demonstrated no treatment emergent adverse events (AEs) or dose limiting toxicity (DLTs).

Harish Dave, CMO of AUM Biosciences, noted, “MSS CRC represents 80-85% of the CRC patient population, and is one of the tumor types in which immunotherapy has proven less effective. Our data indicates combining a checkpoint inhibitor with AUM001 may be effective. We are very optimistic that this will potentially provide a new treatment option for patients with a significant unmet medical need.”