AUM Biosciences, a global clinical-stage biotech company, focused on discovering and developing novel targeted oncology therapies, 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).
“This collaboration with MSD marks a major milestone and enables the joint clinical development of AUM001 in combination with KEYTRUDA. We are optimistic about selective translation inhibitors as a new class of safe and effective treatment options,” said Vishal Doshi, CEO of AUM Biosciences.
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, MB, ChB, CMO of AUM Biosciences, noted, “MSS CRC represents 80-85% of the CRC patient population1, 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.”
Mr. Doshi noted, “Leveraging the favorable single agent activity of AUM001, and combining with KEYTRUDA has the potential for augmented immuno-oncology activity. We are fortunate to have the opportunity to explore this combination with the pioneering and widely used anti-PD-1 therapy to address unmet needs in this space.”
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special
offers from Pharmaceutical Outsourcing – all delivered right to your inbox!
Sign up now!