Plan to conduct a global Phase 2 clinical trial to evaluate MNK inhibitor (AUM001) in combination with MSD’s anti-PD-1 therapy KEYTRUDA for the treatment of MSS colorectal cancer
SINGAPORE, May 05, 2022 (GLOBE NEWSWIRE) — AUM Biosciences, a global clinical-stage biotech company, focused on discovering and developing novel targeted oncology therapies, today announced that it 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.
AUM001 is a highly selective translation inhibitor. It selectively inhibits MNK 1/2 and thereby blocks phosphorylation of eIF4E. This, in turn, interferes with CAP mediated RNA translation, thereby impairing growth signals involved in cancer development, progression, and resistance to therapies. MNK is important in tumor microenvironment (TME) regulation, shifting the balance towards tumor inhibition. Moreover, inhibition of MNK kinases decreases the production of the pro-inflammatory cytokines like TNFα and IL-6, suggesting that MNK kinases and their substrates (eIF4E, hnRNP A1, Spry1/2) play a pivotal role in regulating the innate and adaptive immune compartment. This has the potential to turn “cold” tumors “hot”, increasing the proportion of tumors susceptible to immunotherapies. AUM001 demonstrated encouraging safety, tolerability and target engagement as a monotherapy in two Phase 1 clinical trials.
About AUM Biosciences
AUM Biosciences is a global clinical-stage biotech company, focused on discovering and developing novel targeted oncology therapies. AUM has an extensive track record of selecting distinctive early-stage assets, successfully exiting virtual biotech models, and has contributed significantly to the development of several currently marketed oncology treatments with annual peak sales up to $3 billion. AUM was founded to enable a holistic strategy for drug development and improve the probability of success with a focus on synergism, sustainability, and scalability.
In Oct 2021, AUM Biosciences (AUM) completed a $27 million Series A funding round. The funding fueled AUM’s vision of developing a world-class biotech pipeline focused on drugging what many consider to be undruggable targets, as well as addressing the need to delay and overcome resistance to targeted drugs in oncology. For more information, please visit http://www.aumbiosciences.com/index.html.
For AUM Biosciences
- Maria Lorenzi, Mayur Amonkar, Jacky Zhang, Shivani Mehta, Kai-Li Liaw, “Epidemiology of Microsatellite Instability High (MSI-H) and Deficient Mismatch Repair (dMMR) in Solid Tumors: A Structured Literature Review”, Journal of Oncology, vol. 2020, Article ID 1807929, 17 pages, 2020. https://doi.org/10.1155/2020/1807929