AUM Biosciences, a global clinical-stage biotech company, focused on discovering and developing precision oncology therapeutics, today announced that it has received authorization from the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for the clinical trial evaluating AUM001, a selective translation inhibitor.
SINGAPORE and BETHESDA, Md., June 07, 2022 (GLOBE NEWSWIRE) -- AUM Biosciences, a global clinical-stage biotech company, focused on discovering and developing precision oncology therapeutics, today announced that it has received authorization from the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for the clinical trial evaluating AUM001, a selective translation inhibitor. As a result, AUM plans to evaluate AUM001, in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), in a global Phase 2 clinical trial in patients with microsatellite stable colorectal cancer (MSS CRC).
“The FDA’s authorization of our IND application represents a significant milestone for our lead asset AUM001,” said Vishal Doshi, CEO of AUM Biosciences. “The planned global Phase 2 trial is an important component of our clinical development strategy, which is focused on advancing clinical trials for therapeutics candidates that are designed to reverse cancer resistance.”
“Opening the IND for our mRNA translation inhibitor is a key advancement in the development of precision oncology therapeutics for cancers with high unmet medical needs,” said Harish Dave, MB, ChB, Chief Medical Officer at AUM Biosciences. “MNK inhibition, when combined with a checkpoint inhibitor or conventional chemotherapy drugs, is broadly expected to extend and restore the activity profile of these drugs.”
As previously announced, AUM 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. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About AUM001
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 advancing a clinical pipeline of precision oncology therapeutics designed to deploy multi-faceted inhibition strategies to reverse cancer resistance. The company’s management 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.
The company completed a $27 million Series A funding round. For more information, please visit www.aumbiosciences.com
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