AUM Biosciences Enters Collaboration With Roche for Clinical Development of AUM001 in Combination With Anti-PD-L1 Therapy in Solid Tumor Indications

AUM Biosciences recently announced it has entered into a clinical trial collaboration and supply agreement with Roche to evaluate AUM001, the company’s novel, highly selective MNK1/2 inhibitor, in combination with atezolizumab (Tecentriq), Roche’s anti-PD-L1 therapy, across multiple solid tumor indications, leading with Non-Small Cell Lung Cancer (NSCLC) and Urothelial Cancer (UC).

“This partnership represents a very important milestone as we expand into new indications for the clinical development of AUM001 and realize the full potential of AUM001. This is part of our commitment to conduct a broad clinical development program to evaluate AUM001 to address unmet medical needs in various solid tumor indications,” said Vishal Doshi, CEO of AUM Biosciences.

As a monotherapy, AUM001 demonstrated excellent safety, tolerability, and target engagement in two Phase 1 studies. In a multiple ascending dose Phase 1 trial completed in March 2021, there were no Grade 3/4 treatment emergent AEs or dose limiting toxicities (DLTs).

“Targeted immunotherapies have improved overall survival in a segment of patients with advanced or metastatic cancers. However, there remains a critical need for novel clinical therapies that can further prolong survival in checkpoint inhibitor responsive patients as well as make unresponsive patients responsive AUM001 has a unique proposition where we anticipate preventing or delaying T-cell exhaustion as well as potently stimulating the innate immune system will lead to superior outcomes for cancer patients,” said Harish Dave, MB, ChB, MBA, CMO of AUM Biosciences.

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.

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 $3B. 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, visit http://www.aumbiosciences.com/index.html.