Progressing programs against genetically validated targets ERAP1 and ERAP2, and broadening the platform by identifying novel ERAP-inhibitor generated antigens and MHCI-directed therapies.

Grey Wolf’s lead development candidate, GRWD5769, is a potent and selective oral ERAP1 inhibitor that has shown the potential to elicit a powerful and differentiated immune response against tumors. The first-in-class compound is currently the focus of an ongoing adaptive Phase 1/2 clinical trial in a range of solid tumor types.  The study is evaluating the safety, tolerability, and efficacy of GRWD5769, including combination with the PD-1 inhibitor Libtayo (cemiplimab).  Initial data from the study will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

A second ERAP1 inhibitor, GRWD0715 is advancing through preclinical development as a potential treatment for autoimmune disease. The company intends to move the compound through investigational new drug (IND)-enabling studies with the goal of entering the clinic in 2025.  Potential autoimmune disease targets include Ankylosing Spondylitis, Psoriatic Arthropathy, and Inflammatory Bowel Disease, among others.

The company is also leveraging its leadership in neoantigen creation with an ERAP2 drug discovery program and by therapeutically targeting novel ERAP1 inhibitor-generated cancer antigens with MHC Class I directed therapies such as soluble T cell receptor (TCR) and TCR mimic bispecifics.

Discovery Preclinical Candidate Nomination IND/CTA enabling Phase I Phase II
  • Phase I/II study ongoing
  • Preclinical
  • Discovery
MHCI directed therapies
  • Discovery

The above information is accurate as of May 2024. The safety and efficacy of these investigation molecules is yet to be established. There is no guarantee that these molecules will proceed to market and become commercially available as these are agents in drug development could be terminated during the development process.