Development Status

Our lead therapeutic candidate has completed proof-of-mechanism validation and initiated formal development activities.

Current status includes completed IND-enabling studies and FDA interaction through Type B meetings.

The therapeutic demonstrates dose-dependent restoration of MHC Class I expression in tumor tissue with minimal normal tissue exposure.

Manufacturing capabilities support clinical trial requirements through established GMP partnerships.

Phase I clinical trial design is complete and includes mechanism validation endpoints.

Patient population targets MHC Class I-deficient solid tumors with documented B2M downregulation.

Primary endpoint measures target engagement through restored tumor surface MHC Class I expression.

Safety endpoints follow standard oncology development practices with particular attention to immune-related adverse events.

The program maintains active communication with FDA through formal guidance pathways.

IND submission timing aligns with completed CMC validation and clinical site selection.

Regulatory strategy includes potential Fast Track designation based on unmet medical need and mechanistic novelty.

The therapeutic pathway follows established precedent for immune-oncology therapeutics with novel mechanisms.

Secondary therapeutic candidates remain in discovery research with target validation underway.

These programs focus on complementary mechanisms of MHC Class I restoration and immune recognition enhancement.

Development timing depends on lead candidate clinical validation and platform technology advancement.

The program maintains disciplined capital allocation with milestone-driven advancement criteria.