Development Approach

Our therapeutic programs follow explicit target criteria based on mechanistic validation rather than statistical associations.

Primary requirements include: tumor-selective expression, mechanistic role in MHC Class I dysregulation, and druggable protein structure.

Secondary criteria include limited normal tissue expression, validated function in immune evasion, and therapeutic index potential.

This framework prioritizes mechanistic clarity over epidemiological correlation.

The program emphasizes direct molecular intervention rather than immune stimulation.

Therapeutic candidates are designed to restore normal antigen processing and presentation machinery.

This approach contrasts with checkpoint inhibition and adoptive cell transfer, which assume functional antigen presentation.

The rationale is that restoring immune recognition may be more effective than amplifying immune response.

Clinical trials prioritize mechanism validation over response rate optimization.

Primary endpoints typically include MHC Class I surface expression restoration, confirmed by flow cytometry and immunohistochemistry.

Secondary endpoints examine T cell infiltration, cytokine profiles, and molecular markers of immune activation.

Clinical response is measured as a tertiary endpoint to establish correlation between mechanistic and clinical efficacy.

Our approach emphasizes reproducibility and statistical rigor in preclinical validation.

All preclinical studies include appropriate controls, statistical power calculations, and independent validation.

The program follows NIH guidelines for experimental design and reporting.

This commitment extends to negative results, which receive equal emphasis in therapeutic decision-making.