Clinical Potential

Gliomas represent a significant challenge in neuro-oncology. Glioblastomas are notoriously antigen heterogeneous and immunosuppressive. Finding a tumor surface antigen that is largely expressed by the tumor and not healthy tissue would be ideal. This would increase the chance of complete tumor eradication while eliminating the risk of off-tumor toxicity. To get us there, we have selected the EGFRvIII antigen as the first antigen in a series that will be integrated with the use of our proprietary BRiTE technology. The EGFRvIII mutation, found in approximately 25- 30% of glioblastomas and not in healthy cells, is associated with poor prognosis and limited treatment options.

Current therapeutic strategies often fail to deliver adequate concentrations of drugs to the tumor site, resulting in suboptimal outcomes. Adaptin Bio’s BRiTE technology addresses this challenge head-on. Once our cutting-edge BRiTE technology enhances the transport of the bispecific antibodies to the tumor tissue in the brain, the bispecific antibody simultaneously targets the EGFRvIII mutation on glioma cells and the CD3 receptor on T cells, which redirects the T cell to kill the glioma tumor cells. This targeting strategy ensures that T cells are precisely directed to the tumor site, enhancing the efficacy of the immuneresponse and minimizing off-target effects. Additional bispecific antibodies that target other tumor cell surface antigens can be subsequently administered.

Key clinical benefits include:

• Enhanced Tumor Targeting: Our bispecific antibodies activate local T cells to specially kill the tumor, ensuring a potent and localized anti-tumor
• Improved Patient Outcomes: By effectively targeting the EGFRvIII mutation (and others), we aim to significantly improve survival rates and quality of life for glioma
• Reduced Side Effects: The precision of our approach minimizes collateral damage to healthy tissues, reducing the adverse effects typically associated with cancer therapies.

The commercial landscape for glioma treatments is poised for transformation. With over 15,000 new cases of glioblastoma diagnosed annually in the United States alone, there is a pressing need for more effective and targeted therapies.

Market Opportunities:

• High Unmet Need: Gliomas, especially glioblastomas, have limited treatment options and poor survival rates. The introduction of our BRiTE bispecific antibodies could fill a critical gap in the market.
• Growth Potential: The global glioma treatment market is expected to reach $3.3 billion by 2025, growing at a CAGR of 6.8% from 2020. Adaptin Bio is positioned to capture a significant share of this expanding market.
• Strategic Partnerships: Our partnership with Duke University has already proven fruitful, and we are actively seeking collaborations with leading
  pharmaceutical companies and research institutions to accelerate the development and commercialization of our groundbreaking therapies.

• Preclinical Success: In preclinical models, our BRiTE bispecific antibody demonstrated a complete eradication of EGFRvIII+ orthotopic tumors in 70%-80% of mice 
• Safety Profile: Our approach has shown a favorable safety profile in these and other early-stage studies, with minimal off-target effects observed.