Bioatla (BCAB) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Pipeline overview and development status

• Focus on off-the-shelf invariant natural killer T (iNKT) cell therapies bridging innate and adaptive immunity, with both native and engineered cell programs in development.

• Lead program AGENT-797 is in phase II trials for second-line gastric cancer and acute respiratory distress syndrome (ARDS), targeting diseases with high unmet need and poor survival rates.

• Engineered CAR-iNKT therapy MINK-215 is in preclinical development, with IND filing planned for early 2025 and clinical trials to follow, targeting FAP-expressing solid tumors.

• Strategic partnership with GC Cell to finance and accelerate MINK-215 advancement.

Scientific and manufacturing differentiation

• iNKT cells combine rapid innate response with durable adaptive memory, can home to hostile tissue environments, and are effective in hard-to-treat metastatic sites.

• Unique invariant TCR allows use of donor iNKT cells in unrelated patients without risk of graft-versus-host disease, enabling scalable, off-the-shelf therapies.

• Proprietary antibody and manufacturing process enable high-purity isolation and expansion of iNKT cells, achieving over 99.6% purity and hundreds of billions of cells per donor.

• Cells retain function after cryopreservation and can be distributed globally, supporting broad clinical trial reach.

Clinical trial design and early results

• AGENT-797 phase II gastric cancer trial is a randomized study with induction and combination arms, including iNKT cells plus standard chemotherapy and combinations with immune checkpoint inhibitors.

• Early cohorts show promising activity and tolerability, with data presentation planned for late 2024 or early 2025.

• Phase I data showed durable disease stabilization and a notable partial response in a heavily pretreated gastric cancer patient, attributed to iNKT cell therapy.

• Standard second-line gastric cancer therapies have response rates under 30% and median survival of 4–10 months, highlighting the need for improved options.