IGM Biosciences (IGMS) Guggenheim's Inaugural Healthcare Innovation Conference summary

Strategic focus and pipeline overview

• Recently pivoted to focus exclusively on autoimmune diseases, positioning as a leader in T-cell engager (TCE) development for this area.

• Four active or soon-to-begin phase one studies in autoimmune indications with large unmet needs; all candidates are wholly owned.

• Collaboration with Sanofi on agonist antibodies in autoimmunity, with potential for over $3 billion in milestones.

• Imvotamab, a CD20 TCE, leverages prior clinical experience in NHL for safety and dosing insights in autoimmune trials.

• CD38 x CD3 TCE (IGM-2644) to enter clinical studies in myasthenia gravis (MG) later this year.

Value proposition and differentiation of T-cell engagers

• TCEs offer deeper B-cell depletion in tissue, potentially outperforming existing drugs like Rituxan, especially at low target expression.

• Wide therapeutic window demonstrated by low CRS rates and high dosing tolerance in NHL studies.

• Off-the-shelf administration, no need for preconditioning or hospitalization, and potential for retreatment distinguish TCEs from CAR-T therapies.

• TCEs may achieve more profound B-cell depletion than monoclonal antibodies due to T-cell engagement.

Clinical development and trial design

• Phase one studies in RA, lupus, and myositis are progressing, with initial data expected by mid-2025.

• RA study has cleared the third dose cohort; lupus is enrolling in the second cohort; myositis has dosed its first patient.

• Myositis study allows for deep translational data via tissue biopsies, complementing data from other indications.

• Stringent enrollment criteria in lupus (SLEDAI-2K cutoff of 10) reflect regulatory caution but have not hindered enrollment.

• Clinical outcomes assessed include DAS28 for RA and SLEDAI-2K for lupus; focus on B-cell depletion depth, duration, and reconstitution.