IO Biotech (IOBT) Evercore ISI 8th Annual HealthCONx Conference summary

Platform and clinical progress

• T-win platform targets both immune suppressive cells and cancer cells, aiming for greater therapeutic effect in cancer vaccines.

• Recent phase III trial showed a dramatic effect in progression-free survival (PFS), though narrowly missed statistical significance.

• The platform allows targeting different cells in the tumor microenvironment for improved outcomes.

• Lead product Cylembio (IO-102/IO-103) combined with pembrolizumab was tested globally in 407 patients.

• Phase III results mirrored earlier proof-of-concept studies, with strong PFS but a hazard ratio above the target.

Subgroup analysis and regulatory strategy

• PD-L1 negative subgroup showed a fourfold increase in median PFS compared to control, highlighting a unique mechanism of action.

• Ongoing discussions with the FDA focus on trial design and appropriate comparator arms, adapting to evolving standards of care.

• Next phase III will compare Cylembio plus Opdualag head-to-head with Opdualag, reflecting changes in first-line melanoma treatment.

• Early data from an investigator-initiated trial at MSK show promising PFS benefit for Cylembio plus Opdualag.

• EMA feedback is pending, with potential for a different regulatory path in Europe.

Pipeline expansion and future plans

• Cylembio antigens are expressed in multiple cancers; early signals seen in head and neck and lung cancers.

• Pipeline includes IO-112 (Arginase 1) and IO-170 (TGF-beta), with recent promising preclinical data.

• Plans to expand into colder tumor types like prostate, colorectal, and ovarian cancers, but focus remains on melanoma.

• IND readiness for Arginase 1, with preclinical studies ongoing.

• New adjuvant trial (IOB-032) in melanoma and head and neck is fully enrolled, with data expected next year.