First Tracks Biotherapeutics (TRAX) 3rd Annual Guggenheim Healthcare Innovation Conference summary

CD122 profile and pipeline

• CD122 antagonist blocks both IL-15 and IL-2 signaling; preclinical studies indicated high-affinity activity across cytokine pathways, immune cells and Th1/CD8 responses.

• Subcutaneous dosing offers an administration advantage; management described the program as potentially best-in-class based on celiac data announced the prior month.

• Initial portfolio includes three clinical-stage assets: CD122 antagonist, rosnilimab, a PD-1 depleter, and ANB101, a BDCA2-targeting plasmacytoid dendritic cell depleter; research engine retained.

• Management plans to develop the CD122 drug in four indications across at least two therapeutic areas within a year.

Celiac cohort one results

• Phase Ib cohort one enrolled 34 patients with baseline Vh:Cd >2.0, randomized 1:1 to drug or control; patients received SC doses at baseline, weeks 2 and 4, then 6 g gluten/day for 14 days.

• At week 6, Vh:Cd declined 0.17 on drug vs 0.66 on placebo, a ~0.5 difference; management cited 0.25 as the clinically meaningful decline threshold.

• IELs declined from baseline on drug despite gluten exposure; treated patients had no symptom increase from baseline through the challenge, with statistically significant differences vs control on day one and sustained significance for specified symptom measures.

• Management reported relatively benign AEs on drug, no study dropouts, and fewer symptom-management medications than in the control arm.

• Management cautioned that cross-trial comparisons are difficult because gluten challenge doses and durations differ; it characterized cohort one as protective against clinically meaningful worsening on the active arm.

Celiac development and regulatory plans

• Cohort two evaluates patients with Vh:Cd <2.5, generally with moderate-to-severe mucosal injury, in a 3-month healing study without a gluten challenge.

• Patients receive SC loading doses at baseline, weeks 2 and 4, followed by 8 weeks off drug; week-12 biopsy assesses Vh:Cd and IEL changes vs placebo.

• Management expects numerical advantages in Vh:Cd improvement and IEL reduction, but said clinical meaningfulness at 3 months is uncertain and did not forecast statistical significance; results are expected in Q1 next year.

• Cohort-two findings are intended to de-risk future healing trials; cohort one supports a separate prevention path.

• FDA discussions on prevention endpoints and trial design are planned over the next 3, 6 and 9 months; management expects late-stage celiac studies to start in 2027.