Equillium announces two oral presentations at the annual meeting of the European Society for Blood and Marrow Transplantation.

The presentations include new findings demonstrating durability of clinical response out to one year for patients with high-risk acute graft-versus-host disease (aGVHD) that were treated with itolizumab in the EQUATE study.

Clinical data were presented by Corey Cutler, M.D., associate professor of medicine, Dana Farber Cancer Institute, Harvard Medical School. “These extended twelve-month findings add to the critical mass of data indicating the potential clinical value of itolizumab for patients with high-risk aGVHD initiating therapy with corticosteroids,” said Dr. Cutler. “In addition to these rapid and durable responses, I’m particularly encouraged by a clinically meaningful reduction in the use of corticosteroids and that response at Day 29 was associated with 72 percent overall survival at 12 months, as well as high rates of progression free survival.”

Data demonstrated that across all dose cohorts Day 29 complete response (CR) rate was 52%, overall response rate (ORR) was 64% and that the highest Day 29 CR rate of 61% was achieved in subjects treated with itolizumab within 72 hours of starting systemic corticosteroids. Patients who responded to itolizumab treatment had clinically meaningful reductions in steroid administration during the evaluation period with a median reduction in steroid use of 73% by Day 29 and 96% by 6 months.

Key Highlights, Summary and Conclusions from Oral Presentation: i. First-line itolizumab treatment resulted in rapid and durable response in high-risk aGVHD. ii. Itolizumab treatment was associated with high rates of overall clinical response. iii. At Day 29, CR was 52% and ORR was 64% across all doses. iv. The highest Day 29 CR of 61% was achieved in subjects treated with itolizumab within 72 hours of starting systemic corticosteroids. v. Responses were durable, with 79% of Day 29 responders maintaining response through 6 months and 50% through 12 months. vi. Responders were able to taper corticosteroids by 73% at Day 29 and 96% at Day 169. vii. Response at Day 29 was associated with 72% overall survival at 12 months and improved progression-free survival. ix.Itolizumab was well tolerated across all doses, in the context of a severe aGVHD population. x.Itolizumab offers a favorable benefit-risk profile that supports evaluation in a pivotal Phase III study which has been initiated for the first-line treatment of aGVHD (NCT052639990).

The second study is "Itolizumab, a Novel Targeted Anti-CD6 Therapy, Induces Cleavage of Cell Surface CD6 and Rapid Onset of Efficacy in Subjects with Newly Diagnosed Acute Graft-Versus-Host Disease"- Presenting Author: Stephen Connelly, Ph.D., co-founder and chief scientific officer of Equillium.

Key Highlights, Summary and Conclusions from Oral Presentation: i. Itolizumab was associated with rapid and durable decreases in cell surface CD6. ii.Treatment led to an increase in the ratio of T regulatory to T effector cells iii. Clinical efficacy of itolizumab was associated with higher itolizumab serum concentrations after a single dose, highlighting the importance of achieving high initial itolizumab concentrations early in the treatment period to maximize PD effect and efficacy.