Item 8.01 Other Events.
On April 25, 2022, Equillium, Inc. (“Equillium” or the “Company”) announced the presentation of three posters related to clinical data for itolizumab, the Company’s initial product candidate, at the Transplantation & Cellular Meetings of the American Society of Transplantation and Cellular Therapy, and the Center for International Blood & Marrow Transplant Research.
Details of Itolizumab Data Presented
Title: Updated Interim Results from the EQUATE Study: Preliminary Safety and Efficacy of Itolizumab, a Novel Targeted Anti-CD6 Therapy, in Newly Diagnosed Acute Graft-Versus-Host Disease
First Author: Dr. John Koreth, associate professor of medicine, Dana Farber Cancer Institute, Harvard Medical School
Poster Number: 372
Key Highlights, Summary and Conclusions from Presentation:
| | • | | Itolizumab treatment was associated with high rates of overall clinical response |
| | ○ | | At Day 29, complete response was 52% and overall response was 64% across all doses |
| | ○ | | The highest Day 29 complete response rate (61%) was achieved in subjects treated with itolizumab within 72 hours of starting systemic steroids |
| | • | | Responses were durable, with 79% of Day 29 Responders maintaining response through 6 months and 50% through 12 months |
| | • | | Responders tapered steroids by 73% at Day 29, and 96% at Day 169 |
| | • | | Response at Day 29 was associated with 72% overall survival at 12 months and high rates of progression free survival |
| | • | | Itolizumab was well tolerated across all doses, in the context of a severe acute graft-versus-host disease (“aGVHD”) population |
| | • | | Itolizumab offers a favorable benefit-risk profile that supports evaluation in a pivotal Phase 3 study (“EQUATOR”), which has been initiated for the first-line treatment of aGVHD |
Title: 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
First Author: Cherie Ng, Senior Director of Research, Equillium, Inc.
Poster Number: 371
Key Highlights, Summary and Conclusions from Presentation:
| | • | | Itolizumab is associated with rapid and durable decreases in cell surface CD6 and increases in serum sCD6 in subjects with aGVHD |
| | • | | The observed association between itolizumab serum concentrations and clinical response highlights the importance of achieving high concentrations early in the treatment period to maximize pharmacodynamic effects and clinical efficacy |
| | • | | These results provide evidence of itolizumab activity at the doses evaluated in the EQUATE study and were used to optimize dose selection for the ongoing Phase 3 EQUATOR study |
Title: The CD6-ALCAM Pathway Promotes Effector T Cell Migration
First Author: Valeria Marrocco, Scientist, Equillium, Inc.
Poster Number: 362
Key Highlights, Summary and Conclusions from Presentation:
| | • | | CD4+ and CD8+ T cells that migrate in response to CXCL12 express higher levels of CD6 and that the amount of migration correlates with levels of CD6 expression, suggesting that CD6 is engaged during T cell migration across the endothelial monolayer |
| | • | | Decreasing CD6 expression led to decreased migration of TEM and TEMRA cells while migration of T regulatory cells was unaffected, thus suggesting targeting CD6 in aGVHD would decrease infiltration of pathogenic T cells while still permitting modulation of the immune response by T regulatory cells |
| | • | | Data suggests that CD6-ALCAM pathway is involved in the movement of T cells through the endothelial tissues and confirms CD6 as a target to prevent pathogenic T cell recruitment into inflamed organs |
