Benzinga | Dec 13, 2021 08:04AM EST

Equillium Highlights ASH Poster Presentations

Data from EQUATE study continues to show rapid and durable complete responses, resulting in clinically meaningful reduction in corticosteroid use

79% of responders maintained or achieved a complete response at six months

Pivotal study in aGVHD to commence in early 2022

Equillium, Inc. (NASDAQ:EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced two poster presentations at the 63rd Annual Meeting of the American Society of Hematology (ASH), including additional patient data from EQUATE Phase 1b study in acute graft-versus-host disease (aGVHD) demonstrating a continued positive clinical impact on patients treated with itolizumab. Data collected at six months, at least four months after each patient's last dose of itolizumab, showed that 79% (11 of 14) of patients who achieved any response (CR, VGPR or PR) at Day 29 maintained that response and were evaluated as having a complete response (CR) at six months (Day 169). These patients also experienced a clinically meaningful reduction in steroid administration during the evaluation period. Data were presented by John Koreth, M.D., associate professor of medicine, Dana Farber Cancer Institute, Harvard Medical School. The ongoing EQUATE study is evaluating itolizumab as a first-line treatment in severe aGVHD patients where there are no approved treatments for this severe, life-threatening disease.

"The six-month data, which includes five additional patients -- all dosed at 0.8 mg/kg -- continues to demonstrate the potential clinical value of itolizumab in this patient population who have no alternatives to steroids. I am encouraged to see that the early complete response rates seen in these extremely sick, high-risk aGVHD patients are maintained, as well as the concomitant reduction in systemic corticosteroid use, even after cessation of treatment for over four months," said Dr. Koreth.

Data from 25 patients treated with itolizumab (0.4, 0.8 or 1.6 mg/kg) were presented. In patients treated within 3 days of first steroid administration (n=18), Day 29 complete response rates were 61% (11 of 18). Among all patients that have been evaluated at Day 169, outcomes were notable for durability of responses with 50% (11 of 22) of patients achieving a CR and overall survival rate of 64% (14 of 22), with a total of 12 of 14 (86%) responders alive at Day 169 compared to 2 of 8 (25%) non-responders. Responders also experienced a clinically meaningful mean reduction in steroid administration during the evaluation period. Itolizumab treatment was well tolerated across all doses, with reported adverse events consistent with a hospitalized severe aGVHD population, with 2 of 25 subjects (8%) reporting treatment-related serious adverse events (SAEs). Itolizumab treatment resulted in a dose-dependent reduction of CD6 expression on CD4+ T cells and an increase in the regulatory to effector T cell ratio in patients, consistent with the drug's mechanism of action.

"As we collect additional data from the EQUATE study, we are encouraged by the continued promising impact that itolizumab has on the lives of patients with high-risk aGVHD," said Dolca Thomas, executive vice president of research and development and chief medical officer of Equillium. "There is significant unmet need in this patient population for an effective treatment that resolves severe disease while reducing corticosteroid use. The data presented at ASH provides further validation for targeting CD6 to treat aGVHD. Feedback from hematologists and transplantation specialists is that the EQUATE study results are encouraging as a new potential therapeutic and we are optimistic as we advance itolizumab into a pivotal study in first-line treatment of aGVHD patients."

Details of Itolizumab Data Presented at ASH 2021

Title: Itolizumab, a Novel Targeted Anti-CD6 Therapy, in Combination with Corticosteroids, Is Well-Tolerated, with Rapid Pharmacodynamic and Clinical Response in Newly Diagnosed Acute Graft-Versus-Host Disease

First Author: Dr. John Koreth, associate professor of medicine, Dana Farber Cancer Institute, Harvard Medical School

Session Name: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster II

Publication Number: 2891

Title: Antigenic Modulation of CD6 By Itolizumab Is a New Mechanism for Effector T Cell Inhibition

First Author: Dalena Chu, Senior Research Associate, Equillium, Inc.,

Session Name: 203. Lymphocytes and Acquired or Congenital Immunodeficiency Disorders: Poster I

Publication Number: 995

In addition to these presentations, abstracts were published online in the November supplemental issue of Blood. To view the poster presentations, visit the Publications & Presentations page of Equillium's website: https://www.equilliumbio.com/technology/publications-presentations/default.aspx.