Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Bmab600, Itolizumab
EQ001 · 3 trials · 7 indications
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Overall Response Rate (ORR) is defined as the number of subjects with a partial response (PR), very good partial response (VGPR), or complete response (CR) who are alive at Day 29. Subjects must not have received new systemic therapy for aGVHD before the Day 29 Visit.
| Arm | Type | Description |
|---|---|---|
| EQ001 Type A cohort | EXPERIMENTAL | EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses (up to 5 cohorts with dosing to be determined in the range of 0.4 -- 3.2 mg/kg). |
| EQ001 for Type B cohort | EXPERIMENTAL | EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg). |
| EQ001 Dose Escalation (Part A) | EXPERIMENTAL | Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses. |
| EQ001 (Part B) | EXPERIMENTAL | EQ001 administered in a blinded fashion using the optimal dose selected from Part A by intravenous infusion every two weeks for a total of 5 doses. |
| EQ001 Placebo (Part B) | PLACEBO_COMPARATOR | Placebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses. |
| EQ001 | EXPERIMENTAL | EQ001 administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses. |
| EQ001 Placebo | PLACEBO_COMPARATOR | Placebo administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses. |
| Name | Type | Description |
|---|---|---|
| Itolizumab [Bmab 600] | DRUG | EQ001 |
| EQ001 | BIOLOGICAL | Itolizumab \[Bmab 600\]) |
| EQ001 Placebo | BIOLOGICAL | EQ001 Placebo |
Type A Cohort Key Inclusion Criteria: 1. Is male or female, age ≥ 18 and ≤ 75 years 2. Has previously been documented to have met or currently meets Systemic Lupus International Collaborating Clinics (SLICC) and/or American College of Rheumatology (ACR) criteria for SLE 3. Received at least 1 immun...
EQ001 is an investigational monoclonal antibody being developed by Equillium, Inc. for immune-mediated conditions. It is in Phase 1 clinical development for acute graft-versus-host disease and asthma. EQ001 is also known as itolizumab.
EQ001 is being studied for the treatment of acute graft-versus-host disease, or aGVHD, a complication that can occur after stem cell transplantation. A Phase 1 trial evaluated its safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity in subjects with aGVHD. It is investigational and has not been approved for this use.
EQ001 targets CD6, a receptor expressed on T cells. By binding CD6, the monoclonal antibody is designed to modulate T cell activity, which is the proposed mechanism underlying its development in immunology indications such as acute graft-versus-host disease and asthma.
EQ001 is being developed by Equillium, Inc., a biopharmaceutical company whose common stock trades under the ticker EQ. Equillium is the sponsor of the clinical program evaluating EQ001 in acute graft-versus-host disease and asthma.
EQ001 is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA. The Phase 1 program includes completed trials in acute graft-versus-host disease and in uncontrolled asthma.
EQ001 has been evaluated in two completed Phase 1 trials. NCT03763318 studied EQ001 in subjects with acute graft-versus-host disease in the United States, enrolling 30 participants. NCT04007198 studied itolizumab, also known as EQ001, in uncontrolled asthma in Australia and New Zealand, enrolling 18 participants.
Yes, EQ001 is also known as itolizumab. The two names refer to the same monoclonal antibody. The Phase 1 asthma trial is listed under the name itolizumab, while the acute graft-versus-host disease trial is listed under EQ001.