Slide 1: Interim results from the EQUATE Study: itolizumab in newly diagnosed severe aGVHD
Exhibit 99.1 John Koreth, Alison W. Loren, Ryotaro Nakamura, Marco Mielcarek, Trent Wang, George L. Chen, Sarah Anand, Joseph A. Pidala, Edmund K. Waller, Gabrielle Meyers, Daanish Hoda, Mark Schroeder, Jeremy Pantin, Nosha Farhadfar, Cherie Ng, Lisette M. Acevedo, Maple Fung, Joel Rothman, Stephen
Slide 2: Disclosures
Research Support: BMS, Miltenyi, Clinigen, Amgen, Regeneron Advisory Board: Therakos, Cugene, Regeneron Consulting: EMD Serono/Merck, Biolojic Design, Gentibio, Moderna Therapeutics, Equillium, Inc Investigational use of Itolizumab (EQ001) for aGVHD Disclosures 2
Slide 3: CD6-ALCAM Pathway Central to Immune Inflammation
CD6 is a co-stimulatory receptor expressed on CD4 and CD8 effector T cells (Teff) Multiple CD6 ligands, including activated leukocyte cell adhesion molecule (ALCAM), expressed on both APCs and tissues, including the skin and GI tract CD6 and ALCAM both overexpressed during GI inflammation CD6-ALCAM
Slide 4: Itolizumab Causes Antigenic Modulation of Cell Surface CD6
Itolizumab Causes Antigenic Modulation of Cell Surface CD6 Levels of CD6 on itolizumab treated cells normalized to isotype treated cells IgG binds to domain-1 of CD6 causing shedding Dose-dependent CD6 loss results in hyporesponsive T cells CD6 pharmacodynamic marker can be monitored in patients Cli
Slide 5: EQUATE Part A Phase 1b Study Design
≥ 18 years of age Recipients of first allogeneic HSCT Grade III-IV aGVHD by MAGIC criteria Initial dose of systemic corticosteroid ≤ 72 hours Safety and tolerability of intravenous (IV) dosing of itolizumab Determine itolizumab RP2D EQUATE Part A Phase 1b Study Design Screening Treatment Period Safe
Slide 6: Baseline Demographics and Disease Characteristics
Baseline Demographics and Disease Characteristics Abbreviations: ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; HLA, human leukocyte antigen; M, male; SD, standard deviation Data presented is from an interim analysis of subjects who completed visits through at least Day 85 6
Slide 7: GVHD Characteristics
GVHD Characteristics Ann Arbor Score: 1, MAP <0.141; 2, MAP 0.141-0.290; 3, MAP >0.290 Abbreviations: GVHD, graft versus host disease; LGI; lower gastrointestinal; MAP; MAGIC algorithm probability; UGI, upper gastrointestinal. 1Highest clinical grade at screening or baseline Data presented is from a
Slide 8: Summary of Treatment Emergent Adverse Events
Summary of Treatment Emergent Adverse Events 8 AEs were collected through Day 169 for subjects who completed dosing and Day 85 for subjects who discontinued study treatment early; treatment related is defined as possibly related, probably related, and related DLT is defined as ≥Grade 3 infusion reac
Slide 9: Transient decrease in lymphocytes in the first week
Transient decrease in lymphocytes (predominantly in CD6 expressing cells) in the first week Not associated with infection or clinical sequelae Absolute Lymphocyte Change from Baseline Data presented is from an interim analysis of subjects who completed visits through at least Day 85. Data presented
Slide 10: Efficacy: Response over time
Efficacy: Response over time 10 Abbreviations: CR, complete response; ORR, overall response rate= CR+ VGPR + PR; NR, no response; PR, partial response; VGPR, very good partial response defined as achieving all the criteria for skin, liver, and gut involvement per Martin 2009 Consensus criteria witho
Slide 11: Itolizumab Associated with Dose Reduction in Systemic Steroid Use
Itolizumab Associated with Dose Reduction in Systemic Steroid Use 11 Data presented is from an interim analysis of subjects who completed visits through at least Day 85 Data presented as mean (SD); equivalent prednisone dose was calculated for methylprednisolone and dexamethasone to determine total
Slide 12: Dose Responsive Reduction of CD6 with Itolizumab Treatment
Dose Responsive Reduction of CD6 with Itolizumab Treatment Interim pharmacodynamic data from first three cohorts suggests optimal dose range at 0.8 to 1.6 mg/kg 12 Data from 9 subjects, 3 per cohort. One subject in Cohort 1 was not included due to receiving only a single dose of study drug * adjuste
Slide 13: Key findings for itolizumab
The CD6-ALCAM pathway modulates activity and trafficking of Teff cells CD6high Teff cells are known to be more pathogenic, showing increased proliferation and cytokine secretion Treatment with itolizumab leads to antigenic modulation of CD6 and inhibition of Teff cell responses Itolizumab was genera
Slide 14: Thank you to our patients, sites, and advisors
Thank you to our patients, sites, and advisors! Leslie Kean, MD, PhD Jerome Ritz, MD Robert Soiffer, MD Jamie Ferrara, MD EQUATE DSMC Committee 14 For more information: clinicaltrials@equilliumbio.com