EQ101 / Equillium - LARVOL DELTA

Equillium Reports Second Quarter 2024 Financial Results and Provides Recent Corporate and Clinical Highlights (Businesswire) - P2 | N=36 | NCT05589610 | Sponsor: Equillium | "Announced positive topline data from Phase 2 study of EQ101 in alopecia areata subjects, including 29% of completed subjects with moderate to severe disease achieving SALT (Severity Alopecia Tool) ≤ 20....Anticipated Upcoming Milestones: EQ101: Transition to subcutaneous delivery and initiate Phase 2 dose optimization study in alopecia areata – 2025. EQ302: Initiate Phase 1 study – 2H 2025....Revenue for the second quarter of 2024 was $13.9 million, compared to $9.1 million during the same period in 2023. Revenue in the second quarters of 2024 and 2023 consisted entirely of itolizumab development funding and amortization of the upfront payment resulting from the Asset Purchase Agreement with Ono.

Commercial • New P2 trial • P2 data • Acute Graft versus Host Disease • Alopecia • Immunology

Study of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata (clinicaltrials.gov) - P2 | N=36 | Completed | Sponsor: Equillium | Active, not recruiting ➔ Completed

Trial completion • Alopecia • Dermatology • Immunology

Equillium Reports on Fourth Quarter and Full Year 2023 Financial Results and Corporate and Clinical Highlights (Businesswire) - "Anticipated Upcoming Milestones: (i) EQ101: Phase 2 clinical study in subjects with moderate to severe alopecia areata - topline data anticipated in Q2 2024; (ii) Itolizumab: EQUALISE lupus nephritis topline data to Ono anticipated in the coming weeks; EQUATOR acute graft-versus-host disease interim review anticipated in Q3 2024."

P1 data • P2 data • P3 data • Acute Graft versus Host Disease • Alopecia • Lupus Nephritis

Study of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Equillium | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2023 ➔ Apr 2024 | Trial primary completion date: Oct 2023 ➔ Mar 2024

Enrollment closed • Trial completion date • Trial primary completion date • Alopecia • Immunology

Equillium Reports Third Quarter 2023 Financial Results and Provides Corporate and Clinical Updates (Businesswire) - "EQ101: Phase 2 clinical study in subjects with alopecia areata – initial data anticipated in Q4 2023, topline data anticipated in mid-2024..."

P2 data • Alopecia • Immunology

Equillium to Host Analyst & Investor Day (Businesswire) - "Equillium, Inc...today announced that it will host a virtual analyst and investor day on Monday, October 16, 2023 at 9 a.m. PT / 12:00 p.m. ET. During the event, management will provide a brief review of Equillium’s pipeline and a detailed review of the company’s Multi-Cytokine Platform and clinical-stage Multi-Cytokine Inhibitors, with a focus on its lead asset, EQ101, currently in a Phase 2 clinical trial for moderate to severe alopecia areata."

Clinical • Alopecia • Immunology

Equillium Reports Second Quarter 2023 Financial Results and Provides Corporate and Clinical Updates (Businesswire) - "EQ101: Phase 2 clinical study in subjects with alopecia areata – initial data anticipated in 2H 2023, topline data anticipated in mid-2024; EQ102: Phase 1 first-in-human study in healthy volunteers and subjects with celiac disease – single ascending dose/multiple ascending dose data anticipated in 2H 2023, celiac disease patient data anticipated in 2024..."

P1 data • P2 data • Acute Graft versus Host Disease • Alopecia • Celiac Disease • Graft versus Host Disease • Immunology • Lupus Nephritis

Study of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Equillium | Not yet recruiting ➔ Recruiting

Enrollment open • Alopecia

Equillium Announces Presentation of Data Demonstrating Biological Importance of Multi-Cytokine Inhibitors EQ101 and EQ102 at the La Jolla Immunology Conference (Businesswire) - "Equillium, Inc...announced data presented at the annual La Jolla Immunology Conference. The research highlights the potential for multi-cytokine inhibitors such as EQ101 and EQ102, as potentially effective strategies for the treatment of certain autoimmune diseases....'We look forward to initiating a Phase 2 clinical study of EQ101 in subjects with alopecia areata, and a Phase 1 first-in-human study of EQ102 in normal healthy volunteers – as well as celiac patients – both by the end of this year.'"

Clinical data • New P1 trial • New P2 trial • Acute Graft versus Host Disease • Alopecia • Celiac Disease • Dermatology • Graft versus Host Disease • Immunology

Study of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Equillium

New P2 trial • Alopecia

BNZ1-CT-204: Phase 2 Trial of BNZ-1 in Patients With Moderate to Severe Alopecia Areata (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Equillium | N=125 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Alopecia

[VIRTUAL] Co-Inhibition of IL-2, IL-9 and IL-15 By the Novel Immunomodulator, Bnz-1, Provides Clinical Efficacy in Patients with Refractory Cutaneous T Cell Lymphoma in a Phase 1/2 Clinical Trial (ASH 2020) - P1/2 | "BNZ-1, an IL-2, IL-9, and IL-15 inhibitor, may provide a novel treatment option for CTCL patients who relapsed or were refractory with conventional therapies with a favorable toxicity profile. The multifaceted approach of BNZ-1 leads to direct inhibition of malignant cells, activation of tumor immunity, and suppression of inflammation. Since BNZ-1 showed safety and efficacy in challenging rCTCL patient population, its further development in a phase 3 trial is planned."

Clinical • P1/2 data • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Immune Modulation • Immunology • Inflammation • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • IL15 • IL2 • IL9

Phase 2 Trial of BNZ-1 in Patients With Moderate to Severe Alopecia Areata (clinicaltrials.gov) - P2; N=125; Not yet recruiting; Sponsor: Bioniz Therapeutics; Trial completion date: Mar 2021 ➔ Nov 2022; Trial primary completion date: Mar 2021 ➔ Nov 2022

Clinical • Trial completion date • Trial primary completion date • Alopecia

A Dose-Ranging Study of IV BNZ-1 in LGL Leukemia or Refractory CTCL (clinicaltrials.gov) - P1/2; N=50; Completed; Sponsor: Bioniz Therapeutics; Recruiting ➔ Completed; N=24 ➔ 50; Trial completion date: Sep 2019 ➔ Jun 2020; Trial primary completion date: Aug 2019 ➔ Jun 2020

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Cutaneous T-cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CD8

Bioniz Therapeutics Receives Orphan Drug Designation from the European Commission for BNZ-1 for Treatment of Cutaneous T-Cell Lymphoma (PRNewswire) - "Bioniz Therapeutics, Inc....announced the European Commission (EC) has granted orphan designation to BNZ-1 for the treatment of cutaneous T-cell lymphoma (CTCL), a rare skin cancer....Bioniz recently completed a phase 2 study of BNZ-1 in CTCL in the United States and intends to initiate a phase 3 clinical trial of BNZ-1 for the treatment of patients with relapsed or refractory CTCL (rCTCL). Bioniz expects the phase 3 to begin enrolling the second half of 2021."

Enrollment status • European regulatory • New P3 trial • Trial completion • Cutaneous T-cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Bioniz Announces Positive End of Phase 2 Meeting with the FDA for BNZ-1 for the Treatment of Refractory Cutaneous T-Cell Lymphoma (PRNewswire) - "Bioniz Therapeutics, Inc...announced...that the U.S. Food and Drug Administration (FDA) provided positive feedback during the company's end of Phase 2 (EOP2) meeting for Bioniz's BNZ-1. Based on the FDA's feedback, Bioniz intends to initiate a Phase 3 clinical trial of BNZ-1 for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma...The FDA provided clear guidance for the design of the BNZ-1 Phase 3 trial as well as submission of the New Drug Application (NDA) that would follow a successful pivotal trial. Bioniz expects the Phase 3 to begin enrolling second half of 2021."

FDA event • New P3 trial • Cutaneous T-cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Almirall demonstrates resilient performance year to date despite COVID-19 impacts (PRNewswire) - "Ilumetri® sales grew +125% year-on-year and Seysara® showed Net Sales performance improvement quarter-on-quarter following clinically relevant FDA label improvement...Ilumetri® is showing excellent momentum continuing its growth trend with sales increasing by +125% YoY is versus Q3 2019. In key markets such as Germany, Ilumetri® gained c. 31% share of new patients in the anti-IL-23 class...The company plans to submit Seysara® to the Chinese NMPA in 2023....Almirall would obtain the global rights to BNZ-1, a peptide that selectively blocks the activity of three cytokines of the same family: IL-2, IL-9, and IL-15, and which is currently in Phase 1/2 of development for refractory cutaneous T-cell lymphoma. Almirall expects to make an option exercise decision in Q1 2021. If the company chooses to exercise the option, Almirall plans to start a Phase III trial in CTCL in 2021 to secure launch as early as 2023."

Launch • New P3 trial • Non-US regulatory • Sales • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Immunology • Non-Hodgkin’s Lymphoma • Oncology • Psoriasis

Bioniz Announces Positive Clinical Data of BNZ-1, First Anti-Cytokine Therapy to Demonstrate Efficacy in Treating Refractory Cutaneous T-Cell Lymphoma (PRNewswire) - P1/2, N=24; NCT03239392; Sponsor: Bioniz Therapeutics; "Bioniz Therapeutics...today announced positive clinical data in an oral presentation at the 62nd ASH Annual Meeting And Exposition (ASH 2020) from the company's Phase 1/2 clinical study of BNZ-1 for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (rCTCL), a rare, aggressive cancer...'These data validate our platform technology with the first efficacy demonstration of BNZ-1...and assisted us in the design of a pivotal clinical trial for CTCL, which the company expects to begin in 2021,'...The primary endpoint of the study was overall safety after four weeks of treatment...BNZ-1 demonstrated overall response rate of 63.2% as measured by GRS, which is primarily driven by the mSWAT score..."

New trial • P1/2 data • Cutaneous T-cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Bioniz Announces Oral Presentation at ASH 2020 of Positive Clinical Data of BNZ-1 for the Treatment of Refractory Cutaneous T-Cell Lymphoma (PRNewswire) - “Bioniz Therapeutics, Inc…announced an oral presentation at the 62nd ASH Annual Meeting and Exposition (ASH 2020) of positive safety and efficacy data from the company's Phase 1/2 clinical study of BNZ-1 for the treatment of refractory cutaneous T-cell lymphoma (rCTCL), a rare, aggressive cancer.”

P1/2 data • Cutaneous T-cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology