leiolizumab (ALTB-268) / AltruBio - LARVOL DELTA

ALTB-268, a PSGL-1 Agonist Antibody, Ameliorated the Disease Severity in a Murine Model of Colitis and a Human-Mouse Xeno GVHD Model by Down-regulating T Effector Functions (FOCIS 2025) - P2 | "These results demonstrate the potential of Immune checkpoint enhancers (ICEs) in the treatment of autoimmune or inflammatory diseases and support the clinical development of ALTB-268 in T cell-mediated autoimmune and inflammatory diseases such as ulcerative colitis (UC) and GVHD. ALTB-268 is currently in an ongoing phase 2a study in UC (NCT06109441)."

IO biomarker • Preclinical • Graft versus Host Disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CD4 • CD8 • IFNG • TNFA

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: AltruBio Inc. | Active, not recruiting ➔ Recruiting | Trial completion date: Mar 2026 ➔ Nov 2026 | Trial primary completion date: Apr 2025 ➔ Oct 2025

Enrollment open • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: AltruBio Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

AltruBio Presents New In Vivo data for ALTB-268 at the 9th FIMSA 2024 Congress (GlobeNewswire) - "AltruBio Inc...announced new in-vivo proof-of-concept data for their lead candidate ALTB-268 at the 9th Federation of Immunological Societies of Asia-Oceania (FIMSA) 2024 Congress, taking place in Taipei from October 23-27, 2024. The data demonstrates ALTB-268’s in vivo efficacy and confirms its mechanism of action as an immune checkpoint enhancer in a non-clinical disease model, further supporting its clinical development for ulcerative colitis (UC)....'We look forward to sharing data from the ongoing Phase 2a trial in UC in the second half of 2025 and demonstrating how its distinct mechanism of action may translate into clinical potential.'"

New P2a trial • Preclinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

AltruBio Secures up to $225M Oversubscribed Series B Financing to Advance the Clinical Development of Novel Immune Checkpoint Enhancer Program (GlobeNewswire) - "AltruBio Inc...announced an oversubscribed Series B financing of up to $225 million. AltruBio plans to use the proceeds of the financing to advance the clinical development of the Company’s first-in-class, novel immune checkpoint enhancer (ICE) PSGL-1 agonist antibody, ALTB-268. The funds will be used to support ongoing and planned Phase 2 clinical trials in ulcerative colitis (UC), one of many immunological disorders where the mechanism has been clinically validated....The Company’s first-in-class, novel ICE agonist antibody, ALTB-268, is currently being studied in a Phase 2a exploratory biomarker study in patients with biologic refractory UC with an anticipated readout for its primary endpoint of clinical remission per modified Mayo score in 1H 2025....This study is anticipated to read out in 2H of 2026."

Financing • New P2b trial • P2a data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: AltruBio Inc. | N=15 ➔ 30

Enrollment change • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: AltruBio Inc. | Trial primary completion date: Dec 2024 ➔ Apr 2025

Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A First-In-Human SAD and MAD Study to Evaluate the Safety, Tolerability, PK and PD of SC Administered ALTB-268 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: AltruBio Inc. | Recruiting ➔ Completed

Trial completion

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: AltruBio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

AltruBio Announces Enrollment of First Patient in Phase 2 Clinical Program of ALTB-268 for the Treatment of Ulcerative Colitis (GlobeNewswire) - "AltruBio Inc...announced the first patient enrolled for the Phase 2a clinical study of the company’s subcutaneously administered immune checkpoint enhancer (ICE), ALTB-268 in ulcerative colitis (UC)....In addition to the phase 2a study already underway in patients with biologics refractory disease, in 2024 the company aims to start a larger, global phase 2b randomized, placebo controlled study in patients with moderately to severely active UC."

Enrollment open • New P2b trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics (clinicaltrials.gov) - P2 | N=15 | Not yet recruiting | Sponsor: AltruBio Inc.

Trial completion date • Trial initiation date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: AltruBio Inc. | Phase classification: P2a ➔ P2

Phase classification • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics (clinicaltrials.gov) - P2a | N=15 | Recruiting | Sponsor: AltruBio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

P2a Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics (clinicaltrials.gov) - P2a | N=15 | Not yet recruiting | Sponsor: AltruBio Inc.

New P2a trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

AltruBio Announces FDA Clearance of IND Application for Immune Checkpoint Enhancer ALTB-268 to initiate a Phase 2 Clinical Trial for the Treatment of Ulcerative Colitis (GlobeNewswire) - "AltruBio Inc...today announced clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical study of the company’s subcutaneously administered immune checkpoint enhancer (ICE), ALTB-268 in ulcerative colitis....We look forward to initiating studies in patients with ulcerative colitis by the end of 2023.'...The exploratory biomarker study is expected to start by the end of 2023 and the randomized study is expected to enroll patients in 2024."

IND • New P2 trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

AltruBio Announces Positive Topline Data from Phase 1 Trial of Immune Checkpoint Enhancer ALTB-268 for the Treatment of Ulcerative Colitis (GlobeNewswire) - P1 | N=64 | NCT05723692 | Sponsor: AltruBio Inc. | "ALTB-268 was well tolerated with no serious adverse events across all subject cohorts. ALTB-268 demonstrated substantially greater biological activity than first ICE molecule, ALTB-168, enabling subcutaneous administration....Company expects to begin an exploratory biomarker clinical study for ALTB-268 in biologics-refractory ulcerative colitis patients in 2H 2023 and initiate the Phase 2 global trial evaluating ALTB-268 in ulcerative colitis in 1H 2024."

New P2 trial • New trial • P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

ALTB-268, a Tetravalent anti-psgl-1 Antibody Derived from ALTB-168, Shows Enhanced Potency in Treating T Cell Mediated Inflammatory Diseases (FOCIS 2023) - "Most importantly, a similar safety profile as ALTB-168 was observed for ALTB-268 in NHP toxicology assessments, with a NOAEL of 120 mg/kg in a definitive 28-day weekly repeat-dose toxicity study, and a bioavailability of 70% by subcutaneous (sc) route. These data support the clinical development of ALTB-268, sc, for the treatment of T-cell mediated inflammatory diseases."

Immune Modulation • Immunology • Inflammation

AltruBio to Present at the 2023 BIO International Convention (GlobeNewswire) - "AltruBio Inc...announced that President and Chief Executive Officer Judy Chou, Ph.D., will present an in-person corporate overview at the 2023 BIO International Convention taking place June 5-8, 2023, in Boston, MA. The presentation will highlight recent completed milestones, including clinical trial progress from the company’s novel Immune Checkpoint Enhancer (ICE), ALTB-268, which is currently being evaluated in a Phase 1 study for the treatment of ulcerative colitis."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

AltruBio Announces Panels and Presentations at Three March Healthcare Conferences (GlobeNewswire) - "AltruBio Inc...announced that it will take part in three healthcare conferences in March, including Biologics Manufacturing Asia (March 15-16, 2023 in Singapore), Longwood Healthcare Leaders CEO Conference (March 15-17, 2023 in Miami) and Festival of Biologics World Antibody Congress USA (March 20-22, 2023 in San Diego). AltruBio CEO and President Judy Chou, Ph.D. will share her view in biological drug development, discuss the approaches to address unmet medical needs, and provide a corporate overview highlighting recent progress including the ongoing Phase 1 trial of the company’s subcutaneously administered immune checkpoint enhancer ALTB-268 for the treatment of ulcerative colitis."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A First-In-Human SAD and MAD Study to Evaluate the Safety, Tolerability, PK and PD of SC Administered ALTB-268 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: AltruBio Inc.

New P1 trial

AltruBio Announces First Patient Dosed in Phase 1 Trial of Next-Generation Immune Checkpoint Enhancer ALTB-268 for the Treatment of Ulcerative Colitis (GlobeNewswire) - "AltruBio Inc...announced that it has dosed the first patient in a Phase 1 study evaluating ALTB-268, its next-generation PSGL-1 antibody agonist serving as an immune checkpoint enhancer (ICE), in healthy volunteers."

Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

AltruBio to Present at Biotech Showcase 2023 (Yahoo Finance) - "AltruBio Inc...announced that its President and Chief Executive Officer Judy Chou, Ph.D. will present a corporate overview at Biotech Showcase™ 2023 taking place in San Francisco, California from January 9-11, 2023...ALTB-168, in patients with acute graft-versus-host-disease...plans for initiating the Phase I clinical trial in patients with ulcerative colitis. The company will also share ongoing pipeline progress, clinical updates, and company developments."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

AltruBio Hosting Research & Development Update on Immune Checkpoint Enhancer Platform for T Cell Mediated Immunological Diseases (GlobeNewswire) - "AltruBio Inc...announced that the company will host a research and development update on its immune checkpoint enhancer platform for T cell mediated immunological diseases on Thursday, December 15, 2022 at 12 p.m. ET. AltruBio will provide an overview of its immune checkpoint enhancers (ICEs) which downregulate chronically activated T cells by inhibiting T cell effector function, promoting T cell exhaustion and apoptosis. The management team will present clinical data from ALTB-168, which achieved proof of mechanism in four autoimmune and inflammatory diseases including ulcerative colitis, steroid refractory acute graft-versus-host disease (SR-aGVHD), psoriatic arthritis and psoriasis. The company will share development plans for next generation immune checkpoint enhancer, ALTB-268, bearing the same mechanism of action with increased potency for subcutaneous administration in ulcerative colitis patients."

Clinical data • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

AltruBio Announces FDA Clearance of IND Application for ALTB-268, a Next-Generation Immune Checkpoint Enhancer for the Treatment of Ulcerative Colitis (GlobeNewswire) - "AltruBio Inc...announced clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical study of ALTB-268 in healthy volunteers....The Phase 1 study will examine the safety and tolerability in healthy volunteers with anticipated interim data in 1H 2023, with plans to follow with initiation of the Phase 2 study in ulcerative colitis."

IND • New P1 trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis