neihulizumab (ALTB-168) / AltruBio - LARVOL DELTA

Identification of a Novel Function of B2M Involving T-Cell Exhaustion Via P-Selectin Ligand Upregulation in Diffuse Large B-Cell Lymphoma (ASH 2024) - "Next, using B2M wt and KO DLBCL cells, we inhibited P-selectin and its ligand with a SELPLG antibody (Neihulizumab) and a P-selectin inhibitor (PSI-697) and conducted an in vitro co-culture with CD8+ T-cells...Conclusion : We discovered a novel function of the major component of MHC class I, B2M, which involves the exhaustion of CD8+ T-cells via SELPLG, contributing to the formation of a cold immune microenvironment. Targeting SELPLG could provide a new therapeutic avenue for refractory DLBCL that evades host immunity."

IO biomarker • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • B2M • CD69 • CD8 • CXCL13 • PD-1 • TNFRSF12A • TNFRSF25 • TNFSF12

Neihulizumab for Standard-Risk Acute Graft Versus Host Disease (GVHD) (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Sameem M. Abedin, MD | Recruiting ➔ Completed | Trial completion date: Nov 2024 ➔ Jul 2024

Trial completion • Trial completion date • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

New investigational drugs for Steroid-Refractory Acute Graft-versus-Host disease: a review of the literature. (PubMed, Expert Opin Investig Drugs) - "In light of the pivotal REACH2 trial, ruxolitinib phosphate, a Janus kinase inhibitor, has gained prominence as the standard treatment for SR-aGVHD...This review delves into emerging treatments for SR-aGVHD, including mesenchymal stromal cells (MSCs), fecal microbiota transplantation (FMT), CD3/CD7 blockade, neihulizumab, begelomab, tocilizumab, and vedolizumab. While some of these agents have shown encouraging results in early-phase trials, issues such as treatment-related toxicities and inconsistent responses in larger studies highlight the necessity for ongoing research. Current trials exploring new agents and combination therapies offer hope for fulfilling the unmet clinical needs in SR-aGVHD, potentially leading to more effective and precise treatment strategies."

Journal • Review • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology • Transplantation • CD7

Neihulizumab for Standard-Risk Acute Graft Versus Host Disease (GVHD) (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Sameem M. Abedin, MD | Trial primary completion date: Aug 2023 ➔ Apr 2023

Trial primary completion date • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

Efficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC (clinicaltrials.gov) - P2 | N=24 | Terminated | Sponsor: AltruBio Inc. | Completed ➔ Terminated; As a consequence of operational difficulties at the clinical sites associated with the COVID-19 pandemic

Trial termination • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

AltruBio to Present at the Federation of Clinical Immunology Societies (FOCIS) 2023 Annual Meeting (GlobeNewswire) - "AltruBio...today announced that the company will be giving an oral presentation on its immune checkpoint enhancer (ICE), ALTB-268, as well as feature a poster on ICE ALTB-168 at the 2023 Federation of Clinical Immunology Societies (FOCIS) Annual Meeting, which is being held June 20-23, 2023 in Boston, Massachusetts...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 sc route....ALTB-168 treatment in a pre-clinical graft-versus-host disease (GvHD) model resulted in increased population of apoptotic CD3 T cells, reduced severity of GvHD and prolonged survival of mice....To date more than 200 subjects have been treated with ALTB-168 and no significant adverse events have been reported."

Preclinical • Acute Graft versus Host Disease • Graft versus Host Disease

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

ALTB-168, an Immune Checkpoint Enhancer (ICE) targeting P-selectin glycoprotein-1 (PSGL-1), is effective in treating T-cell mediated inflammatory diseases (FOCIS 2023) - No abstract available

Immune Modulation • Immunology • Inflammation

A NOVEL AI TOOL IS ACCURATE AT INTERPRETING HISTOLOGY AND DETECTS RESPONSE TO NEIHULIZUMAB THERAPY IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS: PROOF OF CONCEPT (DDW 2023) - P2 | "Columns 2-13, arrow with thin border (left), Nancy Index by expert pathologist; arrow with darker dotted border (middle), Nancy Index by AI; dotted arrow (right), neutrophils [% area] by AI. Column 14 neutrophils [% area ] counted as area of neutrophils / area of tissue"

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Immune Modulation • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

AltruBio Announces Poster Presentation at Digestive Disease Week Conference 2023 (GlobeNewswire) - P2 | N=24 | NCT03298022 | Sponsor: AltruBio Inc. | "AltruBio Inc...announced that David T. Rubin, M.D., Professor of Medicine and Pathology at the University of Chicago and AltruBio Scientific Advisory Board member, will share a poster presentation on immune checkpoint enhancer (ICE), ALTB-168, during Digestive Disease Week®, taking place at McCormick Place in Chicago, IL, from May 6-9, 2023....The AI Tool delivered an AI-generated Nancy Index and automatically quantified metrics of cell and tissue types relevant to inflammation in UC, including neutrophil, eosinophil, plasmocyte and lymphocyte densities and percentage change in infiltrated tissue. The AI Tool-determined Nancy Indices demonstrated 87% correlation with the Nancy Indices conducted by an expert pathologist. In the 4 of 12 subjects who achieved clinical remission, the AI Tool demonstrated an average 93% decrease in automatically detected neutrophils."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Neihulizumab (ALTB-168) in Patients with Steroid-Refractory Acute Graft-Versus-Host-Disease (SR-aGVHD) or Treatment-Refractory Acute Graft-Versus-Host-Disease (TR-aGVHD) (ASH 2022) - P1 | "Neihulizumab appeared to be well-tolerated in participants with SR‑aGVHD or TR‑aGVHD. With the current 6-4-4-4 dosing regimen (6 mg/kg followed by 4 mg/kg weekly doses for 3 weeks), RO was maintained at least 80% throughout most of the treatment period. The Day 28 ORR was 69% in Cohort 1 and 50% in Cohort 2."

Clinical • Acute Graft versus Host Disease • Anemia • Cardiovascular • Dermatology • Diabetes • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Heart Failure • Hematological Disorders • Immune Modulation • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Septic Shock • Seronegative Spondyloarthropathies • Ulcerative Colitis

Neihulizumab for Standard-Risk Acute Graft Versus Host Disease (GVHD) (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Sameem M. Abedin, MD | Trial completion date: Dec 2023 ➔ Nov 2024 | Trial primary completion date: Jan 2023 ➔ Aug 2023

Trial completion date • Trial primary completion date • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

AltruBio Announces Poster Presentation on Immune Checkpoint Enhancer, ALTB-168 at Crohn’s & Colitis Congress 2023 (GlobeNewswire) - "The poster being presented on-site by Dr. Rubin will provide data on the Phase 2 open label study of ALTB-168 (neihulizumab) in patients with moderately to severely active anti-TNFα and/or anti-integrin refractory ulcerative colitis (UC)....'I am pleased to present results that demonstrate the safety and tolerability of neihulizumab as well as promising signals of response and remission in this particularly tough to treat group of patients.'"

Media quote

Neihulizumab (ALTB-168) in Patients With Steroid-refractory Acute Graft-versus-host Disease or Treatment-refractory Acute Graft-versus-host Disease (clinicaltrials.gov) - P1 | N=37 | Completed | Sponsor: AltruBio Inc. | Recruiting ➔ Completed

Trial completion • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology • ST2

AltruBio Announces Poster Presentation on Immune Checkpoint Enhancer, ALTB-168 at Crohn’s & Colitis Congress 2023 (GlobeNewswire) - P2 | N=24 | NCT03298022 | Sponsor: AltruBio Inc. | “AltruBio Inc…announced that David T. Rubin, M.D., Professor of Medicine at the University of Chicago and AltruBio Scientific Advisory Board member, will share a poster presentation on first-generation immune checkpoint enhancer (ICE), ALTB-168 (neihulizumab), at the Crohn’s & Colitis Congress 2023, to be held in Denver, Colorado on January 19-21, 2023….The poster…will provide data on the Phase 2 open label study of ALTB-168 (neihulizumab) in patients with moderately to severely active anti-TNFα and/or anti-integrin refractory ulcerative colitis (UC)….In the 5+3 regimen, among the 10 enrolled subjects, 9 were included in the efficacy analysis where 2 (22%) subjects achieved clinical response at Week 12 and 1 (11%) subject achieved clinical response at Week 2. In the 8+2 regimen...7 (50%) subjects achieved clinical response and 29% achieved clinical remission at Week 12.”

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A PHASE II OPEN LABEL STUDY OF NEIHULIZUMAB, AN ANTI-CD162 (PSGL-1) ANTIBODY, IN PATIENTS WITH MODERATE TO SEVERE ACTIVE, ANTI-TNFα AND/OR ANTI-INTEGRIN REFRACTORY ULCERATIVE COLITIS (CCCongress 2023) - P2 | "This phase 2 study of neihulizumab suggest efficacy and safety signals in treatment-refractory UC that warrant further investigation."

Clinical • P2 data • Acute Graft versus Host Disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Immune Modulation • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • 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 Presents New Positive Data from its Completed Phase 1b Study Evaluating ALTB-168 in Patients with Steroid-Refractory or Treatment-Refractory Acute Graft-Versus-Host-Disease at the 64th ASH Annual Meeting 2022 (GlobeNewswire) - P1b | N=37 | NCT03327857 | Sponsor: AltruBio Inc. | "AltruBio Inc....today announced the presentation of new data from its completed Phase 1b clinical trial evaluating ALTB-168 in patients with steroid-refractory (SR-aGVHD) or treatment-refractory (TR-aGVHD) acute graft-versus-host-disease at the 64th American Society of Hematology (ASH) Annual Meeting...'We look forward to sharing final data from this trial and preliminary Phase 1 data from ALTB-268 in 2023.'...Overall response rate (ORR) of 67% in SR-aGVHD patients (N=12) and a complete response (CR) of 17% as measured by best response. ORR of 67% in TR-aGVHD patients (11 of 12 concomitant ruxolitinib) at the multiple dose phase of 6-4-4-4 mg/kg – a COR of 25% at Day 28....Best response ORR of 86% (N=7) at the 3 mg/kg dose and a best response ORR of 50% (N=6) at the 6 mg/kg dose – this includes six CRs at the 3 mg/kg dose and two CRs and 1 PR at the 6 mg/kg dose at Day 28."

P1 data • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

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 to Present at Stifel 2022 Healthcare Conference (GlobeNewswire) - "The Company will conduct one-on-one meetings with investors for the duration of the conference. The corporate overview presentation will highlight the IND filing of their next-generation compound, ALTB-268, and new Phase 1 data in steroid refractory and treatment refractory acute graft-versus-host disease for ALTB-168 to be presented at the 64th ASH Annual Meeting 2022, together with the ongoing pipeline progress, clinical trial updates and company developments."

Clinical • P1 data • Acute Graft versus Host Disease • Graft versus Host Disease

AltruBio to Present New Phase 1b Data Evaluating Neihulizumab (ALTB-168) in Patients with Steroid-Refractory or Treatment-Refractory Acute Graft-Versus-Host-Disease at the 64th ASH Annual Meeting 2022 (GlobeNewswire) - "AltruBio...today announced the poster presentation of new data from its Phase 1b clinical trial evaluating neihulizumab (ALTB-168) in patients with steroid-refractory or treatment-refractory acute graft-versus-host-disease at the 64th American Society of Hematology (ASH) Annual Meeting..."

P1 data • Acute Graft versus Host Disease • Graft versus Host Disease

Neihulizumab for Standard-Risk Acute Graft Versus Host Disease (GVHD) (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Sameem M. Abedin, MD | Trial primary completion date: Oct 2022 ➔ Jan 2023

Trial primary completion date • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

Neihulizumab for Standard-Risk Acute Graft Versus Host Disease (GVHD) (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Sameem M. Abedin, MD | Trial completion date: Feb 2023 ➔ Oct 2023 | Trial primary completion date: Jul 2022 ➔ Oct 2022

Trial completion date • Trial primary completion date • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

AltruBio Announces Completion of Enrollment in Phase 1 Clinical Study of Neihulizumab (ALTB-168) in Patients with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) (GlobeNewswire) - "AltruBio...announced that enrollment has been completed for the Phase 1 clinical study of neihulizumab (ALTB-168) in patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD) or treatment-refractory acute graft-versus-host disease with 24 patients enrolled....We look forward to sharing efficacy and safety data from the Phase 1 study in the coming months.”"

Enrollment closed • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

Neihulizumab (AbGn-168H) in Patients With Steroid-refractory Acute Graft-versus-host Disease or Treatment-refractory Acute Graft-versus-host Disease (clinicaltrials.gov) - P1 | N=37 | Recruiting | Sponsor: AltruBio Inc. | Trial completion date: Jul 2022 ➔ Feb 2023 | Trial primary completion date: Feb 2022 ➔ Sep 2022

Trial completion date • Trial primary completion date • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology • REG3A • ST2