AltruBio presented its novel PSGL-1 agonist antibody program at FOCIS and presented its phase 2a Psoriatic Arthritis study results for lead molecule, Neihulizumab at ACR.

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AltruBio pioneers the development of a number of agonist antibodies targeting the PSGL-1 immune checkpoint regulator. Its lead molecule, Neihulizumab has now demonstrated clinical results in sr-aGVHD, Ulcerative Colitis, Psoriasis, and Psoriatic Arthritis.

AltruBio Inc., a clinical stage biotech company, was invited to give an overview of its PSGL-1 agonist antibody program for the treatment of T cell-mediated inflammatory diseases at the “Allergy and Inflammation” session of Federation of Clinical Immunology Societies (FOCIS) annual conference on October 29, 2020. During the session, the company highlighted research data on the novel mechanism of action as well indications clinically explored with its lead molecule, Neihulizumab. PSGL-1 has been increasingly recognized as an immune checkpoint regulator of T-cells.

Shortly after FOCIS, at ACR convergence on Nov. 7, 2020, AltruBio and Dr. Stanley Cohen of Metroplex Clinical Research Center, presented Phase 2a study results of Neihulizumab for the treatment of Psoriatic Arthritis. This single-arm, open-label Phase 2a study, led by Dr. Mark Genovese of Stanford University, aimed to investigate the efficacy as well as safety, tolerability, and immunogenicity of its lead molecule. During the study, 40% of patients (8/20) achieved ACR20 responder status at week 12. Importantly, the results of an ad hoc analysis of patients who received all 7 doses of AbGn-168H and completed the study (Completed Set) identified 8 ACR20 responders (53.3%), 6 ACR50 responders (40%), and 2 ACR70 responders (13.3%) at Week 12, suggesting there may be clinical utility with this agent for the
treatment of Psoriatic Arthritis. AltruBio is currently evaluating its plans for further advancing its PSGL-1 program in Psoriatic Arthritis.

About Neihulizumab.
Neihulizumab is an immune checkpoint agonist antibody targeting PSGL-1/CD162 that depletes chronically activated T cells. This mechanism has been evaluated in four autoimmune and inflammatory diseases and has demonstrated clinical proof of concept and safety in more than 160 patients with psoriasis, psoriatic arthritis, and biologics-refractory ulcerative colitis. This study drug is currently in Phase 1b trials for the treatment of sr-aGvHD. Phase 1 trial for the treatment of front-line acute GvHD in lieu of steroid is also initiated.

About Psoriatic Arthritis.
Psoriatic arthritis (PsA), a chronic inflammatory arthritis of unknown aetiology, involves axial and peripheral joints, nails and entheses, and is usually accompanied by psoriatic skin lesions. In the United States, an estimated 4.5 million adults suffer from psoriasis, and 1 million have PsA. The pathogenesis of PsA is thought to be mediated by inflammatory elements including T cells and the cytokine pathways they activate. The goal of treatment is to reduce joint pain and swelling, preserve joint function, slow or prevent joint damage and control psoriasis on the skin. While currently available medications including nonsteroidal anti-inflammatory drugs (NSAIDs), disease-modifying anti-rheumatic drugs (DMARDs), biologics, particularly inhibitors of the pro-inflammatory cytokine as well as an oral phosphodiesterase 4 inhibitor Apremilast have provided therapeutic advancement, the overall response rate and maximal effectiveness of these medications have not been fully satisfactory and are associated with safety concerns of immune suppression after long term administration.

About T cell Mediated Inflammatory Diseases.
Excessive activation of T-cells can release several inflammatory mediators which cause tissue damage and, in some instances, may even trigger systemic metabolomic shift with consequences of neurological abnormality. Certain key inflammatory diseases among the worldwide population include aGvHD, rheumatoid arthritis, psoriasis, psoriatic arthritis, multiple sclerosis, ulcerative colitis and Crohn’s disease. Currently these diseases are routinely treated with small molecule drugs, such as steroids, methotrexate and cyclosporine, and many biologics including inhibitors of inflammatory cytokines, T-cell activation modulators, and T-cell direct targeting agents, which require life-long treatment and are associated with adverse side effects triggered by the immunosuppressive-nature of these compounds.

About AltruBio Inc. (
AltruBio is a privately held biotechnology company headquartered in the San Francisco Bay Area that is focused on developing novel antibody therapeutics for the treatment of immunological diseases with high unmet medical needs. Based on unique insights into immune tolerance and epitope dominance sciences, AltruBio’s pipeline includes two clinical stage product candidates: (i) Neihulizumab (AbGn-168H) an immune checkpoint agonist antibody targeting PSGL-1/CD162 that depletes unwanted activated T cells with proof of mechanism in four autoimmune and inflammatory diseases, and (ii) AbGn-107, an antibody-drug conjugate (ADC) employing a unique enzyme cleavable hydrophilic self-immolative linker and targeting a gastrointestinal tumor antigen. AbGn-107 has demonstrated encouraging results in chemo-refractory gastric, pancreatic, colorectal and biliary cancers.

Note on Forward-Looking Statements
Statements made in this news release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as expects, believes, intends, and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as the Company's ability to raise additional capital, and risks related to the Company's ability to initiate, and enroll patients in, planned clinical trials. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by law.

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