AltruBio Announces Poster Presentation at Digestive Disease Week Conference 2023

2023-05-08

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SAN FRANCISCO, May 08, 2023 (GLOBE NEWSWIRE) -- AltruBio Inc. (“AltruBio” or “the Company”), a clinical stage biotech company dedicated to the development of novel therapeutics for the treatment of immunological diseases with high unmet medical needs, today 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. Dr. Rubin will be on-site to present proof of concept data using a novel AI-powered method, which was developed through AltruBio’s partner Image Analysis Group (IAG), to analyze patient tissue from the company’s Phase 2b open label study of ALTB-168 in patients with moderately to severely active anti-TNFα and/or anti-integrin refractory ulcerative colitis (UC). “Histological remission is an important and evolving goal in the treatment of ulcerative colitis. However, application of this treatment target is limited by a number of challenges, including the time and inter-observer variability of interpretation of the mucosa,” said Dr. Rubin. “Our data demonstrate that this novel AI tool for histology correlates very well to the established Nancy Histological Index and shows promise in simplifying interpretation of histological samples. It is encouraging to see that UC patients who respond well to AltruBio’s novel agent also show a significant decrease in neutrophils, but also that the AI-driven assessment provided additional insight into the mechanism of the therapy and its effect on the patients in the trial. AI approaches like this one may establish a new gold standard of histological assessment in clinical trials, but also provide earlier signals for interpretation which is helpful for patients as well as for scientists developing new treatments,” said Dr. Rubin. Jesse Hall, M.D., Chief Medical Officer of AltruBio, added, “We’re pleased to see that IAG’s AI-powered technology can accurately support histological assessment of treatment response to our ICE in development. We look forward to continuing our collaboration with leading clinical sites in gastroenterology to evaluate ALTB-168’s unique mechanism of action specially targeting and eliminating only overactivated T cells to restore immune balance to its natural state, and how this translates to both histological response and clinical benefit. We plan to continue clinical validation of targeting PSGL-1 to treat autoimmune and inflammatory diseases and share further progress this year with clinical updates from our potent subcutaneously administered ICE, ALTB-268 which is currently in Phase 1 trials.” The ALTB-168 Phase 2 trial is an open label, single arm, multiple dose proof of principle study to evaluate efficacy, safety, tolerability, and immunogenicity of ALTB-168 in patients with moderate to severe active UC who are refractory or intolerant to anti-TNFα and/or anti-integrin therapy. Two regimens were tested: 5 weekly IV doses plus 3 bi-weekly IV doses of 9 mg/kg ALTB-168 (5+3 regimen), and 8 weekly IV doses plus 2 bi-weekly IV doses of 9 mg/kg ALTB-168 (8+2 regimen). More information about the trial is available on clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT03298022). Data highlights include: 12 subjects with UC received 10 doses of ALTB-168, administered over a 12-week period, with biopsies taken at weeks 0 and 12. 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. In contrast, patients who did not achieve clinical remission showed an increase in neutrophils. Poster Presentation Details: Session Title: AGA IBD: Disease Activity Assessment Session Date & Time: May 8, 2023 from 12:30 PM to 1:30 PM CDT (UTC –5) Presentation Title: A Novel AI Tool is Accurate at Interpreting Histology and Detects Response to ALTB-168 Therapy in Patients with Moderate to Severe Ulcerative Colitis: Proof of Concept About AltruBio Inc. AltruBio is a privately held biotechnology company headquartered in San Francisco that is focused on developing novel therapeutics for the treatment of immunological diseases with high unmet medical needs. The company has leveraged its deep understanding of the role PSGL-1 plays as an immune checkpoint regulator protein to develop a platform for T-cell mediated immunological diseases. Its first-generation molecule, ALTB-168, a PSGL-1 agonist antibody PSGL-1 agonist antibody serving as an immune checkpoint enhancer (ICE), has achieved proof of mechanism in four autoimmune and inflammatory diseases, including ulcerative colitis, psoriatic arthritis, psoriasis and steroid refractory acute graft-versus-host disease (SR-aGVHD). The next-generation ICE, ALTB-268, is a tetravalent version of ALTB-168 and has demonstrated higher potency via the same mechanism, making it suitable for subcutaneous administration. ALTB-268 is now being evaluated in a Phase 1 clinical trial before advancing towards clinical studies in multiple autoimmune and inflammatory disorders. About Digestive Disease Week Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 6-9, 2023. The meeting showcases more than 3,100 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at . About IAG, Image Analysis Group IAG is a strategic partner to bio-pharmaceutical companies developing new treatments to improve patients’ lives. Their Trial Solutions and Bio-Partnering divisions work closely to meet critical needs of biotechnology companies: funding, clinical development and monetization of their assets. They fuse decades of therapeutic insights, risk-sharing business model and agile culture to accelerate novel drug development. IAG broadly leverages its core imaging expertise, proprietary technology platform DYNAMIKA and capabilities to support an objective early go no/ go decision and drive excellence for tomorrow’s innovative therapeutic agents with speed. 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. Contacts AltruBio Inc: +1-415-655-6603 info@altrubio.com Media Contact: Luke Shiplo LifeSci Communications lshiplo@lifescicomms.com