ICOS

Abcuro is earmarking a portion of new series C funds to prepare for a potential commercial launch of ulviprubart.\n Sanofi-backed Abcuro has secured $200 million in series C funds to power its anti-KLRG1 antibody through a phase 2/3 muscle disease trial ahead of a planned push to regulators.Abcuro is targeting KLRG1 to drive the depletion of cytotoxic T cells in autoimmune diseases. While other players in the space are targeting CD25, CD2, CD52 and ICOS with the same goal in mind, Abcuro has been betting on KLRG1 because expression is restricted to highly cytotoxic late-differentiated effector memory and effector T cells.The idea is that its anti-KLRG1 antibody ulviprubart, also known as ABC008, will deplete cells that drive autoimmune disease without affecting regulatory T cells and central memory T cells.Ulviprubart is currently in a phase 2/3 trial for inclusion body myositis (IBM), a muscle wasting disease that affects about 50,000 people across the U.S. and Europe. Abcuro has a lot riding on the study, with plans to file an approval application with the FDA if the study is a success when it reads out in the first half of 2026.To that end, the biotech is also earmarking a portion of the series C funds to prepare for a potential commercial launch of ulviprubart. Some more of the cash will be spent on expanding the company’s manufacturing capabilities.  The financing round was led by New Enterprise Associates, with new investor Foresite Capital joining a list of previous backers like Sanofi Ventures, RA Capital, Bain Capital Life Sciences, Redmile Group, Samsara BioCapital, Pontifax, Mass General Brigham Ventures, New Leaf Ventures and funds and accounts managed by BlackRock, to name a few.“Continued support from all of our investors in this latest financing round validates our vision for the potential that ulviprubart may have as a novel treatment for progressive and devastating diseases mediated by highly cytotoxic T cells, including inclusion body myositis,” Abcuro CEO Alex Martin said in a Feb. 12 release.IBM looks like a good proving ground for ulviprubart’s potential. The disease is driven by T-cell attacks on muscle fibers that lead to loss of hand function and ability to walk. In 2019, Steven Greenberg, M.D., a neurologist at Brigham and Women’s Hospital and Abcuro founder, co-authored a paper that pointed to a link between KLRG1-expressing T cells and IBM.It led Mass General Brigham Ventures to team up with Sanofi Ventures to oversee a series A-1 round back in 2021 to build on Greenberg’s research. The biotech followed this up with a $155 million series B in 2023.As well as the later-stage study in IBM, the company is also overseeing a phase 1/2 clinical trial of ulviprubart in T-cell large granular lymphocytic leukemia.

Data demonstrate that MTX-201 binds CD8 Treg, selectively eliminates pathogenic CD4 T cells, and may decrease inflammation and reduce epithelial cell damage in IBD SEATTLE, Feb. 6, 2025 /PRNewswire/ -- Mozart Therapeutics, the leading developer of CD8 Treg network modulators in autoimmune disease, announces the presentation of new preclinical data for MTX-201, a bispecific antibody that antagonizes inhibitory KIR and promotes ICOS co-stimulation on CD8 Treg. The data will be presented during the Crohn's and Colitis Congress, February 6–8 in San Francisco, California. The presentation findings highlight that MTX-201 : Selectively binds and activates CD8 Treg; does not activate cells that express only one target, including other ICOS-expressing immune cells Extends survival and decreases disease score in a murine model of acute GvHD Does not inhibit immune responses to common viral and microbial pathogens Reduces gut epithelial cell death and improves epithelial cell health in organoids derived from Crohn's patients' tissues "We are encouraged by these promising results shown in patient-derived tissues and are eager to share our work with leading scientific and clinical experts at the Crohn's and Colitis Congress," said Courtney Crane, Ph.D., Senior Vice President of Translational Medicine at Mozart Therapeutics. "This presentation marks a significant step forward in the development of our second program, which aims to provide patients with a potentially durable solution for highly inflammatory autoimmune diseases like IBD." Presentation Details: The poster can be accessed from the Mozart Therapeutics website following the February 7 presentation. About MTX-201 Inhibitory killer immunoglobulin-like receptors (KIR) are autoimmune checkpoints expressed on CD8 regulatory T cells, restricting their function of killing pathogenic T cells. In highly inflammatory autoimmune disease, the inducible T cell costimulator (ICOS) is upregulated on activated CD8 Treg and critical to CD8 Treg function. MTX-201 is an antigen-agnostic bispecific antibody targeting dysfunctional CD8 Treg. The molecule aims to restore CD8 Treg function through inhibition of KIR, while promoting ICOS-mediated CD8 Treg activation, in chronic and highly inflammatory autoimmune disease. About Mozart Therapeutics Mozart Therapeutics is focused on developing first-in-class disease-modifying therapies for autoimmune diseases, utilizing a novel approach to restore immune system function by targeting the CD8 T regulatory network. The company is headquartered in Seattle, WA. For more information, visit –tx.com and follow the company on LinkedIn @Mozart-tx.com. SOURCE Mozart Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

LA JOLLA, Calif.--( BUSINESS WIRE )-- Equillium Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that a poster was presented over the weekend at the 39 th Annual Meeting of the Society for Immunotherapy of Cancer. The conference took place at the George R. Brown Convention Center in Houston, Texas from November 6 to 10, 2024. “These data provide deeper insights into the dual and synergistic signaling of IL-15 and IL-21 that drives aggressive T and NK cell responses that promote the cytolytic activity and interferon gamma production observed in multiple inflammatory diseases,” said Dr. Stephen Connelly, chief scientific officer at Equillium. “As such, in the context of treating inflammatory disease, or augmenting anti-tumor responses, it would be optimal to inhibit or activate both cytokines in a single agent and is a focus of the multi-cytokine platform at Equillium.” Title: Interleukin (IL)-15 and IL-21 synergistically enhance NK and CD8+ T cell responses Presenting Author: Phoi Tiet, Senior Research Associate, Equillium, Inc. Poster Number: 908 K ey Highlights, Summaries & Conclusions from Presentation: Synergistic signaling of IL-15 and IL-21 enhanced markers of activity including CD25, PD-1, Tim-3 and ICOS, in addition to increased production of granzyme A, granzyme B and perforin, indicating that these two cytokines play important roles in activation, development, and survival of NK and CD8+ T cells. IL-15 and IL-21 cooperatively amplified CD8+T and NK cytolytic activities and IFNγ production, suggesting that targeting these two pathways can amplify cell-based immunity. Preliminary evaluation of IL-15 and IL-21 in an antigen-based T cell exhaustion model described here suggests that the combination of the two cytokines has a modest effect on reversing the phenotype and function of terminally exhausted CD8+ T cells as shown by the increase in the percentage of TCF-1 positive cells, decrease in the percentage of TOX positive cells, and increase the percentage of polyfunctional cells. These results indicate that the combination of IL-15 and IL-21 robustly augments NK and CD8 T cell activity. The ability to not only boost cytolytic function of naïve and effector cells but to partially rescue the exhausted phenotype of cytotoxic CD8+ T cells is a promising therapeutic approach and addresses the challenges of immuno-oncology. The poster presentation is available under the Multi-Cytokine Inhibition tab on the Presentations page of the Technology section on the corporate website. About Multi-Cytokine Platform and Multi-Cytokine Inhibitors EQ101 & EQ302 Our proprietary multi-cytokine platform generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. This approach is expected to avoid the broad immuno-suppression and off-target safety liabilities that may be associated with other therapeutic classes, such as Janus kinase inhibitors. Many immune-mediated diseases are driven by the same combination of dysregulated cytokines, and we believe identifying the key cytokines for these diseases will allow us to target and develop customized treatment strategies for multiple autoimmune and inflammatory diseases. Current platform assets include EQ101, a clinical stage, first-in-class, selective, tri-specific inhibitor of IL-2, IL-9, and IL-15 for intravenous and subcutaneous delivery and EQ302, a preclinical stage, first-in-class, selective, bi-specific inhibitor of IL-15 and IL-21 for oral delivery. About Equillium Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of the following novel first-in-class immunomodulatory assets and product platform targeting immuno-inflammatory pathways. Itolizumab: a monoclonal antibody that targets the CD6-ALCAM signaling pathway which plays a central role in the modulation of effector T cells that drive a number of immuno-inflammatory diseases; currently under evaluation in a Phase 3 clinical study of patients with acute graft-versus-host disease (aGVHD) and announced positive data from a Phase 1b clinical study of patients with lupus/lupus nephritis in April 2024. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited, who also provides commercial manufacturing for the product. EQ101: a selective tri-specific cytokine inhibitor targeting IL-2, IL-9, and IL-15; recently announced positive results from a Phase 2 proof-of-concept clinical study of patients with alopecia areata. EQ302: an orally delivered, selective bi-specific cytokine inhibitor targeting IL-15 and IL-21 at pre-clinical stage. For more information, visit www.equilliumbio.com . Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "anticipate", "believe", “could”, “continue”, "expect", "estimate", “may”, "plan", "outlook", “future” and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are subject to risks and uncertainties, many of which are outside of Equillium’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: Equillium’s ability to execute its plans and strategies; risks related to performing clinical studies; whether the results from clinical studies will validate and support the safety and efficacy of Equillium’s product candidates. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Equillium's filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission’s website at www.sec.gov and on Equillium’s website under the heading “Investors.” Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.