LAPIX Therapeutics Inc. Announces the Issuance of U.S. Patent for LPX-TI641, Its First-in-Class, Orally Administered Tim3/4 Agonist for Treg Expansion to Treat Autoimmune Diseases

BOSTON, May 17, 2023 (GLOBE NEWSWIRE) — LAPIX Therapeutics, Inc. (“LAPIX”), a biopharma company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases and oncology, today announced the U.S. Patent & Trademark Office issued its U.S. Patent No. 11,648,225, entitled “Compositions And Methods For Reducing Immune Intolerance And Treating Autoimmune Disorders.” The patent is directed to LPX-TI641, LAPIX’s novel, first-in-class, immune tolerance restoration small molecule.

LPX-TI641 has been purposefully designed to be a Tim3 and Tim4 agonist that can restore the regulatory T cell (Treg) population in an antigen-agnostic manner for treating autoimmune diseases. LPX-TI641 is currently under development for neuro-autoimmune indications such as multiple sclerosis (MS) with the intent of expanding to other indications and is expected to begin Phase I enrollment in July 2023.

“Treating autoimmune diseases by re-establishing self-tolerance, in an antigen agnostic manner, with an orally administered therapeutic is a new approach that will unleash the power of immune tolerance while breaking free of the limitations of yesteryear’s antigen-specific immune tolerance approaches,” said Anas M. Fathallah, Ph.D., CEO and Co-founder of LAPIX. “This is very promising for the treatment of autoimmune diseases in general and MS in particular. The issuance of this patent marks a significant step towards creating a new patient-centric standard of care that restores the immune system to its natural state without the immune system wrecking ball approach of many other autoimmune treatments.”

MS and other autoimmune diseases are characterized by loss of tolerance towards self and are often associated with the downregulation of functional regulatory T and B-cells (Treg and Breg) and upregulation of autoreactive pathogenic T helper type 17 and type 1 T cells (Th). This new treatment approach allows the adaptive immune system to re-establish self-tolerance by restoring the Treg/pathogenic T-cell imbalance associated with autoimmune diseases, without affecting the innate immune system and without inducing leukopenia or lymphocytopenia (a side effect of many autoimmune treatments). Substantial preclinical data demonstrated the superiority of LPX-TI641 as monotherapy versus standards of care in both treatment escalation and treatment induction/maintenance paradigms currently in use for the clinical management of MS. Pre-clinical efficacy and safety data support positioning LPX-TI641 as a high potency molecule that is effective enough to control aggressive disease and safe for long-term use.

About LAPIX Therapeutics

LAPIX Therapeutics Inc. is a Boston, MA-based company in the biopharma sector, focused on developing novel, orally bioavailable immune system restoration therapies, including immune tolerance restoration therapy for autoimmune diseases, immune tolerance induction therapies for gene therapy and enzyme replacement therapy, and immune function restoration therapies for oncology. To learn more, visit or follow us on LinkedIn and Twitter.

Anas M. Fathallah, Ph.D.
CEO and Co-Founder

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