Clinical trial will assess safety, tolerability and reduction in immunoglobin G (IgG)

Plans to develop S-1117 for treatment of wide array of IgG autoantibody-driven diseases, such as myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and immune thrombocytopenia

WATERTOWN, Mass.: Seismic Therapeutic, Inc., the machine learning immunology company, today announced the dosing of the first healthy subject cohort in a Phase 1 clinical trial of S‑1117, a novel engineered Fc-fused pan-immunoglobin G (IgG) protease targeting IgG autoantibodies for the treatment of autoimmune diseases. The study will build on preclinical evidence of S‑1117’s rapid, deep, and sustained reduction of IgG levels, cleavage of the B cell receptor on memory B cells, and elimination of IgG effector function. Seismic has also shown biological activity in multiple in vivo models demonstrating S‑1117’s potential for chronic and acute treatment of IgG autoantibody-driven diseases, such as myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and immune thrombocytopenia.

“The start of our first-in-human study of S‑1117 marks a significant milestone for Seismic as we transition to a clinical stage company. S‑1117 validates our founding belief that we have the potential to create transformative medicines by leveraging machine learning through our IMPACT platform, guided by the best minds in immunology to discover novel biologics,” said Jo Viney, PhD, Chief Executive Officer of Seismic Therapeutic. “The strength of our approach is reinforced by our two additional drug candidates, S‑4321, a PD-1 FcγRIIb bifunctional agonist, on track to enter the clinic by mid-year, and S-8484, an IgE protease, which has entered IND-enabling studies.”

The Phase 1 study is a randomized, placebo-controlled, double-blind clinical trial to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of S‑1117 in healthy subjects. Key pharmacodynamic markers include the measurement of the speed and depth of IgG reduction and cleavage of the B cell receptor on memory B cells. The study will be conducted in two parts, a single ascending dose stage followed by a multiple ascending dose stage. Seismic intends to investigate S‑1117 as a chronic and acute treatment, used in a treat-to-target approach that can be tailored to a patient’s disease activity for a wide array of IgG autoantibody-driven diseases.

Further details about the S-1117 Phase 1 clinical trial can be found on ClinicalTrials.gov (NCT06828393).

“We designed S‑1117 with a differentiated profile as a novel pan-IgG protease with the ability to address multiple pathogenic mechanisms at the root of IgG autoantibody-driven diseases. Our IMPACT platform enabled us to create a molecule deimmunized for T and B cell epitopes that is suitable for chronic dosing. We also demonstrated successful large scale GMP manufacturing with a formulation that enables convenient subcutaneous dosing,” said John Sundy, MD, PhD, Chief Medical Officer and Head of R&D at Seismic Therapeutic. “We believe this broad approach has the potential to drive deeper responses and offer improved clinical outcomes for patients with autoimmune diseases.”

About S-1117
S‑1117 is a novel engineered Fc-fused pan-IgG protease targeting IgG autoantibodies engineered with Seismic’s IMPACT platform to selectively cleave IgG and have enhanced drug-like properties. S‑1117 is designed to address multiple, clinically validated, orthogonal pathogenic mechanisms within a single molecule, which may result in superior clinical outcomes in disorders such as myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and immune thrombocytopenia. Seismic plans to develop S‑1117 for chronic and acute treatment of IgG autoantibody-driven diseases.

About Seismic Therapeutic
Seismic Therapeutic™ is a clinical-stage biotechnology company making a major shift in how immunology therapies are discovered and developed, enabled by machine learning. The company has a growing preclinical stage best-in-class and first-in-class biologics pipeline, derived from its integrated IMPACT platform, to control dysregulated adaptive immunity and address multiple autoimmune diseases. The company is backed by a strong syndicate of life sciences investors and is located in the Boston biotechnology hub. For more information, please visit www.seismictx.com and follow us on LinkedIn and on X @Seismic_Tx.

Fonte: Business Wire