Science

An ideal modality for cell depletion.
 

With high potency and specificity, T cells engagers (TCEs) represent an off-the-shelf therapeutic modality for resetting the immune system by depleting the proinflammatory cells underlying many immune-mediated diseases. Initial data with TCEs demonstrate the potential to achieve immunological “reset” and induce durable remissions without the need for ongoing immunosuppression.

We plan to evaluate our lead therapeutic candidate, OM336, in a range of IMDs. Initial clinical data with OM336 in autoimmune hemolytic anemia (AIHA) have been reported in the New England Journal of Medicine (NEJM). In a Correspondence, investigator Jun Shi, M.D., Ph.D. highlighted promising responses to OM336 in two patients with severe, potentially life-threatening, relapsed/refractory AIHA. In the NEJM case reports, OM336 appeared to be generally well-tolerated, with a short course of subcutaneously-administered OM336 leading to rapid and deep B cell depletion in the circulation and in tissues, across B and plasma cells. Both patients had AIHA that was relapsed/refractory to numerous treatments, such as glucocorticoids, splenectomy, anti-CD20 antibody, BTK inhibitor, and CD19-directed CAR T cell therapy. Hemoglobin and other laboratory parameters normalized within one month of starting OM336, and the patients remained in sustained remission off of all immunosuppressive therapies through six months after the first injection. 

AIHA and ITP are among the most common types of autoimmune cytopenias, although both qualify as rare diseases in the U.S. Both AIHA and ITP can be severe and life-threatening, with symptoms that can significantly impact patients’ quality of life.

Behind our lead program, we are advancing a set of discovery programs targeting additional dimensions of B cell biology. These programs probe unique subsets of B cells that may prove key to achieving longer remissions for patients with certain diseases.