Hadasit, the technology transfer company of the Hadassah Medical Center, Harvard Medical School (HMS) of Boston, and Brigham and Women’s Hospital (BWH), a teaching affiliate of Harvard, for the first time, in an equally owned joint scientific venture, are collaborating to develop a new orally administered treatment for autoimmune diseases. Beginning this month at Hadassah, a Phase I study will test the efficacy and safety of the new combination therapy on healthy individuals.

The venture joins together the intellectual property of Hadasit and BWH/HMS. “It is especially exciting,” notes Prof. Shlomo Mor-Yosef, Director General of the Hadassah Medical Center, “because it establishes a wonderful and important precedent. This is the first of hopefully many scientific collaborations between Hadasit and BWH/HMS, all world leaders in medical research. We take great pride in working alongside such esteemed partners.” He adds: “Our joint venture is a calculated investment that we believe will not only reap an impressive return for Hadassah and its existing and potential partners, but also make a significant impact on existing treatment protocols.”

The combination therapy is a cocktail of a monoclonal antibody (Anti-CD3), in development at Harvard Medical School, and a line of glycolipid compounds, currently in development at Hadasit, based on research led by a senior Hadassah physician. Clinical data shows that the glycolipid compounds, which activate specific cells in the immune system when given orally, are appropriate for all oral applications and do not have adverse side effects. Pre-clinical studies demonstrated the same results for the monoclonal antibody, but in animal models. Pre-clinical studies also suggest that the core oral administration of the combination of the two has a profound immune modulatory effect and in several models, a direct and beneficial influence on disease activity.

Dr. Howard L. Weiner, Professor of Neurology at Harvard Medical School and the Director of the Partners Multiple Sclerosis Center at Brigham and Women’s Hospital, explains: “Monoclonal antibodies are widely used in medicine intravenously, but they have never been given orally in humans. It now appears possible to correct the imbalances in the immune system and subsequently treat a wide number of human diseases with an oral, non-toxic therapy. We know that both the monoclonal antibody and the glycolipid compound have a stand-alone therapeutic effect; however, we also have evidence, from animal models, that the combination of the two stimulates the immune system better and elicits a stronger, additive effect.”

Among the more than 80 clinically distinct autoimmune diseases are systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Type I and Type II diabetes, and Crohn’s disease.

The Phase I study will investigate not only efficacy and safety, but also the impact of various dosing regimens and it will monitor immunologic effects. If this study goes smoothly, another Phase I study will examine the impact of giving this combination therapy to patients who have autoimmune diseases.