Pfizer will license Gliknik’s preclinical lead recombinant stradomer™ GL-2045 for autoimmune diseases. The drug candidate is being positioned as an improved replacement for pooled human intravenous immunoglobulin or IVIG.
In return for its license to develop GL-2045 for all indications, Pfizer will pay Gliknik $25 million up front. Gliknik will be eligible for an undisclosed amount in payments tied to development, regulatory, and commercial milestones, plus tiered, double-digit royalties on net sales of any products commercialized from the companies’ agreement.
Following promising results in preclinical tests, Gliknik is developing GL-2045 as a potential treatment for a wide variety of autoimmune diseases, including the more than 50 autoimmune diseases in which IVIG is clinically used. Based on the preclinical research, Gliknik expects GL-2045 will address several issues associated with IVIG, by offering patients higher efficacy at a lower protein load, fewer side effects, more convenient dosing, and unlimited supply.
Stradomers are laboratory-made clusters of the Fc portion of human antibodies, envisioned as improving on pooled human IVIG in diseases that include myasthenia gravis and other neurological autoimmune disorders. Stradomers will also compete with antibody therapies used in immune disorders such as rheumatoid arthritis. GL-2045 acts by presenting highly ordered multimers of IgG Fc to its receptors.
“Pooled IVIG has a long history of use but has a number of limitations. We are pleased to partner with Gliknik on this novel therapeutic approach which may provide an important new option in managing debilitating autoimmune disease,” Jose Carlos Gutierrez-Ramos, Ph.D., group svp and head of biotherapeutics R&D at Pfizer, said in a statement.
Gliknik CEO David S. Block said GL-2045 was the first of “several” drug candidates the company is advancing for people with autoimmune diseases and cancer. Gliknik’s lead clinical compound, the immune modulator GL-0817 for cancer, is poised to enter Phase IIb clinical studies, the company said.