Significant progress achieved in programs focused on the neonatal Fc receptor (FcRn) to develop new treatments for IgG-mediated autoimmune diseases

NEW YORK–(BUSINESS WIRE)–Syntimmune, Inc., a development-stage company advancing novel treatments for IgG-mediated autoimmune diseases based on leading expertise in FcRn biology, today announced that it has made important progress by achieving preclinical proof of concept and completing preclinical safety testing, triggering a second tranche of $10 million in its Series A financing, which is expected to total $26 million. The Series A financing is co-led by Apple Tree Partners and Baxalta Ventures, the corporate venture capital arm of Baxalta Incorporated, with participation by the Partners Innovation Fund and additional investors. Funds from this tranche of the Series A round will be used to complete the anticipated Phase 1a clinical trial in healthy volunteers of Syntimmune’s lead candidate, SYNT001. The Company intends to submit an IND application to the Food and Drug Administration for SYNT001 in mid-2016 to authorize initiation of the Phase 1a study later this year. SYNT001 is a biologic that blocks the FcRn-IgG interaction and is being developed for the treatment of IgG-mediated autoimmune diseases.

“The closing of the second tranche in the Series A affirms the progress Syntimmune has achieved and reflects the importance of targeting FcRn as a breakthrough modality for treating IgG-mediated autoimmune diseases,” said Laurence Blumberg, M.D., Founder and COO of Syntimmune. “Over the past year, Syntimmune has made rapid progress in advancing its pipeline of candidates and progressing its lead program, SYNT001, through IND-enabling studies and toward the clinic. SYNT001 is showing a promising preclinical safety profile and robust activity in unique in vivo preclinical models, which we plan to present at appropriate peer-reviewed forums.”

“The opportunity for SYNT001 is substantial,” stated David de Graaf, Ph.D., Venture Partner at Apple Tree Partners. “We are extremely happy with the progress the team has made on the lead molecule, which has the potential to address a large number of autoimmune indications.”

“FcRn is a central mediator of IgG-related immunity and part of an important pathway that enables abnormal IgG responses in a large number of clinical settings, including autoimmune disease,” commented Richard Blumberg, M.D., Scientific Founder of Syntimmune and Division Chief of Gastroenterology, Hepatology and Endoscopy at Brigham and Women’s Hospital, as well as co-Director of the Harvard Digestive Diseases Center and Director of the Brigham Research Institute. “While FcRn is a highly validated target and has attracted substantial industry interest, there are no commercially available therapies designed to block IgG-FcRn interactions, which underlie diseases that affect multiple organ systems and for which there are continuing substantial medical needs, such as inflammatory bowel disease, lupus erythematosus, dermatomyositis and others. I am thrilled with the progress of Syntimmune and look forward to the advancement of the clinical program for SYNT001.”

About Syntimmune
Founded in 2013, Syntimmune is advancing novel therapies based on its leading position in the biology of the neonatal Fc receptor (FcRn). FcRn is a well-validated target for IgG-mediated autoimmune diseases and represents a central common pathway that enables abnormal IgG responses. Syntimmune’s lead candidate, SYNT001, is a biologic progressing through IND-enabling studies that specifically blocks the FcRn-IgG interaction and is being developed for the treatment of IgG-mediated autoimmune diseases. Syntimmune has two additional, earlier-stage therapeutic programs, targeting other unique aspects of FcRn biology. The Syntimmune team has world-class experience in the field of FcRn biology and has successfully pioneered and advanced biologics targeting FcRn, including approved therapies currently on the market. Since its founding, the Company has received a total of $28 million in funding commitments from leading life sciences investors, including Apple Tree Partners, Baxalta Ventures and Partners Innovation Fund.

Contacts
Media:
Burns McClellan
Justin Jackson, 212-213-0006, ext. 327

jjackson@burnsmc.com