NEW YORK--(BUSINESS WIRE)--Syntimmune, Inc., a clinical-stage biotechnology company focused on FcRn biology, today announced a $50 million Series B financing led by Apple Tree Partners, which has committed $48 million to the round, with additional participation from other existing investors. Funds from the Series B financing will further advance Syntimmune’s clinical development program, which includes two ongoing Phase 1b/2a clinical trials of the company’s lead drug candidate, SYNT001, in pemphigus and warm autoimmune hemolytic anemia. SYNT001 is a monoclonal antibody that blocks the FcRn-IgG interaction and is being developed for the treatment of a broad variety of IgG-mediated autoimmune diseases.
Both warm autoimmune hemolytic anemia and pemphigus provide an opportunity to address major unmet medical needs. These IgG-mediated autoimmune diseases occur in distinct tissue compartments and illustrate the broad potential utility and applicability of SYNT001 across the spectrum of IgG-mediated diseases. This highly specific and differentiated approach to blockade of IgG-mediated inflammation preserves other key aspects of the immune system and is expected to enable substantial improvement over current standards of care for these devastating diseases.
The clinical and preclinical profile observed with SYNT001 through a US Phase 1a trial showed safe and rapid onset of clinically meaningful FcRn-IgG blockade, including that associated with IgG-mediated innate and adaptive immune functions. In addition to funding this broad clinical development campaign, the Series B proceeds will be used to support manufacturing scale-up for SYNT001 in preparation for anticipated registration studies. The funds will also support further preclinical development of SYNT002, the company’s second product candidate, as well as additional research activities.
“FcRn-targeted therapies have potential application to a broad range of diseases for which there often are limited treatment options and few or no FDA-approved therapies,” said Sam Hall, Ph.D., of Apple Tree Partners. “The rapid clinical advances at Syntimmune have been shepherded by a highly accomplished and experienced team and build upon breakthrough translational science originating from the laboratory of Richard Blumberg, M.D., Syntimmune’s scientific founder. We are excited by this progress and look forward to the continued advancement of SYNT001 through the company’s ongoing Phase 1b/2a studies and beyond.”
David de Graaf, Ph.D., Syntimmune’s president and chief executive officer, said, “We are grateful for the continuing support of our engaged investor syndicate. This funding will further increase the momentum of our clinical development program. Based on this progress, we anticipate announcing the first clinical data from our Phase 1b/2a program and other translational research findings by early next year. Syntimmune is poised to maintain its position as the leader in FcRn biology as we plan for rapid expansion into pivotal studies and additional indications.”
“Based on these clinical data, together with our preclinical research findings, we are confident that SYNT001 can modulate the critical aspects of FcRn-IgG biology. FcRn-IgG blockade with SYNT001 thus has the potential to change the treatment paradigm of many IgG-mediated autoimmune diseases.” said Laurence Blumberg, M.D., Syntimmune’s business founder and chief operating officer.
Additional Details on the SYNT001 Clinical Development Program
SYNT001 Phase 1b/2a Study in Warm Autoimmune Hemolytic Anemia (WAIHA)
Syntimmune has initiated a multicenter, open-label, safety, tolerability, and activity Phase 1b/2a study of SYNT001 in individuals with chronic, stable WAIHA. The study’s primary outcome measures are safety and tolerability. Secondary measures include pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and effects on disease activity markers. WAIHA is a rare blood disorder in which the immune system produces antibodies that attack a patient’s own red blood cells, the destruction of which can lead to severe, potentially debilitating anemia. There are limited treatment options and no therapies currently approved in their labeling to treat AIHA. For more information, please visit clinicaltrials.gov.
SYNT001 Phase 1b/2a Study in Pemphigus
Syntimmune also has initiated a multicenter, open-label, safety, tolerability, and activity Phase 1b/2a study of SYNT001 in subjects with chronic pemphigus (vulgaris or foliaceus). The study’s primary outcome measures are safety and tolerability. Secondary measures include PK, PD, immunogenicity, and effects on disease activity markers. Pemphigus is characterized by autoimmune blistering of the skin and mucous membranes; in its more severe manifestations this disease can be highly debilitating and potentially fatal. Many patients require long-term use of corticosteroids and other immune system suppressors associated with serious adverse events. For more information, please visit clinicaltrials.gov.
Founded in 2013 by Richard Blumberg, M.D., and Laurence Blumberg, M.D., Syntimmune is advancing novel therapies based on its leading position in the biology of the neonatal Fc receptor (FcRn). As a core part of a central common pathway that enables abnormal IgG responses, FcRn is a well-validated target for the treatment of IgG-mediated autoimmune diseases. Syntimmune’s lead candidate, SYNT001, is a monoclonal antibody that specifically blocks FcRn-IgG interactions and is being studied in multiple 1b/2a trials for the treatment of IgG-mediated autoimmune diseases. In addition to SYNT001, Syntimmune is developing SYNT002, which targets the interaction between FcRn and albumin and promotes clearance of albumin-bound endo- and exotoxins. The Syntimmune team has world-class experience in the field of FcRn biology and has successfully pioneered and advanced biologics that engage FcRn. Since its founding, the company has been funded with a total of $78 million in capital commitments from leading life sciences investors, led by Apple Tree Partners and including Partners Innovation Fund, FMB Research, and AFB Fund. For more information on Syntimmune, please visit the company’s website at www.syntimmune.com.
About Apple Tree Partners
Apple Tree Partners (ATP) is a New York-based venture capital firm dedicated to building transformative life sciences businesses. The firm is actively investing its fourth fund, with $1.5 billion in capital commitments. ATP considers therapeutics and medical device investments at all stages, from discovery research through to commercialization and takes a long-term view to create sustainable value.
Learn more about ATP and its therapeutics portfolio at www.appletreepartners.com.