Alexion to Obtain Syntimmune for $400M up Front

Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Syntimmune have just today announced that Alexion will be acquiring Syntimmune, a company working to produce antibody therapeutics that focus on the neonatal Fc receptor (FcRn). Their self-described pipeline-in-a-product, SYNT001, is a humanized monoclonal antibody which was engineered to reduce the interaction of FcRn with Immunoglobulin G (IgG) and IgG immune complexes. As such, SYNT001 has shown excellent potential for the advancement of medical therapies in a range of IgG-mediated diseases.

“Syntimmune’s lead investigational candidate, SYNT001, holds strong promise to potentially transform patient care in IgG-mediated autoimmune diseases. There are important unmet needs in these diseases, including need for faster onset of action, more effective disease control, improved safety profile, steroid-sparing effect and more. SYNT001 has been designed to optimally bind FcRn at both neutral and endosomic (acid) pH levels, thereby potently inhibiting the interaction of FcRn with IgG and IgG immune complexes . . . SYNT001 blocks FcRn-mediated recycling of IgG to drive degradation of IgG within cells and rapidly reduce circulating IgG. SYNT001 is also predicted to block FcRn-mediated inflammatory cytokine release induced by immune complexes, as well as FcRn-mediated presentation of IgG-complexed antigens. This has the potential to prevent expansion of autoimmune responses by blocking FcRn-mediated activation of new autoreactive T cells and B cells,” explains Syntimmune’s website.

The groundbreaking drug is being appraised in Phase 1b/2a studies involving patients with both warm autoimmune hemolytic anemia (WAIHA) and pemphigus vulgaris (PV) or pemphigus foliaceus (PF). Accelerated IgG reduction has been demonstrated consistently. The current agreement between Alexion and Syntimmune details that Syntimmune will be acquired for an upfront payment of $400 million with the future possibility of supplementary milestone-based payments of up to $800 million, making the total value of the deal up to $1.2 billion.

Ludwig Hantson, Ph.D., chief executive officer of Alexion quotes that “targeting FcRn holds great promise in transforming the treatment of IgG-mediated diseases. SYNT001 has successfully demonstrated proof of mechanism – the ability to rapidly lower IgG levels – in early clinical studies and has the potential to treat a number of rare IgG-mediated diseases. The acquisition of Syntimmune represents a critical step in rebuilding Alexion’s pipeline and further diversifying the company’s clinical-stage rare disease portfolio. It offers a strong strategic fit with Alexion’s existing rare disease franchises and provides the opportunity to transform patient care in diseases like warm autoimmune hemolytic anemia, where SYNT001 is the first, and currently the only, anti-FcRn therapy in clinical development.”

Alexion has been developing breakthrough therapies for rare diseases since its creation. “Since its founding in 1992, Alexion has given hope to people who had none and shined a light on those who felt isolated and alone. But we know that fighting rare diseases takes so much more than hope. It requires persistence, dedication, and a relentless pursuit of the highest levels of medical innovation. At Alexion, our goal is to deliver medical breakthroughs where none currently exist. We are driven because we know people's lives are at stake,” describes their website. In the past, Alexion has worked to gain approval for ALXN1210, a blockbuster blood-disorder drug, as well as multiple other innovative treatments.

Seth Harrison, M.D., chairman of Syntimmune and managing partner of Apple Tree Partners, adds that “Since the company’s founding in 2013, the team at Syntimmune has been focused on developing transformative therapies for patients with autoimmune diseases. We see tremendous promise for SYNT001, which is being evaluated in multiple IgG-mediated autoimmune diseases in ongoing clinical trials. Alexion’s demonstrated rare disease expertise and development and commercial capabilities provide an ideal foundation for continued advancement of SYNT001 and, we believe, will ensure its broad potential is realized.”