Arsanis and privately-held X4 Pharmaceuticals have entered into a definitive merger agreement under which X4 Pharmaceuticals is expected to merge with a wholly-owned subsidiary of Arsanis in an all-stock transaction. The merger would result in a combined company operating under the X4 Pharmaceuticals name that will focus on the development and commercialization of X4’s lead product candidate, X4P-001, and the advancement of X4’s pipeline of treatments for rare diseases of the immune system and rare cancers.
"X4 has pioneered the development of novel, oral drug candidates targeting pathways that have been demonstrated to improve immune cell trafficking and restore healthy immunity in genetically-driven rare diseases and lymphomas. Our lead product candidate, X4P-001, is expected to begin a Phase 3 trial in WHIM syndrome in the first half of 2019," said Paula Ragan, PhD, president and chief executive officer of X4 Pharmaceuticals. "WHIM syndrome is a serious, genetic primary immunodeficiency disease that is caused by a mutation in the CXCR4 receptor, the precise pathway targeted by X4P-001. X4P-001 has been shown in a Phase 2 clinical trial to increase neutrophils and lymphocytes in the blood and decrease wart lesions, a hallmark symptom of WHIM syndrome. In addition to WHIM syndrome, we believe there are other primary immunodeficiencies in which the CXCR4 receptor is implicated and therefore may be treatable with X4P-001."
X4 Pharmaceuticals is a privately-held biopharmaceutical company developing oral, small molecule drug candidates that inhibit the binding of chemokine CXCL12 to C-X-C receptor type 4 (CXCR4), a receptor-ligand pair that plays an essential role in normal immune surveillance. X4’s lead product candidate, X4P-001, is expected to enter a Phase 3 clinical trial in the first half of 2019 for the potential treatment of Warts, Hypogammaglobulinemia, Immunodeficiency, and Myelokathexis (WHIM) syndrome, a rare genetic, primary immunodeficiency disease where patients become susceptible to certain types of viral and bacterial infections due to genetic mutations in the CXCR4 receptor gene. X4 also has additional rare disease programs based on CXCR4 biology in its development pipeline, including programs targeting other primary immunodeficiency diseases and rare lymphomas. In addition, X4 is exploring the use of X4P-001 in immuno-oncology, having completed Phase 1b studies for the treatment of melanoma and renal cell carcinoma (RCC), including in combination therapy, and has an ongoing Phase 2a study in RCC expected to read out in mid-2019.
In addition to the merger agreement, Arsanis announced today that Michael P. Gray has been appointed to the position of president and chief executive officer, effectively immediately. Gray will also join the Arsanis Board of Directors and will continue to serve in his existing role as chief financial officer. Gray succeeds René Russo, PharmD who has resigned as president and chief executive officer to pursue other opportunities. Dr. Russo will remain on the Arsanis Board of Directors.
"I would like to thank René for her leadership at Arsanis, both as chief development officer previously and more recently as president and chief executive officer, and wish her the best in her future endeavors," said Tillman U. Gerngross, Chairman of the Arsanis Board of Directors.
"Following an extensive review of strategic alternatives, we believe the proposed merger with X4 Pharmaceuticals would provide Arsanis stockholders the opportunity to potentially realize value as X4 continues to execute on its promising new approach to rare disease and cancer therapy via the CXCR4 immune pathway," Michael Gray, president and chief executive officer of Arsanis, said. "We are confident that X4’s experienced senior management team will lead the combined company to future success. We are also pleased that X4 has expressed interest in retaining certain members of our clinical development and regulatory staff as well as our scientific team in Vienna, Austria, a team which has deep expertise in the research of virally-mediated infections, as demonstrated by Arsanis’ on-going ASN500 collaboration with the Bill & Melinda Gates Foundation."
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