RESEARCH TRIANGLE PARK – Enzyvant Therapeutics, Inc. and Altavant Sciences, Inc., both wholly owned subsidiaries of the global biopharmaceutical giant Sumitovant Biopharma Ltd., today announced a merger to form a North Carolina-based biopharmaceutical company focused on delivering life-altering therapies for people with rare diseases.

The combined company retains the name Enzyvant, a company that got its start in 2016 in Durham, with a history of Triangle collaboration by manufacturing its unique products in facilities at Duke University.

Enzyvant’s new Cary headquarters. (Image via N.C. Biotech Center)

Enzyvant’s first FDA-approved therapy, RETHYMIC, is an allogeneic processed thymus tissue, a process involving engineered human thymus tissue from a donor that is implanted in the thigh muscle of a child with congenital athymia to help build a functioning immune system.

Athymia is an extremely rare and highly debilitating inheritance of a non-functional thymus at birth. Babies born without a thymus gland face severe immunodeficiency due to a lack of mature T cells, which increases their risk of fatal infections.

Enzyvant says it is now equipping itself with a full range of capabilities spanning non-clinical and clinical development and commercialization by establishing new headquarters in Cary and completing its in-house manufacturing facility nearby in Morrisville, which it revealed in an April announcement.

The company did not disclose its overall investment plans for its move to North Carolina, but said in April it would spend about $34 million on the Morrisville site. It said it expects to complete the build-out of the existing 26,000-square-foot Morrisville facility in the second half of 2024 and to create approximately 40 highly skilled laboratory medicine manufacturing jobs there over the next two years.

The facility is being co-developed by and operated with Sumitomo Pharma, which owns Enzyvant’s immediate parent company, Sumitovant Biopharma.

CEO Bill Symonds. (Photo via N.C. Biotech Center)

Bill Symonds, Pharm.D., chief executive officer of both Enzyvant and Altavant, will lead the merged company. He said of the merger, “Together, our combined team has the proven expertise to take a product from early clinical development through commercialization, and the passion and focus to drive accelerated development of urgently needed rare disease medicines in immunology and cardiopulmonology. Patients and families facing very serious and difficult-to-treat rare conditions are the inspiration for our work and vital partners in moving our programs forward.”

Laura Rowley, Ph.D., vice president of life science economic development for the North Carolina Biotechnology Center, said, “We are grateful that Enzyvant has entrusted North Carolina’s life sciences community to support its work to bring life-changing therapies to families.” Rowley provided technical support to the Enzyvant project.

Last October Enzyvant received U.S. Food and Drug Administration approval of its first commercial product, RETHYMIC (allogeneic processed thymus tissue-agdc), a one-time regenerative tissue-based therapy for immune reconstitution in pediatric patients with congenital athymia.

Enzyvant says it will continue to advance promising therapeutic candidates targeting some of these most-challenging conditions impacting the rare disease community. For example, in its clinical trials, Enzyvant is evaluating an investigational product, rodatristat ethyl, which is designed to address a root cause of pulmonary arterial hypertension (PAH) rather than only managing symptoms.

PAH is a relatively rare, chronic, progressive disease caused by hardening and narrowing of the pulmonary arteries that can lead to heart failure and eventually death. An estimated 30,000 patients in the United States have the condition.

“There is an immense human need for rare disease therapies, but innovation in this field is complex,” said Myrtle Potter, chief executive officer of Sumitovant. “Enzyvant has a proven track record of bringing unique expertise to tackle some of the greatest unmet needs in the space. We believe the combined company will be better positioned to deliver breakthroughs in a way that wouldn’t have been possible separately.”

Enzyvant said it expects its manufacturing facility in Morrisville to provide the size, flexibility, and processing capability to serve its commercial and clinical research needs for regenerative medicines. It did not discuss plans for any changes in its future manufacturing activities at Duke.

The new manufacturing facility is being co-developed by and operated with Sumitomo Pharma, which owns Enzyvant’s immediate parent company, Sumitovant. Enzyvant also will maintain offices in Cambridge, Mass., and Basel, Switzerland.

(C) N.C. Biotech Center