Enzyvant Announces Merger With Altavant

Enzyvant Therapeutics, Inc. and Altavant Sciences, Inc., both wholly owned subsidiaries of Sumitovant Biopharma Ltd., recently announced a merger to form a biopharmaceutical company focused on delivering life-altering therapies for people with rare diseases. The combined company retains the name Enzyvant and is equipped with a full range of capabilities spanning non-clinical and clinical development and commercialization and is in the process of developing in-house manufacturing.

Dr. Bill Symonds, current Chief Executive Officer of both Enzyvant and Altavant, will lead the merged company. “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,” said Dr. Symonds. “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.”

Enzyvant received US FDA 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, in October 2021. The company continues to advance promising therapeutic candidates targeting some of the most challenging conditions impacting the rare disease community. In its clinical trials, Enzyvant is evaluating an investigational product, rodatristat ethyl, which is designed to address a root cause of pulmonary arterial hypertension rather than only managing symptoms.

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

Enzyvant is now headquartered in Cary, NC. The company is developing an in-house regenerative medicine manufacturing facility in Morrisville, NC. Expected to be completed in the second half of 2024, the facility will provide the size, flexibility, and processing capability to serve the company’s commercial and clinical research needs for regenerative medicines. 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. Financial terms of the deal were not disclosed.

Enzyvant is a biopharmaceutical company making life-altering impact for people affected by rare disease, where the communities are small, and the human need is immense. Driven by purpose, we engage with rare disease communities with compassion and commitment, partnering to accelerate the development of transformative medicines they so urgently need. We prioritize collaborative connections with academia, industry, associations, advocacy groups and government, because strong relationships make bold science possible.

A nimble and unique organization, Enzyvant has a full range of capabilities spanning non-clinical and clinical development and commercialization and is developing in-house manufacturing. Enzyvant has delivered a first-of-its-kind FDA approval in regenerative medicine and promising advances against some of the greatest challenges in immunology and cardiopulmonology. Enzyvant is part of Sumitovant, wholly owned by Sumitomo Pharma. For more information, visit www.Enzyvant.com.

Sumitovant is a technology-driven biopharmaceutical company accelerating development and commercialization of new potential therapies for patients with rare conditions and other diseases. Through our proprietary computing and data platforms, scientific expertise and diverse company portfolio, Sumitovant has supported development of multiple FDA-approved products and a robust pipeline of early- through late-stage investigational assets addressing unmet patient needs in pediatrics, urology, oncology, women’s health, specialty respiratory and infectious diseases. Sumitovant is a wholly owned subsidiary of Sumitomo Pharma. Please visit our website www.sumitovant.com for more information on Sumitovant and our portfolio.

Sumitomo Pharma is among the top-10 listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the US, China, and other Asian countries with about 7,000 employees worldwide. Sumitomo Pharma defines its corporate mission as “To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide.” Additional information about Sumitomo Pharma is available through its corporate website at https://www.sumitomo-pharma.com.

RETHYMIC (allogeneic processed thymus tissue-agdc) is a novel one-time tissue-based regenerative therapy used for immune reconstitution in pediatric patients with congenital athymia. RETHYMIC is engineered human thymus tissue designed to regenerate the thymic function children with congenital athymia are missing and does not require donor-recipient matching. RETHYMIC has been studied across 10 clinical trials for more than 25 years and was granted multiple US FDA designations including Regenerative Medicine Advanced Therapy, Breakthrough Therapy, Rare Pediatric Disease, and Orphan Drug. It also has been granted the Orphan Drug designation and the Advanced Therapy Medicinal Product designation by the European Medicines Agency (EMA). RETHYMIC is the first and only treatment approved by the FDA for the immune reconstitution in pediatric patients with congenital athymia.

Rodatristat ethyl, a tryptophan hydroxylase (TPH) inhibitor, is an investigational medicine currently being evaluated in a Phase 2 study in patients with pulmonary arterial hypertension (PAH). The US FDA and EMA granted rodatristat ethyl orphan drug designation for PAH. Please see Full Prescribing Information for RETHYMIC.