Minaris And Genetix Biotherapeutics Expand Manufacturing Partnership To Support Commercial Supply For LYFGENIA™ (lovotibeglogene autotemcel)

Minaris expands commercial manufacturing for LYFGENIA™, a first-in-class FDA approved gene therapy for patients with sickle cell disease

Expanded capacity meets growing patient demand while delivering improved manufacturing efficiency and accelerated treatment timelines for patients

Philadelphia, PA — Minaris, a global cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) and multimodality biosafety testing provider, and Genetix Biotherapeutics Inc., a commercial-stage biotechnology company dedicated to delivering genetic therapies for patients with severe rare diseases, today announced an expanded manufacturing partnership to increase commercial-scale production of LYFGENIA, Genetix’s FDA-approved, one-time gene therapy for individuals 12 years and older with sickle cell disease. The collaboration significantly increases manufacturing capacity, enabling Genetix to meet growing commercial demand while maintaining the quality, consistency, and regulatory rigor required for commercial CGT manufacturing. The partnership builds on a strong existing relationship and reflects Minaris’ ability to grow alongside its partners as products advance and supply needs expand.

To facilitate the expansion, Minaris Advanced Therapies has implemented process and operational improvements that increase manufacturing efficiencies and reduce turnaround times, while significantly increasing output. Minaris has continued to invest in infrastructure, talent, and capacity to ensure it can support long-term commercial supply and respond to increasing demand without disruption.

“Minaris is proud to partner with Genetix to continue to bring this transformative therapy to patients. This expansion reflects the reality of commercial cell and gene therapies, where demand can increase quickly,” said Dr. Eytan Abraham, Chief Commercial & Technology Officer at Minaris. “Our focus is on investing early, building efficiency into the process, and ensuring our partners have the capacity and cost structure to scale as patient needs grow.”

The collaboration reinforces Minaris’ broader mission to support advanced therapy developers through the transition from development to sustained commercial supply. With strengthened capacity and a focus on continuous improvement, Minaris is positioned to support Genetix’s growth while maintaining the operational excellence required for regulated commercial manufacturing.

“The increasing growth in commercial demand for LYFGENIA requires us to meaningfully expand our manufacturing capacity. Minaris has been a reliable, highly effective and innovative partner bringing our curative therapies to patients in need.,” said Brian Riley, President & Chief Technical Officer at Genetix. “They understand the technical demands of manufacturing a genetic therapy and have consistently demonstrated the essential capabilities needed to support our growing commercial supply needs.”

About Minaris Advanced Therapies

Minaris is a global cell and gene therapy (CGT) CDMO and a multimodality biosafety testing provider. With more than 25 years of CGT development and manufacturing expertise and more than 40 years in biosafety testing, Minaris combines deep legacy experience with state-of-the-art GMP facilities, and is a fully US-owned organization under new ownership and management, built for today’s evolving therapeutic landscape. Our CDMO team supports CGT innovators from IND through commercial supply, and our testing business delivers GMP analytics, biosafety, viral clearance, and product characterization across CGT and biologics. With 5 global sites on 3 continents, we operate with one mission—to support clinical and commercial therapeutic programs hand in hand with our partners to get more therapies to more patients. We are united by our commitment to excellence, reliability, and a patient-focused purpose as we enable innovators to deliver new therapies and expand patient access worldwide. For more information, visit https://minaris.com or follow us on LinkedIn.

About Genetix Biotherapeutics

Genetix Biotherapeutics Inc. is a privately held, commercial-stage biotechnology company dedicated to delivering genetic therapies for patients with severe rare diseases. Backed by more than 30 years of pioneering genetic therapy innovation, the company has FDA-approved therapies for sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy that directly treat the underlying cause of disease. Genetix is committed to commercial execution, scaling patient access, and improving the treatment experience for patients and providers. Genetix is headquartered in Somerville, Massachusetts.

About LYFGENIA™ (lovotibeglogene autotemcel)

LYFGENIA is a one-time ex-vivo lentiviral vector (LVV) gene addition therapy approved for eligible patients with sickle cell disease, in which a functional β-globin gene is added to patients’ own hematopoietic (blood) stem and progenitor cells (HSPCs). This addition results in the production of adult hemoglobin with anti-sickling properties (HbAT87Q) which has a similar oxygen-binding affinity to wild-type HbA. LYFGENIA has been shown to limit sickling of red blood cells and reduce or eliminate vaso-occlusive events (VOEs).

LYFGENIA is indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of VOEs.

The FDA previously granted orphan drug designation, fast track designation, regenerative medicine advanced therapy (RMAT) designation, and rare pediatric disease designation for lovotibeglogene autotemcel.