StrideBio Announces Achievement of Significant Operational Milestones Supporting Transition of Novel Gene Therapy Pipeline to Clinical Stage

- 100^th team member hired, bolstering internal capabilities from capsid platform to clinic with an emphasis on in-house manufacturing capability -

- Completed construction of GMP manufacturing facility with 1000L production capacity to support clinical trials -

- Current HQ expanded to 47,000 sq ft incorporating additional state-of-art laboratory and office space -

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--StrideBio, Inc., a leading developer of novel adeno-associated viral (AAV) based gene therapies, today announced the achievement of several significant operational milestones. These include the hiring of StrideBio’s 100^th team member, completion of its 6,700 square-foot in-house Good Manufacturing Practice (GMP)-grade manufacturing facility, and an additional 15,000 square foot expansion of its laboratory and office spaces.

StrideBio’s fully integrated functional capabilities and exceptional team now span from structure-based capsid engineering (STRIVE^TM Platform), through therapeutic discovery and pre-clinical development, to clinical development. Underpinning StrideBio’s therapeutic product engine is an in-house vector production, analytical development and quality team, now supported by an on-site GMP production facility with 1000L capacity. The additions and expansions announced today have grown StrideBio’s campus, located in Research Triangle Park, N.C., to 47,000 square feet, providing the company with greater capabilities for discovery, GMP production, warehousing, and development of products enabled by novel engineered AAV capsids for potentially life-enhancing or curative genetic medicines. With these additions, StrideBio is well-positioned to advance its robust pipeline of wholly-owned and partnered programs into IND-enabling studies and the clinic, and has the internal GMP manufacturing capabilities to manufacture early-stage clinical products in-house.

“Since closing our most recent $81.5M Series B financing in March of this year, we have been focused on continuing to build the team and infrastructure necessary to execute and achieve critical milestones as we seek to advance therapeutic programs into the clinic. We are thrilled to announce the hiring of our 100^th Strider and the vital expansions to StrideBio’s laboratory and GMP manufacturing facilities, which will ensure our novel engineered capsids that address current challenges with existing vectors have an opportunity to benefit patients,” said Sapan Shah, Ph.D., Chief Executive Officer, StrideBio, Inc. “Combined with our wholly-owned proprietary cell-line, manufacturing process and on-site capability, which are optimized for the novel capsids resulting from our STRIVE™ platform, we now have the flexibility to scale and support translation and clinical development of differentiated gene therapies.”

StrideBio’s current therapeutic pipeline of internal and partnered programs is enabled by novel engineered capsids that have unique and differentiated properties such as reduced seroprevalence, improved tropism to target tissues including neurons, enhanced expression in multiple tissues and liver de-targeting, all of which address key challenges the gene therapy field is facing with first generation approaches. The operational achievements announced today will in particular enable StrideBio’s wholly-owned programs to advance rapidly towards the clinic, beginning with a lead program targeting Alternating Hemiplegia of Childhood, and followed by three additional undisclosed CNS and cardiac targets.

With the expansion announced today, StrideBio’s RTP campus now houses:

• 28,000 square-foot laboratory space supporting all research functions: from therapeutic discovery, platform development and preclinical activities to research production, process development (from 1L to 1000L scale), analytical development, and research Quality Control
• 6,700 square-foot GMP manufacturing facility consisting of 1000L single use bioreactor, Upstream processing suite and Downstream purification and filling suite and associated GMP warehouse
• 12,000 square-foot corporate office space

“We are very excited to see the progress being made at StrideBio since co-leading the company’s Series B financing. This amazing new state-of-the-art facility coupled with a growing team with exceptional gene therapy expertise positions StrideBio to rapidly advance best-in-class AAV gene therapies into the clinic in hopes of bringing new therapeutics to patients in need,” said Karen Hong, StrideBio Board Director and Partner at Novo Ventures.

About StrideBio

Founded in 2015 based on the groundbreaking research of Mavis Agbandje-McKenna, Ph.D., and Aravind Asokan, Ph.D., StrideBio, Inc., is a fully integrated gene therapy company focused on creating best-in-class genetic medicines with life-changing or curative potential for children and adults. Our proprietary structure-inspired adeno-associated viral (AAV) vector engineering platform (STRIVE™) creates unique and differentiated capsids that overcome current limitations of first-generation gene therapies. Key targeted improvements include reduced seroprevalence, improved tropism for specific cell types, liver de-targeting and increased gene transfer efficiency, with the potential for improved safety and reduced doses in the clinic. StrideBio is advancing a robust pipeline of gene therapy candidates enabled by these novel engineered capsids, initially focused on genetically defined CNS and cardiovascular disorders. For more information, please visit www.stridebio.com or follow us on LinkedIn.