Research Triangle Park, N.C., February 4, 2022 – StrideBio, Inc., a leading developer of novel adeno-associated viral (AAV) based gene therapies, today announced the appointment of industry veteran Mark Velleca, M.D., Ph.D. as Chief Executive Officer and a member of its Board of Directors. Mark succeeds Sapan Shah, Ph.D., who is leaving StrideBio to pursue other opportunities after having served as Chief Executive Officer for the past three years.

“StrideBio has undergone a period of spectacular growth under Sapan’s leadership, and we thank him wholeheartedly for his invaluable contributions to the company,” said Dr. Aravind Asokan, co-founder and member of the Board of Directors. “As we continue on our journey to bring gene therapies to patients, we welcome Mark Velleca to lead us through the next exciting chapter. Mark is an accomplished leader with an impressive track record of clinical experience and building innovative biotech companies developing transformative medicines.”

Dr. Mark Velleca joins StrideBio from Hatteras Venture Partners where he is a Venture Partner. Until 2021, Mark served as CEO of G1 Therapeutics (GTHX), where he took the company public and led the development of its first therapy (COSELA) from IND filing to FDA approval. He continues as a Senior Advisor to and board member of GTHX. Mark has served as an advisor to the StrideBio Board of Directors since November 2021. He also serves on the Board of Directors of Black Diamond Therapeutics (BDTX). Previously, Mark was Executive Vice President at the Leukemia & Lymphoma Society (LLS). Prior to LLS, Mark was a co-founder and Senior Vice President of CGI Pharmaceuticals, where he managed the company from its inception through clinical trials of multiple drug candidates. After Gilead Sciences acquired CGI, he served as a Senior Advisor to Gilead in R&D Strategy and Corporate Development.

Earlier in his career, Mark was an attending physician at Yale New Haven Hospital and on the faculty of the Yale University School of Medicine. Mark earned an M.D. and Ph.D. from Washington University in St. Louis, and a B.S. from Yale University.

“I am thrilled to join StrideBio at this critical stage in its development, and want to thank Sapan for his contributions,” said Dr. Velleca. “Stride’s pipeline holds enormous promise for patients in need of better treatment options. I look forward to working with the entire Stride team as we leverage our novel capsid technology and state-of-the-art manufacturing capabilities to advance our therapeutic candidates into the clinic.”

“Leading StrideBio for the past 3 years has been a privilege and I am very grateful to have had the opportunity to work with our talented group of Striders and supportive investors to build such a strong foundation for future success,” said Dr. Shah. “I look forward to supporting Mark through this transition as the company continues on its important mission to advance novel gene therapies enabled by StrideBio’s capsid engineering and manufacturing platform into the clinic where they can benefit patients.”

About StrideBio, Inc.

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.

Contacts

StrideBio:
Robert Hughes
984-213-7301

For Media:
Carolyn Noyes or Susan Sharpe
781-235-3060
MacDougall
[email protected]

[email protected]

100th 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., October 4, 2021 – 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, Inc.

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.

Contacts

StrideBio:
Robert Hughes
984-213-7301

For Media:
Carolyn Noyes or Susan Sharpe
781-235-3060
MacDougall
[email protected]

Newly created roles will support StrideBio’s operations across strategy, regulatory affairs, quality, and patient advocacy

Research Triangle Park, N.C., June 15, 2021 – StrideBio, Inc., a leading developer of novel adeno-associated viral (AAV) based gene therapies, today announced the expansion of its leadership team with the appointments of Ariane Hamaide, as Vice President, Strategy and Operations, Mike Havert, Ph.D., as Vice President, Regulatory Affairs, Sandra Lueken, as Vice President, Quality Operations, and Jodi Wolff, Ph.D., M.S.S.W., as Vice President, Patient Engagement & Advocacy.

“We are very excited to welcome Ariane, Mike, Sandra and Jodi to StrideBio in these critical leadership roles necessary for our long-term success. Following our recently announced Series B financing, these key additions ensure StrideBio has the right capabilities in place as we advance our pipeline of next-generation gene therapies to the clinic,” said Sapan Shah, Ph.D., Chief Executive Officer, StrideBio, Inc. “The diverse backgrounds and extensive accomplishments of these new team members reflects StrideBio’s focus on building a world-class gene therapy company with a mission to bring novel treatments to patients.”

Ariane Hamaide most recently served as Vice President, Corporate Development at Cellectis where she piloted core strategic initiatives and prepared the company for early commercial operations. Previously, she spent over five years at The Boston Consulting Group as a Project Leader where she led early commercialization and U.S. launch preparations for a large immuno-oncology company’s autologous CAR-T cell therapy and supported several European pharmaceutical companies. Ariane also served in the French military and earned a Commando military medal. She received a M.Sc. in Strategic Management from HEC Paris and a M.Sc. in Management of Innovation from École Polytechnique.

Mike Havert, Ph.D., most recently served as Senior Director, Regulatory Science, Chemistry Manufacturing and Controls (CMC) at bluebird bio, where he engaged with the FDA on multiple regulatory submissions and managed cross-functional teams supporting FDA-related activities. Previously, Mike worked in CBER’s Gene Therapy branch as a Biologist/CMC reviewer for 15 years where he helped guide the development of a number of different advanced therapies. His accomplishments at FDA include serving as BLA Review Chair, championing the release of guidance documents, and working toward different global harmonization efforts. He also worked as a Clinical Trial Specialist at Technical Resources International, and as an adjunct faculty member at Northern Virginia Community College. At the beginning of his career, Mike completed postdoctoral fellowships at Johns Hopkins University and the National Institutes of Health. Mike received his undergraduate degree from Boston University and graduate degree from the University of Wisconsin – Madison.

Sandra Lueken most recently served as Vice President, Quality Operations at KBI Biopharma, Inc. where she was responsible for strategic planning and oversight of Quality initiatives, including technical operations, staff management, system implementations, standards and procedures, and leadership support for contract manufacturing. Previously, Sandra served as Senior Director, Quality Assurance at AstraZeneca Biologics (MedImmune) and as Director at Quality of Baxter Pharmaceutical Solutions, LLC., for five years each. Prior to Baxter, she held positions of increasing responsibility in the pharma industry at Hollister-Stier, Ventana Medical Systems, Systems Integration Drug Discovery Company and the Jerry L. Pettis Memorial VAMC in Mineral Metabolism Research. Sandra has extensive experience in pharmaceutical quality systems and regulatory compliance, having supported four biologic approvals. Sandra received her B.A. in Biochemistry from the University of Arizona and an MBA from the University of Arizona’s Eller Graduate School of Management.

Jodi Wolff, Ph.D., M.S.S.W., most recently served as Head of Global Patient Advocacy at Santhera Pharmaceuticals where she established and maintained patient advocacy initiatives throughout lifecycle development of early and late-stage therapies for rare diseases. She previously served as Director of Clinical Services for the Muscular Dystrophy Association where she spent fourteen years in positions of increasing responsibility. She also serves as a Retreat Director for the Jett Foundation’s Camp Promise summer program. Jodi served as a program supervisor at Arizona State University, the University of Arizona, and Indiana University in the departments of Social Work and Psychoeducational Studies. She received her Ph.D. in Rehabilitation from the University of Arizona and her M.S.S.W. from the University of Wisconsin.

About StrideBio, Inc.

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. Combined with our genetic construct design expertise and in-house manufacturing capability at a 1000L scale, we are well positioned to advance novel best-in-class AAV gene therapies. StrideBio is based in a state-of-the-art 40,000-square-foot facility in Research Triangle Park, N.C., which houses our offices, research labs and in-house AAV manufacturing facilities. For more information, please visit www.stridebio.com or follow us on LinkedIn.

Contacts

StrideBio:
Robert Hughes
984-213-7301

For Media:
Carolyn Noyes or Susan Sharpe
781-235-3060
MacDougall
[email protected]

Research Triangle Park, N.C., April 27, 2021 – StrideBio, Inc., a leading developer of novel adeno-associated viral (AAV) based gene therapies, today announced the appointment of Deborah D. Ascheim, M.D., to the newly created position of Chief Medical Officer. In this role, she will lead all clinical initiatives including the strategy, design and execution of clinical trials, as StrideBio, both independently and in collaboration with key partners, advances a pipeline of therapeutic programs that utilize internally discovered, novel engineered AAV capsids that can improve potency, evade neutralizing antibodies and enhance specific tropism to tissues critical for efficacy.

Dr. Ascheim brings to StrideBio a 30-year track record of success as a physician, clinical investigator and director of national and international clinical trials, as well as extensive expertise in developing novel, disruptive therapeutic innovations including gene therapies that target rare and complex diseases. Prior to joining StrideBio, she was President of d2a Ltd., providing independent strategic consulting to biotech and device companies, as well as academics. From 2015 to 2019, she was Chief Medical Officer of Capricor, Inc., a biotechnology company evaluating cardiosphere-derived cells for Duchenne Muscular Dystrophy. Before Capricor, Dr. Ascheim was Professor of Health Policy and Medicine (Cardiology) at the Icahn School of Medicine at Mount Sinai in New York, where she was also the director of the International Center for Health Outcomes and Innovation Research’s Clinical Trial Unit. Previously, Dr. Ascheim was on faculty in the Department of Medicine and division of Cardiology at the College of Physicians & Surgeons at Columbia University. Since 2008, she has served on the board of Physicians for Human Rights, a not-for-profit that uses medicine and science to document and advocate against mass atrocities and severe human rights violations around the world. Dr. Ascheim received her M.D. from New York University School of Medicine and a B.A. from Wellesley College.

“Dr. Ascheim is an experienced clinician with an impressive track record in the effective and efficient execution of gene therapy investigations, and her wealth of knowledge will be invaluable as we progress StrideBio to the next stage,” said Sapan Shah, Ph.D., Chief Executive Officer, StrideBio, Inc. “We are pleased to welcome Dr. Ascheim to our leadership team as we continue to harness the potential of our proprietary platform and advance next generation gene therapies to patients in need.”

“I am thrilled to join StrideBio at this important time of growth and development for the company,” said Dr. Ascheim. “The extraordinary team in place has the scientific vision, rigor, and innovative approach necessary to advance the field of gene therapy. I look forward to taking on the leadership of the clinical development of StrideBio’s therapeutic programs, working to bring them to and through the clinic for the benefit of patients suffering from severe diseases.”

About StrideBio, Inc.

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. Combined with our genetic construct design expertise and in-house manufacturing capability at a 1000L scale, we are well positioned to advance novel best-in-class AAV gene therapies. StrideBio is based in a state-of-the-art 40,000-square-foot facility in Research Triangle Park, N.C., which houses our offices, research labs and in-house AAV manufacturing facilities. For more information, please visit www.stridebio.com or follow us on LinkedIn.

Contacts

StrideBio:
Robert Hughes
984-213-7301
[email protected]

For Media:
Carolyn Noyes or Susan Sharpe
781-235-3060
MacDougall
[email protected]

StrideBio receives exclusive license to novel cross-species evolved AAV vectors and an enzymatic approach for neutralizing antibody evasion

Master Sponsored Research Agreement will support collaborative research and development of multiple novel gene therapies with ability to expand

First therapeutic program under the collaboration is a gene therapy targeting Alternating Hemiplegia of Childhood, a devastating pediatric neurological disorder with no effective treatment

Research Triangle Park, N.C., April 14, 2021 – StrideBio, Inc., a leading developer of novel adeno-associated viral (AAV)-based gene therapies, today announced the signing of a multi-technology collaboration with Duke University that will enable novel next-generation gene therapies against a broad range of disorders. StrideBio is advancing multiple products incorporating these technologies with an initial program targeting a novel treatment for the pediatric neurological disorder Alternating Hemiplegia of Childhood (AHC).

The agreements announced today provide StrideBio an exclusive license to multiple technologies that will enable best-in-class next-generation gene therapies developed at Duke University. Included are novel engineered AAV vectors which complement StrideBio’s existing STRIVE^TM capsid engineering platform, having been selected through a cross-species evolution that results in significantly enhanced tropism and potency versus AAV9 across a wide range of tissues such as CNS, skeletal and cardiac muscle. Data on these novel vectors were presented by Duke researcher and StrideBio co-founder, Aravind Asokan, Ph.D., at the American Society of Gene & Cell Therapy 23^rd Annual Meeting in an abstract titled “Cross Species Evolution of Synthetic AAV Strains for Clinical Translation” (Gonzalez et al., ASGCT 2020, Abstract 24). In addition, StrideBio has licensed exclusive rights covering a novel use of IgG-degrading enzyme IdeZ to clear neutralizing antibodies in conjunction with AAV gene therapy administration. This innovative approach was recently published by members of the Asokan Lab in a manuscript titled “Rescuing AAV gene transfer from neutralizing antibodies with an IgG-degrading enzyme” (Elmore et al., JCI Insight, 2020, 5(19): e139881). Finally, StrideBio obtained license rights to a novel gene therapy approach for the treatment of AHC recently published by Duke researcher Mohamad Mikati, M.D., in a manuscript titled “AAV Mediated Gene Therapy in the Mashlool, Atp1a3^Mashl/+, Mouse Model of Alternating Hemiplegia of Childhood” (Hunanyan et al., Human Gene Therapy, February 12, 2021).

Under the Master Sponsored Research Agreement (SRA), StrideBio will fund collaborative work to advance novel gene therapies initially against AHC and other undisclosed targets. AHC is a devastating pediatric neurological disorder with mutations in a causative gene, ATP1A3, that was first identified by a team of Duke University researchers, including Dr. Mikati, in 2012. StrideBio will work closely with Dr. Mikati using a mouse model of AHC developed in his lab to select and rapidly advance a novel gene therapy candidate to the clinic, leveraging the engineered AAV vectors developed by StrideBio along with its manufacturing and translational development capabilities.

The Master SRA between StrideBio and Duke University also provides a framework for additional new programs to be brought under the collaboration. These programs will aim to utilize novel engineered AAV capsids developed by StrideBio to improve potency, evade neutralizing antibodies and enhance specific tropism to tissues of interest. One additional undisclosed program targeting the CNS vasculature has been initiated.

“We are very excited to partner with Duke University to advance these technologies that can improve and expand on the potential benefits of gene therapies for patients who desperately need them,” stated Sapan Shah, Ph.D., Chief Executive Officer, StrideBio, Inc. “We look forward to working together with a fantastic group of Duke researchers and clinicians to bring next-generation AAV-based gene therapies to patients with rare CNS diseases and beyond, starting with Alternating Hemiplegia of Childhood.”

“This License and Master Sponsored Research Agreement will ensure that these innovative technologies receive the resources and expertise necessary to develop treatments that can ultimately benefit patients. We are delighted to have StrideBio as a partner on this important effort in the gene therapy area,” commented Robin Rasor, Executive Director of the Office of Licensing and Ventures, Duke University.

Specific terms were not disclosed, but include equity, upfront and milestone-driven payments, and sponsored research commitments from StrideBio to Duke University, along with royalties on future product sales.

About StrideBio, Inc.

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. Combined with our genetic construct design expertise and in-house manufacturing capability at a 1000L scale, we are well positioned to advance novel best-in-class AAV gene therapies. StrideBio is based in a state-of-the-art 40,000-square-foot facility in Research Triangle Park, N.C., which houses our offices, research labs and in-house AAV manufacturing facilities. For more information, please visit www.stridebio.com or follow us on LinkedIn.

Contacts

StrideBio:
[email protected]

For Media:
Carolyn Noyes or Susan Sharpe
781-235-3060
MacDougall
[email protected]

Proceeds to advance structure-guided AAV capsid engineering platform and pipeline of novel gene therapy candidates into the clinic, including four new wholly-owned programs

Financing will also support organizational growth and GMP manufacturing expansion, building on the company’s current 1000 liter scale in-house production process

Research Triangle Park, N.C., Mar. 16, 2021 – StrideBio, Inc., a leading developer of novel engineered adeno-associated virus (AAV) based gene therapies, today announced the closing of an oversubscribed Series B funding round, which raised $81.5 million. The financing was co-led by Northpond Ventures and Novo Holdings A/S and included new investors Pontifax, Octagon Capital, Sarepta Therapeutics, CaaS Capital and UF Innovate Ventures, along with existing investors Hatteras Venture Partners, UCB Ventures, Takeda Ventures and Alexandria Venture Investments. In conjunction with the financing, Shaan C. Gandhi, M.D., D.Phil., Director at Northpond Ventures, and Karen Hong, Ph.D., Partner at Novo Ventures, an affiliate of Novo Holdings A/S, have joined the company’s Board of Directors.

“We are very pleased to receive such tremendous support from these top-tier healthcare investors and appreciate the confidence they have placed in our entire team,” said Sapan Shah, Ph.D., Chief Executive Officer of StrideBio. “With this additional funding secured, we will be able to translate next generation gene therapies enabled by our lead engineered capsids into the clinic to benefit patients. We are also delighted to welcome Shaan and Karen to our Board of Directors and look forward to drawing on their expertise as we enter this exciting phase of our development.”

“AAV vectors are proven to be one of the most effective strategies for delivering gene therapies for a variety of human diseases, but there is room for improvement,” said Shaan C. Gandhi, M.D., D.Phil., Director at Northpond Ventures. “StrideBio’s unique approach demonstrates the potential to yield differentiated and best-in-class AAV vectors. The leadership team is highly experienced and we are very impressed with what they have accomplished in advancing their gene therapy programs to date. Northpond is proud to join StrideBio’s circle of investors and co-lead this most recent financing round.”

Financing proceeds will be used to advance the company’s robust pipeline to the clinic, including four new wholly-owned programs targeting monogenic central nervous system (CNS) and cardiovascular disorders. These programs will leverage StrideBio’s lead proprietary AAV capsids with features including reduced seroprevalence, neuronal and cardiovascular tropism, liver de-targeting and enhanced gene transfer efficiency compared to first-generation AAV serotypes. StrideBio will also continue to build on its STRIVE™ platform with the goal to improve safety and reduce doses required for effective gene therapies.

Since StrideBio’s Series A financing in 2018 the company has made significant progress, including executing partnerships with CRISPR Therapeutics, Takeda Pharmaceuticals and Sarepta Therapeutics, generating a robust panel of AAV vectors characterized in multiple, preclinical animal models, as well as successfully establishing and scaling an in-house manufacturing process to 1000L at its facility in RTP. Funds raised as part of the Series B will be used to support continued operational growth and manufacturing capacity expansion, building on the company’s current infrastructure which includes a 6,000 sq ft GMP clean suite.

“We are so excited to support StrideBio as they seek to leverage their innovative AAV capsids to advance their internal and partnered pipeline, bringing multiple programs into the clinic,” said Karen Hong, Ph.D., Partner at Novo Ventures, an affiliate of Novo Holdings A/S. “Novel gene therapies enabled by StrideBio‘s unique lead vectors have the potential to benefit patients with no other treatment options.”

About StrideBio, Inc.

StrideBio, Inc is a gene therapy company focused on creating and developing novel adeno-associated viral (AAV) therapies for rare diseases and beyond. We leverage our proprietary structure-inspired adeno-associated virus AAV vector engineering platform (STRIVE™) to create unique and differentiated vectors that improve upon naturally occurring AAV serotypes to overcome current limitations of first-generation gene therapies. Combined with our genetic construct design expertise and in-house manufacturing capabilities, StrideBio is positioned to generate best-in-class genetic medicines that allow more patients to benefit with maximum efficiency, leading to improved treatment outcomes. StrideBio is based in a state-of-the-art 24,000-square-foot facility in Research Triangle Park, N.C., which houses our offices, research labs and in-house AAV manufacturing facilities. Current investors include Hatteras Venture Partners, Takeda Ventures, UCB Ventures and Alexandria Real Estate Equities, Inc. For more information, please visit www.stridebio.com.

StrideBio Contact
Robert Hughes
984-213-7301
[email protected]

Media Contact

Carolyn Noyes or Susan Sharpe
781-235-3060
MacDougall
[email protected]

Research Triangle Park, N.C., August 11, 2020 – StrideBio, Inc, a leading developer of novel engineered adeno-associated virus (AAV) based gene therapies, today announced the appointment of William (Bill) Monteith as Chief Operating Officer. In this key position, Mr. Monteith will play a lead role in expanding the scale and breadth of StrideBio’s operations, including manufacturing, quality controls and facilities management, as the company advances a robust portfolio of partnered and independent gene therapy programs towards clinical development and ultimate commercialization. In addition, he will work closely with StrideBio’s current leadership team to continue to build a world-class organization and culture as the company undergoes a period of rapid growth in support of its mission to bring novel gene therapies to patients that overcome limitations of first-generation approaches.

Mr. Monteith brings nearly 40 years of experience to StrideBio, having overseen clinical development and commercial scale manufacturing, quality, supply chain and facility operations spanning small molecules, biologics and cell & gene therapies. Mr. Monteith joins StrideBio from Cellectis, where he served as Executive Vice President of Technical Operations. Prior roles have included Chief Operating Officer of Hitachi Chemical Advanced Therapy Solutions, Executive Vice President Technical Operations at Dendreon, as well as site operations and quality positions with Sandoz, Shire, and Wyeth.

“We are very excited to have Bill join the StrideBio leadership team as Chief Operating Officer at such an important time given our trajectory,” stated Sapan Shah, Ph.D., Chief Executive Officer, StrideBio, Inc. “Bill’s significant experience building and expanding infrastructure for leading life science companies as they advance through the clinical development and commercial stage, with an emphasis on cGMP production and quality, matches perfectly with StrideBio’s focus. I am confident Bill will be a fantastic addition as we continue to build an exceptional and capable organization that is advancing a robust pipeline of innovative gene therapies to patients with rare diseases and beyond.”

“This is an incredible time for StrideBio as we transition novel engineered AAV vectors discovered through our innovative structure inspired platform into gene therapy products that can ultimately benefit patients,” noted Mr. Monteith. “I am inspired by our team and the significant progress made to date, which already includes in-house production capability at 1000L scale. I look forward to applying my years of experience to help StrideBio continue to build an exceptional organization with world-class manufacturing, quality and facilities infrastructure that can support our clinical development and commercial goals.”

About StrideBio, Inc.

StrideBio, Inc is a gene therapy company focused on creating and developing novel adeno-associated viral (AAV) therapies for rare diseases and beyond. We leverage our proprietary structure-inspired adeno-associated virus AAV vector engineering platform (STRIVE™) to create unique and differentiated vectors that improve upon naturally occurring AAV serotypes to overcome current limitations of first-generation gene therapies. Combined with our genetic construct design expertise and in-house manufacturing capabilities, StrideBio is positioned to generate best-in-class genetic medicines that allow more patients to benefit with maximum efficiency, leading to improved treatment outcomes. StrideBio is based in a state-of-the-art 24,000-square-foot facility in Research Triangle Park, N.C., which houses our offices, research labs and in-house AAV manufacturing facilities. Current investors include Hatteras Venture Partners, Takeda Ventures, UCB Ventures and Alexandria Real Estate Equities, Inc. For more information, please visit www.stridebio.com.

StrideBio Contact
Robert Hughes
984-213-7301
[email protected]

Newly Created Role Will Oversee the Translation of Programs from Research Stage into the Clinic

Research Triangle Park, N.C., April 2, 2020 – StrideBio, Inc., a leading developer of novel adeno-associated viral (AAV) based gene therapies, today announced the appointment of Maritza McIntyre, Ph.D., as Chief Development Officer. In this newly created role, Dr. McIntyre will oversee the translational development of StrideBio’s research-stage gene therapy programs, including Investigational New Drug (IND)-enabling preclinical studies, assay development, regulatory filings and interactions, and initiation of early clinical studies. Both independently and in collaboration with key partners, StrideBio is advancing a pipeline of therapeutic programs that utilize novel engineered AAV capsids discovered in-house that can improve potency, evade neutralizing antibodies and enhance specific tropism to tissues critical for efficacy.

Dr. McIntyre is a virologist with over 20 years of experience in the development, evaluation and regulation of gene therapy, biological and small molecule products. Prior to joining StrideBio, she served as President of Advanced Therapy Partners, Executive Vice President of Regulatory Affairs and Product Development and Gene Therapy Clinical Project Lead at Bamboo Therapeutics, Vice President of Regulatory Affairs at REGENXBIO, and Chief of the Gene Therapy Branch at the U.S. Food and Drug Administration (FDA), among other notable industry leadership roles. Dr. McIntyre is a member of the Boards of the American Society of Gene and Cell Therapy (ASGCT) and GenSight Biologics. She holds a Ph.D. in Virology from the University of Chicago and B.S. in Biology from Wayne State University.

“We are delighted to have Dr. McIntyre join the StrideBio team as Chief Development Officer,” said Sapan Shah, Ph.D., Chief Executive Officer. “She brings an incredible depth of expertise in translational development to StrideBio, drawing on her time at FDA as well as working with numerous companies in the gene therapy space as an executive, advisor and Board member. Dr. McIntyre’s appointment reflects StrideBio’s focus on building the internal capabilities necessary to become a fully integrated gene therapy company and bring innovative therapies to patients with rare diseases and beyond.”

“I am very excited to be joining StrideBio, having previously worked with the founders and followed the company’s progress,” said Dr. McIntyre. “StrideBio has developed a strong and innovative platform to engineer novel AAV capsids in order to improve upon naturally occurring AAV serotypes which, together with in-house manufacturing capabilities, has positioned the company to be a leader in advancing AAV-based gene therapies. StrideBio’s platform has been validated by recent partnerships and a growing pipeline of therapeutic programs, which are testaments to the company’s future promise. I look forward to leading StrideBio’s programs through this next phase of translational development and into the clinic.”

About StrideBio, Inc.

StrideBio is a gene therapy company focused on creating and developing novel adeno-associated viral (AAV) therapies to expand the treatment-eligible population and improve outcomes for patients with serious monogenic rare diseases and beyond. Our STRucture Inspired DEsign approach generates unique and differentiated AAV capsids with improved characteristics including potency, tissue tropism, manufacturability and evasion of pre-existing antibodies. Combined with our wholly owned proprietary cell-line in-house manufacturing capability, the company is positioned to rapidly advance best-in-class genetic medicines. StrideBio is based in a state-of-the-art 24,000-square-foot facility in Research Triangle Park, N.C., which houses the company’s offices, research labs and AAV manufacturing facilities. Current investors include Hatteras Venture Partners, Takeda Ventures, UCB Ventures and Alexandria Real Estate Equities, Inc. For more information, please visit www.stridebio.com.

StrideBio Contact
Robert Hughes
984-213-7301
[email protected]

Agreement leverages StrideBio’s novel, industry-leading, structure-driven capsid engineering platform and expands Sarepta’s early stage gene therapy pipeline

Cambridge, Mass., and Research Triangle Park, N.C., Nov. 14., 2019 – Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, and StrideBio, Inc., a leading developer of novel adeno-associated viral (AAV) based gene therapies, today announced the signing of a collaboration and license agreement to develop in vivo AAV-based therapies for up to eight central nervous system (CNS) and neuromuscular targets. Pursuant to the agreement, Sarepta is granted an exclusive license on selected targets to leverage StrideBio’s novel, structure-driven capsid technology, intended to enhance specific tropism to tissues of interest and evade neutralizing antibodies. The parties also plan to focus on strategies intended to address re-dosing challenges in patients who have received AAV-delivered gene therapy. StrideBio will conduct all investigational new drug (IND) enabling research, development and manufacturing for the first four CNS targets, which are MECP2 (Rett syndrome), SCN1A (Dravet syndrome), UBE3A (Angelman syndrome), and NPC1 (Niemann-Pick). Additionally, Sarepta will have an exclusive option to four additional targets based on StrideBio’s capsid technology.

StrideBio possesses an innovative and proprietary platform that is enabled by a deep knowledge of AAV structure and a unique approach to engineering capsids with novel functions, and was co-founded by Mavis Agbandje-McKenna, Ph.D., and Aravind Asokan, Ph.D., leading scientists in the field of AAV biology and gene therapy. StrideBio has created a growing portfolio of novel AAV capsids evolved in non-human primates that show reduced seroprevalence and potential for improved tropism to targeted tissues.

“With our partnership with StrideBio, Sarepta continues to build on its leadership position in gene therapies to treat rare diseases. We are excited to work with StrideBio and access its innovative AAV platform for next-generation capsids,” said Doug Ingram, Sarepta’s President and Chief Executive Officer. “Our partnership with StrideBio expands our research portfolio by up to eight new targets and, through our strategic partnering approach that has our collaborator lead all IND-enabling research and development, ensures that we gain access to new technology and targets while not distracting Sarepta from its near-term priorities.”

“We are very excited to initiate this multi-target collaboration with Sarepta, an established leader in the development and commercialization of genetic medicines,” stated Sapan Shah, Ph.D., Chief Executive Officer, StrideBio. “This partnership will provide significant resources and expertise to enable StrideBio’s continued rapid expansion of our research and manufacturing platform, as well as accelerate the development of AAV gene therapies for multiple rare disease targets. We are looking forward to working together with Sarepta to bring novel treatments to patients as quickly as possible.”

Terms of Agreement

Under the terms of the agreement, StrideBio will be responsible for AAV capsid development, non-clinical development and manufacturing of preclinical candidates to be selected for advancement into clinical studies. The parties will also share early clinical development activities for selected targets, with Sarepta responsible for late stage development and commercialization. A total of four initial targets are specified under the collaboration. StrideBio will receive a $48 million upfront payment in the form of cash and Sarepta stock, in addition to significant future development, regulatory and commercial milestones for the four programs. StrideBio will also receive royalties on worldwide net sales of any commercial products developed through the collaboration. Sarepta has also obtained an exclusive option to expand the collaboration to include up to an additional four targets with an upfront payment of up to $42.5 million along with future downstream milestone payments, while StrideBio has an option to obtain co-development and co-commercial rights to one of the collaboration targets. In addition, Sarepta has made a commitment to invest in StrideBio’s next financing round. Further financial terms were not disclosed.

About Sarepta Therapeutics

Sarepta is at the forefront of precision genetic medicine, having built an impressive and competitive position in Duchenne muscular dystrophy (DMD) and more recently in gene therapies for Limb-girdle muscular dystrophy diseases (LGMD), MPS IIIA and other CNS-related disorders, totaling over 20 therapies in various stages of development. The Company’s programs and research focus span several therapeutic modalities, including RNA, gene therapy and gene editing. Sarepta is fueled by an audacious but important mission: to profoundly improve and extend the lives of patients with rare genetic-based diseases. For more information, please visit www.sarepta.com.

About StrideBio, Inc.

StrideBio, Inc is a gene therapy company focused on creating and developing novel adeno-associated viral (AAV) therapies for rare diseases. Our STRucture Inspired DEsign approach holds the potential to generate unique AAV capsids with improved characteristics including potency, tissue tropism, and ability to evade pre-existing antibodies. This powerful new approach has broad application, enabling gene addition, gene silencing and gene editing modalities for a wide range of diseases, including rare genetic diseases. StrideBio is headquartered in Research Triangle Park, NC. Current investors include Hatteras Venture Partners, Takeda Ventures, UCB Ventures and Alexandria Real Estate Equities, Inc. For more information, please visit
www.stridebio.com.

Forward-Looking Statements

This press release contains “forward-looking statements.” Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding the potential benefits of the collaboration between Sarepta and StrideBio, including enhancing specific tropism to tissues of interest, evading neutralizing antibodies, granting Sarepta access to new technology and targets, providing significant resources and expertise to enable StrideBio’s continued rapid expansion of its research and manufacturing platform, and accelerating the development of AAV gene therapies for multiple rare disease targets; the potential of StrideBio’s portfolio to improve tropism to targeted tissues; the parties’ plan to focus on strategies intended to address re-dosing challenges in patients who have received AAV-delivered gene therapy; the terms of the agreement between Sarepta and StrideBio, including expected and future payments, future development, regulatory and commercial milestones, future royalties, options and Sarepta’s commitment to invest in StrideBio’s next financing round; and Sarepta’s mission to profoundly improve and extend the lives of patients with rare genetic-based diseases.

These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Known risk factors include, among others: the expected benefits and opportunities related to the collaboration between Sarepta and StrideBio may not be realized or may take longer to realize than expected due to challenges and uncertainties inherent in product research and development; in particular, the collaboration may not result in any viable treatments suitable for commercialization due to a variety of reasons, including any inability of the parties to perform their commitments and obligations under the agreement, the results of research may not be consistent with past results or may not be positive or may otherwise fail to meet regulatory approval requirements for the safety and efficacy of product candidates, possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, and regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover Sarepta’s product candidates; and those risks identified under the heading “Risk Factors” in Sarepta’s most recent Annual Report on Form 10-K for the year ended December 31, 2018 and most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect the Company’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of Report on Form 10-K and most recent Quarterly Report on Form 10-Q filed with the SEC as well as other SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

Contacts
Sarepta Therapeutics, Inc.
Investors: Ian Estepan, 617-274-4052, [email protected]
Media: Tracy Sorrentino, 617-301-8566, [email protected]

StrideBio Inc.
Robert Hughes
984-213-7301
[email protected]

Multi-target deal will utilize StrideBio’s platform to identify unique AAV capsids for delivery of gene therapies targeting neurological diseases, including Friedreich’s Ataxia

Durham, N.C., March 28, 2019 – StrideBio, Inc, a leading developer of novel adeno-associated viral (AAV) based gene therapies, today announced the signing of a collaboration and license agreement with Takeda Pharmaceutical Company Limited (Takeda) to develop in vivo AAV based therapies for Friedreich’s Ataxia (FA) and two additional undisclosed targets.  These programs aim to utilize novel AAV capsids developed by StrideBio to improve potency, evade neutralizing antibodies and enhance specific tropism to tissues including the central nervous system.

“We are very excited to partner with Takeda given their expertise and commitment to developing treatments for patients with neurological diseases,” stated Sapan Shah, Ph.D. Chief Executive Officer, StrideBio, Inc. “We look forward to working together to bring transformative and novel AAV-based gene therapies to patients, while continuing to validate and expand StrideBio’s platform, manufacturing capabilities and pipeline.”

“StrideBio’s expertise and unique gene therapy technology holds great potential for significantly advancing the field of neurological disease research,” said Emiliangelo Ratti, Head, Neuroscience Therapeutic Area Unit at Takeda. “Our collaboration is a natural extension of Takeda’s neuroscience research and development strategy, including modality diversification, identifying targets with a high degree of association with disease, and a focus on developing innovative medicines for neurologic diseases that have a high unmet medical need.”

Terms of Agreement

Under the terms of the agreement, StrideBio will be responsible for AAV capsid development, non-clinical development and manufacturing of preclinical candidates to be selected for advancement into clinical studies.  Takeda will be responsible for clinical development and commercialization of selected candidates arising from the collaboration.  A total of three targets are specified under the collaboration, with the initial target being Friedreich’s Ataxia.  StrideBio is eligible to receive approximately $30 million in upfront and near term pre-clinical milestones, as well as an additional $680 million in future development and commercial milestones from Takeda.  StrideBio will also receive royalties on worldwide net sales of any commercial products developed through the collaboration.  Further financial terms were not disclosed.

In 2018, Takeda Ventures, Inc. (TVI), the corporate venture capital group of Takeda, participated in an oversubscribed Series A Financing round led by Hatteras Venture Partners, and including UCB Ventures and Alexandria Real Estate Equities. The purpose of the financing is to support StrideBio in the development of their novel AAV technology.

About StrideBio, Inc.

StrideBio, Inc is a gene therapy company focused on creating and developing novel adeno-associated viral (AAV) therapies for rare diseases.  Our STRucture Inspired DEsign approach holds the potential to generate unique AAV capsids with improved characteristics including potency, tissue tropism, and ability to evade pre-existing antibodies.  This powerful new approach has broad application, enabling gene addition, gene silencing and gene editing modalities for a wide range of diseases, including rare genetic diseases. StrideBio is headquartered in Durham, NC.  Current investors include Hatteras Venture Partners, Takeda Ventures, UCB Ventures and Alexandria Real Estate Equities, Inc.  For more information, please visit www.stridebio.com.

StrideBio Contact
Richard E. T. Smith, PhD
609-865-0693
[email protected]