StrideBio Announces Mark Velleca, M.D., Ph.D., as Chief Executive Officer

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]

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

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 100th 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 (STRIVETM 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 100th 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]

StrideBio Expands Leadership Team with Accomplished Industry Executives

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]

StrideBio Appoints Deborah D. Ascheim, M.D. as Chief Medical Officer

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 Announces a Multi-technology License and Master SRA with Duke University to Advance Next-generation Gene Therapies

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 STRIVETM 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 23rd 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, Atp1a3Mashl/+, 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]