CONROE, Texas, June 3, 2024 /PRNewswire/ -- VGXI, Inc., a leading contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, has entered into a strategic partnership with Sutro Biopharma, Inc. (Sutro) to support clinical production of luveltamab tazevibulin, abbreviated as "luvelta", a novel Folate Receptor-a (FRa)-targeting antibody-drug conjugate (ADC) with the potential to address the unmet need in several FRa-expressing cancers.
Sutro, a clinical-stage oncology company pioneering site-specific and novel-format ADCs, has just initiated the randomized portion (Part 2) of REFRaME-O1, a global, registration-directed clinical trial of luvelta (NCT05870748) in platinum-resistant ovarian cancer (PROC). VGXI will supply cGMP plasmids at 1500L production scale for use in Sutro's XpressCF® cell-free expression system to manufacture luvelta. With evidence of clinical activity and the potential to benefit 8 out of 10 PROC patients, luvelta could address a high unmet medical need in patients with low to medium FRa expression.
"We are thrilled to establish this partnership to support the clinical production of luvelta and all of Sutro's ongoing projects," stated Young Park, CEO of VGXI. "Our expertise in large-scale cGMP plasmid production will be instrumental in advancing Sutro's promising therapy through its late-stage clinical trial evaluation and towards commercialization."
"Our partnership with VGXI has been a cornerstone in our achievements to further enable our Cell Free manufacturing platform at commercial scale as our lead product candidate progresses to registrational clinical studies," commented Dr. Venkatesh Srinivasan, Chief Technical Operations Officer, Sutro Biopharma.
As the demand for advanced therapies and targeted cancer treatments continues to grow, VGXI's state-of-the-art facilities and cutting-edge technologies enable the production of high-quality cGMP plasmid materials with the scale and speed necessary to bring these treatments to patients, now and into the future.
ABOUT VGXI, INC.
With over 20 years of experience VGXI, Inc. is a leading provider of plasmid DNA manufacturing and development services. The company has a reputation of success in manufacturing DNA products under cGMP conditions for clinical trials in the US, EU, Asia, Canada, and Australia, and its cGMP and non-GMP products have passed rigorous reviews by several international regulatory agencies. VGXI's ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible cGMP production facility, and highly experienced development team. VGXI, Inc. is a GeneOne company. To learn more, visit https://www.vgxii.com.
ABOUT GENEONE LIFE SCIENCE
GeneOne Life Science Inc. ("GeneOne" KOSPI: 011000) headquartered in Seoul, South Korea is an international biotechnology company and a leading contract manufacturer of DNA plasmids for use in vaccines, gene therapies, and cell therapies. GeneOne has recently expanded into the manufacture and development of mRNA. GeneOne has maintained a focus on vaccines against emerging infectious diseases to address global needs, including in resource challenged regions. Its small molecule portfolio of immunomodulators address diseases such as prevention of upper respiratory bacterial and viral diseases, and treatment of autoimmune and inflammatory diseases. GeneOne has three products against COVID-19 in clinical development: GLS-5310 DNA vaccine (Phase I/IIa), GLS-1200 nasal spray to prevent COVID-19 infection (Phase II), and GLS-1027 to prevent the inflammation and clinical worsening for those infected with COVID-19 (Phase II).
For more information, visit https://www.genels.com.
ABOUT SUTRO BIOPHARMA
Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, transforming what science can do for patients. Sutro's fit-for-purpose technology, including cell-free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience. Sutro has multiple clinical stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FRa)-targeting ADC in clinical studies. A robust pipeline, coupled with high-value collaborations and industry partnerships, validates our continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media?@Sutrobio, or visit www.sutrobio.com.
CONTACT: Justin Smith, Director of Marketing, [email protected].
SOURCE VGXI, Inc.
