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-α (FRα)-targeting antibody-drug conjugate (ADC) with the potential to address the unmet need in several FRα-expressing cancers.
Sutro, a clinical-stage oncology company pioneering site-specific and novel-format ADCs, has just initiated the randomized portion (Part 2) of REFRαME-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 FRα 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.
SOURCE: PRNewswire