Pharma Focus America

VGXI Inc. and Sutro Biopharma Inc. Form Strategic Alliance to Support Growing Clinical Pipeline

Tuesday, June 04, 2024

VGXI, Inc., a prominent contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, has formed a strategic partnership with Sutro Biopharma, Inc. (Sutro) to support the clinical production of luveltamab tazevibulin, known as "luvelta," an innovative antibody-drug conjugate (ADC) targeting Folate Receptor-α (FRα) in various FRα-expressing cancers.

Sutro, a leader in site-specific and novel-format ADCs in oncology, has initiated the randomized portion (Part 2) of REFRαME-O1, a global clinical trial (NCT05870748) focusing on platinum-resistant ovarian cancer (PROC). VGXI will supply cGMP plasmids at a 1500L production scale for use in Sutro's XpressCF® cell-free expression system to manufacture luvelta. Luvelta has demonstrated clinical activity and potential benefits for 8 out of 10 PROC patients, addressing a significant unmet medical need in individuals with low to medium FRα expression.

"We are excited about this partnership to support luvelta's clinical production and Sutro's ongoing projects," said Young Park, CEO of VGXI. "Our expertise in large-scale cGMP plasmid production will be vital in advancing Sutro's therapy through late-stage clinical trials and towards commercialization."

"Our collaboration with VGXI has been crucial in scaling our Cell-Free manufacturing platform for our lead product candidate as it progresses to registrational clinical studies," commented Dr. Venkatesh Srinivasan, Chief Technical Operations Officer at Sutro Biopharma.

With rising demand for advanced therapies and targeted cancer treatments, VGXI's advanced facilities and technologies enable the production of high-quality cGMP plasmid materials, facilitating the delivery of treatments to patients now and in the future.



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