PLYMOUTH MEETING, Pa., GERMANTOWN, Md. & HILDEN, Germany—QIAGEN and INOVIO Pharmaceuticals have extended their existing partnership with a new master collaboration agreement for the development of liquid biopsy-based companion diagnostic products based on next-generation sequencing technology to accompany INOVIO's therapies.
The partners announced a collaboration in 2019 under which they would develop a companion diagnostic to support clinical decision-making with regards to INOVIO's DNA-based immunotherapy for cervical dysplasia caused by HPV. This new agreement focuses on the development of companion diagnostics for INOVIO's HPV therapies for a variety of sample types and technologies, including PCR and next-generation sequencing. Financial details were not disclosed.
"We are pleased to support INOVIO by developing companion diagnostics to identify patients who would benefit from VGX-3100. Our experience in developing liquid biopsy-based diagnostic solutions for precision medicine in immuno-oncology will help INOVIO address a larger unmet medical need," said Jean-Pascal Viola, senior vice president, head of the Molecular Diagnostics Business Area and Corporate Business Development at QIAGEN. "We bring to this partnership our proven leadership in PCR companion diagnostics, as well as longstanding experience in developing innovative and custom NGS panels for our customers. Our recognized bioinformatic capabilities will help improve the efficacy of biomarker signatures. Our team is looking forward to applying our expertise for HPV-related cervical pre-cancer identification with INOVIO.”
Initially, the goal of the expanded agreement will be the co-development of a diagnostic test to identify women who are most likely to benefit from clinical use of VGX-3100, INOVIO's immunotherapy to treat advanced cervical dysplasia associated with the human papillomavirus (HPV). The assay will be developed for use on the Illumina NextSeq 550Dx platform.
VGX-3100 is a late-stage DNA immunotherapy candidate. INOVIO is currently evaluating VGX-3100 in two Phase 3 trials—REVEAL 1 and REVEAL 2—and the compound could become the first non-surgical treatment for advanced pre-cancerous cervical lesions associated with the HPV virus (HPV-16 and HPV-18). The candidate is being assessed as a treatment for three HPV-16/18-related diseases: cervical dysplasia, vulvar dysplasia, and anal dysplasia. VGX-3100 uses a patient's immune system to eradicate HPV-16/18-associated high-grade precancerous lesions.
"As we advance our DNA medicines platform, we are always looking for ways to drive innovation with our own technology or that of a creative and accomplished partner. QIAGEN is contributing an extensive track record of developing and commercializing novel diagnostic tests," noted Dr. J. Joseph Kim, INOVIO's president and CEO. "INOVIO is developing VGX-3100 as a non-surgical treatment for cervical pre-cancer and pre-treatment biomarkers we have discovered could be a targeted way to identify patients most likely to respond to treatment. The goal is to increase the absolute efficacy of the immunotherapy."
HPV is the most common viral infection of the reproductive tract and the fourth most common cancer among women, with an estimated 300 million women globally infected with HPV and roughly 30 million additional cases that have progressed to the precancerous stage. The high-risk HPV 16 and HPV 18 genotypes are believed to be responsible for at least 70 percent of cervical cancers.
Photo credit: QIAGEN GmbH