INOVIO and QIAGEN expand collaboration to develop next generation sequencing (NGS) companion diagnostic for INOVIO’s VGX-3100 for advanced cervical dysplasia

On Feb 24, 2021

QIAGEN and INOVIO Pharmaceuticals announced an extension of their partnership with a new master collaboration agreement to develop liquid biopsy-based companion* diagnostic products based on next-generation sequencing (NGS) technology to complement INOVIO’s therapies. (*Complementary when referring to the US regulatory pathway.)

The initial project in this expanded collaboration focuses on the co-development of a diagnostic test that identifies 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). QIAGEN’s bioinformatic expertise will further increase the predictive power of INOVIO’s preliminary biomarker signature – and the assay will now be developed for use on the Illumina NextSeq™ 550Dx platform, the first development based on a partnership QIAGEN and Illumina signed in October 2019.

VGX-3100 is INOVIO’s late-stage DNA immunotherapy candidate. It is currently in two Phase 3 trials (REVEAL 1 and REVEAL 2), with the potential to become the first non-surgical treatment for advanced pre-cancerous cervical lesions associated with the virus (HPV-16 and HPV-18).

“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,” said 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.”

QIAGEN and INOVIO in 2019 announced a collaboration to develop a companion diagnostic to guide clinical decision-making for the use of INOVIO’s DNA-based immunotherapy to treat cervical dysplasia caused by HPV. The new master collaboration agreement covers the development of companion diagnostics for INOVIO’s HPV therapies for a range of sample types and technologies such as PCR and NGS. QIAGEN pioneered HPV testing with the gold-standard digene Hybrid Capture 2 High-Risk HPV DNA Test, which became a driving force in HPV screening as a standard of care in cervical cancer prevention.

“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 long-standing 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.”

HPV is the most common viral infection of the reproductive tract and the fourth most common cancer among women. The World Health Organization (WHO) reported an estimated 570,000 new cases of cervical cancer and 311,000 deaths in 2018. Almost 300 million women globally are estimated to be infected with HPV, and about 30 million additional cases have progressed to the precancerous stage. At least 70% of cervical cancers are estimated to be the result of the high-risk HPV 16 and HPV 18 – genotypes that VGX-3100 instructs a suitable patient’s immune system to reduce or fully eliminate.

QIAGEN is a pioneer in precision medicine and the global leader in collaborating with pharmaceutical and biotechnology companies to develop companion diagnostics that can detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making about diseases like cancer. The company offers an unmatched depth and breadth of technologies from polymerase chain reaction (PCR) to next-generation sequencing (NGS) for companion diagnostic development. The ability to tailor a CDx to partners’ needs, proven IVD development expertise, and a global commercialization track record allow QIAGEN to develop novel and innovative NGS products and other diagnostic solutions.