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Qiagen to Develop Companion Diagnostic for BioNTech Head, Neck Cancer Treatment

NEW YORK – Qiagen said on Wednesday that it has forged a collaboration with BioNTech to develop and commercialize a tissue-based companion diagnostic to identify patients with squamous cell head and neck cancer caused by specific human papillomavirus (HPV) infections, who may be eligible for BioNTech's investigational cancer treatment BNT113.

Qiagen said the assay will detect the presence of specific HPV genotypes and will be developed on its real-time PCR-based RGQ MDx platform. Qiagen plans to expand the panel for use across HPV-driven cancers, such as cervical cancer, with the goal of providing a universal HPV companion diagnostic for its pharmaceutical partners.

Financial terms of the agreement were not disclosed.

"This CDx project will help to identify patients who might benefit from BioNTech's innovative BNT113 treatment option," Jean-Pascal Viola, senior VP and head of molecular diagnostics at Qiagen, said in a statement. "Qiagen's sample-to-insight workflows and experience in developing diagnostic solutions for precision medicine are well-suited to aid in evaluating patients with squamous cell carcinoma of the head and neck. We will leverage our world-leading position in HPV testing to commercialize the new HPV companion diagnostics in all target markets of BioNTech."

BioNTech's BNT113 is designed to elicit an immune response against the well-characterized HPV16-derived oncoproteins E6 and E7, which are strongly immunogenic viral neoantigens found in HPV16-positive solid tumors such as squamous cell head and neck cancer, according to the company's website. The treatment is currently being studied by the University of Southampton in an investigator-sponsored Phase I/II basket study in HPV-positive cancers, including head and neck cancer, the company said.

In May 2019, Qiagen and Inovio Pharmaceuticals announced a collaboration to develop a companion diagnostic to guide clinical decision making with Inovio's DNA-based immunotherapy for cervical dysplasia caused by HPV. Qiagen said it currently has master collaboration agreements with more than 30 companies to develop and commercialize companion diagnostics for drug candidates.