August 17, 2020 -- Precigen has dosed the first patients with Prgn-2009, an off-the-shelf investigational immunotherapy candidate, in a phase I/II clinical trial for the treatment of cancers associated with human papillomavirus (HPV).
The immunotherapy utilizes the company's UltraVector and AdenoVerse platforms targeting HPV solid tumors. The therapy uses gorilla adenovectors that have large payload capacities and the potential for repeat administration due to very low to no seroprevalence in the human population.
The phase I clinical study will use a 3+3 dose escalation to evaluate the safety of the drug as a monotherapy to determine dosage for the phase II study, followed by safety evaluation in combination with bintrafusp alfa (M7824), an investigational bifunctional fusion protein in patients with recurrent or metastatic HPV-associated cancers. The phase II study will evaluate Prgn-2009 as a monotherapy or in combination with bintrafusp alpha as a neoadjuvant or induction therapy in patients with stage II/III HPV16-positive oropharyngeal cancer.
The investigational immunotherapy is being developed in collaboration with the Center for Cancer Research and the U.S. National Cancer Institute.