Therapy triumph

DNA immunotherapy and checkpoint inhibitor combination lead to remission

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PLYMOUTH MEETING, Pa.—Human papillomavirus (HPV), the most common sexually transmitted disease in the United States, infects approximately 79 million Americans, according to the U.S. Centers for Disease Control and Prevention. HPV plays a critical role in the development of head and neck cancers, including cancers of the oral cavity, oropharynx, nose/nasal passages and larynx. In 2018, about 48,330 people will get oral cavity or oropharyngeal cancer in the U.S., and the incidence of head and neck cancers are on the rise. Worldwide, squamous cell carcinoma of the head and neck is diagnosed in about 500,000 patients, or about 5 percent of all malignancies.
Inovio Pharmaceuticals Inc.—a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies for treating cancer and infectious diseases—described HPV-associated head and neck cancer (HNSCCa) as “an emerging global epidemic, where despite the availability of highly curative treatments, some patients will eventually develop recurrent or metastatic disease,” in an article in Clinical Cancer Research. In that article, the company also described an answer: “The availability of checkpoint inhibitors for metastatic HNSCCa has changed the outcomes for this disease.” By combining HPV-specific immunotherapy with checkpoint inhibitors, Inovio feels it can boost patient response.
In a clinical trial, a patient with head and neck cancer treated with MEDI0457 achieved full remission on treatment with a subsequent PD-1 checkpoint inhibitor, and the remission has lasted more than two years. In the study of 22 patients with head and neck squamous cell carcinoma, Inovio reported 91 percent (20 of 22) showed T cell activity in blood or tissue. MEDI0457, formerly called INO-3112, was licensed to MedImmune, the global biologics research and development arm of AstraZeneca, in 2015.
Researchers are finding increasing evidence showing that the response rates from checkpoint inhibitors can be amplified when used in conjunction with cancer vaccines such as MEDI0457 that generate tumor-specific T cells. In addition, interim data from a MEDI0457 monotherapy study of head and neck cancer patients showed that MEDI0457 “generated robust HPV16/18 specific CD8+ T cell responses in peripheral blood and increased CD8+ T cell infiltration in resected tumor tissue samples,” Inovio said.
According to Dr. J. Joseph Kim, Inovio’s president and CEO, “The study lends support to all of our HPV and oncology programs. These data demonstrated that Inovio’s technology based in MEDI0457 can generate durable HPV16/18 antigen-specific peripheral and tumor immune responses. The study supports our belief that this approach may be used as a complementary strategy to PD-1/PD-L1 inhibition in HPV-associated head and neck and other types of cancer to improve therapeutic outcomes. We believe Inovio has the most well-thought-out strategy of combining immunotherapy with PD-1 inhibitors.”
Founded in 2000 by researchers from the University of Pennsylvania, Inovio has developed a proprietary platform technology that applies antigen sequencing and DNA delivery to activate potent immune responses to targeted diseases. The company’s most advanced clinical program, VGX-3100, is in Phase 3 for the treatment of HPV-related cervical pre-cancer. Also in development are Phase 2 immuno-oncology programs targeting head and neck cancer, bladder cancer and glioblastoma, as well as platform development programs in hepatitis B, Zika, Ebola, MERS and HIV.
“Inovio is collaborating with MedImmune (with MEDI0457) as well as Genentech and Regeneron (with INO-5401) in efficacy trials coupling Inovio’s DNA-based cancer immunotherapies with checkpoint inhibitors designed to increase response rates, with data expected in 2019,” Kim added.
Dr. Charu Aggarwal, the HNSCCa study’s principal investigator and an assistant professor of hematology-oncology at the University of Pennsylvania’s Perelman School of Medicine, summarized, “We wanted to know if this vaccine (MEDI0457) can boost the immune systems of patients with HPV-related head and neck cancer, potentially opening the door for better response rates to other existing therapies, and our findings show that we can.”

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