CUE-101 gets fast tracked for recurrent/metastatic head and neck squamous cell carcinoma

Source: www.onclive.com Author: Kristi Rosa The FDA has granted a fast track designation to CUE-101 for use as a monotherapy and in combination with pembrolizumab (Keytruda) in patients with human papillomavirus (HPV16+) recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).1 CUE-101 is an off-the-shelf therapy that was designed to trigger and expand HPV16 tumor-specific T cells by exhibiting 2 cues to T cells. The first signal includes the HPV E7 protein, which is harbored by HPV-induced cancer cells and interacts with the HPV-specific T-cell receptor to offer selectivity. The second signal is comprised of an engineered interleukin-2 variant that fuels T cell activity. “We are very pleased to have received fast track designation from the FDA for CUE-101. This designation not only underscores the large unmet need for patients with recurrent/metastatic head and neck cancer who currently rely on available non-targeted therapies, but also highlights the potential of CUE-101 to provide a significant clinical benefit,” Matteo Levisetti, MD, senior vice president of Clinical Development at Cue Biopharma, Inc., stated in a press release. Previously, investigators evaluated the potential of CUE-101 to selectively activate and expand HPV16 E7–specific CD8-positive T cells in patients with HPV-driven cancers, including HNSCC, cervical cancer, and anal cancer.2 To showcase the activity of the product, human E7-specific T cells and peripheral blood mononuclear cells (PMBCs) were tested. To evaluate the in vivo activity of CUE-101, investigators evaluated the product in HLA-A2 transgenic mice. The agent was found to selectively bind, activate, and expand HPV16 [...]

Trial underway for novel agent plus immunotherapy for HPV-related head and neck cancer

Source: www.curetoday.com Author: Brielle Benyon Results from a phase 2 clinical trial demonstrated promise for the combination of the novel agent PDS0101 plus Keytruda (pembrolizumab) in treating human papillomavirus (HPV)-associated head and neck cancer. As such, the trial will now progress to full enrollment of 54 patients who have not been previously treated with a checkpoint inhibitor. The trial, VERSATILE-002, involves two groups of HPV16-positive patients with head and neck cancer that is either metastatic or has returned after treatment. One group consists of patients who have no prior treatment with checkpoint inhibition immunotherapy, while the other group is made up of 21 patients whose disease failed checkpoint inhibition — assessment for this group is still ongoing. In the checkpoint inhibitor-naïve group, four or more of the 17 patients achieved an objective response, which was classified by a 30% or more reduction in tumor size. “The achievement of this important milestone in the VERSATILE-002 phase 2 clinical trial strengthens the evidence of our novel Versamune platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer to achieve tumor regression,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech, the developer of PFS101, in a statement. “The initial data solidifies our belief that PDS0101’s demonstrated preclinical efficacy when combined with Keytruda has the potential to significantly improve clinical outcomes for patients with advanced HPV16-positive head and neck cancers.” PDS0101 works by inducing large quantities of CD4+ helper and CD8+ killer T cells, a [...]

2022-02-03T10:51:38-07:00February, 2022|Oral Cancer News|

Saliva testing may allow early detection of human papillomavirus–driven head and neck cancers

Source: medicalxpress.com Author: Elsevier Cancer causing high-risk human papillomaviruses (HR-HPV) are responsible for the rising incidence of HR-HPV–driven head and neck cancers (HNC), particularly oropharyngeal cancers (OPC, or throat cancers). Investigators have determined that HR-HPV DNA can be detected in saliva in most patients with HPV-driven OPC at the time of diagnosis. This work highlights a potentially life-saving screening program based on salivary HR-HPV DNA testing for early cancer detection and patient monitoring. Their findings appear in The Journal of Molecular Diagnostics. "Despite the upsurge in HPV-driven HNC, there are no early detection methods or screening strategies for this cancer type, unlike cervical cancer, which is caused by the same virus. Biomarkers enabling early detection, monitoring and disease prognostication are warranted to combat the rising incidence of HPV-driven OPC," observed lead investigator Chamindie Punyadeera, Ph.D., head, Saliva & Liquid Biopsy Translational Laboratory, School of Biomedical Science, Faculty of Health, Queensland University of Technology (QUT), and Translational Research Institute, Brisbane, QLD, Australia. Dr. Punyadeera and her colleagues investigated the efficacy of salivary HPV detection as a biomarker of HPV-HNC and survival patterns in patients with OPC to evaluate the utility of salivary HR-HPV as a prognostic biomarker for OPC. Saliva testing was performed on 491 patients at the time of first diagnosis of HNC and 10 patients with recurring HNC. Forty-three percent were positive for salivary HR-HPV DNA. HPV16, a high-risk strain of the virus, was detected in 92% of the HPV-positive saliva samples. The vast majority of HPV-HNC had arisen [...]

2021-09-22T09:38:25-07:00September, 2021|Oral Cancer News|

Antibodies against HPV16 can develop up to 40 years before throat cancer is diagnosed

Source: www.eurekalert.org Author: news release An international group of researchers has found that antibodies to the human papilloma virus type 16 (HPV16) develop in the body between six to 40 years prior to a clinical diagnosis of throat cancer, and their presence indicates a strong increased risk of the disease. The study, which is published in the leading cancer journal Annals of Oncology [1] today (Wednesday), also found that having HPV16 antibodies increased the risk of throat cancer far more in white people than in black: nearly 100-fold in white people, but 17-fold in black people. Patients with HPV-associated throat cancer tend to respond better to treatment than those whose cancer is not associated with the infection; the researchers say this may partly explain the worse survival rates among black patients. The main causes of throat cancer (known as oropharyngeal squamous cell carcinoma, OPSCC) are smoking, alcohol use and infection with HPV16. In the USA the proportion of OPSCCs attributable to HPV16 is around 70%; in some European countries a similar proportion is caused by HPV16, although this varies from country to country. [2] Dr Mattias Johansson, a cancer epidemiologist at the International Agency for Research on Cancer (IARC) in Lyon, France, who led the research, said: "Importantly, the proportion of throat cancers caused by HPV16 has been increasing over the past few decades, particularly in men, and in some countries the overwhelming majority are now caused by the virus. "Investigating the range in time prior to diagnosis in which [...]

Research Update: Vaccine Plus Checkpoint Inhibitor Combos for HPV-related Cancers

Source: MedPage Today Author: Mark L. Feurst Two new studies show the profound impact of a combined vaccine and anti-programmed death-1 (PD-1) antibody approach in the treatment of human papilloma virus (HPV)-related cancers. HPV causes nearly all cervical cancers, as well as most oropharyngeal, anal, penile, vulvar, and vaginal cancers. HPV16 and HPV18 are the leading viral genotypes that increase cancer risk. Given the viral cause of these cancers, immunotherapy has been considered a strong potential approach. Many patients with the HPV16 and HPV18 subtypes of head and neck squamous cell carcinoma have good outcomes from treatment that includes surgery or chemotherapy and radiation. Although anti-PD-1 therapy is approved for patients who do not respond to treatment or who develop metastatic disease, it benefits only about 15% of patients. The theory, therefore, is that a vaccine could potentially boost the immune systems of patients with HPV-related head and neck cancer, opening the door for better responses to other existing therapies. Vaccine + Nivolumab in Phase II Study In the first study, a phase II trial, a tumor-specific vaccine combined with the immune checkpoint inhibitor nivolumab was found to shrink tumors in patients with incurable HPV-related cancers. "Ours are the first results with this particular approach," Bonnie Glisson, MD, of the Department of Thoracic Head and Neck Medical Oncology at the University of Texas MD Anderson Cancer Center in Houston, told the Reading Room. "The rates of response and survival are approximately double what have been observed with nivolumab given alone [...]

2018-11-08T13:07:57-07:00November, 2018|Oral Cancer News|

Scientists untangle the evolutionary history of the world’s most common STI

Source: www.iflscience.com Author: Rosie McCall Scientists have analyzed the genomes of viruses to reveal the surprisingly complex evolutionary past of the human papillomavirus (HPV), exposing the salacious details of our ancestors' sexual history in the process. HPV comes in several flavors but HPV16 is the most common subtype worldwide – and it is the one most frequently identified in cervical cancer. Together HPV16 and HPV18 are responsible for 70 percent of all cases, accord to stats from the World Health Organization (WHO). The problem is, it isn't exactly clear how HPV strains contribute to cervical cancer (and other types, including cancer of the anus, the throat, the base of the tongue, and the tonsils). Or why the virus naturally clears in some people but not others. Researchers hope that studying the evolution of the virus will expose biological insights and point at mechanisms that might explain how cervical cancer develops. To try to untangle HPV16's thorny evolutionary past, scientists led by the Chinese University of Hong Kong isolated and examined oral, perianal, and genital samples in 10 adult female squirrel monkeys (Saimiri sciureus) and eight adult rhesus monkeys (Macaca mulatta), half of whom were male and half of whom were female. They found that the virus strains with most in common came from the same part of the body – meaning the oral samples from the squirrel monkeys and rhesus monkeys had more in common than oral and genital samples from the same species, for example. This, the authors say, [...]

2018-11-05T12:52:42-07:00November, 2018|Oral Cancer News|

HPV16 vaccine yields added benefit in recurrent throat cancer

Source: www.medpagetoday.com Author: Ian Ingram, Deputy Managing Editor, MedPage Today Adding a tumor-specific vaccine to PD-1 checkpoint inhibition was safe and effective in HPV16-positive patients with recurrent or metastatic oropharyngeal cancer, a small phase II trial found. Among 24 patients treated with nivolumab (Opdivo) and the ISA101 long peptide vaccine, 22 of whom had oropharyngeal cancer, 33% responded and median overall survival was 17.5 months, Cornelis Melief, PhD, of ISA Pharmaceuticals in the Netherlands, reported here at the 4th annual Cancer Immunotherapy Conference. All eight of the responders had oropharyngeal cancer (36%), with two complete and six partial responses. The median duration of response among these patients was 10.3 months, and responses were seen in both platin- and cetuximab-refractory patients, and those refractory to both. Melief noted that one of the partial responders had total clearance of the primary tumor, but a solitary lung metastasis remained, but was stable at 2.5 years. Rate of overall survival at 6 and 12 months was 75% and 70%, respectively. The combination was well tolerated and safe, said Melief, with no increase in the rate of serious adverse events. A randomized trial is planned to confirm the findings. "The results of our trial are among the first clinical data to support the general concept of combining cancer vaccination with immune checkpoint blockade to enhance efficacy of vaccine-activated T cells in the immunosuppressive tumor environment," Melief's group wrote in JAMA Oncology, where the findings were also published. The findings compare favorably to outcomes in a [...]

Blood test for HPV may help predict risk in cancer patients

Source: www.newswise.com Author: University of North Carolina Health Care System A blood test for the human papillomavirus, or HPV, may help researchers forecast whether patients with throat cancer linked to the sexually transmitted virus will respond to treatment, according to preliminary findings from the University of North Carolina Lineberger Comprehensive Cancer Center. HPV can cause oropharyngeal cancer, which is a cancer of the throat behind the mouth, including the base of the tongue and tonsils. Studies have shown that patients with HPV-positive oropharyngeal cancer have better outcomes than patients whose cancer is not linked to the virus. Preliminary findings presented at this year’s American Society for Radiation Oncology Annual Meeting suggest a genetic test for HPV16 in the blood could be useful to help assess risk for patients, and could help identify patients suitable for lower treatment doses. “Our work on this blood test is ongoing, but we are optimistic that ‘liquid biopsy’ tests such as ours may be useful in the personalization of therapy for many patients with HPV-associated oropharyngeal cancer,” said the study’s senior author Gaorav P. Gupta, MD, PhD, UNC Lineberger member and assistant professor in the UNC School of Medicine Department of Radiation Oncology. To avoid over-treating patients and to spare them from toxic treatment side effects, UNC Lineberger’s Bhisham Chera, MD, an associate professor in the radiation oncology department, led studies testing whether favorable-risk patients with HPV-positive oropharyngeal cancer can be treated successfully with lower doses of radiation and chemotherapy. A phase II clinical trial [...]

Genetic variants are associated with susceptibility to mouth and throat cancer

Source: www.eurekalert.org Author: news release A number of genetic variants associated with susceptibility to oral cavity and pharyngeal cancer have been described in an international study published in the journal Nature Genetics. The most noteworthy finding was an association between cancer of the oropharynx and certain polymorphisms (alternative versions of a given DNA sequence) found in the human leukocyte antigen (HLA) genomic region. HLAs, proteins found on the surface of most cells in the body, play an important role in recognizing potential threats and triggering the immune response to foreign substances. According to Eloiza Helena Tajara, a professor at the São José do Rio Preto Medical School (FAMERP) in São Paulo State, Brazil, and co-author of the article, a specific group of variants in this region, located on chromosome 6, is associated with enhanced protection against oropharyngeal cancer caused by human papilloma virus (HPV). "Previous research showed that these same variants confer protection against cancer of the uterine cervix, which is known to be associated with HPV," Tajara said. "Our findings suggest that the genes that control the immune system play a key role in predisposition to HPV-related tumors. This discovery points to the possibility of clarifying the mechanisms whereby such tumors develop and of designing methods for monitoring risk groups." The study was coordinated by the International Agency for Research on Cancer (IARC) and involved 40 research groups in Europe, the United States, and South America. The Brazilian participants are members of the Head & Neck Genome Project (GENCAPO), [...]

2016-12-17T11:02:17-07:00December, 2016|Oral Cancer News|

Blood-borne HPV antibodies indicate head, neck cancer prognosis

Source: medicalxpress.com Author: provided by Brown University People with head and neck cancers with evidence of human papillomavirus (HPV) infection generally have a better prognosis than people without evidence of infection. A new study in JAMA Oncology suggests that to produce a strong, reliable prognostic signal, all that's needed is a blood serum test for two specific HPV antibodies, rather than lab work on a biopsy. Further, the researchers said, the study shows that this blood-based biomarker is predictive of outcome for all types of head and neck cancer. The human papillomavirus causes not only cervical cancer but also cancers of the head and neck. Credit: National Cancer Institute "What this adds is that it helps us know how best to measure clinically the HPV contribution to this disease," said study senior author Karl Kelsey, a professor of epidemiology and of pathology and laboratory medicine at Brown University. Kelsey collaborated with lead author Heather Nelson of the University of Minnesota Masonic Cancer Center in making the findings. Moreover, Nelson, Kelsey and their colleagues wrote, referring to the common HPV16 strain of the virus: "These data are among the first to demonstrate a convincing relationship between HPV16 and improved patient survival for tumors of the larynx and oral cavity." Appraising antibodies The study examined blood serum samples and five-year survival rates among more than 1,000 Boston-area head and neck cancer patients diagnosed between 1999 and 2011. Overall, those who tested positive for antibodies to the oncogenic HPV proteins E6 [...]

2016-12-11T09:48:32-07:00December, 2016|Oral Cancer News|
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