Uterine Cervix Adenocarcinoma

BRONX, N.Y., Sept. 7, 2023 /PRNewswire/ -- In findings with potentially important implications for cervical cancer screening, scientists at the National Cancer Institute (NCI)-designated Montefiore Einstein Cancer Center (MECC) have developed a test for detecting a type of cervical cancer that Pap tests often miss. The findings published online today in the Journal of the National Cancer Institute (JNCI). "Our novel test appears sensitive for detecting cervical adenocarcinoma [ADC]—which now accounts for up to 25% of cervical cancer cases—as well as its precursor lesions, adenocarcinoma in situ [AIS], that often develop into ADCs," said Howard Strickler, M.D., M.P.H., co-senior and corresponding author of the JNCI paper and a member of MECC. "Because ADCs are often missed by current screening methods, they have higher mortality rates than the more common cervical squamous cell cancer," Dr. Strickler added. "Our goal is to catch the disease early, before it develops into cancer." Dr. Strickler is also professor and head of the division of epidemiology and the Harold and Muriel Block Chair in Epidemiology and Population Health at Albert Einstein College of Medicine. A Novel Approach to Testing The widespread use of the Pap test, in which a pathologist examines tissue samples for abnormal cells, has significantly reduced the incidence of cervical squamous cell cancer over the past six decades. However, the incidence of ADC has not decreased, probably because the Pap test is less effective at detecting it. In recent years, testing for human papillomaviruses (HPVs)—which cause virtually all cases of cervical cancer—joined the Pap test as a standard screening tool for cervical cancer. Although there are more than 100 types of HPV, three types—HPV 16, 18, and 45—account for more than 70% of all cervical cancer cases and more than 90% of ADC cases. The current HPV tests cover all three types and can alert infected women that they face a high risk for developing cervical cancer. While vaccines for preventing cervical cancer—including Gardasil-9, which protects against nine HPV types—are safe and effective, several generations of women are above the age for receiving the vaccine. Therefore, screening and treatment for prevention of cervical cancer will remain critical for decades to come. The MECC-developed HPV test assessed HPV 16, 18, and 45 in a novel way: by specifically looking at methylation levels. "The advent of next-generation genetic testing has opened up opportunities for us to more accurately detect oncogenic HPV strains and patterns in the genomes that correspond with the development of AIS and ADC," said Robert D. Burk, M.D., professor of pediatrics, of microbiology & immunology, of epidemiology and population health, and of obstetrics & gynecology and women's health at Einstein and MECC member, who co-led the study. Methylation—the addition of methyl (CH3) groups to a region of DNA—is a routine occurrence in DNA, both viral and human, and plays a critical role in altering gene expression. The JNCI study, a collaborative project with the NCI, part of the National Institutes of Health, investigated methylation levels in cervical tissue samples from 1,400 women who had undergone cervical cancer screening at Kaiser Permanente Northern California before 2014 and whose cervical cancer status was known. In assessing the HPVs in the cytological samples, the researchers tallied up the methylation percentages for each of 35 different viral-genome sites, with each sample receiving a final "methylation score" equal to the average methylation percentage across all 35 sites. Those women with methylation scores in the upper 25% had very high odds for having developed either ADC or AIS. "Our findings, if confirmed by clinical trials, suggest that women with a high methylation score may benefit from colposcopy and specialized tissue evaluation, beyond just a Pap test, which could lead to early diagnosis and treatment for ADC or the removal of AIS lesions before they develop into ADC," said Dr. Burk. Improving Equity in Cervical Cancer Screening "Given that our test uses equipment that could be simplified, it has the potential to expand testing in lower-resourced countries," said Dr. Strickler, who has long studied HPV in women living with HIV, who are more likely to acquire an HPV infection. Cervical cancer remains the fourth most common type of cancer in women, with the burden significantly higher in lower- and middle-income countries, including those in Sub-Saharan Africa, where HIV-HPV coinfections are common. There are also significant disparities within the United States. In New York City, rates of cervical cancer in the Bronx, which is home to the poorest urban congressional district in the country, are 50% higher than in Manhattan. More frequent and effective screening could help address this health disparity. "Ideally, the new HPV methylation test would only need to be done once every three to five years," said Dr. Strickler. "We are hopeful that this test will be able to increase cervical cancer screening equity in the U.S. as well." The paper is titled "A Novel HPV/Host DNA Methylation-Score and Detection of Cervical Adenocarcinoma." In addition to Drs. Strickler and Burk, other Einstein authors on the study were Ana Gradissimo, Ph.D., Xiaonan Xue, Ph.D., and Philip E. Castle, Ph.D, M.P.H. (also affiliated with the NCI). Other contributors were Megan A. Clarke, Ph.D., M.H.S., Mark Schiffman, M.D., M.P.H., and Nicolas Wentzensen, M.D., Ph.D., M.PH., all at NCI, and Tina R. Raine-Bennett, M.D., M.P.H. at Kaiser Permanente. About Montefiore Einstein Cancer Center Montefiore Einstein Cancer Center (MECC) is a national leader in cancer research and care located in the ethnically diverse and economically disadvantaged borough of the Bronx, N.Y. MECC combines the exceptional science of Albert Einstein College of Medicine with the multidisciplinary and team-based approach to cancer care of Montefiore Health System. Founded in 1971 and a National Cancer Institute (NCI)-designated Cancer Center since 1972, MECC is redefining excellence in cancer research, clinical care, education and training, and community outreach and engagement. Its mission is to reduce the burden of cancer for all, especially people from historically marginalized communities. SOURCE Montefiore Einstein Cancer Center

VTP-200 was generally well-tolerated and was administered with no product-related grade 3 unsolicited adverse events and no product-related serious adverse events (SAEs) in women with low grade human papillomavirus-related cervical lesions Interim data showed encouraging initial immunogenicity results, particularly in relation to the E1, E2 and E6 antigens OXFORD, United Kingdom, April 17, 2023 (GLOBE NEWSWIRE) -- Vaccitech Limited (NASDAQ: VACC), a clinical-stage biopharmaceutical company focused on the development of novel T cell immunotherapeutics designed to harness the power of the immune system to treat and cure chronic infectious diseases, autoimmune diseases and cancer, will present topline data from the APOLLO clinical trial at the 35th Annual International Papillomavirus Conference (IPVC). The APOLLO trial (also known as HPV001) is a fully enrolled Phase 1b/2 study of VTP-200 in women with low-grade cervical lesions associated with persistent human papillomavirus (HPV) infection. The data will be presented as a poster at IPVC in Washington, D.C. on Thursday, April 20, 2023 at 2 PM EDT, by Dr. Meg Marshall, Chief Medical Officer of Vaccitech. “The safety and immunogenicity data presented at IPVC shows the potential of VTP-200 in treating persistent high-risk HPV (hrHPV) infections. Currently, women with persistent HPV infections have no treatment options until they develop high grade lesions,” said Meg Marshall, CMO of Vaccitech. “We believe VTP-200 has the potential to address a serious unmet need and look forward to sharing the results of the final analysis, to include data on clearance of infection and cervical lesions, in 2024.” The poster shows data for 42 women at Day 35, 7 days after the last dose of VTP-200, split by active treatment versus placebo. VTP-200 was generally well-tolerated and was administered with no product-related grade 3 unsolicited adverse events and no product-related SAEs. While the placebo group showed no antigen-specific T cell responses as measured by IFNg ELISpot, 26 of 29 women receiving varying doses of VTP-200 showed a response. The pooled active groups showed meaningful responses, with the average being greater than 1,000 spot-forming units per million peripheral blood mononuclear cells. Responses were strongest to the E1, E2 and E6 antigens. In addition, intracellular cytokine staining data from the active groups showed both CD4 and CD8 responses. About APOLLO (HPV001) APOLLO (NCT04607850) is a fully-enrolled, randomized, placebo-controlled Phase 1b/2 multi-center trial evaluating the safety, immunogenicity and efficacy of VTP-200, which utilizes the ChAdOx1-HPV and MVA-HPV combination approach in women with persistent HPV infection and low grade cervical lesions. The primary objective is to evaluate the safety and tolerability of VTP-200. The trial is also designed to determine the effect of VTP-200 on the hrHPV infection and lesion(s), as well as select the appropriate dose for further development. The study consists of an open label, non-randomized, dose escalation lead-in phase of 9 women, followed by a blinded, randomized main phase of approximately 96 women with high-risk HPV. About VTP-200 VTP-200 is an investigational immunotherapeutic combination regimen consisting of an initial dose using the ChAdOx vector and a second dose using MVA, both encoding the same HPV antigens (i.e.: E1, E2, E4, E5, E6, E7), designed to elicit an antigen-specific T cell immune response to HPV. VTP-200 is being developed as a potential non-invasive treatment for persistent high-risk HPV infections and associated pre-cancerous lesions. About HPV It is estimated that approximately 291 million women worldwide are carriers of human papillomavirus DNA.1 Persistent genital HPV infection is responsible for almost all cases of cervical pre-cancerous lesions, which can lead to cervical carcinoma.2 Over 95% of cervical cancers are caused by HPV infection.2 Cervical cancer was the fourth most common cancer in women in 2020, with approximately 604,000 cases and 342,000 deaths from the disease worldwide.2 The American Cancer Society predicts that in 2023, approximately 13,960 new cases of invasive cervical cancer will be diagnosed in the US with over 4,310 women dying from the disease.3 About Vaccitech Vaccitech is a clinical-stage biopharmaceutical company focused on the development of novel T cell immunotherapeutics designed to utilize the power of the immune system to treat and cure chronic infectious diseases, autoimmune diseases, and cancer. The company stands apart through a proprietary, multi-platform approach that has shown the ability to induce higher magnitudes of T cells compared with other technologies. Vaccitech is uniquely positioned to address the needs of large, underserved patient populations through a diverse clinical-stage pipeline of investigational therapies targeting life-threatening diseases that pose significant public health risk and have limited treatment options. The company’s lead product candidates include VTP-300, an immunotherapy candidate designed as a component of a potential functional cure for chronic hepatitis B viral (HBV) infection; VTP-200, a non-invasive, early-stage investigational treatment for persistent, high-risk human papillomavirus (HPV); VTP-850, a novel T cell investigational therapy for prostate cancer; and VTP-1000, a preclinical T cell therapeutic candidate for immune tolerance in celiac disease. Vaccitech has proven drug development and scientific expertise in the field of immunization, co-inventing a COVID-19 vaccine with the University of Oxford, which is now approved and exclusively licensed worldwide to AstraZeneca. For more information, visit . Forward Looking Statements This press release contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “intend,” “promising,” “believe,” “potential,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding: the company’s plans and strategy with respect to the HPV001 study, the timing for completion and reporting of results or additional data for the HPV001 study, and the potential benefits of VTP-200 for the treatment of HPV infections. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of the company’s product development activities and planned and ongoing clinical trials, the company’s ability to execute on its strategy, regulatory developments, the company’s ability to fund its operations, global economic uncertainty, including disruptions in the banking industry, the impact that the COVID-19 pandemic may have on the company’s clinical trials and preclinical studies, and access to capital and other risks identified in the company’s filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2022, its Quarterly Reports on Form 10-Q and subsequent filings with the SEC. The company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The company expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. References Lancet Infect Dis. 2007 Jul;7(7):453-9. doi: 10.1016/S1473-3099(07)70158-5 WHO, Cervical Cancer, 2022 American Cancer Society, Key Statistics for Cervical Cancer, 2022. IR contacts: Christopher M. Calabrese  Managing Director  LifeSci Advisors 917-680-5608 ccalabrese@lifesciadvisors.com  Kevin Gardner Managing Director LifeSci Advisors 617-283-2856 kgardner@lifesciadvisors.com Media contact: Mike Beyer Sam Brown, Inc. 312-961-2502 mikebeyer@sambrown.com  Company contact: Jonothan Blackbourn IR & PR Manager Vaccitech IR@vaccitech.co.uk

VTP-200 was generally well-tolerated with no product-related serious adverse events (SAEs)Interim data showed encouraging initial immunogenicity results, particularly in relation to the E1, E2 and E6 antigens used in VTP-200HPV001 clinical trial will continue as planned to the 12-month primary endpoint OXFORD, United Kingdom, March 20, 2023 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ: VACC), a clinical-stage biopharmaceutical company focused on the development of novel T cll immunotherapeutics designed to use the power of the immune system to potentially treat and cure chronic infectious diseases, autoimmune diseases and cancer, today announced topline interim data from the HPV001 study (NCT04607850), a Phase 1b/2 clinical trial of VTP-200 in women with low-grade cervical human papillomavirus (HPV) lesions. “These interim data are a promising step in the right direction, and we look forward to seeing the final data in early 2024. Currently people with persistent HPV infections have no treatment options until they develop high grade lesions. Being told to return for a repeat cervical screening every 6 to 12 months without a treatment option can be frustrating and anxiety-provoking,” said Bill Enright, CEO of Vaccitech. “VTP-200 is intended to treat HPV infections, potentially before the virus causes these high-grade lesions.” Data from the first 58 women enrolled who reached their 6-month timepoint in the HPV001 placebo-controlled study were reviewed internally and the trial will continue as planned to the 12-month primary endpoint. Immunogenicity results showed high responses, defined as an average greater than 1,000 spot-forming units per million peripheral blood mononuclear cells in an ELISPOT assay, especially to the E1, E2 and E6 antigens. VTP-200 was generally well-tolerated with no product-related grade 3 unsolicited events and no product-related SAEs. Results were unblinded by group however, to preserve the integrity of these data, the results will not be fully reported until the trial is complete and the data are fully unblinded. These interim data will be presented orally at the upcoming International Papillomavirus Conference in Washington D.C., which is taking place 17-21 April 2023. About HPV001HPV001 (NCT04607850) is a fully-enrolled, randomized, placebo-controlled Phase 1b/2 multi-center trial evaluating the safety, efficacy and immunogenicity of VTP-200, which utilizes the ChAdOx1-HPV and MVA-HPV heterologous approach, in women with HPV-related low grade cervical lesions. The study consists of an open label, non-randomized, dose escalation lead-in phase of 9 participants, followed by a blinded, randomized main phase of approximately 96 participants with high-risk HPV. About VTP-200VTP-200 is an investigational heterologous prime boost immunotherapy consisting of an initial dose using the ChAdOx vector and a second dose using MVA, both encoding the same HPV antigens, to elicit an immune response to HPV. VTP-200 is being developed as a potential non-invasive treatment for persistent high-risk HPV infections and associated pre-cancerous lesions. About HPVIt is estimated that approximately 291 million women worldwide are carriers of human papillomavirus (HPV) DNA.1 Persistent genital HPV infection is responsible for almost all cases of cervical pre-cancerous lesions, which can lead to cervical carcinoma.2 Over 95% of cervical cancers are caused by HPV infection.2 Cervical cancer was the fourth most common cancer in women in 2020, with approximately 604,000 cases and 342,000 deaths from the disease worldwide.2 The American Cancer Society predicts that in 2022, approximately 14,100 new cases of invasive cervical cancer were diagnosed in the US with over 4,280 women dying from the disease.3 About VaccitechVaccitech is a clinical-stage biopharmaceutical company focused on the development of novel T cell immunotherapeutics designed to utilize the power of the immune system to potentially treat and cure chronic infectious diseases, autoimmune diseases, and cancer. The Company believes that its proprietary, multi-platform approach has the ability to induce higher magnitudes of T cells compared with other technologies. The Company believes that it is well positioned to address the needs of large, underserved patient populations through a diverse clinical-stage pipeline of investigational therapies targeting life-threatening diseases that pose significant public health risk and have limited treatment options. The Company’s lead product candidates include VTP-300, an immunotherapy candidate designed as a component of a potential component of a functional cure for chronic hepatitis B viral (HBV) infection; VTP-200, a non-invasive, early-stage investigational treatment for persistent, high-risk human papillomavirus (HPV); VTP-850, a novel T cell investigational therapy for prostate cancer; and VTP-1000, a preclinical T cell therapeutic product candidate for immune tolerance in celiac disease. Vaccitech has proven drug development and scientific expertise in the field of immunization, co-inventing a COVID-19 vaccine with the University of Oxford, which is now approved and exclusively licensed worldwide to AstraZeneca. For more information, visit www.vaccitech.co.uk. Forward Looking StatementsThis press release contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “intend,” “promising,” “believe,” “potential,” “forward,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward looking statements include, without limitation, express or implied statements regarding: the Company’s plans and strategy with respect to the HPV001 study, the timing for completion and reporting of results or additional data for the HPV001 study, and the potential benefits of VTP-200 for the treatment of HPV infections. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to: the success, cost and timing of the Company’s product development activities and planned and ongoing clinical trials, the Company’s ability to execute on its strategy, regulatory developments, the Company’s ability to fund its operations, global economic uncertainty, including disruptions in the banking industry, the impact that the COVID-19 pandemic may have on the Company’s clinical trials and preclinical studies, and access to capital and other risks identified in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2021, its Quarterly Reports on Form 10-Q and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. References Lancet Infect Dis. 2007 Jul;7(7):453-9. doi: 10.1016/S1473-3099(07)70158-5 WHO, Cervical Cancer, 2022 American Cancer Society, Key Statistics for Cervical Cancer, 2022. IR contacts: Christopher M. CalabreseManaging DirectorLifeSci Advisors917-680-5608ccalabrese@lifesciadvisors.comKevin GardnerManaging DirectorLifeSci Advisors617-283-2856kgardner@lifesciadvisors.com Media contactMike BeyerSam Brown, Inc.312-961-2502mikebeyer@sambrown.com  Company contact:Jonothan BlackbournIR & PR ManagerVaccitechIR@vaccitech.co.uk