- 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-200
- HPV001 clinical trial will continue as planned to the 12-month primary endpoint
“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
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
About HPV001
HPV001 (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-200
VTP-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 HPV
It 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
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,” “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
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:
Managing Director 917-680-5608 ccalabrese@lifesciadvisors.com | Managing Director 617-283-2856 kgardner@lifesciadvisors.com |
Media contact
312-961-2502
mikebeyer@sambrown.com
Company contact:
IR & PR Manager
IR@vaccitech.co.uk
© OMX, source