Vaccitech’s VTP-200 Ph 1b/2 Study Demonstrates Favorable Tolerability and Immunogenicity Profile at Interim Analysis in Women with Low-Grade Human Papillomavirus (HPV)-related Cervical Lesions

Rhea-AI Summary

Vaccitech plc (NASDAQ: VACC) announced positive interim results from the HPV001 study, a Phase 1b/2 trial for its investigational product, VTP-200. The trial, targeting women with low-grade cervical HPV lesions, reported no serious adverse events and favorable immunogenicity results, particularly concerning E1, E2, and E6 antigens. The study will continue towards its primary endpoint at 12 months. The CEO emphasized the importance of VTP-200 as a potential treatment for HPV infections, which currently have no options until high-grade lesions develop. Data will be presented at the International Papillomavirus Conference in April 2023.

Positive

• VTP-200 was well-tolerated, with no serious adverse events reported.
• Interim data showed strong immunogenicity results, especially for E1, E2, and E6 antigens.
• The HPV001 trial is progressing as planned towards a 12-month primary endpoint.

Negative

• None.

• 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
  

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 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 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 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 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 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

1. Lancet Infect Dis. 2007 Jul;7(7):453-9. doi: 10.1016/S1473-3099(07)70158-5 
2. WHO, Cervical Cancer, 2022 
3. 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

FAQ

What are the interim results of the HPV001 study for VTP-200?

The interim results are positive, showing no serious adverse events and favorable immunogenicity results for VTP-200.

How does VTP-200 aim to treat HPV infections?

VTP-200 is designed to potentially treat HPV infections before they lead to high-grade lesions.

When will the final results of the HPV001 trial be available?

Final results are expected in early 2024.

What will be discussed at the International Papillomavirus Conference?

The interim data from the HPV001 study will be presented at the conference in April 2023.

What is the status of the HPV001 clinical trial?

The HPV001 clinical trial is fully enrolled and will continue as planned to its primary endpoint at 12 months.