Vaccitech Presents Interim Data from Phase 1b/2 Study of VTP-200 at 35th Annual International Papillomavirus Conference (IPVC) Highlighting Favorable Tolerability and Immunogenicity Profile

Rhea-AI Summary

Vaccitech plc (NASDAQ: VACC) announced the topline data from the APOLLO clinical trial of VTP-200, a treatment for women with low-grade cervical lesions due to human papillomavirus (HPV). The study, which is in Phase 1b/2, showed that VTP-200 was well-tolerated with no serious adverse events. Initial immunogenicity results reported significant T cell responses to E1, E2, and E6 antigens, with 26 of 29 participants responding positively. The trial aims to address the lack of treatment options for women with persistent HPV infections, a condition affecting approximately 291 million women globally. Vaccitech plans to present final results in 2024, focusing on the clearance of infection and cervical lesions.

Positive

• VTP-200 was well-tolerated with no serious adverse events reported.
• 26 out of 29 women showed positive T cell responses after treatment.
• Initial immunogenicity results demonstrated significant responses to key HPV antigens.

Negative

• None.

• 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 plc (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 35^th 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 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,” 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

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 key findings from the APOLLO trial for VTP-200?

The APOLLO trial found that VTP-200 was well-tolerated with no serious adverse events, and 26 out of 29 women showed significant T cell responses.

What is the purpose of the VTP-200 trial?

The trial aims to assess the safety and efficacy of VTP-200 in treating low-grade cervical lesions caused by persistent HPV infection.

When will the final results of the VTP-200 trial be available?

Vaccitech plans to share the final results of the trial in 2024, including data on infection clearance and lesion resolution.

How many women participated in the VTP-200 trial?

The trial included 42 women, with data reported for 29 receiving the active treatment.

What is the significance of the results for women with HPV?

The results indicate a potential treatment option for women suffering from persistent HPV infections, addressing a significant unmet medical need.