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Primary safety endpoints were met. VTP-200 was generally well tolerated, with no treatment-related grade 3 or higher adverse events (AEs) or serious AEs (SAEs).
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Positive trends in clearance rates for both high-risk (time) HPV (60%, group 2) and cervical lesions (67%, groups 2 and 5) were observed in the group receiving the highest ChAdOx dose. I did.
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Pooled data from five different active dose groups showed no statistically significant improvement in either hrHPV or cervical lesion clearance compared to the placebo group.
OXFORD, UK, April 18, 2024 (Globe Newswire) — Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, has launched a new T A clinical-stage biopharmaceutical company developing cellular immunotherapy candidates. The APOLLO study (HPV001 (also known as) released final top-line data today. With persistent hrHPV infection.
“This is a dose-ranging, in-human clinical trial of VTP-200 in women with hrHPV-related low-grade cervical lesions, currently treated until progression to high-grade lesions. It's for women who don't have a choice,” Bill Enright said. , CEO of Balinsas Bio. “Although we did not observe a significant improvement from her VTP-200 in overall composite results, a positive trend was observed in the highest dose cohort.”
Apollo (NCT04607850) is a UK and EU study evaluating the safety, tolerability and immunogenicity of VTP-200 in women aged 25-55 with persistent hrHPV infection and low-grade cervix. It was a randomized, placebo-controlled, phase 1b/2 multicenter trial involving 108 participants. Lesion. The primary objective was to evaluate the safety and tolerability of VTP-200. This study was also designed to evaluate the effect of her VTP-200 on the clearance of hrHPV infection and cervical lesions and to select an appropriate dose for further development.
The APOLLO trial met its primary safety endpoints, showing that VTP-200 was generally well-tolerated, with no treatment-related unsolicited grade 3 or higher AEs or treatment-related AEs when administered. It was demonstrated that no SAE occurred.
The highest hrHPV clearance rate of 60% was observed at 12 months in group 2, which included the highest dose of ChAdOx, compared to a 33% clearance rate in the placebo group. Groups 1, 3, 4, and 5 showed hrHPV clearance rates of 12%, 11%, 33%, and 36%, respectively.
This study also evaluated the removal rate of cervical lesions in participants with both reported lesions at screening and visualization of the cervical deformity zone after 12 months (n=57). The highest cervical lesion clearance rate was observed in groups 2 and 5, which received the highest dose of ChAdOx, with 67% compared to 39% in the placebo group. Groups 1, 3, and 4 showed cervical lesion clearance rates of 40%, 20%, and 33%, respectively.
Pooled data from the five effective dose groups showed no significant improvement in hrHPV clearance or cervical lesion clearance rate compared to the placebo group. Future development options for the VTP-200 program are currently being evaluated and further analysis is ongoing.
“We are pleased to confirm that VTP-200 was generally well tolerated and met the study's primary safety endpoints. The most promising hrHPV and cervical lesion clearance data observed in the ChAdOx-HPV dose group and is informative for future development,” said Nadege Pelletier, Chief Scientific Officer at Barinthus Bio. “However, these differences compared to placebo were not statistically significant given that this trial was not conducted based on comparisons of individual dose groups. It primarily focused on immunological responses. Further analysis is underway and detailed results will be shared in due course.”
About the APOLLO exam
Apollo (NCT04607850) was a randomized, placebo-controlled, phase 1b/2 multicenter trial of 108 participants in the UK and EU, targeting women aged 25 to 55 years with persistent high-risk (time) HPV. The safety, tolerability, and immunogenicity of VTP-200 were evaluated. Infections and low-grade cervical lesions. The primary objective was to evaluate the safety and tolerability of VTP-200. This study was also designed to evaluate the effect of her VTP-200 on the clearance of hrHPV infection and cervical lesions and to select an appropriate dose for further development. The study consisted of an open-label, non-randomized, dose-escalation lead-in phase (n=9) followed by a blinded, randomized main phase (n=99; 67 people were randomized to VTP-200; The study consisted of 32 people (randomized to placebo). Participant groups received consecutive doses of her ChAdOx and her MVA 28 days apart as follows: Group 1, ChAdOx 2×109 Virus particles (VP), MVA 1×107 Plaque forming units (pfu); group 2, ChAdOx 2×10Ten vp, MVA 1×107 n/a. Group 3, ChAdOx 2×108 vp, MVA 1×108 n/a. Group 4, ChAdOx 2×109 vp, MVA 1×108 n/a. Group 5, ChAdOx 2×10Ten vp, MVA 1×108 n/a.
About VTP-200
VTP-200 is an investigational immunotherapy combination therapy consisting of an initial dose using a ChAdOx vector and a second dose using an MVA vector, both encoding the same HPV antigen and providing antigen-specific Designed to elicit a T-cell immune response. VTP-200 is being developed as a potential non-invasive treatment for persistent high-risk HPV infections and associated precancerous cervical lesions.
About HPV
Approximately 291 million women worldwide are estimated to be carriers of human papillomavirus DNA.2 Persistent genital HPV infection is responsible for nearly all cases of cervical precancerous lesions and can lead to cervical cancer.3 More than 95% of cervical cancers are caused by HPV infection.3 Cervical cancer will become the fourth most common cancer in women in 2022, affecting approximately 660,000 people and causing 350,000 deaths worldwide.3 The American Cancer Society predicted that approximately 13,960 new cases of invasive cervical cancer will be diagnosed in the United States in 2023, and more than 4,310 women will die from the disease.Four
About Balinsus Biotherapeutics
Barinthus Bio is a clinical-stage biopharmaceutical company developing novel T-cell immunotherapy candidates designed to induce the immune system to overcome chronic infections, autoimmunity, and cancer. Supporting people living with serious illnesses and their families is a core guiding principle of Balinsas's bio. With a broad pipeline built around three proprietary platform technologies: ChAdOx, MVA, and SNAP, Balinsus Bio is advancing a pipeline of five product candidates across diverse therapeutic areas, including: VTP-300, an immunotherapeutic drug candidate designed as a potential component for the functional treatment of chronic HBV infection. VTP-200, a non-surgical product candidate for persistent high-risk human papillomavirus (HPV). VTP-1000 is an autoimmune candidate designed to treat patients with celiac disease utilizing a SNAP-resistant immunotherapy (TI) platform. VTP-850 is a second-generation immunotherapy candidate designed to treat recurrent prostate cancer. Barinthus Bio's proven scientific expertise, diversified portfolio, and focus on pipeline development make the company uniquely positioned to deliver treatments to patients with infectious diseases, autoimmunity, and cancers that significantly impact their daily lives. is in the position of For more information, please visit: www.barinthusbio.com.
Forward-looking statements
This press release contains forward-looking statements about Balinsus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that generally include statements such as “may,” “will,” and “plan.” “, “”Forward-looking statements include words such as “forward-looking,” “encouraging,” “believes,” “potential,” and similar expressions, although not all forward-looking statements contain these specific words. contained. These forward-looking statements include express or implied statements regarding our product development activities and clinical trials, including the timing of interim data readouts and next steps in our programs, including the VTP-200 and APOLLO trials; including but not limited to. the tolerability or potential benefits of VTP-200 and our ability to develop and advance current and future product candidates and programs; The forward-looking statements in this press release are based on the current expectations and beliefs of the Company's management and may cause actual events or results to differ materially from those expressed or implied by the forward-looking statements. are subject to a number of risks, uncertainties and important factors that may result in: The information contained in this press release relates to the success, cost and timing of our pipeline development activities and plans and ongoing clinical trials, our ability to execute on our strategy, regulatory developments and our ability to obtain financing. including, but not limited to, risks and uncertainties. business operations and access to capital; the risk that interim or top-line data may not reflect final data or results; global economic uncertainty, including disruption in the banking industry; the Ukraine conflict; the Israel-Gaza conflict; , and other risks identified in our filings; Annual Report on Form 10-K for the year ended December 31, 2023; Quarterly Reports on Form 10-Q; and Current Reports on Form 8-K. Cooperation with the Securities and Exchange Commission (“SEC”), including: You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date they are made. We do not release such statements publicly to reflect expectations or changes in events, conditions or circumstances on which such statements are based or that may affect the likelihood that actual results will differ from those stated. We expressly disclaim any obligation to update or modify the Site. In forward-looking statements.
References
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Women's Health (London). 2021; 17: 17455065211020702. doi: 10.1177/17455065211020702
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Lancet Infectious Diseases 2007 July;7(7):453-9. doi: 10.1016/S1473-3099(07)70158-5
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WHO, Cervical Cancer, 2024.
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American Cancer Society, Cervical Cancer Key Statistics, 2022.
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