Portfolio

Pipeline

Vaccitech is a late-stage T cell immunotherapy company developing non-replicating viral vectors to treat and prevent cancer and infectious diseases.

Internal Pipeline

Vaccitech’s lead program is a universal influenza A vaccine in Phase 2b studies, with human challenge data anticipated in Q1 2020. We also have clinic-ready HBV and HPV therapeutics with first-in-human studies to be initiated within the next 6 months. We are developing a personalised cancer vaccine using a rapid adenovirus manufacturing process that enables our ChAdOx vector to deliver neoantigens.

Internal Programs

VTP-100

Program: Influenza pandemic/seasonal
Stage: Phase 2

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VTP-100: A universal influenza A vaccine clinically developed to address both pandemic and seasonal influenza

Funded by BARDA

Unmet need

Seasonal influenza typically causes more than 200,000 hospitalizations and 36,000 deaths every year in the United States alone, according to the U.S. Centers for Disease Control and Prevention. Four worldwide influenza pandemics over the past century have resulted in millions of deaths. While a yearly influenza vaccination provides some protection, subtypes not covered by the vaccine can emerge rapidly. This phenomenon was evident in the 2009 spread of the H1N1 (“swine flu”) subtype that killed an estimated 151,700 to 575,400 people worldwide.

Our approach

Vaccitech’s VTP-100 universal influenza vaccine is designed to protect against all strains of the influenza A virus as both an add-on to seasonal vaccines and as an option for pandemic preparedness. VTP-100 is a Modified Vaccinia Ankara (MVA) vector encoding Nuclear Protein (NP) and Matrix Protein 1 (M1), antigens that are conserved across all families of influenza A virus. VTP-100 has demonstrated an ability to generate strong CD4+ and CD8+ T-cell responses in human trials that match or exceed those found in persons who are protected in each influenza season.

Development status

Vaccitech has manufactured its VTP-100 influenza vaccine at scale together with its partners. It is now in two Phase 2 trials, with read outs expected in Q1 2020. Trial FLU010 will test the ability of VTP-100 to protect healthy adult study participants from a challenge with the A/Belgium/4217/2015 (H3N2) influenza virus strain. Trial FLU009 has commenced in Australia and over 2,000 participants of an expected 6,000 participants have received VTP-100 or placebo in addition to a standard seasonal influenza vaccine. The study includes a cohort of 65 years and will assess the effect of VTP-100 on the reduction of laboratory confirmed influenza when given as an adjunct to licensed quadrivalent influenza vaccine (QIV).

This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201900013C.


 

Key references

  • Berthoud, T.K., et al., Potent CD8+ T-cell immunogenicity in humans of a novel heterosubtypic influenza A vaccine, MVA-NP+M1. Clin Infect Dis, 2011.
  • Lillie, P.J., et al., A preliminary assessment of the efficacy of a T cell-based influenza vaccine, MVA-NP+M1, in humans. Clin Infect Dis, 2012.
  • Antrobus, R.D., et al., A T cell-inducing influenza vaccine for the elderly: safety and immunogenicity of MVA-NP+M1 in adults aged over 50 years. PLoS One, 2012.
  • Lambe T., et al., Immunity Against Heterosubtypic Influenza Virus Induced By Adenovirus And MVA Expressing Nucleoprotein And Matrix Protein-1. Sci Rep. 2013
  • Powell T.J., Examination of Influenza Specific T Cell Responses after Influenza Virus Challenge in Individuals Vaccinated with MVA-NP+M1 Vaccine. PLoS One. 2013
  • Mullarkey, C.E., et al., Improved adjuvanting of seasonal influenza vaccines: preclinical studies of MVA-NP+M1 coadministration with inactivated influenza vaccine. Eur J Immunol, 2013.
  • Antrobus, R.D., et al., Coadministration of seasonal influenza vaccine and MVA-NP+M1 simultaneously achieves potent humoral and cell-mediated responses. Mol Ther, 2014
  • Hayward, A.C., et al., Natural T Cell-mediated Protection against Seasonal and Pandemic Influenza. Results of the Flu Watch Cohort Study. Am J Respir Crit Care Med, 2015
  • Antrobus R.D. et al., Clinical Assessment of a Novel Recombinant Simian Adenovirus ChAdOx1 as a Vectored Vaccine Expressing Conserved Influenza A Antigens Mol Ther. 2014
  • Folegatti P.M. et al., Safety and Immunogenicity of the Heterosubtypic Influenza A Vaccine MVA-NP+M1 Manufactured on the AGE1.CR.pIX Avian Cell Line. MDPI Vaccines, 2019

Clinical trial references

FLU008 – NCT03277456 (ClinicalTrials.gov)
FLU009 – NCT03880474 (ClinicalTrials.gov)
FLU010 – NCT03883113 (ClinicalTrials.gov)

Vaccitech awarded BARDA contract for Phase II trial for Influenza vaccine
Universal flu vaccine passes Phase 2b clinical milestones

VTP-300

Program: HBV therapeutic
Stage: IND-enabling

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VTP-300: A novel therapeutic for HBV

Unmet need

There are over 600,000 deaths associated with HBV infection per year. Between 250-350 million chronic HBV patients are at risk for cirrhosis or hepatocellular carcinoma (HCC), which is the most common type of primary liver cancer in adults and the second leading cause of cancer mortality worldwide. There is usually no cure for chronic HBV, due to the persistence of covalently closed circular DNA (cccDNA), which results in renewed viral production after cessation of antiviral therapy. Complete clearance of hepatitis B is naturally associated with a CD8+ T cell response, but progress is limited in the use of T cell approaches due to T cell exhaustion, or other local related immune suppression activity.

Our approach

VTP-300 is a novel HBV therapeutic that has been shown to induce powerful, broad anti-HBV CD8+ and CD4+ T cell and antibody responses in mice. VTP-300 utilises Vaccitech’s heterologous prime-boost viral vector platform, ChAdOx-MVA, against three full length HBV antigens, genetically optimised from a consensus sequence of the genotype C virus by the laboratory of Professor Eleanor Barnes at University of Oxford. To alleviate immunosuppression in the liver microenvironment, VTP-300 will initially be administered in combination with a low dose checkpoint inhibitor.

Development status

The vaccine is in GMP manufacture with clinical trials planned for Q1 2020.


 

Key references

  • Barnes, E., 2015. Therapeutic vaccines in HBV: lessons from HCV. Medical microbiology and immunology, 204(1), pp.79-86.

  • Kelly, C., et al. 2016. Chronic hepatitis C viral infection subverts vaccine‐induced T‐cell immunity in humans. Hepatology, 63(5), pp.1455-1470.

  • Bolte, F.J. and Rehermann, B., 2017. Tissue-resident T cells in hepatitis B: A new target for cure?

VTP-200

Program: HPV therapeutic
Stage: IND-enabling

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VTP-200: An HPV immunotherapy

Unmet need

Human papillomavirus (HPV) is the most common sexually transmitted virus. 14 million new HPV infections occur per year in the U.S alone. Persistent infection results in a variety of pre-cancerous lesions as well as cancer of the cervix, anus, and head and neck. HPV causes almost all cases of cervical cancer, annually there are over 500,000 newly diagnosed cases and over 260,000 cervical cancer deaths worldwide. Cervical intraepithelial neoplasia (CIN) is a premalignant condition of the uterine cervix, for which persistent infection with high-risk HPV types is the main cause. CIN can progress to cancer if untreated. No therapeutic drugs are available for the treatment of CIN.

Our approach

Our multigenic construct (VTP-200) is based on a wider array of strains and antigens than other HPV therapeutics in development. Clinical conditions that can be treated with the therapy alone include persistent high-risk HPV infection, CIN and anal intraepithelial neoplasia.

Development Status

Our VTP-200 vaccine has shown robust immunogenicity, viral clearance and tumour protection in preclinical tumour models. The product will be studied in a Phase 1 trial to treat cervical lesions and CIN 1/2 in patients with persistent high-risk HPV infection beginning Q1 2020.


 

Key references

  • Hellner, K. and Dorrell, L., 2017. Recent advances in understanding and preventing human papillomavirus-related disease. F1000Research, 6.

  • Adams, A., et al. 2014. Human papillomavirus induced transformation in cervical and head and neck cancers. Cancers, 6(3), pp.1793-1820.

  • Hancock, G., Hellner, K. and Dorrell, L., 2018. Therapeutic HPV vaccines. Best Practice & Research Clinical Obstetrics & Gynaecology, 47, pp.59-72.

  • Ewer, K.J., Lambe, T., Rollier, C.S., Spencer, A.J., Hill, A.V. and Dorrell, L., 2016. Viral vectors as vaccine platforms: from immunogenicity to impact. Current opinion in immunology, 41, pp.47-54.

VTP-700

Program: Personalised Cancer Vaccine
Stage: Preclinical

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VTP-700: A rapid method for personalized cancer immunotherapy

Our approach

Identification of tumour-specific targets (neoantigens) for each individual cancer patient provides highly precise targets for novel immunotherapies. Vaccitech is developing a proprietary rapid and scalable manufacturing process that reduces adenoviral manufacture time from 24 weeks to 5-6 weeks, enabling the production of a personalized cancer immunotherapeutic – VTP-700. VTP-700 will employ the ChAdOx vector to deliver neoantigens that stimulate durable immune responses personalised to specific tumour antigens in individual patients.

Development status

Currently in GMP development to enable first patient enrolment in Q2/Q3 2020.

Partnered Programs

VTP-800

Program: Prostate CA therapeutic with checkpoint inhibitor
Stage: Phase 2
Vaccitech rights: Worldwide

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VTP-800: A novel prostate cancer immunotherapy

Partnered with UNIVERSITY OF OXFORD

Unmet need

Prostate cancer is the second most common cancer in men. It represents 26% of all male cancer diagnoses in the UK and is the third leading cause of male cancer death in the US.
The usual method of diagnosis is routine PSA (prostate specific antigen) testing followed by biopsies. The majority of prostate cancers are diagnosed at an early stage. Local prostate cancer is often managed by active surveillance, surgery, brachytherapy (insertion of radio-therapeutic beads) castration (chemical or surgical). In later stage and metastatic disease, chemotherapy is often employed.

Our approach

Vaccitech’s approach – VTP-800 – is the prime-boost combination of ChAdOx1 and MVA, both encoding oncofetal antigen. VTP-800 is administered in combination with a licensed checkpoint inhibitor.

Development status

In a Phase 1 study, 5T4-specific T cells were induced in 64% of early stage, prostate cancer patients. The ex vivo levels of CD8+ T cells are quantitatively higher than in human studies previously reported for cancer vaccines in prostate cancer or any solid tumour indication. T cells also infiltrated the majority of tumour biopsy and surgical samples. These data were presented at ASCO 2018.
Evaluation of VTP-800 continues in a Phase 2a Investigator initiated study in metastatic prostate cancer patients and for those with intermediate risk cancer undergoing prostatectomy, receiving the therapeutic vaccination in combination with a checkpoint inhibitor. The trial is sponsored by the University of Oxford. Vaccitech retains all commercial rights to the product.


 

Key references

  • Cappuccini, F., et al. 2016. Immunogenicity and efficacy of the novel cancer vaccine based on simian adenovirus and MVA vectors alone and in combination with PD-1 mAb in a mouse model of prostate cancer. Cancer immunology, immunotherapy, 65(6), pp.701-713.

  • Cappuccini, F., Pollock, E., Stribbling, S., Hill, A.V. and Redchenko, I., 2017. 5T4 oncofoetal glycoprotein: an old target for a novel prostate cancer immunotherapy. Oncotarget, 8(29), p.47474.

  • Redchenko, I., et al. 2018, June. VANCE: First-in-human phase I study of a novel ChAdOx1-MVA 5T4 vaccine in low and intermediate risk prostate cancer. American Society of Clinical Oncology.

     

Clinical trial references

VANCE – NCT02390063 (ClinicalTrials.gov)
ADVANCE – NCT03815942 (ClinicalTrials.gov)

VTP-600

Program: MAGE-NYESO
Stage: IND-enabling
Vaccitech rights: Worldwide

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VTP-600: A novel cancer immunotherapy

Strategic Collaboration with LUDWIG INSTITUTE FOR CANCER RESEARCH

Unmet Need

The World Health Organization (WHO) has estimated that there were 1.76 million deaths due to lung cancer in 2018. Lung cancer is the most common cancer in men and the third most common in women. Lung cancer deaths are an estimated 25% of all cancer deaths in the US and 20% of total cancer deaths in Japan and EU countries. Non-small cell lung cancer (NSCLC) accounts for roughly 85% of all cases of lung cancer.

Our Approach

VTP-600 is a novel therapeutic comprised of Vaccitech’s proprietary, best-in-class T cell induction platform; ChAdOx1 priming agent and MVA boost agent that each encode full length NY-ESO-1 and MAGE-A3 antigens. NY-ESO-1 and MAGE-A3 antigens are highly prioritized as immunologic targets within oncology. They are found in a wide array of cancers, including lung, gastro-esophageal, melanoma and synovial sarcoma.
VTP-600 can be personalized per patient depending on tumor positivity for each antigen to optimize tumor-specific immune responses and maximize the number of patients that can benefit from the therapy. The therapeutic will be given in combination with a checkpoint inhibitor to provide clinical benefit for patients with NSCLC.

Development status

Vaccitech has established a joint initiative with the Ludwig Institute for Cancer research, Vaccitech Oncology Limited (VOLT), to progress the clinical development of VTP-600. VOLT has completed the CMC and preclinical development packaging for the therapeutic products, anticipated to enter the clinical in Q3 2020.


 

Key references

  • Chen, X., et al. 2017. Expression and prognostic relevance of MAGE-A3 and MAGE-C2 in non-small cell lung cancer. Oncology letters, 13(3), pp.1609-1618.

  • Näslund, T.I., et al. 2007. Comparative prime-boost vaccinations using Semliki Forest virus, adenovirus, and ALVAC vectors demonstrate differences in the generation of a protective central memory CTL response against the P815 tumor. The Journal of Immunology, 178(11), pp.6761-6769.

  • Coulie, P.G., Van den Eynde, B.J., Van Der Bruggen, P. and Boon, T., 2014. Tumour antigens recognized by T lymphocytes: at the core of cancer immunotherapy. Nature Reviews Cancer, 14(2), p.135.

  • Romero, P., et al. 2016. The Human Vaccines Project: A roadmap for cancer vaccine development. Science Translational Medicine, 8(334), pp.334ps9-334ps9.

VTP-400

Program: Zoster
Stage: IND-enabling
Vaccitech rights: Worldwide ex China

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VTP 400: A vaccine for the prevention of Shingles

Partnered with CANSINO BIO

Unmet need

Shingles is a painful recurrence of varicella zoster virus (VZV, or chickenpox), that markedly increases in frequency with age. Shingles can only develop in individuals previously infected with VZV; normally immune responses are able to keep the infection in check to prevent the virus from reactivating. With age, cellular and other immune responses decline to the point at which the low-level latent infection is no longer well controlled, resulting in shingles.

Our Approach

VTP-400 uses ChAdOx1 encoding the VZV gE glycoprotein to boost the existing T and B cell responses to potentially protective levels. In addition to a highly acceptable safety profile, induction of protective immune responses after a single dose, and durable immunity, adenoviral vaccines can be manufactured efficiently at large scale, and stored at 4°C.

Development Status

VTP-400 has demonstrated outstanding immunogenicity, including induction of T cells as well as antibodies, in pre-clinical models. GMP manufacture is underway with CanSino Biologics who are developing the product in China, as part of a collaboration agreement with Vaccitech that leads into a joint clinical partnership. A Phase 1 trial is scheduled to commence in late 2020.

VTP-500

Program: MERS
Stage: Phase 1
Vaccitech rights: Licensed to Vaccitech Oncology

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VTP 500: A vaccine for the prevention of Middle East Respiratory Syndrome (MERS)

Partnered with UNIVERSITY OF OXFORD, JANSSEN and CEPI

Unmet Need

MERS is a viral respiratory disease caused by a novel coronavirus, with over 2,000 reported cases since it was first identified in Saudi Arabia in 2012. Coronaviruses are known to cause diseases ranging from the common cold to Severe Acute Respiratory Syndrome (SARS).
Typical MERS symptoms include fever, cough and shortness of breath. Pneumonia is common, but not always present, and up to 35% of individuals reported with clinical MERS have died. MERS is an emerging infection, which has been recognized by the Coalition for Epidemic Preparedness Innovation (CEPI) as one of the major pathogens upon which to focus.

Our Approach

Vaccitech’s VTP-500 MERS vaccine utilises the ChAdOx1 virus platform to encode MERS coronavirus spike protein.

Development status

The vaccine has now been manufactured according to GMP practice and has been successfully tested in a Phase 1 clinical trial at Oxford University. CEPI, Oxford University and Janssen have entered into a collaboration worth up to $19M to progress the vaccine through Phase 2 studies and establish a human vaccine stockpile. Vaccitech retains commercial rights for the product while licensing certain rights back to Oxford for non-profit development of the vaccine.


 

Key references

  • Ewer, K., Sebastian, S., Spencer, A.J., Gilbert, S., Hill, A.V. and Lambe, T., 2017. Chimpanzee adenoviral vectors as vaccines for outbreak pathogens. Human vaccines & immunotherapeutics, 13(12), pp.3020-3032.

Clinical trial references

NCT03399578 – (ClinicalTrials.gov)