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 is initiating first-in-human studies for HBV and HPV therapeutics in H1 2020. We are also developing a rapid adenovirus manufacturing process for accelerated ChAdOx vector production.

Internal Programs

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. Over 250 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 a Phase 1 clinical trial initiated in 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?

  • Chinnakannan, S., et al. 2020. The Design and Development of a Multi-HBV Antigen Encoded in Chimpanzee Adenoviral and Modified Vaccinia Ankara Viral Vectors; A Novel Therapeutic Vaccine Strategy against HBV. Vaccines, 8(2), p.184.

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 1/2a trial to treat cervical lesions and CIN 1/2 in patients with persistent high-risk HPV infection planned for H1 2020.


 

Key references

  • Hancock, G., et al. 2019. A multi-genotype therapeutic human papillomavirus vaccine elicits potent T cell responses to conserved regions of early proteins. Nature Scientific Reports, 9(1), pp.1-12.
  • 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.

Programs in co-development

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.

In the 23 mCRPC patients who received VTP-800 in conjunction with an anti-PD-1, 5 patients (22%) had a >50% reduction in PSA level at any timepoint compared to baseline (median of 88 ng/ml). This compares favourably to the 9% response rate reported from a previous anti-PD-1 monotherapy study, KEYNOTE-199, which evaluated 243 mCRPC patients with similar baseline PSA levels. Vaccitech retains all commercial rights to the product.


 

Key references

Clinical trial references

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

VTP-600

Program: NSCLC therapeutic with checkpoint inhibitor
Stage: IND-enabling
Vaccitech rights: Worldwide

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VTP-600: A novel cancer immunotherapy

Strategic Collaboration with LUDWIG INSTITUTE FOR CANCER RESEARCH and CANCER RESEARCH UK

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.

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. A Phase 1/2a trial sponsored by Cancer Research UK is planned for Q4 2020. NSCLC patients will receive VTP-600 in combination with chemotherapy and anti-PD-1 standard of care.


 

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 in the chinese market

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 Coronavirus
Stage: Phase 1
Vaccitech rights: Licensed to Vaccitech Oncology

VTP-500

Program: MERS Coronavirus
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 in order to induce T cells, but also antibodies which block virus-host cell receptor binding and fusion or neutralize virus infection.

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. Results published from the trial show that a single dose of ChAdOx1 induced strong Ab and T cell responses which persisted when measured 1 year post vaccination.

Oxford University are also collaborating with The King Abdullah International Medical Research Centre (KAIMRC), to test the MERS vaccine in an ongoing Phase 1 clinical trial in the Kingdom of Saudi Arabia (KSA).

Vaccitech retains commercial rights for the product while licensing certain rights back to Oxford for non-profit development of the vaccine.


 

Key references

  • Folegatti, P.M., Bittaye, M., Flaxman, A., Lopez, F.R., Bellamy, D., Kupke, A., Mair, C., Makinson, R., Sheridan, J., Rohde, C. and Halwe, S., 2020. Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial. The Lancet Infectious Diseases.

  • van Doremalen, N., Haddock, E., Feldmann, F., Meade-White, K., Bushmaker, T., Fischer, R.J., Okumura, A., Hanley, P.W., Saturday, G., Edwards, N.J. and Clark, M.H., 2020. A single dose of ChAdOx1 MERS provides protective immunity in rhesus macaques. Science Advances
  • Alharbi, N.K., Padron-Regalado, E., Thompson, C.P., Kupke, A., Wells, D., Sloan, M.A., Grehan, K., Temperton, N., Lambe, T., Warimwe, G. and Becker, S., 2017. ChAdOx1 and MVA based vaccine candidates against MERS-CoV elicit neutralising antibodies and cellular immune responses in mice. Vaccine35(30), pp.3780-3788.

Clinical trial references

NCT03399578 – (ClinicalTrials.gov)

NCT04170829 – (ClinicalTrials.gov)

Out-licensed Products

VTP-900/AZD1222: A vaccine for the prevention of COVID-19

Program: COVID-19 Coronavirus prophylactic
Stage: Phase 1
Vaccitech rights: Partnered with OU-AZ

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VTP-900/AZD1222: A vaccine for the prevention of COVID-19

Partnered with UNIVERSITY OF OXFORD, ASTRAZENECA

Unmet need

The COVID-19 pandemic is an ongoing global crisis. Many millions of cases and hundreds of thousands of deaths are already confirmed. Caused by the coronavirus, SARS-CoV-2, the clinical spectrum of the COVID-19 disease is wide, encompassing asymptomatic infection to severe viral pneumonia, respiratory failure, and death. Countermeasures to control the spread of the coronavirus are urgently needed to protect lives and prevent further damage to the economy. Vaccines are an essential countermeasure, however, due to the novelty of the SARS-CoV-2 virus, there are no specific treatments or vaccines currently available. Vaccine platforms which are safe, low-cost, highly effective and can be rapidly manufactured to produce many millions of doses could help stop the pandemic and re-establish a safe, normal society.

Our approach

The VTP-900/AZD1222 COVID-19 vaccine utilised the ChAdOx1 platform encoding the full-length spike protein of SARS-CoV-2 which is responsible for receptor binding and entry into human cells. Technical expertise from development of the MERS vaccine, which contains an equivalent antigen and has a clinically proven ability to induce neutralising antibodies against coronavirus spike proteins in human trials, was leveraged for the creation of VTP-900/AZD1222.

Development status

Since the University of Oxford (Oxford) and Vaccitech designed the vaccine in January 2020, it has shown an ability to protect against COVID-19 in multiple preclinical settings. Oxford commenced large scale manufacture, and the vaccine has now been administered to over a thousand participants in clinical trials conducted by Oxford. The Oxford trials are planned to expand to over 10,000 participants in the UK. Through a new partnership with AstraZeneca, trials with over 30,000 participants will be conducted in the US and hundreds of millions of doses will be available before the end of year if the vaccine is shown to be safe and effective.

For more information, visit:

University of Oxford COVID-19 Research

AstraZeneca


 

Key references

  • van Doremalen, N., Lambe, T., Spencer, A., Belij-Rammerstorfer, S., Purushotham, J., Port, J., Avanzato, V., Bushmaker, T., Flaxman, A., Ulaszewska, M. and Feldmann, F., 2020. ChAdOx1 nCoV-19 vaccination prevents SARS-CoV-2 pneumonia in rhesus macaques. bioRxiv.

     

Clinical trial references

NCT04324606– (ClinicalTrials.gov)