Infectious Diseases

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

Partnered with UNIVERSITY OF OXFORD

Unmet Need

MERS is a viral respiratory illness that is transferred to humans from infected dromedary camels, caused by MERS-CoV.[1] MERS-CoV was first detected in humans in 2012 and has infected more than 2,400 people globally, with an approximately 35% mortality rate.[1]

As with disease caused by other coronaviruses, MERS varies from asymptomatic infection to a respiratory illness, including fever, cough, and shortness of breath, and in some patients, severe respiratory disease and death.[1] Although human-to-human transmission appears to be rare and cases have been mostly limited to the Middle East, a single traveller caused an outbreak in South Korea involving 186 diagnosed individuals and 38 fatalities, in 2015.[2] The Asian outbreak lasted from May to July, and 16,752 people were isolated with MERS-like symptoms.[3] This outbreak in South Korea demonstrates the potential of MERS to cause epidemics outside of the Middle East, and ongoing transmission from the camel host to humans continues.

Our Approach

Barinthus Biotherapeutics is developing VTP-500, a prophylactic vaccine product candidate, to prevent infection and subsequent disease caused by MERS-CoV. VTP-500 is based on the use of one or two doses of ChAdOx1 encoding the spike glycoprotein of MERS-CoV and was developed at the University of Oxford.

Development status

Preclinical activity in transgenic mice, camels and monkeys, along with positive data from two human Phase 1 safety and immunogenicity clinical trials funded by the UK government have been achieved. In 2018 the University of Oxford received funding from CEPI. To enable the CEPI-OU non-profit collaboration, Barinthus Biotherapeutics licensed non-exclusive development rights to the University of Oxford.

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

Barinthus Biotherapeutics 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. Vaccine, 35(30), pp.3780-3788.

Clinical trial references

NCT03399578 – (ClinicalTrials.gov)

NCT04170829 – (ClinicalTrials.gov)

VTP-400: A prophylactic vaccine candidate for the prevention of Shingles

Partnered with CANSINO BIO in China and Southeast Asia 

Unmet need

Shingles is the local recurrence of previous chickenpox infection and causes extreme morbidity throughout the world. Due to a natural decline in cell-mediated immunity with increasing age, approximately 80% of the 140 million global annual shingles cases occur in individuals over the age of 50, and immunocompromised patients, who together experience 7 to 25 deaths per 100,000 cases.[4] The most devastating consequence of shingles is the occurrence of localized pain at the site of recurrence, known as post-herpetic neuralgia, which increases with age and can be debilitating to the point of requiring opioid-based analgesia.[5]

Our Approach

Barinthus Biotherapeutics is developing VTP-400, a next-generation shingles prophylactic product candidate, to prevent shingles in adults aged 50 years and older. The vaccine candidate is based on one or two doses of ChAdOx1 encoding the validated varicella zoster virus glycoprotein E antigen.

Development Status

Preclinical studies have been conducted for VTP-400, with resulting data showing that VTP-400 generated a superior T cell response in outbred mice as compared to Shingrix and generated a similar antibody response in both young and aged mice.
Barinthus Biotherapeutics holds global commercial rights to the vaccine candidate outside China and Southeast Asia and is in an ongoing licence and collaboration in China and Southeast Asia with its regional partner, CanSino.

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

Outlicensed to UNIVERSITY OF OXFORD, ASTRAZENECA

Unmet need

The COVID-19 pandemic has been a global public health and economic crisis. Over 650 million cases and over 6.6 million deaths are confirmed worldwide.[6] Caused by the coronavirus, SARS-CoV-2, the clinical spectrum of the COVID-19 disease is wide, encompassing asymptomatic infection to severe viral pneumonia, multi-organ failure, and death. Countermeasures to control the spread of SARS-CoV-2 are urgently needed to protect lives and prevent further damage to the economy. Vaccines are an essential countermeasure. One fast and safe way to introduce widespread COVID-19 immunity in the population includes the use of effective prophylactic vaccination to induce a durable immune response.

Our approach

The Vaxzevria® COVID-19 vaccine utilises 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 Vaxzevria®.

Development status

In partnership with the University of Oxford’s Jenner Institute, we co-invented and jointly developed our COVID-19 vaccine candidate VTP-900, now Vaxzevria, which we assigned to OUI to facilitate the licensing of those rights by OUI to AstraZeneca. More than 3 billion doses had been delivered to 180 countries by the end of 2022​ and it was estimated that over 6 million lives have been saved worldwide. ​
We are eligible to receive a share of royalties and other revenue received by OUI pursuant to its agreement with AstraZeneca for AZD1222.

For more information, visit: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.

• Folegatti, P.M., Ewer, K.J., Aley, P.K., Angus, B., Becker, S., Belij-Rammerstorfer, S., Bellamy, D., Bibi, S., Bittaye, M., Clutterbuck, E.A. and Dold, C., 2020. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. The Lancet, 396(10249), pp.467-478.

Clinical trial references

NCT04324606– (ClinicalTrials.gov)