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Open Orphan and Codagenix receive MHRA approval for Covid vaccine challenge study

14 Dec 2020 | by: Daniel Flynn

Open Orphan (LSE:ORPH)

Monday saw Open Orphan (LSE:ORPH) strengthen its position in the global fight against Covid-19 with yet more progress in its human challenge activities.

The pharma services CRO said the first in-human study of Codagenix’s intranasal SARS-CoV-2 vaccine candidate had been approved by the UK’s independent Medicines and Healthcare Products Regulatory Agency (“MHRA”).

As first announced in late July, hVIVO, which is wholly-owned by Open Orphan, is working in collaboration with Codagenix to conduct the Phase 1 study of the vaccine.

The study will evaluate the safety and immunogenicity of a single-dose nasal vaccine candidate in 48 healthy young adult volunteers at hVIVO’s state-of-the-art Quarantine Facility in Whitechapel, London.

Codagenix’s vaccine is one of few that uses the “live-attenuated virus” – the entire virus in a weakened form. Most simply contain the viral spike.

As a result, it has the potential to induce broad antibody, cellular, and mucosal immunity with a single intranasal dose. It could be one of the first vaccines to provide long-term immunity from Covid-19.

The study is expected to begin in January, with first data expected in early Q2 2020, and hVIVO has already started to recruit volunteers.

Cathal Friel, Executive Chairman of Open Orphan, said:

“We are delighted to have MHRA approval to begin recruiting volunteers for this much needed clinical trial. The volunteers who attend our unique quarantine facility in East London are expertly supervised in a safe, controlled clinical environment and could be contributing to the development of a new breakthrough vaccine candidate that has the potential to confer immunity to individuals over a much longer timescale.

We hope to demonstrate safety and immunogenicity through this trial, which will then allow us to support Codagenix as they move into a larger Phase II / Phase III programme.”

Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix, said:

We are very excited to be moving forward with our collaboration with hVIVO for this first-in-human study of COVI-VAC, our live attenuated vaccine against COVID-19. The initial safety and immunogenicity data from healthy adults will position us well to move into larger studies in 2021 with our partners at Serum Institute of India. We believe COVI-VAC, a needle-free, single dose vaccine, is well-suited to address potential gaps in supplying the global community, as there is likely to be significant unmet need even after the initial roll-out of first generation COVID-19 vaccines.”

Open Orphan has been taking great strides forward in its efforts to support the global fight against Covid-19 in recent months.

Most notably, the firm won a £40m contract with the British government in October to develop the UK’s first human challenge study models for the virus. As well as using Europe’s only 24-bed quarantine unit for the trials, the UK government has donated the use of the Royal Free Hospital, which hosts the UK’s only high-level isolation unit for the treatment of infectious disease.

The deal will see Open Orphan’s subsidiary hVIVO create the challenge virus for use on patients and the first-in-human characterisation study. After hVIVO scientists select an appropriate strain and dose of the virus, vaccinated volunteers are intentionally infected, bringing forward results much faster than in conventional trials. Since the beginning of the 2020 Open Orphan’s market cap has grown from £36m to £165m.

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