Open Orphan signs £10.4m contract with global pharma client

Specialist contract research organisation Open Orphan announced on Monday that its subsidiary hVIVO has signed a £10.4m contract with an existing, unnamed top-five global pharmaceutical client to manufacture a new batch of H1N1 flu challenge virus, and to conduct a human challenge trial to test the client's antiviral product.

The AIM-traded firm said the study would evaluate the efficacy profile of the antiviral against the specific flu subtype, generating data quickly and efficiently.

It would be the third human challenge contract signed with the client, which the board said highlighted the company's “leading expertise” and the “clear benefits” of human challenge trials to big pharma's drug development process.

Good manufacturing practice (GMP)-compliant virus manufacturing activities would start immediately, and were expected to be completed by the second quarter of 2023.

Once that was finished, hVIVO would conduct a phase 2a double-blinded placebo-controlled human challenge study, which was expected to be completed by the fourth quarter of 2023.

The company said hVIVO would recruit healthy volunteers through its dedicated volunteer recruitment arm, FluCamp.

It said the majority of revenue from the contract was expected to be recognised in 2023.

“We're delighted to be working again with this top-five global pharmaceutical company to test its antiviral, using a new influenza strain developed by our highly experienced team,” said Open Orphan's chief executive officer Mo Khan.

“This contract is the third challenge study with this client, and our second end-to-end full-service contract overall.

“Our one-stop shop service offerings from manufacturing bespoke challenge agents to conducting full challenge studies is unique in the market.”

Khan said he was confident that, with the firm’s “highly-qualified teams” and their clinical development expertise, it was well-placed to address the growing infectious disease and respiratory research markets.

“Influenza poses a serious global health threat, causing an estimated 290,000 to 650,000 deaths per year with significant pandemic potential, and as such, the development of new vaccines and antivirals to fight flu remains vitally important.”

At 0935 BST, shares in Open Orphan were up 4.99% at 11.81p.

Reporting by Josh White at Sharecast.com.