ORPH.L Regulatory News (ORPH)

Open Orphan plc

("Open Orphan" or the "Company")

Contract extension with Carna Biosciences

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces a further contract renewal with Carna Biosciences, Inc. ("Carna"), extending its integrated drug development consultancy services with Venn Life Sciences ("Venn"), part of Open Orphan plc.

Carna Biosciences is a clinical-stage biopharmaceutical company which focuses on the discovery and development of innovative therapies to treat serious unmet medical needs, focusing on small molecule drugs. The renewal of this contract is expected to deliver significant revenue for Venn over the next twelve months.

The Venn team in the Breda office in the Netherlands, will provide Chemistry, Manufacturing & Control (CMC), Non-Clinical, Clinical and Regulatory consultancy services to this client for two of the client's leading development programmes. This successful collaboration has been extended until the end of December 2021.

Cathal Friel, Executive Chairman of Open Orphan, said: "The extension of this contract further demonstrates our ability to collaborate successfully with our clients and provide a service that results in repeat business. Venn and Carna have built up a good working relationship over a period of several years where both parties closely collaborated on drug development planning and its execution through consultancy services contracts. We look forward to delivering this contract for Carna in the year ahead."

Masaaki Sawa, Ph.D., Chief Scientific Officer and Head of Research and Development at Carna Biosciences, said: "The partnership with Venn Life Sciences complements our clinical development team and underlines our commitment to become a clinical stage company. By continuing the collaboration with the Venn team, we will accelerate our drug development."

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Notes to Editors 

About Carna Biosciences, Inc. (www.carnabio.com/english)

Carna Biosciences is a clinical-stage biopharmaceutical company founded in April 2003 in Kobe, Japan to discover and develop innovative therapies to treat serious unmet medical needs, focusing on small molecule drugs, mainly targeting kinases. We also offer a broad range of high-quality products and innovative drug discovery services to scientists worldwide to help efficiently identify new kinase inhibitors.

About Open Orphan plc (www.openorphan.com)

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe's only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO's challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com. The hVIVO facility offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development. Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.

The Company has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. hVIVO also works with companies in the UK and Ireland to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its COVID Clear offering. 

Open Orphan comprises of two commercial specialist CRO services businesses, hVIVO  and  Venn Life Sciences and is also building out a valuable data platform business. hVIVO has built up one of the world's largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteers via wearables during clinical trials. Therefore, Open Orphan's data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc. Venn is an integrated drug development consultancy firm which offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company's customer base and with complementary specialist CRO services, widened the range of the Company's service offerings.