hVIVO Regulatory News (HVO)

hVIVO plc

("hVIVO" or the "Company")

FDA grants Breakthrough Therapy and Fast Track designations to SAB Biotherapeutics' influenza candidate

Data from hVIVO Phase 2a influenza human challenge trial instrumental in FDA decisions

hVIVO plc (AIM & Euronext: HVO), (formerly Open Orphan plc) a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, notes the announcements dated 13 April 2023 and 18 April 2023 from SAB Biotherapeutics (NASDAQ: SABS) ("SAB"), reporting that the US Food and Drug Administration ("FDA") has granted Breakthrough Therapy and Fast Track designations for its investigational therapeutic for the treatment of seasonal influenza, SAB-176. hVIVO conducted a Phase 2a human challenge trial to assess the efficacy of SAB-176 using its Influenza Human Challenge Study Model.

Both FDA designations are designed to expedite the development and review of medicines that are intended to treat a serious or life-threatening condition. Breakthrough Therapy designation confers more benefits than Fast Track products and requires that preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over therapies currently available on a clinically significant endpoint(s). A significant portion of the evidence submitted to achieve the designations was data from the successful challenge study conducted by hVIVO.

SAB-176 is a novel, highly potent immunotherapy that is grounded in fundamentals of the natural immune response to neutralise Type A and Type B influenza viruses, which mutate rapidly. The randomised, double-blinded, placebo-controlled Phase 2a challenge trial conducted by hVIVO showed SAB-176 offers broad cross protection that included strains of influenza that were not specifically targeted in the original manufacturing of the therapeutic.

hVIVO has three decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of influenza, respiratory syncytial virus (RSV), human rhinovirus (HRV - common cold virus), COVID-19, asthma, as well as malaria.

Alex Mann, Senior Director Clinical Science of hVIVO, said: "hVIVO's range of influenza challenge models, utilising different influenza challenge agents manufactured in-house, allows our clients to test their therapeutics against various virus strains and subtypes."

"The broad-spectrum efficacy of SAB-176 was demonstrated in our Phase 2a human challenge study against an influenza strain that was not specifically targeted in the manufacturing of the therapeutic. The clinical efficacy data formed an integral part of the package enabling the FDA's decision to grant Fast Track and Breakthrough Therapy designations and underlines the value of rapid efficacy data achievable only through human challenge trials. Validation of a candidate's clinical potential, as well as the expedited review process can be a key inflection point for the asset and company value, particularly for biotechnology clients such as SAB Biotherapeutics. I look forward to monitoring SAB-176's progress as it advances through later stage clinical development."

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Notes to Editors

About hVIVO

hVIVO plc (ticker: HVO) (formerly Open Orphan plc) is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and therapeutics using human challenge clinical trials. The Group provides end-to-end early clinical development services to its large, established and growing repeat client base, which includes four of the top 10 largest global biopharma companies.

The Group's fast-growing services business includes a unique portfolio of 11 human challenge models, with a number of new models under development, to test a broad range of infectious and respiratory disease products. The Company has world class challenge agent manufacturing, specialist drug development and clinical consultancy services via its Venn Life Sciences brand, and a lab offering via its hLAB brand, which includes virology, immunology biomarker and molecular testing. The Group offers additional clinical field trial services such as patient recruitment and clinical trial site services.

hVIVO runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capability via its FluCamp volunteer screening facilities in London and Manchester.

About SAB Biotherapeutics

SAB Biotherapeutics, Inc. (SAB) is a clinical-stage biopharmaceutical company focused on the development of powerful and proprietary immunotherapeutic polyclonal human antibodies to treat and prevent infectious diseases and immune and autoimmune disorders. Our development programs include infectious diseases resulting from outbreaks and pandemics, as well as immunological, gastroenterological, and respiratory diseases that have significant mortality and health impacts on immune compromised patients. SAB has applied advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™. Our versatile DiversitAb™ platform is applicable to a wide range of serious unmet needs in human diseases. It produces natural, specifically targeted, high-potency, fully-human polyclonal immunotherapies without the need for human donors. SAB currently has multiple drug development programs underway and collaborations with the US government and global pharmaceutical companies. For more information on SAB, visit: https://www.SAb.bio/ and follow SAB on Twitter and LinkedIn.