RCS - hVIVO PLC - FDA Breakthrough and Fast Track for US biotech

hVIVOAnnouncement

26/04/2023 07:00

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RNS Number : 4397X  hVIVO PLC  26 April 2023

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
(https://ir.sab.bio/news-releases/news-release-details/sab-biotherapeutics-granted-fast-track-designation-fda-sab-176)
and 18 April 2023
(https://ir.sab.bio/news-releases/news-release-details/sab-biotherapeutics-announces-us-fda-grants-breakthrough-therapy)
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."

 

For further information please contact:

 

 hVIVO plc                                       +44 (0) 20 7756 1300
 Yamin 'Mo' Khan, Chief Executive Officer

 Stephen Pinkerton, Chief Financial Officer

 Liberum Capital (Nominated Adviser and Joint Broker)                       +44 (0) 20 3100 2000
 Ben Cryer, Edward Mansfield, Phil Walker, Will King

 finnCap plc (Joint Broker)                                                +44 (0) 20 7220 0500
 Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)

 Davy (Euronext Growth Adviser and Joint Broker)                           +353 (0) 1 679 6363
 Anthony Farrell, Niall Gilchrist

 Walbrook PR (Financial PR & IR)                 +44 (0) 20 7933 8780 or hvivo@walbrookpr.com

 Stephanie Cuthbert / Phillip Marriage /         +44 (0) 7796 794 663 / +44 (0) 7867 984 082 /

Louis Ashe-Jepson
+44 (0) 7747 515 393

 

 

 

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
(https://eur05.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.flucamp.com%2F&data=05%7C01%7CCarol.Dalton%40openorphan.com%7Cfb9f1a50aaa9492d81ed08da875cca71%7C131abc777e104bbd90170559abc5d601%7C1%7C0%7C637971129881295595%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=fQdtQTHu9Bo70yRgWcZW5liNTXPYiWl9YayUA01E%2FlA%3D&reserved=0)
 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/
(https://www.globenewswire.com/Tracker?data=NqI-Iis9lATdxyoS0t5Ia6iXsCl_WnzRAcxMJKXSjc0QL9kvesLZejqnxF2r5JjEuXUOuI7_HeyfjQALP5uxWZNDWr2LkYWD0vorRaR72Z8rzfoxXj_OFEz2cMufjQe8N5_IKI9LhA0FFHLOOTAUJFweVQcHBLLRDRhoG1rzYr5Qt9XwPSt-KqrjaLgGkgoXQABEt6zY-Bav2CM6nSxZrrJH7NL5cBlmzk3gBDaJmvA=)
 and follow SAB on Twitter
(https://www.globenewswire.com/Tracker?data=9rrrsb6vW3dUDqIfNl76Jmz1_HAEHKTuTLlqOAvHAzus9aCSJ99L87BWhRkL7bEVWqOrA5np5OqeVMsfFpStg0mpCk20uzy200GF7DHe-Rlrm9SQ7aZB8T6Fk0Y2aLc6yyQckbOPAr0om83eDjkyC_TYXyjoNCHc5jYSDEtUr1nTOiAnWg4E8a_Rr0Lt2i_RwRH8dkjpZLfqzkg-HpOQImqu_f5pm-mqCFWvZSxRKfA=)
 and LinkedIn
(https://www.globenewswire.com/Tracker?data=umTXxmjUGkGQux-2y2nfUS-AFoh4ShI0nxOWetGad6-vYl4KIPAYohtKQjlMHtDjingbeF2BPTFTysfdRKDL_RhpTFyuumhzDvSEAYg3lVe2iHnhnKW2vLs8RaiFKVFYnsm2L6jKAf1hy_8RePPaYdSEQa_tB7UnHZxkf2TkU_zDH1oa8CZvynGvrgR2z12SwFoVD2cmA-LWLizdXYfeZ6mFaSLiSWM6hP_bQmsAOB3ZJOpqON7kHG5UQLM11G4ERRgfiJweplpImo9bKRh49Q==)
.

 

 

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