VHsquared is focused on creating innovative antibody domains that are designed to remain stable within the gastrointestinal tract. These novel antibodies will be used to develop a range of functional food products aimed at addressing gastrointestinal infections and immune-mediated diseases. The company utilizes domain antibodies that are engineered to resist degradation in the gut and are locally active in the gastrointestinal tract. These products are expected to offer advantages in terms of specificity, safety, efficacy, convenience, and cost.

Tags

Digestive System Disorders

Bispecific antibody

Disease domain score

A glimpse into the focused therapeutic areas

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Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Top 5 Drug Type	Count

Bispecific antibody	1

Top 5 Target	Count

IL-23p19 x TNF-α	1

Drugs associated with VHsquared Ltd.

V56B2

Target

IL-23p19 x TNF-α

Mechanism

IL-23p19 inhibitors [+1]

Active Org.

VHsquared Ltd.

Originator Org.

VHsquared Ltd.

Active Indication

Colitis, Ulcerative [+1]

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

V-565

Target

TNF-α

Mechanism

TNF-α inhibitors

Active Org.-

Originator Org.

VHsquared Ltd.

Active Indication-

Inactive Indication

Colitis, Ulcerative [+1]

Drug Highest PhasePending

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with VHsquared Ltd.

NCT03705117 / CompletedPhase 1

An Open-label Exploratory Study in Patient Volunteers With Ulcerative Colitis (UC), to Investigate Lamina Propria Presence and Evidence of Biological Effect of the Oral Domain Antibody V565

The purpose of the study is to confirm that V565 enters inflamed tissue, binds to TNF and reduces inflammation after oral dosing to patients with IBD.

Start Date23 May 2017

Sponsor / Collaborator

VHsquared Ltd.

NCT02976129 / CompletedPhase 2

Phase 2 Study to Investigate the Efficacy, Safety, and Tolerability of Six Weeks Treatment With V565 in Subjects With Active Crohn's Disease

The purpose of this study is to evaluate the efficacy and safety of V565 in participants with active Crohn's Disease (CD).

Start Date01 Dec 2016

Sponsor / Collaborator

VHsquared Ltd.

NCT03010787 / CompletedPhase 1

A Four Part, Phase 1, First Time in Human, Single Centre Study in Healthy Male Subjects, Patient Volunteers With Crohn's Disease and in Healthy Patient Volunteers With a Terminal Ileostomy

A multi-part study to investigate the safety, tolerability and local and systemic pharmacokinetics of V565

Start Date01 Sep 2015

Sponsor / Collaborator

VHsquared Ltd.

100 Clinical Results associated with VHsquared Ltd.

0 Patents (Medical) associated with VHsquared Ltd.

Literatures (Medical) associated with VHsquared Ltd.

04 Mar 2019·Drug Development and Industrial PharmacyQ4 · MEDICINE

Oral delivery of the anti-tumor necrosis factor α domain antibody, V565, results in high intestinal and fecal concentrations with minimal systemic exposure in cynomolgus monkeys

Q4 · MEDICINE

Article

Author: Roberts, Kevin J. ; Crowe, J. Scott ; Carlton, Timothy M. ; West, Michael R. ; Robinson, Jan R. ; Whale, Gary A. ; Maggiore, Luana ; Wahlich, John C. ; Ray, Keith P. ; Donnelly, Mary C. ; Cubitt, Marion F. ; Humphreys, Jonathan I.

OBJECTIVEV565 is a novel oral anti-tumor necrosis factor (TNF)-α domain antibody being developed for topical treatment of inflammatory bowel disease (IBD) patients. Protein engineering rendered the molecule resistant to intestinal proteases. Here we investigate the formulation of V565 required to provide gastro-protection and enable optimal delivery to the lower intestinal tract in monkeys.METHODSEnteric-coated V565 mini-tablets were prepared and dissolution characteristics tested in vitro. Oral dosing of monkeys with enteric-coated mini-tablets containing V565 and methylene blue dye enabled in vivo localization of mini-tablet dissolution. V565 distribution in luminal contents and feces was measured by enzyme-linked immunosorbent assay (ELISA). To mimic transit across the damaged intestinal epithelium seen in IBD patients an intravenous (i.v.) bolus of V565 was given to monkeys and pharmacokinetic parameters of V565 measured in serum and urine by ELISA.RESULTSEnteric-coated mini-tablets resisted dissolution in 0.1 M HCl, before dissolving in a sustained release fashion at neutral pH. In orally dosed monkeys methylene blue intestinal staining indicated the jejunum and ileum as sites for mini-tablet dissolution. Measurements of V565 in monkey feces confirmed V565 survival through the intestinal tract. Systemic exposure after oral dosing was very low consistent with limited V565 mucosal penetration in healthy monkeys. The rapid clearance of V565 after i.v. dosing was consistent with renal excretion as the primary route for elimination of any V565 reaching the circulation.CONCLUSIONSThese results suggest that mini-tablets with a 24% Eudragit enteric coating are suitable for targeted release of orally delivered V565 in the intestine for topical treatment of IBD.

Scientific ReportsQ3 · CROSS-FIELD

Preclinical development of a bispecific TNFα/IL-23 neutralising domain antibody as a novel oral treatment for inflammatory bowel disease

Q3 · CROSS-FIELD

ArticleOA

Author: Crowe, J Scott ; Cubitt, Marion F ; Carlton, Timothy M ; West, Michael R ; Maggiore, Luana ; Clare, Simon ; Harcourt, Katherine ; Roberts, Kevin J ; Vossenkämper, Anna ; MacDonald, Thomas T ; Chai, Ray ; Ray, Keith P ; Rodrigues-Duarte, Lurdes

AbstractAnti-TNFα and anti-IL-23 antibodies are highly effective therapies for Crohn’s disease or ulcerative colitis in a proportion of patients. V56B2 is a novel bispecific domain antibody in which a llama-derived IL-23p19-specific domain antibody, humanised and engineered for intestinal protease resistance, V900, was combined with a previously-described TNFα-specific domain antibody, V565. V56B2 contains a central protease-labile linker to create a single molecule for oral administration. Incubation of V56B2 with trypsin or human faecal supernatant resulted in a complete separation of the V565 and V900 monomers without loss of neutralising potency. Following oral administration of V900 and V565 in mice, high levels of each domain antibody were detected in the faeces, demonstrating stability in the intestinal milieu. In ex vivo cultures of colonic biopsies from IBD patients, treatment with V565 or V900 inhibited tissue phosphoprotein levels and with a combination of the two, inhibition was even greater. These results support further development of V56B2 as an oral therapy for IBD with improved safety and efficacy in a greater proportion of patients as well as greater convenience for patients compared with traditional monoclonal antibody therapies.

Scientific ReportsQ3 · CROSS-FIELD

Preclinical Development of a Novel, Orally-Administered Anti-Tumour Necrosis Factor Domain Antibody for the Treatment of Inflammatory Bowel Disease

Q3 · CROSS-FIELD

ArticleOA

Author: Cubitt, Marion F ; Vossenkämper, Anna ; Reckless, Jill ; West, Michael R ; MacDonald, Thomas T ; Maggiore, Luana ; Clare, Simon ; Carlton, Timothy M ; Harcourt, Katherine ; Roberts, Kevin J ; Ray, Keith P ; Crowe, J Scott

AbstractTNFα is an important cytokine in inflammatory bowel disease. V565 is a novel anti-TNFα domain antibody developed for oral administration in IBD patients, derived from a llama domain antibody and engineered to enhance intestinal protease resistance. V565 activity was evaluated in TNFα-TNFα receptor-binding ELISAs as well as TNFα responsive cellular assays and demonstrated neutralisation of both soluble and membrane TNFα with potencies similar to those of adalimumab. Although sensitive to pepsin, V565 retained activity after lengthy incubations with trypsin, chymotrypsin, and pancreatin, as well as mouse small intestinal and human ileal and faecal supernatants. In orally dosed naïve and DSS colitis mice, high V565 concentrations were observed in intestinal contents and faeces and immunostaining revealed V565 localisation in mouse colon tissue. V565 was detected by ELISA in post-dose serum of colitis mice, but not naïve mice, demonstrating penetration of disrupted epithelium. In an ex vivo human IBD tissue culture model, V565 inhibition of tissue phosphoprotein levels and production of inflammatory cytokine biomarkers was similar to infliximab, demonstrating efficacy when present at the disease site. Taken together, results of these studies provide confidence that oral V565 dosing will be therapeutic in IBD patients where the mucosal epithelial barrier is compromised.

News (Medical) associated with VHsquared Ltd.

15 Jul 2024

·www.prnewswire.com

SKYRIZI's Approval For Ulcerative Colitis Treatment Expands AbbVie's Portfolio Across Immune-mediated Inflammatory Diseases | DelveInsight

AbbVie's rapidly expanding Humira successor, SKYRIZI, is already achieving impressive sales growth. This IL-23 inhibitor is set to capture an even greater portion of Humira's diminishing market share with its crucial expansion into treating ulcerative colitis. LAS VEGAS, July 15, 2024 /PRNewswire/ -- Ulcerative colitis is an idiopathic inflammatory bowel disease affecting ~1.5 million patients in the US and with an unknown exact cause. It affects the colonic mucosa and is clinically characterized by diarrhea, stomach discomfort, pain, and hematochezia. The disease's extent varies, affecting either the rectum, the splenic flexure of the left side of the colon, or the whole of the rectum and bowel. As per DelveInsight analysis, the total ulcerative colitis diagnosed prevalent cases in the 7MM comprised approximately 3 million cases in 2023 and are projected to increase by 2034. Per analyst estimates, approximately 60% of cases accounted for moderate to severe cases of ulcerative colitis among the 7MM. The current treatments for ulcerative colitis depend on the severity of the disease and are broadly divided into six classes, comprising conventional therapies, Anti-TNFs, Anti-integrin agents, IL-12/IL-23 dual inhibitors, S1P-receptor modulators, and JAK inhibitors. The emergence of several mechanisms of action, like LANCL2 protein stimulators, miR-124 enhancers, tumor necrosis factor (TNF)-like ligand 1A inhibitors, toll-like receptor 9 agonists, and others will be expanding the treatment landscape of ulcerative colitis. There have been significant advancements in treating ulcerative colitis over the years. However, safety remains a major challenge. The lack of a safer and curative treatment option severely impacts patients' quality of life and daily activities. While current treatments are effective for some patients with ulcerative colitis, others need multiple lines of therapy, indicating a need for alternative treatments to achieve disease control. Several major pharmaceutical companies are collaborating to develop new solutions to address these issues. Learn more about the FDA-approved ulcerative colitis drugs @ Drugs for Ulcerative Colitis Treatment A few FDA-approved drugs for ulcerative colitis treatment include SIMPONI (Janssen Pharmaceuticals), ENTYVIO (Takeda Pharmaceuticals), OMVOH (Eli Lilly) VELSIPITY (Arena Pharmaceuticals/Pfizer), and SKYRIZI (AbbVie). SIMPONI is a human monoclonal antibody that targets and neutralizes excess tumor necrosis factor (TNF)-alpha, a protein associated with inflammation and tissue damage in chronic inflammatory diseases. It is the first subcutaneous anti-TNF-alpha treatment administered every four weeks as maintenance therapy for ulcerative colitis. Approved for treating moderately to severely active ulcerative colitis in adults, SIMPONI is also being evaluated in ongoing trials for pediatric patients with the same condition. Vedolizumab is a humanized monoclonal antibody that targets and inhibits the alpha 4 beta 7 integrin, preventing it from binding to the intestinal mucosal addressing cell adhesion molecule 1 (MAdCAM-1). This integrin is found in a subset of circulating white blood cells that play a role in the inflammatory processes of ulcerative colitis and Crohn's disease. By blocking the alpha 4 beta 7 integrin, vedolizumab may reduce the infiltration of these white blood cells into gut tissues. It is currently approved as an IV and SC formulation for the treatment of moderately to severely active ulcerative colitis in adults who have not responded to, lost response to, or were intolerant to conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist. VELSIPITY (Etrasimod) is an innovative, once-daily oral medication that acts as a highly selective modulator of the sphingosine 1-phosphate (S1P) receptor. Discovered by Arena, it is designed for optimized interaction with S1P receptors 1, 4, and 5, potentially offering better efficacy and safety. Etrasimod targets specific immune cells both systemically and locally and has the potential to treat various immune-mediated inflammatory diseases, such as Crohn's disease and ulcerative colitis. It is currently approved by the FDA and EMA for adults with moderately to severely active ulcerative colitis who have not responded adequately, lost response, or were intolerant to conventional or advanced therapies. Recently, on 18 June 2024, the FDA approved SKYRIZI for treating adult patients with moderately to severely active ulcerative colitis. This approval extends the drug's reach to approximately 1 million US patients and makes SKYRIZI the first IL-23 inhibitor approved for both UC and Crohn's disease, the two types of inflammatory bowel disease (IBD). After a 12-week induction period, patients can self-administer the medication at home using an on-body injector device, which AbbVie's press release describes as "designed with patients in mind." The device attaches to the body and delivers the medication in about five minutes. Since its approval for Crohn's in 2022, Skyrizi has emerged as a strong competitor to Johnson & Johnson's blockbuster drug STELARA in the IBD market. The AbbVie medication has captured a "significant share" of STELARA's sales. To know more about ulcerative colitis treatment options, visit @ New Treatment for Ulcerative Colitis The ulcerative colitis market is crowded with so many companies including Arena Pharmaceuticals, Pfizer, Abivax, Reistone Biopharma, InDex Pharmaceuticals, AbbVie, Boehringer Ingelheim, Janssen Pharmaceuticals, Landos Biopharma, NImmune, Merck, Mesoblast, and others are running clinical trials to improve the treatment space. The ulcerative colitis pipeline possesses potential drugs in mid-stage developments to be launched shortly. Some of the promising drugs in the pipeline include TREMFYA, ABX464, BT-11 (Omilancor), PRA023, Remestemcel-L, SHR0302 (Ivarmacitinib), and others that hold the potential to create a significant positive shift in the ulcerative colitis market size. Discover which therapies are expected to grab major ulcerative colitis market share @ Ulcerative Colitis Market Report TREMFYA (guselkumab) is a human monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, created by Janssen. IL-23 plays a crucial role in the pathogenesis of inflammatory diseases like ulcerative colitis and Crohn's disease. TREMFYA, an IL-23 inhibitor, is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody, produced in a mammalian cell line using recombinant DNA technology. It specifically binds to the p19 subunit of IL-23 and blocks its interaction with the IL-23 receptor. In May 2024, Johnson & Johnson released the initial data from the Phase III QUASAR maintenance study in ulcerative colitis, which achieved its primary endpoint and all major secondary endpoints, including highly statistically significant rates of endoscopic remission. Based on these findings, the company has submitted a supplemental Biologics License Application (sBLA) to the FDA. SHR0302, developed by Reistone Biopharma, is an innovative and potent oral JAK1 inhibitor aimed at treating inflammatory bowel diseases like ulcerative colitis and Crohn's disease. Due to its selectivity for JAK1, it may offer a safer and more effective alternative to pan-JAK inhibitors. Ongoing long-term clinical studies are investigating whether JAK1 selectivity can minimize hematological side effects associated with JAK2 inhibition, aiming to confirm a favorable risk-benefit profile (Reistone Biopharma, 2021a). SHR0302 is currently being tested in a Phase III clinical trial (NCT05181137) for the treatment of moderate to severe ulcerative colitis in adults. Discover more about drugs for ulcerative colitis in development @ Ulcerative Colitis Clinical Trials The anticipated launch of these emerging therapies for ulcerative colitis are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the ulcerative colitis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for ulcerative colitis is expected to grow from USD 8.4 billion in 2023 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the disease. The anticipated launch of these therapies is also expected to attract new entrants to the ulcerative colitis market, resulting in increased competition and innovation. DelveInsight's latest published market report titled as Ulcerative Colitis Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the ulcerative colitis country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The ulcerative colitis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Ulcerative Colitis Age-specific Cases of Ulcerative Colitis Severity-specific Cases of Ulcerative Colitis Total Treated Patients of Ulcerative Colitis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM ulcerative colitis market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this ulcerative colitis market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the ulcerative colitis market. Also, stay abreast of the mitigating factors to improve your market position in the ulcerative colitis therapeutic space. Related Reports Ulcerative Colitis Epidemiology Forecast Ulcerative Colitis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted ulcerative colitis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Ulcerative Colitis Pipeline Ulcerative Colitis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ulcerative colitis companies, including Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, GlaxoSmithKline, Galapagos, Celgene, Gossamer Bio, Eisai, UCB, Suzhou Connect Biopharmaceuticals, Landos Biopharma, Seres Therapeutics, Abivax, Genentech, ParaTech A/S, I-Mab Biopharma, Sublimity Therapeutics Holdco, Reistone Biopharma, Qu Biologics, PurGenesis Technologies, Protagonist Therapeutics, Pfizer, Palobiofarma, Novartis Pharmaceuticals, Bristol-Myers Squibb, Bridge Biotherapeutics, Amgen, Allergan, Applied Molecular Transport, AbGenomics International, Protalix BioTherapeutics, LTT Bio-Pharma Co Ltd, Dongwha pharma, Seres Therapeutics, Innovation Pharmaceuticals, Holy Stone Healthcare, SLA Pharma, OSE Immunotherapeutics, Bridge Biotherapeutics, Mitsubishi Tanabe Pharma, Sterna Biologicals, Mesoblast, Oncostellae, First Wave Bio, Oppilan Pharma, NeuClone, Morphic Therapeutic, Metacrine, LG Chem, Koutif Therapeutics, Kiniksa Pharmaceuticals, Avaxia Biologics, Algernon Pharmaceuticals, Akeso Biopharma, Kaleido Biosciences, Rebiotix, Prometheus Biosciences, PNB Vesper Life Science, Pandion Therapeutics, Palatin Technologies, Theravance Biopharma, VHsquared, Seres Therapeutics, Hoffmann-La Roche, Provention Bio, Bacainn Therapeutics, Landos Biopharma, Bristol-Myers Squibb, Janssen Research & Development, GlaxoSmithKline, Assembly Biosciences, NuBiyota, Tarus Therapeutics, Servatus, Athos Therapeutics, Aclaris Therapeutics, Exeliom Biosciences SAS, Voronoi Group, Ventria Bioscience, TheraSource LLC, Synlogic Inc, Synedgen, Surrozen Inc, StemRIM Inc, Shaperon Inc, Sareum Holdings, Saniona, RhemaStem, Regentys, Progenity, Pharmaxis, Pharmabiome, PanTheryx, Oncodesign, Nyrada, Microbiotica, MAKScientific, KoBioLabs, Istesso, Intract Pharma, Innovimmune Biotherapeutics, Impetis Biosciences, Finch Therapeutics Group, Vivreon Biosciences, NuMedii, Intact Therapeutics, Giiant Pharma, among others. Crohn's Disease Market Crohn's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Crohn's disease companies, including Celgene, AstraZeneca, Abbvie, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, Amgen, Priothera, SLA Pharma, HAV Vaccines Ltd, Enzo Biochem Inc., VHsquared Ltd., among others. Irritable Bowel Syndrome Market Irritable Bowel Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key irritable bowel syndrome companies, including Arena Pharmaceuticals, 4D Pharma, OrphoMed, Boston Pharmaceuticals, RedHill Biopharma Limited, Takeda, Cosmo Technologies, CinRx Pharma, Rottapharm, Synthetic Biologics, Biomica, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

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100 Deals associated with VHsquared Ltd.

100 Translational Medicine associated with VHsquared Ltd.

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Pipeline Snapshot as of 29 Sep 2024

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Drug(Targets)	Indications	Global Highest Phase

V56B2 ( IL-23p19 x TNF-α )	Colitis, Ulcerative More	Preclinical
V-565 ( TNF-α )	Colitis, Ulcerative More	Pending

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