A Phase 1/2 Open-Label, Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors

The purpose of the study is to characterize the safety and pharmacokinetic (PK) profile of UCB6114 administered as monotherapy or in combination with selected standard of care (SOC) regimens.

Start Date09 Jul 2020

Sponsor / Collaborator

UCB Biopharma SRL

100 Clinical Results associated with Ginisortamab

100 Translational Medicine associated with Ginisortamab

100 Patents (Medical) associated with Ginisortamab

Literatures (Medical) associated with Ginisortamab

31 Dec 2023·mAbs

Discovery of ginisortamab, a potent and novel anti-gremlin-1 antibody in clinical development for the treatment of cancer

Article

Author: West, Shauna ; Rowley, Tania F ; Ottone, Cristina ; Kevorkian, Lara ; Wright, Michael ; Dedi, Neesha ; Davies, Gareth C G ; Jones, Paul S ; Scott-Tucker, Anthony ; Schulze, Monika-Sarah E D ; Tewari, Roohi ; McMillan, David

Gremlin-1, a high-affinity antagonist of bone morphogenetic proteins (BMP)-2, -4, and -7, is implicated in tumor initiation and progression. Increased gremlin-1 expression, and therefore suppressed BMP signaling, correlates with poor prognosis in a range of cancer types. A lack of published work using therapeutic modalities has precluded the testing of the hypothesis that blocking the gremlin-1/BMP interaction will provide benefits to patients. To address this shortfall, we developed ginisortamab (UCB6114), a first-in-class clinical anti-human gremlin-1 antibody, currently in clinical development for the treatment of cancer, along with its murine analog antibody Ab7326 mouse immunoglobulin G1 (mIgG1). Surface plasmon resonance assays revealed that ginisortamab and Ab7326 mIgG1 had similar affinities for human and mouse gremlin-1, with mean equilibrium dissociation constants of 87 pM and 61 pM, respectively. The gremlin-1/Ab7326 antigen-binding fragment (Fab) crystal structure revealed a gremlin-1 dimer with a Fab molecule bound to each monomer that blocked BMP binding. In cell culture experiments, ginisortamab fully blocked the activity of recombinant human gremlin-1, and restored BMP signaling pathways in human colorectal cancer (CRC) cell lines. Furthermore, in a human CRC - fibroblast co-culture system where gremlin-1 is produced by the fibroblasts, ginisortamab restored BMP signaling in both the CRC cells and fibroblasts, demonstrating its activity in a relevant human tumor microenvironment model. The safety and efficacy of ginisortamab are currently being evaluated in a Phase 1/2 clinical trial in patients with advanced solid tumors (NCT04393298).

18 Feb 2022·International Journal of OphthalmologyQ4 · MEDICINE

Inhibitory effect on subretinal fibrosis by anti-placental growth factor treatment in a laser-induced choroidal neovascularization model in mice

Q4 · MEDICINE

ArticleOA

Author: Zhou, Ai-Yi ; Zhang, Yi ; Yang, Xi-Ting ; Wang, Jian-Ming ; Wang, Li-Jun ; Liao, Ding-Ying

AIM: To investigate whether anti-placental growth factor (PGF) can inhibit subretinal fibrosis and whether this effect is mediated by the inhibitory effect of PGF on epithelial-mesenchymal transition (EMT) of retinal pigment epithelial (RPE) cells. METHODS: Subretinal fibrosis model was established in laser induced choroidal neovascularization (CNV) mice on day 21 after laser photocoagulation. Immunofluorescence staining (IFS) of cryosections and enzyme-linked immunosorbent assay (ELISA) were used to detect the expression of PGF. IFS of whole choroidal flat-mounts was used to detect the degree of subretinal fibrosis. IFS of cryosections and ELISA were used to detect the expression of EMT related indicators in subretinal fibrosis lesions. RESULTS: The expression of PGF protein in subretinal fibrosis lesions was significantly up-regulated (P&#x003C;0.05), and mainly co-stained with pan-cytokeratin labeled RPE cells. Intravitreal injection of anti-PGF neutralizing antibody reduced the area of subretinal fibrosis and the ratio of fibrotic/angiogenic area significantly at the concentrations of 0.25, 0.5, 1.0, and 2.0 μg/μL (all P&#x003C;0.05). The expression of E-cadherin in the local RPE cells decreased, while α-SMA increased significantly in subretinal fibrosis lesions, and the application of anti-PGF neutralizing antibody could reverse these changes (P&#x003C;0.05). CONCLUSION: The expression of PGF is up-regulated in the lesion site of subretinal fibrosis and mainly expressed in RPE cells. Intravitreal injection of anti-PGF neutralizing antibody can significantly inhibit the degree of subretinal fibrosis in CNV mice, and this effect may be mediated by the inhibition of PGF on EMT of RPE cells.

01 Nov 2015·Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery

[EPIDERMAI GROWTH FACTOR SECRETED BY ASTROCYTES STIMULATED WITH TACROLIMUS PROMOTING NEURITE OUTGROWTH].

Article

Author: Cao, Xiaojian ; Cai, Jun ; Ge, Yingbin ; Sun, Yu

OBJECTIVETo illustrate the role of epidermal growth factor (EGF) secreted by astrocytes in the process of tacrolimus (FK506) in promoting neurite outgrowth.METHODSThe spinal cord astrocytes and neuronal cells were isolated respectively from 2-day-old Sprague Dawley (SD) rats and 15-day SD pregnant rats, and cultured in vitro and identified by immunofluorescence staining. The spinal cord astrocytes were cultured with 20 µmol/L FK506 medium in the experimental group, and with FK506 free medium in the control group. The supernatant was collected after 24 hours for preparing conditioned medium, and astrocytes were collected. EGF proteins in the conditioned medium were detected with ELISA, and EGF gene expressions of astrocytes were detected with real-time quantitative PCR (RT-qPCR). The spinal cord neurons were cultured respectively with conditioned medium from the experimental group (FK506-CM) and the control group (C-CM) in group A and group B, also with neutralized C-CM and neutralized FK506-CM with anti-EGF neutralizing antibodies in group C and group D. Both the total neurite length and the longest neurite length were measured and compared among groups.RESULTSBoth astrocytes and neurons were confirmed by immunofluorescence staining. The EGF content of experimental group (0.241 ± 0.044) was significantly higher than that of the control group (0.166 ± 0.014) (t = 3.93, P = 0.01); EGF gene expression of the experimental group (1.12 ± 0.25) was significantly higher than that of the control group (0.46 ± 0.11) (t = 5.78, P = 0.00). The neurite length measurement displayed that the total neurite length and the longest neurite length of groups C and D were significantly shorter than those of groups A and B (P < 0.05). Both the total and longest neurite length of group A were significantly longer than those of group B (P < 0.05), but no significant difference was shown between groups C and D (P > 0.05).CONCLUSIONThe EGF secreted by spinal cord astrocytes can promote the neurite outgrowth. So spinal cord astrocytes can be used as an important intermediary target of FK506 to promote the recovery of neurological function.

News (Medical) associated with Ginisortamab

09 Mar 2023

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UCB and Cancer Research UK partner for oncology antibody candidates

The collaboration will focus on the development of UCB’s UCB6114 and UCB4594 investigational antibody candidates. Credit: Tatiana / Pixabay. Global biopharmaceutical firm UCB and Cancer Research UK have entered a multi-project partnership to advance two of the former’s oncology antibody candidates through clinical trials. Free Whitepaper PepSetsTM and their Applications Peptide libraries are a powerful tool in biological research for screening large numbers of peptides in the search for the few, critical bioactive peptides. Mimotopes PepSets are custom-synthesized peptide libraries supplied unpuried for fast, efcient screening work. These sets of chemically synthesized individual peptides are made on a small scale using Mimotopes’ unique proprietary parallel array synthesis platform. PepSets comprising hundreds, or even thousands of peptides, are rapidly synthesized and shipped within a few weeks of ordering. 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British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo Submit By clicking the Download Free Whitepaper button, you accept the terms and conditions and acknowledge that your data will be used as described in the Mimotopes Thematic privacy policy By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Whitepaper. The clinical development partnership will focus on the development of UCB6114 and UCB4594 investigational antibody candidates. It will combine Cancer Research UK’s oncology-focused translational research and clinical development capabilities and the antibody discovery expertise of UCB . If the clinical trials are successful, these candidates might have the potential to provide access to new targeted treatment options for cancer patients. The potential first-in-class antibody UCB6114 targets a glycoprotein secreted by the tumour stroma, gremlin-1. UCB4594 targets the immune checkpoint, human leukocyte antigen G, which is also called HLA-G. Under the partnership, the Centre for Drug Development of Cancer Research UK will appoint the chief clinical and scientific investigators. It will also lead the design, preparation, funding, and delivery of Phase I/II studies for both candidates, while UCB will continue their manufacturing. UCB will also be responsible for completing the ongoing UCB6114 clinical study (ONC001) and performing other supporting works. UCB chief scientific officer Dhaval Patel said: “UCB’s strong research productivity together with our antibody expertise and desire to better understand and target the drivers of disease, has resulted in two novel and potentially disruptive candidates in oncology. “As these candidates move forward, we are happy to enter this collaboration with Cancer Research UK, where they will bring world-leading oncology expertise and access to a large network of clinical oncologists who can enable the clinical trials.” The company will retain exclusive rights for further development and commercialisation of both candidates and obtain a licence for the clinical trial results from Cancer Research UK. In return, UCB will make undisclosed success-based milestones and royalty payments to Cancer Research UK. Early R&D projects coverage on Pharmaceutical Technology is supported by Mimotopes . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper PepSetsTM and their Applications Peptide libraries are a powerful tool in biological research for screening large numbers of peptides in the search for the few, critical bioactive peptides. Mimotopes PepSets are custom-synthesized peptide libraries supplied unpuried for fast, efcient screening work. These sets of chemically synthesized individual peptides are made on a small scale using Mimotopes’ unique proprietary parallel array synthesis platform. PepSets comprising hundreds, or even thousands of peptides, are rapidly synthesized and shipped within a few weeks of ordering. 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Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 2	BE	UCB SA	30 Jan 2022
Advanced Malignant Solid Neoplasm	Phase 2	US	UCB Biopharma SRL	09 Jul 2020
Advanced Malignant Solid Neoplasm	Phase 2	GB	UCB Biopharma SRL	09 Jul 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04393298 (ONC001, AACR2023) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors	25	ginisortamab	(iauuesodyj) = zpfodrdejr aotwqdefxn (wcnowcbcot ) View more	Positive	14 Apr 2023

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