Delving into the Latest Updates on Begelomab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Begedina, anti-CD26 begelomab, murine anti-CD26 BT 5/9

+ [2]

Target

DPP-4

Mechanism

DPP-4 inhibitors(Dipeptidyl peptidase IV inhibitors)

Therapeutic Areas

Immune System Diseases

Active Indication-

Inactive Indication

Graft vs Host DiseaseSteroid Refractory Graft Versus Host Disease

Originator Organization

Adienne SA

Active Organization-

Inactive Organization

Adienne SA

Drug Highest PhaseDiscontinuedNDA/BLA

First Approval Date-

RegulationOrphan Drug (EU)

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Structure/Sequence

Sequence Code 319372741L

Source: *****

Sequence Code 319372666H

Source: *****

The objectives of this study are to determine the efficacy and safety of BEGEDINA® in subjects with steroid resistant acute graft versus host disease (GvHD). GvHD is a rare and complex immunological disease occurring in some recipients of allogeneic hematopoietic stem cell transplants (HSCTs) and affecting principally the skin, liver and gastrointestinal (GI) tissues. The disease is life threatening and may be acute or chronic and the first choice treatment for patients with acute GvHD (Grade II or higher) is the immunosuppressive corticosteroid hormone methylprednisolone. However, some GvHD patients may be resistant to this treatment leading to disease progression and a high rate of morbidity and mortality, primarily from infections and/or multi-organ failure. There are currently no other satisfactory therapies. BEGEDINA® is a therapeutic monoclonal antibody that recognises and binds to CD26 on CD4+ T lymphocytes. BEGEDINA® reduces the activity of CD26 in these cells and inhibits the immune response leading to improvement in patients that have shown steroid resistance. This study is therefore aimed at demonstrating that BEGEDINA® is a safe and effective treatment for steroid-resistant GvHD patients where no other such treatments are currently available.

Start Date01 Feb 2016

Sponsor / Collaborator

Adienne SA

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100 Clinical Results associated with Begelomab

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100 Translational Medicine associated with Begelomab

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100 Patents (Medical) associated with Begelomab

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6

Literatures (Medical) associated with Begelomab

02 Aug 2024·Expert Opinion on Investigational Drugs

New investigational drugs for steroid-refractory acute graft-versus-host disease: a review of the literature

Review

Author: Hamadani, Mehdi ; Kim, Na Hyun ; Abedin, Sameem

INTRODUCTIONSteroid-refractory acute graft-versus-host disease (SR-aGVHD) remains a formidable obstacle in the field of allogeneic hematopoietic cell transplantation (allo-HCT), significantly contributing to patient morbidity and mortality. The current therapeutic landscape for SR-aGVHD is limited, often yielding suboptimal results, thereby emphasizing the urgent need for innovative and effective treatments.AREAS COVEREDIn light of the pivotal REACH2 trial, ruxolitinib phosphate, a Janus kinase inhibitor, has gained prominence as the standard treatment for SR-aGVHD. Nevertheless, a considerable number of patients either do not respond to or cannot tolerate this therapy. This review delves into emerging treatments for SR-aGVHD, including mesenchymal stromal cells (MSCs), fecal microbiota transplantation (FMT), CD3/CD7 blockade, neihulizumab, begelomab, tocilizumab, and vedolizumab. While some of these agents have shown encouraging results in early-phase trials, issues such as treatment-related toxicities and inconsistent responses in larger studies highlight the necessity for ongoing research.EXPERT OPINIONCurrent trials exploring new agents and combination therapies offer hope for fulfilling the unmet clinical needs in SR-aGVHD, potentially leading to more effective and precise treatment strategies.

01 Apr 2022·Human ImmunologyQ4 · MEDICINE

Designing of a bispecific antibody against SARS-CoV-2 spike glycoprotein targeting human entry receptors DPP4 and ACE2

Q4 · MEDICINE

Article

Author: Ratnakar, Tadi Sai ; Mishra, Amit ; Ojha, Rupal ; Gurjar, Kiran ; Prajapati, Vijay Kumar

COVID-19 originated in Wuhan city, China, in 2019 erupted a global pandemic that had put down nearly 3 million lives and hampered the socio-economic conditions of all nations. Despite the available treatments, this disease is not being controlled totally and spreading swiftly. The deadly virus commences infection by hACE2 receptor and its co-receptors (DPP4) engagement with the viral spike protein in the lung alveolar epithelial cells, indicating a primary therapeutic target. The current research attempts to design an in-silico Bispecific antibody (BsAb) against viral spike glycoprotein and DPP4 receptors. Regdanvimab and Begelomab were identified to block the D614G mutated spike glycoprotein of SARS-CoV-2 and host DPP4 receptor, respectively. The designed BsAb was modified by using KIH (Knobs into Holes) and CrossMAb techniques to prevent heavy chain and light chain mispairings. Following the modifications, the site-specific molecular docking studies were performed, revealing a relatively higher binding affinity of BsAb with spike glycoprotein and DPP4 co-receptor than control BsAb. Also, for blocking the primary entry receptor, hACE2, an anti-viral peptide was linked to the Fc region of BsAb that blocks the hACE2 receptor by linker cleavage inside the infected host. Thus, the designed BsAb and anti-viral peptide therapy could be a promising triumvirate way to obstruct the viral entry by blocking the receptor engagement.

01 Aug 2020·Bone Marrow TransplantationQ3 · MEDICINE

Treatment of steroid resistant acute graft versus host disease with an anti-CD26 monoclonal antibody—Begelomab

Q3 · MEDICINE

Article

Author: Musso, Maurizio ; Selleri, Carmine ; Ciceri, Fabio ; Benedetti, Edoardo ; Sica, Simona ; Raiola, Anna Maria ; Bertaina, Alice ; Algeri, Mattia ; Zallio, Francesco ; Parma, Matteo ; Gualandi, Francesca ; Di Grazia, Carmen ; Angelucci, Emanuele ; Chiusolo, Patrizia ; Bacigalupo, Andrea ; Rambaldi, Alessandro ; Iori, Anna Paola ; Bonifazi, Francesca ; Martino, Massimo ; Onida, Francesco ; Prezioso, Lucia ; Risitano, Antonio ; Varaldo, Riccardo ; Borghero, Carlo ; Locatelli, Franco

We have treated 69 patients with steroid refractory acute graft versus host disease (SR-aGvHD), with an anti-CD26 monoclonal antibody (Begelomab): 28 patients in two prospective studies (EudraCT No. 2007-005809-21; EudraCT No. 2012-001353-19), and 41 patients on a compassionate use study. The median age of patients was 42 and 44 years; the severity of GvHD was as follows: grade II in 8 patients, grade III in 33, and grade IV in 28 patients. There were no adverse events directly attributable to the antibody. Day 28 response was 75% in the prospective studies and 61% in the compassionate use patients, with complete response rates of 11 and 12%. Response for grade III GvHD was 83 and 73% in the two groups; response in grade IV GvHD was 66 and 56% in the two groups. Non relapse mortality (NRM) at 6 months was 28 and 38%. Overall there were 64, 56, 68% responses for skin, liver, and gut stage 3-4 GvHD. The overall survival at 1 year was 50% for the prospective studies and 33% for the compassionate use patients. In conclusion, Begelomab induces over 60% responses in SR-aGvHD, including patients with severe gut and liver GvHD, having failed one or more lines of treatment.

100 Deals associated with Begelomab

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Steroid Refractory Graft Versus Host Disease	NDA/BLA	DE	Adienne SA	01 Feb 2016
Steroid Refractory Graft Versus Host Disease	NDA/BLA	CH	Adienne SA	01 Feb 2016
Steroid Refractory Graft Versus Host Disease	NDA/BLA	IT	Adienne SA	01 Feb 2016
Steroid Refractory Graft Versus Host Disease	NDA/BLA	ES	Adienne SA	01 Feb 2016
Steroid Refractory Graft Versus Host Disease	NDA/BLA	FR	Adienne SA	01 Feb 2016
Steroid Refractory Graft Versus Host Disease	NDA/BLA	US	Adienne SA	01 Feb 2016
Steroid Refractory Graft Versus Host Disease	NDA/BLA	GB	Adienne SA	01 Feb 2016
Graft vs Host Disease	NDA/BLA	EU	Adienne SA	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02411084 (CTgov)	Phase 3	Steroid Refractory Graft Versus Host Disease	36	Begelomab (BEGEDINA® (Begelomab))	(ztponqrugz) = kghqzjjijt qepbqjlnqe (ucbwunhvej, odymcqyqic - caioupgfuz) View more	-	30 Jan 2020
NCT02411084 (CTgov)	Phase 3	Steroid Refractory Graft Versus Host Disease	36	Conventional Second-line Treatment (Conventional Second-line Treatment)	(ztponqrugz) = kqhafglifb qepbqjlnqe (ucbwunhvej, gpjjiubwll - keariyzubs) View more	-	30 Jan 2020
EUCTR2007-005809-21-IT (EBMT2019)	Not Applicable	Steroid Refractory Graft Versus Host Disease anti-CD26	69	Begelomab	(loximyrbvn) = yrwpkfiwzb mwuqxdggbe (odseonafbo ) View more	-	24 Mar 2019