Begedina (begelomab) / ArcticZymes, Adienne - LARVOL DELTA

Begelomab (BEGESAND®) Salvages Steroid-Resistant Acute GVHD in Pediatric Patients. (PubMed, J Clin Med) - "Existing second-line agents-ruxolitinib, tocilizumab, or extracorporeal photopheresis-have delayed onset or high toxicity. Flow cytometry showed preserved T-cell subsets, and IHC demonstrated CD26 localization at sites of epithelial injury. Begelomab (BEGESAND®) showed promising timely and durable responses with excellent safety in pediatric SR/SD-aGVHD, supporting further evaluation in multicenter pediatric trials."

Journal • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Pediatrics • Respiratory Diseases • Septic Shock • Transplantation • DPP4

New investigational drugs for Steroid-Refractory Acute Graft-versus-Host disease: a review of the literature. (PubMed, Expert Opin Investig Drugs) - "In light of the pivotal REACH2 trial, ruxolitinib phosphate, a Janus kinase inhibitor, has gained prominence as the standard treatment for SR-aGVHD...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. Current 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."

Journal • Review • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology • Transplantation • CD7

Begelomab Salvages Steroid Resistant Acute Graft Versus (SR aGVHD) Host Disease in Pediatric Patients: A Single Center Case Serie (TCT-ASTCT-CIBMTR 2024) - "At the time of Begelomab administration, all patients were receiving systemic steroids and at least 2 other second-line agents, such as calcineurin inhibitors, infliximab, basiliximab, ruxolitinib, ECP, and alpha-1 antitrypsin. 75% response rate by day 28 and >50% overall response in grade III/IV acute (a) GvHD. Here, we present our experience with pediatric patients who received Begelomab for SR aGvHD. Five patients (3-20 years) received Begelomab for SR aGVHD at Stanford Children's Health from 2017 to 2021 (IRB#4134, 46969)."

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Graft versus Host Disease • Hematological Malignancies • Leukemia • Oncology • Pediatrics • CD4 • DPP4

Designing of a bispecific antibody against SARS-CoV-2 spike glycoprotein targeting human entry receptors DPP4 and ACE2. (PubMed, Hum Immunol) - "Regdanvimab and Begelomab were identified to block the D614G mutated spike glycoprotein of SARS-CoV-2 and host DPP4 receptor, respectively. 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."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Begelomab for severe refractory dermatomyositis: A case report. (PubMed, Medicine (Baltimore)) - "Blockade of DPP-4/CD26, which is expressed on T cells and mediates T cell activation and function, is safe and might be effective in patients with refractory DM."

Clinical • Journal • Dermatomyositis • Dysphonia • Immunology • Myositis

[VIRTUAL] Efficacy and Toxicity Profile of Investigational Monoclonal Antibodies for the Treatment of Acute Gvhd (ASH 2020) - "Natalizumab: In a phase II trial, 20 patients with newly diagnosed lower GI aGVHD received natalizumab along with methylprednisone...In this study, patients received vedolizumab as a 2nd line...Brentuximab vedotin: Ina phase I study, n= 34 SR aGVHD patients (70% grade ≥III-IV) demonstrated ORR of 38% at day 28...Begelomab: A phase I/II study evaluated 28 patients with SR aGVHD...Tocilizumab: A study of 16 patients with GI aGVHD (94% of grade ≥III-IV) demonstrated ORR of 69%, CR rate of 62.5%, and median OS of 7.6 months... Monoclonal antibodies for the treatment of aGVHD show encouraging results. Responses appear to be related to the duration and timing of the therapy, GVHD severity, organ involvement, and the number of previous lines of therapy received. Large prospective clinical trials are needed to further solidify the role of monoclonal antibodies in aGVHD treatment."

Clinical • Graft versus Host Disease • Immunology • Infectious Disease • Neutropenia • Septic Shock • Transplantation

[VIRTUAL] Targeting Chronic Myeloid Leukemia Stem/Progenitor Cells Using Immunolipsome Loaded Venetoclax (ASH 2020) - "Herein we designed a pegylated liposomal nanocarrier conjugated with a specific antibody against CD26 (Begelomab, ADIENNE, Lugano, Switzerland). Liposomes are suitable carriers because of their biocompatibility, self-assembly, large drug payload, and minimal toxicity. This strategy may help us to increase the number of patients attaining and maintaining TFR without relapsing."

IO Biomarker • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • CD34 • CD38 • IL2RA

The CoV-2 outbreak: how hematologists could help to fight Covid-19. (PubMed, Pharmacol Res) - "The most promising drugs might be: Ruxolitinib, a JAK1/2 inhibitor, with a rapid and powerful anti-cytokine effect, tyrosine kinase inhibitors (TKIs), with their good anti-inflammatory properties, and perhaps the anti-Cd26 antibody Begelomab. We also present immunological data from gene expression experiments where TKIs resulted effective anti-inflammatory and pro-immune drugs. A possible combined treatment algorithm for COVID-19 is here proposed."

Journal • Graft versus Host Disease • Hematological Disorders • Novel Coronavirus Disease

Treatment of steroid resistant acute graft versus host disease with an anti-CD26 monoclonal antibody-Begelomab. (PubMed, Bone Marrow Transplant) - P2; "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."

Journal

TREATMENT OF STEROID RESISTANT ACUTE GRAFT VERSUS HOST DISEASE WITH AN ANTI-CD26 MONOCLONAL ANTIBODY - BEGELOMAB (EBMT 2019) - P2; "In conclusion, Begelomab induces a high remission rate on day+28 in patients with SR-GvHD, including a significant proportion of patients wih severe gut and liver GvHD. Clinical Trial Registry: EudraCT No. 2007-005809-21 Eudtract No."