Last update 21 Nov 2024

BD-368-2

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

SARS-CoV-2 anti-spike glycoprotein neutralizing monoclonal antibody(Peking University/Sino Biological/Beijing Danxu Pharmaceuticals), SARS-CoV-2 virus-neutralizing monoclonal antibodies(Peking University/Sino Biological/Beijing Danxu Pharmaceuticals)

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Target

SARS-CoV-2 S protein

Mechanism

SARS-CoV-2 S protein modulators(SARS-CoV-2 S protein modulators)

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

COVID-19

Inactive Indication-

Originator Organization

Peking University Shenzhen Graduate School

Active Organization

Sino Biological Inc.

Beijing Danxu Biopharmaceutical Co., Ltd.

Peking University Shenzhen Graduate School

Inactive Organization-

Drug Highest PhasePreclinical

First Approval Date-

Regulation-

100 Clinical Results associated with BD-368-2

100 Translational Medicine associated with BD-368-2

100 Patents (Medical) associated with BD-368-2

Literatures (Medical) associated with BD-368-2

01 Oct 2024·Toxicological Research

Adverse events associated with SARS-CoV-2 neutralizing monoclonal antibodies using the FDA adverse event reporting system database

Article

Author: Oh, Se-Hun ; Song, Yun-Kyoung ; Ki, Sung Hwan ; Choi, Min Joung

The purpose of this study was to analyze the important medical events (IMEs) of anti-severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) monoclonal antibodies using the reports from the United States Food and Drug Administration (US FDA) adverse event reporting system (FAERS) and to detect safety signals. In this study, data from the FAERS from January 2020 to December 2022 were used to investigate signals associated with five monoclonal antibody products (bamlanivimab, bamlanivimab/etesevimab, bebtelovimab, casirivimab/imdevimab, sotrovimab) in coronavirus disease 2019 (COVID-19) patients and one monoclonal antibody product (tixagevimab/cilgavimab) in patients wherein COVID-19 vaccination was not recommended. Disproportionality analyses were conducted using the reporting odds ratio, and an information component to identify safety signals. There were 17,937,860 drug AE reports associated with all drugs in the FAERS documented during research period. Among them, 42,642 were AE reports associated with anti-SARS-CoV-2 monoclonal antibodies. The SOCs including respiratory, thoracic and mediastinal, and vascular disorders were frequently reported for all the six products. The three most commonly detected IMEs were hypoxia, COVID-19 pneumonia, and anaphylactic reaction due to SARS-CoV-2 neutralizing antibodies. Even though the purposes of use were different, the types of signals between drugs were similar. Careful monitoring of these AEs should be considered for certain COVID-19 patients, at risk, when they are treated with monoclonal antibody products.

01 Jun 2024·Bioorganic Chemistry

Synthesis and biological evaluation of Halogen-Substituted novel α-Ketoamides as potential protein aggregation modulators in Alzheimer’s disease

Article

Author: Kumar, Rajnish ; Darreh-Shori, Taher ; Das, Bhanuranjan ; Thakur, Banita ; Tiwari, Vinod ; Chen, Gefei ; Chakrabarti, Sourabh ; Chouhan, Deepak ; Tk Baidya, Anurag

The escalating prevalence of Alzheimer's disease (AD) has prompted extensive research into potential therapeutic interventions, with a specific focus on molecular targets such as amyloid beta (Aβ) and tau protein aggregation. In this study, a series of α-ketoamide derivatives was synthesized from β,γ-unsaturated α-keto thioesters, achieving high purity and good yield. Thioflavin T based Aβ aggregation assay identified four promising compounds (BD19, BD23, BD24, and BD27) that demonstrated significant inhibitory effects on Aβ aggregation. BD23, selected for its better solubility (0.045 ± 0.0012 mg/ml), was further subjected to in vitro Parallel Artificial Membrane Permeability Assay to determine the Blood-Brain-Barrier permeability and emerged as BBB permeable with permeability rate (Pe) of 10.66 ± 8.11 × 10^-⁶ cm/s. In addition to its Aβ inhibitory properties, BD23 exhibited significant inhibition of heparin-induced tau aggregation and demonstrated non-toxicity in SHSY5Y cell lines. Subsequent in vivo assays were conducted, administering compound BD23 to an Aβ induced mouse model of AD at various doses (1, 2, & 5 mg/kg). The results revealed a noteworthy enhancement in cognitive functions, particularly when BD23 was administered at a dosage of 5 mg/kg, comparable to the effects observed with the standard dose of Donepezil (DNP). In silico investigations, including molecular docking, molecular dynamics simulations, and Density Functional Theory calculations provided insights into BD23's interactions with the targets and electronic properties. These analyses contribute to the understanding of the therapeutic potential of the lead compounds BD23 which further pave the way for further exploration of its therapeutic potential in the context of AD.

01 Jan 2024·Pathogens & immunity

Safety, Efficacy, and Pharmacokinetics of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies BMS-986414 (C135-LS) and BMS-986413 (C144-LS) Administered Subcutaneously in Non-Hospitalized Persons with COVID-19 in a Phase 2 Trial.

Article

Author: Corado, Katya C ; Smith, Davey M ; Javan, Arzhang Cyrus ; Fletcher, Courtney V ; Giganti, Mark J ; Caskey, Marina ; Eron, Joseph J ; Moser, Carlee B ; Currier, Judith S ; Mu, Ying ; Li, Jonathan Z ; Chew, Kara W ; Neytman, Gene ; Wohl, David A ; Daar, Eric S ; Ritz, Justin ; Hughes, Michael D

BackgroundOutpatient COVID-19 monoclonal antibody (mAb) treatment via subcutaneous delivery, if eﬀective, overcomes the logistical burdens of intravenous administration.MethodsACTIV-2/A5401 was a randomized, masked placebo-controlled platform trial where participants with COVID-19 at low risk for progression were randomized 1:1 to subcutaneously administered BMS-986414 (C135-LS) 200 mg, plus BMS-986413 (C144-LS) 200 mg, (BMS mAbs), or placebo. Coprimary outcomes were time to symptom improvement through 28 days; nasopharyngeal SARS-CoV-2 RNA below the lower limit of quantification (LLoQ) on days 3, 7, or 14; and treatment-emergent grade 3 or higher adverse events (TEAEs) through 28 days.ResultsA total of 211 participants (105 BMS mAbs and 106 placebo) initiated study product. Time to symptom improvement favored the active therapy but was not significant (median 8 vs 10 days, P=0.19). There was no significant diﬀerence in the proportion with SARS-CoV-2 RNA ConclusionsWhile safe, the BMS mAbs delivered subcutaneously were not eﬀective at treating COVID-19 at low risk for progression. The lack of clinically significant activity may relate to the pharmacokinetics of subcutaneous administration of mAbs.

100 Deals associated with BD-368-2

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Preclinical	CN	Peking University Shenzhen Graduate School	-
COVID-19	Preclinical	AU	Sino Biological Inc.	-
COVID-19	Preclinical	CN	Beijing Danxu Biopharmaceutical Co., Ltd.	-
COVID-19	Preclinical	AU	Peking University Shenzhen Graduate School	-
COVID-19	Preclinical	AU	Beijing Danxu Biopharmaceutical Co., Ltd.	-
COVID-19	Preclinical	CN	Sino Biological Inc.	-

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Translational Medicine

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