Delving into the Latest Updates on BCD-264 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Target-

Action-

Mechanism-

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [2]

Active Indication

Relapse multiple myeloma

Inactive Indication-

Originator Organization

Biocad CJSC

Active Organization

Biocad CJSC

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy.

Start Date21 Dec 2023

Sponsor / Collaborator

Biocad CJSC

NCT05974969

/ CompletedPhase 1

A Randomized, Double-Blind, Comparative Clinical Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of Single Intravenous Infusion of BCD-264 and Darzalex® in Healthy Volunteers

The goal of this clinical study is to establish the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-264 and Darzalex following a single intravenous infusion in healthy subjects.

Start Date17 May 2023

Sponsor / Collaborator

Biocad CJSC

100 Clinical Results associated with BCD-264

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100 Translational Medicine associated with BCD-264

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100 Patents (Medical) associated with BCD-264

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100 Deals associated with BCD-264

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Relapse multiple myeloma	Phase 3	Russia	Biocad CJSC	21 Dec 2023

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Clinical Result

Indication

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Evaluation

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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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