Delving into the Latest Updates on AMG-224 with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

Target

BCMA x Tubulin

Action

inhibitors

Mechanism

BCMA inhibitors(B-cell maturation protein inhibitors), Tubulin inhibitors

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [2]

Active Indication-

Inactive Indication

Refractory Multiple MyelomaRelapse multiple myeloma

Originator Organization

Amgen, Inc.

Active Organization-

Inactive Organization

Amgen, Inc.

License Organization-

Drug Highest PhasePendingPhase 1

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC12H16N2O3

InChIKeyIBLSXJXHUXUHIM-UHFFFAOYSA-N

CAS Registry104676-09-7

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A multi-center, phase 1, open-label, first-in-human study was conducted investigating the safety and tolerability, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics, and efficacy of AMG 224 in patients with relapsed or refractory (R/R) multiple myeloma (MM) with ≥ 3 lines of prior therapy including an immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs).In the dose expansion, patients were divided into groups A (prior anti-CD38 antibody) and B (no prior anti-CD38 antibody) and received i.v. AMG 224 at the preliminary MTD determined during dose escalation, adjusted for body weightIn the dose escalation, patients received i.v. AMG 224 every 3 wk (Q3W) at prespecified doses of 30-300 mg in a 3 + 3 design, with no mandated premedications.Objective responses occurred in 5/21 patients refractory to prior IMiDs, 3/14 refractory to prior PIs, 3/13 refractory to prior IMiDs and PIs, and 1/7 refractory to prior daratumumab.In conclusion, this phase 1 first-in-human study of AMG 224 in patients with R/R MM demonstrated a favorable pharmacokinetic and manageable safety profile and single-agent activity with the achievement of durable responses in some patients.

100 Deals associated with AMG-224

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory Multiple Myeloma	Phase 1	Australia	Amgen, Inc.	20 Nov 2015
Refractory Multiple Myeloma	Phase 1	United States	Amgen, Inc.	20 Nov 2015
Relapse multiple myeloma	Phase 1	Australia	Amgen, Inc.	20 Nov 2015
Relapse multiple myeloma	Phase 1	United States	Amgen, Inc.	20 Nov 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02561962 (CTgov)	Phase 1	Relapse multiple myeloma \| Refractory Multiple Myeloma	42	AMG 224 (Dose Exploration: AMG 224 Dose A)	ozsizzmowy(bsddsmkqls) = opfyppuwqf quizbezhti (mqckkajhma, npyxchdlzz - mitvqpcufd) View more	-	07 Oct 2021
				AMG 224 (Dose Exploration: AMG 224 Dose B)	ozsizzmowy(bsddsmkqls) = vvcbklpzaz quizbezhti (mqckkajhma, fvqfecclhz - mmgziheqtv) View more

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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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