Delving into the Latest Updates on Latikafusp with Synapse

Overview

Basic Info

Drug Type

Antibody fusion proteins

Synonyms

Target

IL-21 x PD-1

Mechanism

IL-21 inhibitors(Interleukin-21 inhibitors), PD-1 inhibitors(Programmed cell death protein 1 inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Solid tumorAdvanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Amgen, Inc.

Active Organization

Amgen, Inc.

BeiGene Pharmaceuticals (Guangzhou) Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 656084790H

Source: *****

Sequence Code 656085964L

Source: *****

Sequence Code 319346044H

Source: *****

Author: Mytych, Daniel T ; Gupta, Shalini ; Starcevic Manning, Marta ; Ahern, Elizabeth ; Hui, Mun ; Kroenke, Mark A ; Saini, Gurleen ; Wang, Jin ; Zuch de Zafra, Christina L ; Cabanas, Elena Garralda ; Lolkema, Martijn P ; Aeffner, Famke ; Archer, Michael ; Govindan, Ramaswamy ; Zhang, Xinwen ; Cook, Kevin D ; Hoofring, Sarah

AMG 256 is a bi-specific, heteroimmunoglobulin molecule with an anti-PD-1 antibody domain and a single IL-21 mutein domain on the C-terminus. Nonclinical studies in cynomolgus monkeys revealed that AMG 256 administration led to the development of immunogenicity-mediated responses and indicated that the IL-21 mutein domain of AMG 256 could enhance the anti-drug antibody response directed toward the monoclonal antibody domain. Anti-AMG 256 IgE were also observed in cynomolgus monkeys. A first-in-human (FIH) study in patients with advanced solid tumors was designed with these risks in mind. AMG 256 elicited ADA in 28 of 33 subjects (84.8%). However, ADA responses were only robust and exposure-impacting at the 2 lowest doses. At mid to high doses, ADA responses remained low magnitude and all subjects maintained exposure, despite most subjects developing ADA. Limited drug-specific IgE were also observed during the FIH study. ADA responses were not associated with any type of adverse event. The AMG 256 program represents a unique case where nonclinical studies informed on the risk of immunogenicity in humans, due to the IL-21-driven nature of the response.

100 Deals associated with Latikafusp

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 1	CN	BeiGene Pharmaceuticals (Guangzhou) Co. Ltd.	30 Jan 2022
Advanced Malignant Solid Neoplasm	Phase 1	US	Amgen, Inc.	15 Sep 2020
Advanced Malignant Solid Neoplasm	Phase 1	BE	Amgen, Inc.	15 Sep 2020
Advanced Malignant Solid Neoplasm	Phase 1	AU	Amgen, Inc.	15 Sep 2020
Advanced Malignant Solid Neoplasm	Phase 1	ES	Amgen, Inc.	15 Sep 2020