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Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Recombinant humanized anti-tissue factor pathway inhibitor (TFPI) monoclonal antibody, KN-057, KN057

Target

TFPI

Action

inhibitors

Mechanism

TFPI inhibitors(Tissue factor pathway inhibitor inhibitors)

Therapeutic Areas

Congenital DisordersHemic and Lymphatic DiseasesOther Diseases

Active Indication

Hemophilia AHemophilia BVon Willebrand Diseases

Inactive Indication-

Originator Organization

Suzhou Alphamab Co., Ltd.

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Active Organization

Suzhou Alphamab Co., Ltd.

Inactive Organization-

License Organization

NANOLEK LLC

Grand Shuyang Life Sciences (Chengdu) Co., Ltd.

Suzhou Alphamab Co., Ltd.

+ [1]

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (United States)

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Structure/Sequence

Sequence Code 695392666H

Source: *****

Sequence Code 695392668L

Source: *****

The purposes of this open-label, multicenter III clinical trial are to evaluate the safety and efficacy of long-term preventive treatment with KN057 in Haemophilia A or B patients with or without inhibitors, and to assess the pharmacokinetic characteristics of the new and old processes KN057.
The participants in Part PK will be randomly assigned to Old process Group or New process Group in a 1:1 ratio. The participants in Old process Group will receive old process KN057 prophylaxis for the first 26 weeks and new process KN057 prophylaxis for the following 26 weeks. The participants in New process Group will receive new process KN057 prophylaxis for both the first 26 weeks and the last 26 weeks.
The participants in Part non-PK will be non-randomized and treated with new process KN057 for 52 weeks prophylaxis after enrollment.
Priority screening and enrollment of participants who have participated in the KN057-A-301 or KN057-A-302 study.

Start Date13 Mar 2026

Sponsor / Collaborator

Suzhou Alphamab Co., Ltd.

NCT06747416

/ Not yet recruitingPhase 2

A Phase II Multicenter, Open Label Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and PK/PD Profile of Multiple Subcutaneous Injection of KN057 in Male Patients with Severe Hemophilia a or Moderate-to-Severe Hemophilia B with or Without Inhibitors

The goal of this clinical trial is to evaluate the safety and efficacy of KN057 in adult patients with severe Hemophilia A (coagulation factor FVIII activity <1%) or moderate-to-severe Hemophilia B (FIX activity ≤2%). Participants will be administered subcutaneously with KN057 once a week for 20 weeks. KN057 works differently than factor replacement products and will work in the presence of inhibitors. The potential for once weekly subcutaneous administration provides better convenience and compliance.

Start Date02 Sep 2025

Sponsor / Collaborator

Suzhou Alphamab Co., Ltd.

NCT06569108

/ Active, not recruitingPhase 3

A Randomized, Open-label Study to Evaluate the Efficacy and Safety of KN057 Injection Prophylaxis in Patients With Hemophilia A or B Without Inhibitors

The purpose of this study is to show that KN057 can prevent bleeds in patients with haemophilia A or B without inhibitors and is safe to use. Participants receiving on-demand treatment prior to screening will be randomly assigned to Experimental group or Control group at a ratio of 2:1 in Part A. Participants receiving prophylaxis prior to screening will be nonrandomly assigned to Prophylaxis group in Part B. Participants in Experimental group will receive KN057 prophylaxis for 52 weeks upon enrollment. Participants in Control group will first receive on-demand treatment for 26 weeks, then switch to KN057 prophylaxis for 26 weeks. Participants in Prophylaxis group will first receive prophylaxis with coagulation factor for 26 weeks, then switch to KN057 prophylaxis for 26 weeks.

Start Date01 Apr 2024

Sponsor / Collaborator

Suzhou Alphamab Co., Ltd.

100 Clinical Results associated with Armocibart

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100 Translational Medicine associated with Armocibart

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100 Patents (Medical) associated with Armocibart

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1

Literatures (Medical) associated with Armocibart

HAEMOPHILIA

An Ex Vivo Pharmacodynamic Study of KN057, a Tissue Factor Pathway Inhibitor Neutralizing Antibody, in Plasma Samples From Patients With Haemophilia or VWD3

Article

Author: Sun, Wei ; Ju, Mankai ; Yang, Renchi ; Xu, Ting ; Xue, Feng ; Li, Fang

ABSTRACT:

Introduction:

Tissue factor pathway inhibitor (TFPI), a key regulator of tissue factor‐initiated coagulation through FXa‐dependent inhibition of the tissue factor‐FVIIa complex, has emerged as a promising target for restoring thrombin generation.

Aim:

This ex vivo pharmacodynamic study aimed to evaluate the KN057, a novel humanized TFPI‐neutralizing antibody, in plasma samples from participants with haemophilia or type 3 von Willebrand disease (VWD3).

Methods:

In this ex vivo spiking study, plasmas obtained from haemophilia or VWD3 participants were supplemented with KN057 at the concentration of 0–140.00 nM. The thrombin generation assay (TGA) and the dilute prothrombin time (dPT) assay were performed to assess coagulation responses.

Results:

Between 26, May 2021, and 3, September 2021, a total of 29 participants were enrolled in this study, including 10 haemophilia A (HA) without inhibitors, 6 haemophilia B (HB) without inhibitors, 6 HA with inhibitors, 3 HB with inhibitors, and 4 VWD3. In participant plasmas supplemented with KN057, peak thrombin and endogenous thrombin potential (ETP) increased notably between 1.12–5.60 nM, and reached a maximal level at 28.00 nM. A dose‐dependent decrease in dPT was observed in all participants with haemophilia or VWD3.

Conclusions:

KN057 exhibited a consistent ex vivo pharmacodynamic profile, including both the response trend and effective concentration range, across plasma samples from patients with HA or HB, irrespective of inhibitor status. Furthermore, its pharmacodynamic activity in plasma from patients with VWD3 was comparable to that observed in haemophilia plasma.

100 Deals associated with Armocibart

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemophilia A	Phase 3	China	Suzhou Alphamab Co., Ltd.	09 Jan 2024
Hemophilia B	Phase 3	China	Suzhou Alphamab Co., Ltd.	09 Jan 2024
Von Willebrand Diseases	Preclinical	United States	Suzhou Alphamab Co., Ltd.	18 Nov 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20220429 \| CTR20201606 (Company_Website) Manual	Phase 1	Hemophilia	-	KN057	apgenvqomt(lwngyirker) = 1.0 mg/kg和2.5 mg/kg剂量组给药后 48h血药浓度达到峰值，半衰期在一周左右，且PK参数显示KN057呈现典型的非线性代谢特征, KN057浓度28 nM时作用达峰。 txbropoalt (ajsmizpeas ) View more	Positive	28 Jun 2024

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Biosimilar

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