Delving into the Latest Updates on M-254 with Synapse

Overview

Basic Info

Drug Type

Fusion protein

Synonyms

Hypersialylated IgG, Hypersialylated immunoglobulin, hsIgG

+ [2]

Target-

Action

modulators

Mechanism

Immunomodulators

Therapeutic Areas

Immune System DiseasesHemic and Lymphatic DiseasesNervous System Diseases+ [1]

Active Indication-

Inactive Indication

Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPurpura, Thrombocytopenic, Idiopathic

Originator Organization

Momenta Pharmaceuticals, Inc.

Active Organization-

Inactive Organization

Momenta Pharmaceuticals, Inc.

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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The purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic purpura (ITP) patients. The pharmacodynamics of the drug will be measured as platelet response in patients with ITP.

Start Date21 Dec 2018

Sponsor / Collaborator

Momenta Pharmaceuticals, Inc.

100 Clinical Results associated with M-254

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100 Translational Medicine associated with M-254

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100 Patents (Medical) associated with M-254

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2

Literatures (Medical) associated with M-254

17 Mar 2015·Proceedings of the National Academy of SciencesQ1 · CROSS-FIELD

Controlled tetra-Fc sialylation of IVIg results in a drug candidate with consistent enhanced anti-inflammatory activity

Q1 · CROSS-FIELD

Article

Author: Mekala, Divya ; Schultes, Birgit C. ; Sarvaiya, Hetal ; Tyler, Steven ; Cochran, Edward ; Nimmerjahn, Falk ; Medeiros, Amy ; Washburn, Nathaniel ; Garofalo, Kevin ; Ortiz, Daniel ; Meccariello, Robin ; Schwab, Inessa ; Avery, William ; Kaundinya, Ganesh V. ; Bhatnagar, Naveen ; Rutitzky, Laura ; Bosques, Carlos J. ; Meador, James W. ; Ling, Leona ; Manning, Anthony M. ; Lansing, Jonathan C.

Despite the beneficial therapeutic effects of intravenous immunoglobulin (IVIg) in inflammatory diseases, consistent therapeutic efficacy and potency remain major limitations for patients and physicians using IVIg. These limitations have stimulated a desire to generate therapeutic alternatives that could leverage the broad mechanisms of action of IVIg while improving therapeutic consistency and potency. The identification of the important anti-inflammatory role of fragment crystallizable domain (Fc) sialylation has presented an opportunity to develop more potent Ig therapies. However, translating this concept to potent anti-inflammatory therapeutics has been hampered by the difficulty of generating suitable sialylated products for clinical use. Therefore, we set out to develop the first, to our knowledge, robust and scalable process for generating a well-qualified sialylated IVIg drug candidate with maximum Fc sialylation devoid of unwanted alterations to the IVIg mixture. Here, we describe a controlled enzymatic, scalable process to produce a tetra-Fc-sialylated (s4-IVIg) IVIg drug candidate and its qualification across a wide panel of analytic assays, including physicochemical, pharmacokinetic, biodistribution, and in vivo animal models of inflammation. Our in vivo characterization of this drug candidate revealed consistent, enhanced anti-inflammatory activity up to 10-fold higher than IVIg across different animal models. To our knowledge, this candidate represents the first s4-IVIg suitable for clinical use; it is also a valuable therapeutic alternative with more consistent and potent anti-inflammatory activity.

PLoS ONEQ3 · CROSS-FIELD

Human Anti-Plague Monoclonal Antibodies Protect Mice from Yersinia pestis in a Bubonic Plague Model

Q3 · CROSS-FIELD

ArticleOA

Author: Michael M. Wormald ; Christopher K. Cote ; Dimiter S. Dimitrov ; Jennifer L. Dankmeyer ; Kei Amemiya ; Zhongyu Zhu ; Randy L. Fast ; Xiaodong Xiao ; Patricia L. Worsham

Yersinia pestis is the etiologic agent of plague that has killed more than 200 million people throughout the recorded history of mankind. Antibiotics may provide little immediate relief to patients who have a high bacteremia or to patients infected with an antibiotic resistant strain of plague. Two virulent factors of Y. pestis are the capsid F1 protein and the low-calcium response (Lcr) V-protein or V-antigen that have been proven to be the targets for both active and passive immunization. There are mouse monoclonal antibodies (mAbs) against the F1- and V-antigens that can passively protect mice in a murine model of plague; however, there are no anti-Yersinia pestis monoclonal antibodies available for prophylactic or therapeutic treatment in humans. We identified one anti-F1-specific human mAb (m252) and two anti-V-specific human mAb (m253, m254) by panning a naïve phage-displayed Fab library against the F1- and V-antigens. The Fabs were converted to IgG1s and their binding and protective activities were evaluated. M252 bound weakly to peptides located at the F1 N-terminus where a protective mouse anti-F1 mAb also binds. M253 bound strongly to a V-antigen peptide indicating a linear epitope; m254 did not bind to any peptide from a panel of 53 peptides suggesting that its epitope may be conformational. M252 showed better protection than m253 and m254 against a Y, pestis challenge in a plague mouse model. A synergistic effect was observed when the three antibodies were combined. Incomplete to complete protection was achieved when m252 was given at different times post-challenge. These antibodies can be further studied to determine their potential as therapeutics or prophylactics in Y. pestis infection in humans.

100 Deals associated with M-254

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 2	United States	Momenta Pharmaceuticals, Inc.	11 Jan 2020
Purpura, Thrombocytopenic, Idiopathic	Phase 2	Spain	Momenta Pharmaceuticals, Inc.	28 Jan 2019
Purpura, Thrombocytopenic, Idiopathic	Phase 2	Hungary	Momenta Pharmaceuticals, Inc.	28 Jan 2019
Purpura, Thrombocytopenic, Idiopathic	Phase 2	Belgium	Momenta Pharmaceuticals, Inc.	28 Jan 2019
Purpura, Thrombocytopenic, Idiopathic	Phase 2	Italy	Momenta Pharmaceuticals, Inc.	28 Jan 2019
Purpura, Thrombocytopenic, Idiopathic	Phase 2	United States	Momenta Pharmaceuticals, Inc.	28 Jan 2019
Purpura, Thrombocytopenic, Idiopathic	Phase 2	France	Momenta Pharmaceuticals, Inc.	28 Jan 2019
Purpura, Thrombocytopenic, Idiopathic	Phase 2	Germany	Momenta Pharmaceuticals, Inc.	28 Jan 2019
Purpura, Thrombocytopenic, Idiopathic	Phase 2	Poland	Momenta Pharmaceuticals, Inc.	28 Jan 2019
Purpura, Thrombocytopenic, Idiopathic	Phase 2	Netherlands	Momenta Pharmaceuticals, Inc.	28 Jan 2019

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