Interferon-β (IFN-β)

Modality

Interferons (INFs) are cytokines secreted during the early stages of viral infection that have antiviral and antiproliferative effects. INFs include three categories, namely IFN-α, IFN-β, and IFN-γ. IFN-α and IFN-β have similar amino acid sequences, associated with the same cellular receptors, and therefore have analogous biological effects, particularly antiviral infection and antiproliferative effects for tumor cells. And recombinant IFN-β has been approved for the treatment of relapsing forms of multiple sclerosis.

INFs are usually produced in Escherichia coli (E. coli) and are currently used in clinical practice as it does not need to undergo posttranslational modification to exhibit biological activity.

Application of Interferon-β (IFN-β)

Interferon beta-1b

Produced using recombinant DNA techniques, betaseron (Interferon beta-1b, IFN-β-1b) is a purified, sterile, lyophilized protein product. Interferon-β-1b, produced by bacterial differentiation of an E. coli strain, carrys a genetically engineered plasmid bearing the gene for human interferon betaser17. The native gene is derived from human fibroblasts and modified by replacing cystine (Cys) with serine (Ser) at position 17. Interferon beta-1b contains 165 amino acids and has a molecular weight of approximately 18.5 kDa. And betaseron was developed by and originally approved by FDA in 1993.

Subsequently, Novartis acquired the marketing rights to the Betaseron replica and paid royalties to Bayer. Extavia, a new formulation of IFN-beta-1b, was approved by the European Medical Agency (EMA) in May 2008 and by the US Food and Drug Administration (FDA) in August 2009 as a biosimilar for human use. It is recombinant formulation of IFN-β1b produced from a strain of E. coli through genetic engineering.

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Interferon-β (IFN-β) Pipelines

Generic Name	Brand Name/ Alternative Name	Expression System	Indications	Manufacturer	R&D Stage
Recombinant interferon β-1b	Betaseron, 倍泰龙	Escherichia coli (E. coli)	Multiple sclerosis (MS)	Bayer AG	Approval
Recombinant human interferon β-1b	Extavia, ベタフェロン	E. coli	Multiple sclerosis (MS)	Novartis AG	Approval
interferon β-1b	Actoferon	Pending update	Multiple sclerosis (MS)	AMEGA Biotech	Approval
interferon β-1b	Pending update	Pending update	Multiple sclerosis (MS)	Biocad	Approval
Recombinant human interferon β-1b	Pending update	Pending update	Multiple sclerosis (MS)	International Biotech Center Generium	Approval
interferon β-1b	Pending update	Pending update	Multiple sclerosis (MS)	Pressure BioSciences	Phase III
interferon β-1b	Rec Hu-IFN beta 1a-44 microgram, ReciGen	Pending update	Multiple sclerosis (MS)	CinnaGen	Phase III
interferon β-1b	Pending update	Pending update	Multiple sclerosis (MS)	Probiomed SA de CV	Approval
interferon β-1b	Pending update	Pending update	Multiple sclerosis (MS)	Bio-Ker s.r.l.	Pre-clinical
Polyethylene glycol recombinant interferon β	Peginterferon beta	Pending update	Multiple sclerosis (MS)	Merck, Ambrx Biopharma	Pre-clinical
Recombinant human interferon β-1a	Blastoferon	Pending update	Multiple sclerosis (MS)	Biosidus	Approval
Recombinant human interferon β-1a	Interferon beta-1a, PLEGRIDY, BG-9418, Avonex, アボネックス	CHO cell	Multiple sclerosis (MS)	Biogen, Inc., Eisai Co.,	Approval
Polyethylene glycol recombinant interferon β-1a	Peginterferon beta-1a, Plegridy, BIIB-017	CHO cell	Multiple sclerosis (MS)	Biogen, Inc., Eisai Co., Ltd., UCB SA	Approval
Recombinant human interferon β-1a	REBIF	CHO cell	Multiple sclerosis (MS)	Merck, FLAMEL IRELAND LTD, Serono Pharma Schweiz, Pfizer	Approval
interferon β-1a	Pending update	Pending update	Multiple sclerosis (MS)	Insight Biopharmaceuticals Ltd.	Approval
interferon β-1a	Xerfelan	Pending update	Multiple sclerosis (MS)	Landsteiner Scientific SA de CV	Approval
Recombinant human interferon β-1a	Interferon beta-1a	Pending update	Multiple sclerosis (MS)	Reliance Life Sciences	Approval
interferon β-1a	Pending update	Pending update	Multiple sclerosis (MS)	Probiomed SA de CV	Approval
Peginterferon beta-1a	Cinnaferon	Pending update	Multiple sclerosis (MS)	CinnaGen	Phase III
interferon β-1a	FP-1201, FP-1201-lyo, MR-11A8, Traumakine	Pending update	Multiple sclerosis (MS)	Lee's Pharmaceutical	Phase III
Sampeginterferon beta-1a	TENEXIA, BCD 054, BCD-054	Pending update	Multiple sclerosis (MS)	Biocad	Phase III
interferon β-1b	Pending update	Pending update	Multiple sclerosis (MS)	Pfenex, Inc.	Phase I
Interferon beta-1a extended release	Pending update	Pending update	Multiple sclerosis (MS)	Weizmann Institute of Science	Phase I
Recombinant human interferon β-1a	Interferon beta-1a	Pending update	Multiple sclerosis (MS)	CinnaGen	Phase I
Pegylated interferon β	TRK-560, PEG-IFN-beta	Pending update	Multiple sclerosis (MS)	Toray Industries, Inc.	Phase I
BBT-012	long-acting interferon beta 1b, BBT-032	Pending update	Multiple sclerosis (MS)	Bolder BioTechnology	Pre-clinical
Interferon beta biobetter	Interferon-β, ABN101	Pending update	Multiple sclerosis (MS)	ABION, Inc.	Pre-clinical

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Interferon-β (IFN-β)

Modality