Delving into the Latest Updates on Peginterferon lambda-1a biosimilar(Nanogen Biopharmaceutical Co) with Synapse

Overview

Basic Info

Drug Type

Interferons, Biosimilar

Synonyms

Peginterferon lambda-1a biosimilar, Peglamda, Pegylated interferon lambda 1

Target

IFNLR1

Action

agonists

Mechanism

IFNLR1 agonists(interferon lambda receptor 1 agonists)

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication-

Inactive Indication

Hepatitis C, Chronic

Originator Organization

Nanogen Pharmaceutical Biotechnology JSC

Active Organization-

Inactive Organization

Nanogen Pharmaceutical Biotechnology JSC

License Organization-

Drug Highest PhasePendingPhase 1

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 199195

Source: *****

This is a phase 2b prospective, randomized, single-blind, controlled trial of a single subcutaneous injection of peginterferon lambda-1a versus placebo for prevention of SARS-CoV-2 infection in non-hospitalized participants at high risk for infection due to household exposure to an individual with coronavirus disease (COVID-19). The study will also evaluate the regimens participants with asymptomatic SARS-CoV-2 infection detected at study entry. All participants will be followed for up to 12 weeks.

Start Date29 Jun 2020

Sponsor / Collaborator

The Johns Hopkins University

[+1]

NCT02063607

/ CompletedPhase 1

The Phase 1a/1b Study of Safety, Pharmacokinetics, Pharmacodynamics of Peglamda (Peginterferon Lamda 1) on Healthy Volunteers and the Preliminary Evaluation of Peglamda and Hepasig (Ribavirin) Treatment's Effects on Chronic Hepatitis C Patients

This is an open label, dose ranging, phase1a/1b clinical trial to study the safety, Pharmacokinetics and Pharmacodynamics of Peglamda 60, 120, 180 and 240 mcg in healthy volunteers and antiviral activity of once weekly Peglamda administration in combination with daily Ribavirin in Hepatitis C naive patients up to 4 weeks period. The objective of the study to establish safety, PK/PD data on healthy subjects and preliminary efficacy and safety in Hepatitis C naive patients.

Start Date01 Dec 2013

Sponsor / Collaborator

Nanogen Pharmaceutical Biotechnology JSC

100 Clinical Results associated with Peginterferon lambda-1a biosimilar(Nanogen Biopharmaceutical Co)

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100 Translational Medicine associated with Peginterferon lambda-1a biosimilar(Nanogen Biopharmaceutical Co)

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100 Patents (Medical) associated with Peginterferon lambda-1a biosimilar(Nanogen Biopharmaceutical Co)

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3

Literatures (Medical) associated with Peginterferon lambda-1a biosimilar(Nanogen Biopharmaceutical Co)

01 May 2012·Journal of Interferon & Cytokine ResearchQ4 · MEDICINE

Pharmacokinetics and Pharmacodynamics of Pegylated Interferon Lambda-1 in Cynomolgus Monkeys

Q4 · MEDICINE

Article

Author: Lopez-Talavera, Juan Carlos ; Klucher, Kevin M. ; Miller, Dennis M. ; Pederson, Susan ; Byrnes-Blake, Kelly A. ; Freeman, Jeremy A. ; Anderson-Haley, Monica

Type III lambda interferons (IFNs) have activity similar to type I IFNs, but a more restricted receptor distribution. A pegylated human IFN lambda-1 (pegIFNλ) is under development for chronic hepatitis C. Induction of receptor signaling (STAT1 phosphorylation) and expression of interferon-stimulated genes (ISGs) by pegIFNλ were assessed in, respectively, cynomolgus monkey leukocyte subsets and hepatocytes stimulated in vitro. ISG induction by pegIFNλ or IFNα was also assessed in peripheral leukocytes and liver biopsies after single and repeat (x3) dosing of pegIFNλ (0.03, 0.3, 3.0 mg/kg) or unpegylated IFNα-2b (10(7) IU/kg). Single-dose pharmacokinetics of pegIFNλ were evaluated. Strong ISG induction occurred in cultured hepatocytes and liver biopsies with both pegIFNλ and IFNα. However, STAT1 phosphorylation, MHC class 1 upregulation, and ISG induction in leukocytes only occurred with IFNα. Serum neopterin was unaffected by pegIFNλ; however, β-2-microglobulin was elevated at all doses. The terminal half-life of pegIFNλ was 23 h with a 59 mL/kg volume of distribution, consistent with other pegylated IFNs. Serum exposure was dose-proportional across the dosing range. These data demonstrate the suitability of cynomolgus monkeys for the preclinical evaluation of pegIFNλ. Additionally, the absence of pegIFNλ pharmacologic activity in leukocytes is consistent with its low receptor expression in blood.

01 Sep 2010·HepatologyQ1 · MEDICINE

Phase 1b Study of Pegylated Interferon Lambda 1 With or Without Ribavirin in Patients with Chronic Genotype 1 Hepatitis C Virus Infection†

Q1 · MEDICINE

Article

Author: de la Torre, Andrew ; Yoffe, Boris ; Lopez-Talavera, Juan Carlos ; Lawitz, Eric ; Muir, Andrew J. ; Flamm, Steven ; Gray, Todd ; Morotta, Paul ; Hausman, Diana ; Fontana, David ; Hunder, Naomi N. ; Gordon, Stuart C. ; Shiffman, Mitchell L. ; Byrnes-Blake, Kelly ; Vierling, John M. ; Zaman, Atif ; Freeman, Jeremy

AbstractInterferon lambda 1 (IFN-λ1) is a type III IFN that produces intracellular responses similar to those of IFN-α but in fewer cell types because of differences in the receptor distribution pattern, and this could potentially result in an improved safety profile. This was an open-label three-part study of patients with chronic hepatitis C virus (HCV) genotype 1 infection. Part 1 evaluated single-agent pegylated interferon lambda (PEG-IFN-λ) at 1.5 or 3.0 μg/kg administered every 2 weeks or weekly for 4 weeks in patients who had relapsed after previous IFN-α-based treatment. Part 2 evaluated weekly doses of PEG-IFN-λ ranging from 0.5 to 2.25 μg/kg in combination with ribavirin (RBV) for 4 weeks in treatment-relapse patients. Part 3 evaluated weekly PEG-IFN-λ at 1.5 μg/kg in combination with RBV for 4 weeks in treatment-naive patients. Fifty-six patients were enrolled: 24 patients in part 1, 25 patients in part 2, and 7 patients in part 3. Antiviral activity was observed at all PEG-IFN-λ dose levels (from 0.5 to 3.0 μg/kg). Two of seven treatment-naive patients (29%) achieved rapid virological response. Treatment was well tolerated with minimal flu-like symptoms and no significant hematologic changes other than RBV-associated decreases in hemoglobin. The most common adverse events were fatigue (29%), nausea (12%), and myalgia (11%). Six patients experienced increases in aminotransferases that met protocol-defined criteria for dose-limiting toxicity (DLT) or temporarily holding therapy with PEG-IFN-λ. Most DLT occurred in patients with high PEG-IFN-λ exposure.Conclusion:Weekly PEG-IFN-λ with or without daily RBV for 4 weeks is well tolerated with minimal adverse events and hematologic effects and is associated with clear antiviral activity across a broad range of doses in patients with chronic HCV.

01 Aug 2010·Journal of Interferon & Cytokine ResearchQ4 · MEDICINE

Preclinical and Clinical Development of Pegylated Interferon-Lambda 1 in Chronic Hepatitis C

Q4 · MEDICINE

Article

Author: Ramos, Eleanor L.

Current treatment of chronic hepatitis C consists of pegylated interferon-alpha (PEG-IFN-alpha) in combination with ribavirin. This regimen is associated with adverse effects that can limit its use. PEG-IFN-lambda 1 (pegIFNlambda) is a novel IFN that shares many of the biological effects of IFN-alpha but may have fewer side effects due to its more selective receptor distribution. Preclinical data show that pegIFNlambda has antiviral activity against hepatitis C virus (HCV) but does not inhibit myeloid colony formation. A phase 1 study in healthy volunteers demonstrated that pegIFNlambda is well tolerated. Elevated liver enzymes resulted in a dose-limiting toxicity after a single dose of 7.5 microg/kg, the highest dose tested. A phase 1b study in genotype 1 HCV patients who either relapsed after IFN-alpha therapy or naive to therapy was initiated. Interim data from the treatment relapse subset showed viral load reductions of 2.3 to 4.0 logs when pegIFNlambda was administered weekly as a single agent with or without ribavirin for up to 4 weeks. Drug-related side effects included elevation of liver enzymes. Decreases in hemoglobin were observed only in patients receiving ribavirin. Constitutional symptoms appeared lower than historical data for PEG-IFN-alpha. These results form the basis of further development of pegIFNlambda as a novel treatment for chronic hepatitis C.

100 Deals associated with Peginterferon lambda-1a biosimilar(Nanogen Biopharmaceutical Co)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis C, Chronic	Phase 1	Vietnam	Nanogen Pharmaceutical Biotechnology JSC	01 Dec 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04344600 (PROTECT, CTgov)	Phase 2	COVID-19	6	Peginterferon lambda alfa-1a subcutaneous injection (Peginterferon Lambda Alfa-1a)	prryjxbhzr(owlcdhllry) = euxdnvwazm adlfkifbec (egyzvayfdo, ffewrsgrrr - impvwaedpg) View more	-	14 Jul 2022
				Saline (Placebo)	prryjxbhzr(owlcdhllry) = kurenwpkvh adlfkifbec (egyzvayfdo, xaumuzvpoe - xsfmvluspr) View more

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Biosimilar

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