Tyruko (natalizumab-sztn) News

|||||||||| Tysabri (natalizumab) / Biogen, Royalty, Tyruko (natalizumab-sztn) / Genefar, Sandoz
Journal, HEOR: Budget impact analysis of biosimilar natalizumab in the US. (Pubmed Central) - Jul 12, 2024
Adoption of biosimilar NTZ can yield considerable cost savings to US health plans that could result in increased treatment access for patients with RRMS.

|||||||||| Tysabri (natalizumab) / Biogen, Royalty, Tyruko (natalizumab-sztn) / Genefar, Sandoz
Review, Journal: PB006: A Natalizumab Biosimilar. (Pubmed Central) - May 11, 2024
The tolerability, safety and immunogenicity profiles of PB006 were similar to those of reference natalizumab, and switching from reference natalizumab to PB006 appeared to have no impact on tolerability or immunogenicity. The role of reference natalizumab in the management of RRMS is well established and PB006 provides an effective biosimilar alternative for patients requiring natalizumab therapy.

|||||||||| Tysabri (natalizumab) / Biogen, Royalty, Tyruko (natalizumab-sztn) / Genefar, Sandoz
Clinical, P3 data, Journal: Efficacy and Safety of Proposed Biosimilar Natalizumab (PB006) in Patients With Relapsing-Remitting Multiple Sclerosis: The Antelope Phase 3 Randomized Clinical Trial. (Pubmed Central) - Oct 23, 2023
P3
This phase 3 trial supports proposed biosim-NTZ as a biosimilar alternative to ref-NTZ for treating RRMS. ClinicalTrials.gov Identifier: NCT04115488.

|||||||||| Tysabri (natalizumab) / Biogen, Royalty
PK/PD data, Journal: Göttingen pigs as a potential model for natalizumab pharmacokinetics, pharmacodynamics, and immunogenicity evaluation. (Pubmed Central) - Oct 30, 2022
All animals treated appeared to produce ADA. The concentrations of the ADA ranged from 15.8 to 16,748 ng/mL Göttingen pigs represent a suitable model for pharmacokinetic analysis and mechanism of action evaluation related to saturation of CD49d.

|||||||||| Tysabri (natalizumab) / Biogen, Royalty, PB006 (natalizumab biosimilar) / Genefar, Novartis
Phase I PK/PD similarity study of proposed biosimilar natalizumab PB006: A single dose study in healthy individuals (Virtual) - Jul 18, 2022 - Abstract #EAN2022EAN_2019;

|||||||||| Tysabri (natalizumab) / Biogen, Royalty, PB006 (natalizumab biosimilar) / Genefar, Novartis
Effect of proposed biosimilar natalizumab on clinical endpoints in RRMS patients: Data from the Phase III Antelope study (Virtual) - Jul 18, 2022 - Abstract #EAN2022EAN_2010;

|||||||||| Tysabri (natalizumab) / Biogen, Royalty, PB006 (natalizumab biosimilar) / Genefar, Novartis
Effect of proposed biosimilar natalizumab on MRI endpoints in RRMS patients: Data from the Phase III Antelope study (Virtual) - Jul 18, 2022 - Abstract #EAN2022EAN_2009;

||||||||||  Tyruko (natalizumab-sztn) / Genefar, Novartis
Trial completion, Trial completion date, Trial primary completion date:  Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri (clinicaltrials.gov) -  Apr 12, 2022
P3, N=265, Completed,  Sponsor: Polpharma Biologics S.A.
The concentrations of the ADA ranged from 15.8 to 16,748 ng/mL Göttingen pigs represent a suitable model for pharmacokinetic analysis and mechanism of action evaluation related to saturation of CD49d. Active, not recruiting --> Completed | Trial completion date: Aug 2021 --> Feb 2022 | Trial primary completion date: Mar 2021 --> Aug 2021

|||||||||| Tysabri (natalizumab) / Biogen, PB006 (natalizumab biosimilar) / Genefar, Novartis
Efficacy and safety of proposed natalizumab biosimilar PB006 versus Tysabri® in patients with relapsing remitting multiple sclerosis: Primary data from the Phase III Antelope study (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_3832;
P3
Analysis of the primary endpoint and safety data suggest that Biosim-NTZ matches Ref-NTZ for efficacy and safety. No new safety signals were observed in the Biosim-NTZ group.

|||||||||| Tysabri (natalizumab) / Biogen, PB006 (natalizumab biosimilar) / Genefar, Novartis
Journal: 4-Week toxicity study of biosimilar natalizumab in comparison to Tysabri by repeated intravenous infusion to cynomolgus monkeys. (Pubmed Central) - Feb 24, 2022
There were no noteworthy differences between PB006 and Tysabri with respect to local tolerance, toxicity and pharmacokinetic profile in cynomolgus monkeys. In conclusion, obtained data are valid and suitable to support entry into clinical studies of PB006 in man.

|||||||||| Tysabri (natalizumab) / Biogen
[VIRTUAL] Efficacy and safety of proposed natalizumab biosimilar PB006 versus Tysabri® in patients with relapsing remitting multiple sclerosis: primary data from the phase III Antelope study (ePoster Library) - Sep 23, 2021 - Abstract #ECTRIMS2021ECTRIMS_2468;
P3
Analysis of the primary endpoint and safety data suggest that Biosim-NTZ matches Ref-NTZ for both efficacy and safety. Importantly, no new safety signals were observed in the Biosim-NTZ group.

|||||||||| Tysabri (natalizumab) / Biogen
[VIRTUAL] Efficacy and safety of proposed natalizumab biosimilar PB006 versus Tysabri® in patients with relapsing remitting multiple sclerosis: primary data from the phase III Antelope study (ePoster Library) - Sep 23, 2021 - Abstract #ECTRIMS2021ECTRIMS_2467;
P3
Analysis of the primary endpoint and safety data suggest that Biosim-NTZ matches Ref-NTZ for both efficacy and safety. Importantly, no new safety signals were observed in the Biosim-NTZ group.

|||||||||| JQ-1 / Roche, PB006 (natalizumab biosimilar) / Genefar, Novartis
Journal: Discovery of a Positron Emission Tomography Radiotracer Selectively Targeting the BD1 Bromodomains of BET Proteins. (Pubmed Central) - Feb 20, 2021
Further blocking studies demonstrated the significant radioactivity decreasing (20-30% reduction compared with baseline) by pretreating unlabeled PB006 and JQ1, suggesting the high binding selectivity and specificity of [F]PB006. Our study indicated that [F]PB006 is a potent PET probe selectively targeting BET BD1, and further structural optimization of the radiotracer is still required to improve brain uptake to support neuroepigenetic imaging.

||||||||||  Tyruko (natalizumab-sztn) / Genefar, Novartis
Enrollment closed:  Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri (clinicaltrials.gov) -  Aug 23, 2020
P3, N=260, Active, not recruiting,  Sponsor: Polpharma Biologics S.A.
Our study indicated that [F]PB006 is a potent PET probe selectively targeting BET BD1, and further structural optimization of the radiotracer is still required to improve brain uptake to support neuroepigenetic imaging. Recruiting --> Active, not recruiting

||||||||||  Tyruko (natalizumab-sztn) / Genefar, Novartis
Enrollment open:  Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri (clinicaltrials.gov) -  Nov 4, 2019
P3, N=260, Recruiting,  Sponsor: Polpharma Biologics S.A.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

||||||||||  Tyruko (natalizumab-sztn) / Genefar, Novartis
New P3 trial:  Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri (clinicaltrials.gov) -  Oct 3, 2019
P3, N=260, Not yet recruiting,  Sponsor: Polpharma Biologics S.A.



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