PMDA JAPAN APPROVED 2022 2022/9/26 Nanozora
anti-TNFα Nanobody®; ATN-103; Nanozora; PF-5230896; TS-152
Ozoralizumab is a humanized monoclonal antibody designed for the treatment of inflammatory diseases.
Ozoralizumab has been used in trials studying the treatment of Rheumatoid Arthritis and Active Rheumatoid Arthritis.
Ozoralizumab is a 38 kDa humanized trivalent bispecific construct consisting of two anti-TNFα NANOBODIES® and anti-HSA NANOBODY® that was generated at Ablynx by a previously described method (23). Llamas were immunized with human TNFα and human muscle extract, which is rich in HSA, to induce the formation of anti-TNFα VHH and anti-HSA VHH. Both the anti-TNFα VHH and anti-HSA VHH were humanized by a complementary determining regions (CDR) grafting approach in which the CDR of the gene encoding llama VHH was grafted onto the most homologous human VHH framework sequence. Since binding to serum albumin prolongs the half-life of VHH (23, 26, 27), an anti-HSA VHH which efficiently binds murine serum albumin as well was incorporated into the two anti-TNFα VHHs. The three components were fused using a flexible Gly-Ser linker.
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|Chemical and physical data|
|Molar mass||38434.85 g·mol−1|
- DeveloperAblynx; Eddingpharm; Pfizer; Taisho Pharmaceutical
- ClassAnti-inflammatories; Antirheumatics; Monoclonal antibodies; Proteins
- Mechanism of ActionTumour necrosis factor alpha inhibitors
- Orphan Drug StatusNo
- New Molecular EntityYes
- RegisteredRheumatoid arthritis
- DiscontinuedAnkylosing spondylitis; Crohn’s disease; Psoriatic arthritis
- 05 Oct 2022Sanofi’s affiliate Ablynx has worldwide patent pending for Nanobodies® (Sanofi website, October 2022)
- 05 Oct 2022Sanofi’s affiliate Ablynx has worldwide patent protection for Nanobodies® (Sanofi website, October 2022)
- 26 Sep 2022First global approval – Registered for Rheumatoid arthritis in Japan (SC)
- ^ Kratz F, Elsadek B (July 2012). “Clinical impact of serum proteins on drug delivery”. J Control Release. 161 (2): 429–45. doi:10.1016/j.jconrel.2011.11.028. PMID 22155554.
////////Ozoralizumab, Nanozora, Monoclonal antibody, nanobody, Treatment inflammation, ATN 103, APPROVALS 2022, JAPAN 2022
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