Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 155 |
| INN | Ozoralizumab |
| Status | Approved |
| Drug code(s) | TS-152, ATN-103 |
| Brand name | Nanozora |
| mAb sequence source | mAb humanized |
| General Molecular Category | Bispecific |
| Format, general category | Fragment |
| Format details | sdAb, VHH-VHH-VHH |
| Isotype (Fc) | None |
| Light chain isotype | None |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Camelid-derived |
| Target(s) | TNF, Albumin |
| Indications of clinical studies | Rheumatoid Arthritis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved Japan |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2008 |
| Start of Phase 2 | February 15, 2010 |
| Start of Phase 3 | October 02, 2019 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2022 |
| Date of first US approval | |
| INN, US product name | Ozoralizumab |
| US or EU approved indications | None |
| Company | Sanofi |
| Licensee/Partner | Taisho Pharmaceutical co., Eddingpharm |
| Comments about company or candidate | Sep 26, 2022: Taisho Pharmaceutical Co., Ltd. announced today that it received approval to manufacture and market NanozoraⓇ 30mg Syringes for S.C. Injection ("NanozoraⓇ"), the anti-TNFα NANOBODYⓇ therapeutic licensed from Ablynx [Ghent (Belgium)] (currently a Sanofi company) in 2015 and developed by Taisho in Japan (generic name: ozoralizumab (genetically recombined)) from the Ministry of Health, Labour and Welfare for the indication of rheumatoid arthritis (RA), which is inadequately managed by the current available treatments. March 2021: Taisho Pharmaceutical (TYO: 4581) has submitted an application for approval to manufacture and market the anti-TNFα Nanobody therapeutic ozoralizumab to the Ministry of Health, Labor and Welfare (MHLW) for the planned indication of rheumatoid arthritis (RA), which is to-date inadequately managed by the current available treatments. Taisho is sponsoring a Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) Therapy started in Oct 2018 in Japan (JAPIC ID: JapicCTI-184031; https://rctportal.niph.go.jp/en/detail?trial_id=JapicCTI-184031); this study is still recruiting as of Aug 2019. Asset is available for licensing (excluding Japan, China, Hong Kong, Macau, Taiwan) as of Aug 2018. June 19, 2018 – Sanofi and Ablynx announced today that Sanofi has now acquired all outstanding shares (including shares represented by American Depositary Shares (“ADSs”)), warrants and convertible bonds (together, the “Securities”) of Ablynx NV (“Ablynx”) following the expiration of the Squeeze-out procedure, i.e., acquisition is completed. Jan 2018: Ablynx will be acquired by Sanofi; Ablynx anticipates a potential Phase III trial of ozoralizumab for rheumatoid arthritis to start in 2018. Listed as Phase 2 on Ablynx website accesses Aug 2017. As of Sep 2014, licensed to Eddingpharm for development in People'sRepublic of China, the Hong Kong and Macao Special Administrative Regions, andTaiwan, for all indications. Listed as Phase 2 in Ablynx pipeline as of Feb 2014; Ablynx is currently looking for a partner to bring ozoralizumab to the next step of clinical development |
| Full address of company | Paris, France Europe France https://www.sanofi.us/en/contact-us |
Single chain, trivalent bispecific (2xTNF, 1xalbumin) 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. (https://www.frontiersin.org/articles/10.3389/fimmu.2022.853008/full)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |