Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 316 |
| INN | Suvratoxumab |
| Status | No development reported |
| Drug code(s) | AR-320, MEDI4893, LC10 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (VelocImmune) |
| Target(s) | S. aureus alpha toxin |
| Indications of clinical studies | Prevention of pneumonia caused by bacterial infection with Staphylococcus aureus in high-risk patients |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Phase 3 |
| Status | No development reported |
| Start of clinical phase (IND filing or first Phase 1) | January 15, 2013 |
| Start of Phase 2 | August 15, 2014 |
| Start of Phase 3 | September 15, 2022 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | AstraZeneca |
| Licensee/Partner | Aridis |
| Comments about company or candidate | Q3 2023 results - Until the clinical development activities for AR-301 and AR-320 resume, the current clinical development activities are focused primarily on AR-501. On March 20, 2023, Aridis Pharmaceuticals, Inc. received written notice from MedImmune Limited that it has terminated that certain License Agreement by and between MedImmune and the Company dated as of July 12, 2021, and as amended by Amendment No. 1 to License Agreement, dated as of August 9, 2021, pursuant to Section 9.2.1 of the License Agreement for non-payment of the Upfront Cash Payment which was due on December 31, 2021. Aridis has placed the phase 3 trial of suvratoxumab in ventilator-associated pneumonia on hold. Listed as Phase 3 asset in company presentation dated Q1 2023. Aug 16, 2022: Aridis completed successful discussions with the European Medicines Agency (EMA) via their Scientific Advisory meeting and with the FDA via an End-of-Phase 2 meeting, including obtaining agreement on the planned Phase 3 study serving as a single pivotal trial. The regulatory feedback from these agencies is incorporated in the Company's clinical study design. The Company launched the Phase 3 study (also referred to as 'SAATELLITE-2 Study') of AR-320 in collaboration with the public-private COMBACTE-Net consortium of HAP/VAP experts, funded by the Innovative Medicines Initiative program of the European Commission in the amount of up to 25 million Euros. Details of the Phase 3 SAATELLITE-2 clinical trial can be viewed at https://www.clinicaltrials.gov using identifier: NCT05331885. NCT05331885 Phase 3 in Ventilator Associated Pneumonia caused by Staph aureus started in Sep 2022. July 2021: Licensed to Aridis; they are planning to launch the phase 3 study of suvratoxumab in the fourth quarter of this year – the company will receive up to €25m from the European Commission’s (EC) Innovative Medicines Initiative (IMI) COMBACTE clinical trial consortium for this trial. Listed as Phase 2 for prevention of nosocomial Staphylococcus aureus pneumonia in AZ pipeline update dated Nov 5 2020. Fast track designation. NCT01769417 Phase 1 started in January 2013 completed in May 2014. Phase 2 listed in EudraCT (Number: 2014-001097-34), NCT02296320 study was conducted between 10 Oct2014 and 02 Oct2018. Results of a Phase 1 study: 1) MEDI4893 administration at 2250 and 5000 mg would provide effective immunoprophylaxis against systemic SA disease; (2) MEDI4983 distributes to the upper respiratory tract and retains neutralising activity against AT; and (3) potential for emergence of MEDI4893 resistance is low. Ruzin et al. Characterisation of anti‐alpha toxin antibody levels and colonisation status after administration of an investigational human monoclonal antibody, MEDI4893, against Staphylococcus aureus alpha toxin. (https://onlinelibrary.wiley.com/doi/full/10.1002/cti2.1009) |
| Full address of company | Cambridge, United Kingdom Europe United Kingdom https://www.astrazeneca.com/our-company/contact-us.html |
Extended Half-Life Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin. MEDI4893 was generated by introducing the YTE mutations into the previously reported anti-AT MAb LC10, to extend the antibody half-life. LC10 is an affinity-optimized 2A3 variant; 2A3 was derived from VelocImmune platform. INN alt. spelling may be Savratoxumab, susatoxumab
| Anticipated events | Termination |
| Factor(s) contributing to discontinuation | None |