Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 315 |
| INN | Tosatoxumab |
| Status | Clinical |
| Drug code(s) | AR-301, KBSA301 |
| Brand name | Salvecin |
| 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 | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Human B cell derived (Kenta Biotech’s proprietary MabIgX® technology) |
| Target(s) | S. aureus alpha toxin |
| Indications of clinical studies | Secondary S. aureus bacterial pneumonia in COVID-19 patients, Pneumonia Due to Staphylococcus Aureus |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | May 15, 2012 |
| Start of Phase 2 | |
| Start of Phase 3 | June 15, 2019 |
| 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 | Kenta Biotech Ltd |
| Licensee/Partner | Aridis Pharmaceuticals, Serum AMR, Shenzhen Arimab Biopharmaceuticals Co. Ltd. |
| Comments about company or candidate | June 2024: The discussions with potential partners to continue the development of AR-301 are expected to reach a definitive outcome in the 4th quarter. The clinical data and the proposed design for the second and final Phase 3 study were presented to the FDA and the European Medicines Agency (EMA). Concurrence has been achieved with the regulators on a single, globally harmonized Phase 3 study for licensure. July 12, 2023: Aridis Pharmaceuticals, Inc. announced that the FDA has granted Qualified Infectious Disease Product (QIDP) Designation under the Generating Antibiotic Incetives Now (GAIN) Act for AR-301, a fully human IgG1 monoclonal antibody currently in Phase 3 clinical development as an adjunctive therapy for pneumonia caused by gram-positive Staphylococcus aureus in critically ill hospitalized patients. QIDP designation provides priority review status. June 8, 2023: First Quarter 2023 Financial Results and Business Update "Reported positive results from the first Phase 3 study of AR-301 in mechanically ventilated hospitalized patients, especially in the prespecified older adult population of 65+ years." and "Received positive feedback from the US Food and Drug Administration (FDA) on the Company’s proposed single confirmatory Phase 3 study of AR-301 to support the submission of a Biologics License Application (BLA). The FDA agreed to the proposed expansion of the confirmatory Phase 3 study in S. aureus ventilator associated pneumonia (VAP) patients to include ventilated hospital acquired pneumonia (HAP) and ventilated community acquired pneumonia (CAP) patients." https://ir.aridispharma.com/news-releases/ FDA/EMA meeting on P3 data expected in H1 2023. Aug 2022: the company anticipates reporting top-line data in the second half of 2022. Sept. 30, 2019: Aridis Pharmaceuticals, Inc., a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening bacterial infections, announced today that it has consummated a licensing agreement with Serum AMR, an affiliate of Serum International BV (SIBV) and the Serum Institute of India, Ltd. The agreement grants Serum AMR a license to multiple programs from Aridis for certain limited territories and access the Company's MabIgX® platform technology for asset identification and selection. Serum AMR is granted a license to Aridis' clinical stage programs AR-301 (ventilator associated pneumonia), AR-105 (ventilator associated pneumonia), and AR-101 (hospital acquired pneumonia): these license rights will be exclusive and to a limited territory, which includes territories outside of the U.S., Europe, Canada, UK, China, Australia, New Zealand and Japan. Aug 2019: During the second quarter, Aridis continued enrolling its Phase 3 global clinical trial for AR-301, which targets gram-positive S. aureus in critically ill VAP patients. The trial, which was initiated in the first quarter of 2019, is expected to enroll 240 patients at approximately 140 clinical centers in 20 countries. Interim data is expected in Q1 2020 and top line data is expected in late 2020. Described as in Phase 3 studies on company website accessed Jan 26, 2019. NCT03816956 Phase 3 study in ventilator-associated pneumonia (VAP) due to Staphylococcus aureus (S. aureus) in combination with standard of care (SOC) antibiotic therapy in patients with confirmed S. aureus infection recruiting as of Feb 15, 2019. June 2019: CTR20191544 phase III clinical study evaluating the efficacy and safety of AR-301 as a combination of antibiotics in the treatment of Staphylococcus aureus ventilator-associated pneumonia (VAP) started in China July 2018: Still listed in company pipeline. Aridis intends to initiate a Phase 3 clinical study evaluating AR-301 near the end of 2018. Feb 2018: Joint venture Shenzhen Arimab Biopharmaceuticals Co., Ltd., headquartered in China’s largest technology hub, Shenzhen will be launched with significant capital commitment to advance two of Aridis’ clinical candidates, AR-301 and AR-101, through potential China Food and Drug Administration (CFDA) approvals in acute pneumonia caused by Gram-positive Staphylococcus aureus and Gram-negative Pseudomonas aeruginosa infection, respectively. June 2017: Positive Phase 2a study results presented. Listed in Aridis pipeline as of June 2016. AR-301 was granted Fast Track designation by the FDA and orphan drug designation in the European Union. AR-301 is currently being evaluated in a global Phase 3 clinical study; interim clinical data from this study is expected in late 2019. |
| Full address of company | Löberenstrasse 47 6301 Zug Switzerland Europe Switzerland https://pitchbook.com/profiles/company/62137-00 |
KBSA301 is a human monoclonal IgG1 lambda2 antibody specifically targeting S. aureus alpha-toxin
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |