Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 490 |
| INN | Rademikibart |
| Status | Clinical |
| Drug code(s) | SIM0718, CBP-201 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IL-4R alpha |
| Indications of clinical studies | Atopic dermatitis, asthma, Chronic Rhinosinusitis With Nasal Polyps |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | April 15, 2018 |
| Start of Phase 2 | June 23, 2020 |
| Start of Phase 3 | July 15, 2024 |
| 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 | Suzhou Connect Biopharmaceuticals Ltd. |
| Licensee/Partner | Simcere Pharmaceutical Co. Ltd |
| Comments about company or candidate | Phase 3 studies for Atopic dermatitis (CTR20242160 / NCT06477835), Asthma (CTR20242195 / NCT06488755). CTR20242160 Phase 3 initiated in July 2024. Simcere Pharmaceutical Co., Ltd., Connect’s partner in Greater China who holds responsibility for future development and New Drug Application submission of rademikibart, has announced the initiation of Phase 3 trials in China in moderate-to-severe AD and asthma. https://investors.connectbiopharm.com/news-releases/news-release-details/connect-biopharma-reports-first-half-2024-financial-results-and Nov. 21, 2023 -- Connect Biopharma Holdings Limited announced that two of its wholly owned subsidiaries, Connect Biopharma Hong Kong Limited and Suzhou Connect Biopharma Co., Ltd., have entered into an exclusive license and collaboration agreement with Simcere Pharmaceutical Co., Ltd., a subsidiary of Simcere Pharmaceutical Group Ltd. (“Simcere”), to develop and commercialize Connect Biopharma’s rademikibart in Greater China April 2023: The Company believes it is on track to complete the 36-week stage 2 maintenance phase of the trial in patients with severe-to-moderate AD in the second half of 2023. This stage of the trial includes a once-a-month (Q4W) dosing regimen. Based on feedback received from the CDE, the Company plans to submit an NDA by the end of the first quarter of 2024 for potential approval in 2025. Global Phase 3 program: The Company is seeking strategic partnerships to advance this product candidate to the next phase of clinical development with potential global and regional partners to provide the necessary infrastructure and deliver a differentiated therapeutic program with improved efficacy and dosing convenience." (https://investors.connectbiopharm.com/news-releases/news-release-details/connect-biopharma-reports-full-year-2022-financial-results-and) Mar 2023: Data from Stage 1 of the ongoing pivotal CBP-201 China trial in moderate-to-severe atopic dermatitis (AD) showed rapid relief from symptoms, as early as week one in some cases, and no efficacy plateau at Week 16. The study met primary and secondary endpoints with mostly mild-to-moderate adverse effects reported. The data were presented as a late-breaking oral presentation today at the American Academy of Dermatology Annual Meeting, taking place in New Orleans, March 17-21, 2023. https://www.connectbiopharm.com/wp-content/uploads/AAD2023-late-breaker-11Mar2023_FINAL.pdf NCT05614817 Phase 3 in atopic dermatitis due to start in Dec 2022 was withdrawn. July 2022: Suzhou Connect Biopharmaceuticals announces the projected timeline of the Company’s global Phase 3 program in moderate-to-severe AD remains unchanged including to enroll the first patient by the end of 2022, intention to submit NDA to National Medical Products Administration (NMPA), China for Atopic dermatitis in 2024. July 2022: NCT04783389 Phase 2 in Chronic Rhinosinusitis With Nasal Polyps Terminated (Trial was discontinued in 2022 due to COVID-19 pandemic and Ukraine/Russia conflict related enrollment challenges. Discontinuation was not related to safety.) NCT05017480 Phase 2 in atopic dermatitis due to start in Sep 2021. Phase-II clinical trials in Atopic dermatitis (In adults, In the elderly) in USA (SC) (NCT04444752) started in June 2020. Jan 2020: Connect Biopharma announced positive topline data from the Phase Ib study of CBP-201, in patients with moderate-to-severe atopic dermatitis (AD). Results from the study show that CBP-201 has an efficacy profile that is superior to data from clinical studies of the current standard of care therapy for AD after four weeks of treatment, with a favorable safety profile. ACTRN12619000395134 Phase 1 study. |
| Full address of company | East R&D Building, 3rd floor, 6 Beijing West Road, Taicang, China, 215400 Asia China https://www.connectbiopharm.com/contact/ |
CBP-201 is a hinge-stabilized monoclonal antibody against IL-4Rα, a receptor found on immune cells that mediates the biological activities of both IL-4 and IL-13, two important cytokines that drive a broad range of allergic inflammation such as asthma and atopic dermatitis. Preclinical studies showed that CBP-201 is extremely potent in inhibiting IL-4Rα signaling (IC50 is approximately 40 pM). Phase 1b study in moderate-to-several atopic dermatitis has been completed and the data showed that four-week treatment of CBP-201 resulted in significant and rapid improvement in all disease metrics including skin lesion and pruritus, supporting the first-in-class potential. http://www.connectbiopharm.com/product289/detail490.html
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |