- |||||||||| Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci, Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
SAVE: A prospective, single-arm, single-center clinical study of disitamab vedotin in combination with toripalimab in patients with advanced penile cancer that has progressed or is intolerant to cisplatin chemotherapy. (Hall A; Poster Bd #: 513a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2289; About 20 patients with advanced penile cancer who have progressed or are intolerant to chemotherapy are planned to be enrolled with antibody-drug conjugates (Disitamab Vedotin for injection, 1 time/2 weeks, 2.0 mg/kg) and PD-1 (Toripalimab, 1 time/2 weeks, 3.0 mg/kg; or1 time/3 weeks, 240 mg/kg), regimen until the disease progresses or is intolerant. This study is expected to provide a basis for the treatment of advanced penile cancer using this regimen.
- |||||||||| Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Adjuvant or rescue disitamab vedotin (RC48-ADC) for high-risk non-muscle invasive bladder cancer with HER2 overexpression: A phase II multi-center study. (Hall A; Poster Bd #: 311a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1790; P2 Secondary endpoints encompass the 6-month recurrence-free rate (Cohort A), duration of response (Cohort B), recurrence-free survival, progression-free survival, overall survival, and quality of life (assessed through eEuroQoL EQ-5D and FACT-BI). Additionally, exploratory endpoints will investigate the relationship between biomarkers in tumor tissues, blood, and urine, and treatment efficacy.
- |||||||||| Fruzaqla (fruquintinib) / Takeda, Aidixi (disitamab vedotin) / Pfizer
Trial completion date, Trial primary completion date, Metastases: HCCSC-C03: Disitamab Vedotin Combined With Fruquintinib for mCRC With HER2 Expression (clinicaltrials.gov) - Apr 16, 2024 P4, N=51, Active, not recruiting, These results will support further investigation for DV plus toripalimab in this population. Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Retrospective data, Journal, Real-world evidence, Real-world: Efficacy and safety of telitacicept in patients with lupus nephritis: a single-center, real-world retrospective study. (Pubmed Central) - Apr 13, 2024 Telitacicept treatment reduced disease severity in patients with LN. The initial clinical trial provided supportive evidence for the effectiveness and safety of Telitacicept as a viable treatment option for LN, allowing a reduction in the daily glucocorticoid intake while maintaining a good safety profile, and improving hypocomplementation in LN management.
- |||||||||| Benlysta (belimumab) / GSK, Tai'ai (telitacicept) / Rongchang Pharma
COMPARISON OF TELITACICEPT AND BELIMUMAB IN PATIENTS WITH SLE (Poster View) - Mar 29, 2024 - Abstract #EULAR2024EULAR_817; Both telitacicept and belimumab performed well regarding SLEDAI. Telitacicept can slightly improve treatment outcomes, especially in addressing serum C4 levels, and as well as IgG levels in patients with lupus nephritis.
- |||||||||| Kadcyla (ado-trastuzumab emtansine) / Roche, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Journal: Comparison of trastuzumab emtansine, trastuzumab deruxtecan, and disitamab vedotin in a multiresistant HER2-positive breast cancer lung metastasis model. (Pubmed Central) - Mar 28, 2024 In a mouse model, all three ADCs inhibited the growth of L-JIMT-1 lung metastases compared to a vehicle, but DV and T-DXd more strongly than T-DM1, and DV treatment led to the smallest tumor burden. The L-JIMT breast cancer lung metastasis model developed may be useful in the evaluation of anti-cancer agents for multiresistant HER2-positive advanced breast cancer.
- |||||||||| Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
MMAE payload uncoupled from HER2 targeting agent is selectively activated at tumors through click chemistry in vivo | Poster Board #1701 (In-person; Poster Board #1701; Hall C (Ernest N. Morial Convention Center)) - Mar 12, 2024 - Abstract #ACSSp2024ACS_Sp_2920; In the NCI-N87 model, the administration of SQT01 followed by SQP22 resulted in a significant inhibition of tumor growth on day 29 (80% TGI) as compared to a non-binding control (28% TGI) or the ADC disitamab vedotin (47% TGI), which targets HER2 and carries MMAE...Thus, the rate of MMAE accumulation in tumors is highly differentiated from the profile reported with vedotin ADCs. These results confirm that click chemistry selectively activates an auristatin protodrug and provides a new avenue to get cytotoxic agents directly to tumors.
- |||||||||| Review, Journal: Advances in the treatment of IgA nephropathy with biological agents. (Pubmed Central) - Mar 7, 2024
There are four main categories of biological agents used to treat IgA nephropathy, specifically anti-CD20 monoclonal antibodies, anti-BLyS or APRIL monoclonal antibodies, monoclonal antibodies targeting both BLyS and APRIL (telitacicept and atacicept), and monoclonal antibodies inhibiting complement system activation (narsoplimab and eculizumab). However, further research on the dosages, treatment duration, long-term efficacy, and safety of these biological agents is required.
- |||||||||| Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Improving anti-tumor efficacy by modulating a separate HER2 activator and an MMAE payload and reuniting both through click chemistry (Section 26) - Mar 5, 2024 - Abstract #AACR2024AACR_9278; In efficacy studies, this activation resulted in significant tumor growth inhibition compared to an isotype control or disitamab vedotin, an ADC that targets HER2 and carries an MMAE payload...Additional toxicology studies are ongoing. This data indicates that the CAPAC platform, which separates the targeting agent from the payload, can be optimized for antigen specific efficacy and safety by modulating dose amounts and time intervals between both components.
- |||||||||| Herceptin (trastuzumab) / Roche, Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
A click chemistry-based HER2 targeting agent activates a decoupled MMAE payload making it highly differentiated in efficacy and safety than ADCs (Section 26) - Mar 5, 2024 - Abstract #AACR2024AACR_9276; Dosing with SQT01 with a protease cleavable dipeptide-TCO protodrug analog or a molar equivalent dose of HER2-Fab-vedotin were highly toxic and intolerable. Based on preclinical observations, SQT01+SQP22 was safe and tolerated, and there was no observed body weight loss.These data demonstrate that the CAPAC platform, which separates the targeting agent from the payload, provides a clear benefit in terms of safety and efficacy compared with small or large format proteins with the classic fixed construct of ADCs (e.g. a fixed drug to antibody ratio).
- |||||||||| Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer, RC148 / Rongchang Pharma
RC148, a novel bispecific antibody targeting PD-1 and VEGF for cancer immunotherapy (Section 6) - Mar 5, 2024 - Abstract #AACR2024AACR_5545; RC148 allows dimeric VEGF crosslinking and gradually enhances PD-1 binding activity, potentially reduces systemic toxicity of anti-VEGF therapy and enhances antitumor potency via VEGF trigged enrichment in tumor areas. In preclinical studies, RC148 blocks the binding of VEGF to VEGFR and PD-1 to PD-L1, prevents the growth and migration of human umbilical vein endothelial cells, enables efficient T cell activation, exhibited synergistic antitumor effects in rodent models and showed safety profiles in non-human primate studies.
- |||||||||| misitatug blivedotin (RC88) / Rongchang Pharma
Trial completion date, Trial primary completion date, Metastases: A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Feb 20, 2024 P1/2, N=200, Recruiting, Not yet recruiting --> Recruiting | Initiation date: Jan 2024 --> Jul 2023 Trial completion date: May 2024 --> Sep 2025 | Trial primary completion date: Dec 2023 --> Sep 2024
- |||||||||| Aidixi (disitamab vedotin) / Pfizer
Enrollment open, Combination therapy, Monotherapy: A Study of Disitamab Vedotin Alone or With Other Anticancer Drugs in Solid Tumors (clinicaltrials.gov) - Feb 9, 2024 P1/2, N=198, Recruiting, This study further summarizes and analyzes the potential mechanism of the PI3K-AKT signaling pathway in MTA resistance and reveals that the PIK3CA H1047R mutation may be a potential molecular marker for the efficacy prediction of mTOR inhibitors, providing new insights and potential therapeutic strategies for the application of MTAs to MBC patients. Not yet recruiting --> Recruiting
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