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  • ||||||||||  MODULE 4: Novel Investigational Agents and Strategies in the Treatment of mUBC (San Francisco Marriott Marquis, Yerba Buena ) -  Feb 2, 2023 - Abstract #ASCOGU2023ASCO_GU_930;    
    CME Provider and Supporter(s): This event is organized and accredited by Research to Practice and supported through educational grants provided by Astellas and Seagen Inc, AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, and Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC. Mechanism of action of the antibody-drug conjugate disitamab vedotin; efficacy and safety findings and ongoing evaluation in mUBC Early activity and safety data with the combination of trastuzumab deruxtecan and nivolumab for HER2-expressing mUBC Biologic rationale for the investigation of PARP inhibitors for mUBC; implications of recently reported studies of PARP inhibition (eg, BAYOU, ATLANTIS) for future research and patient care Preliminary data with and ongoing studies of FGFR inhibitors beyond erdafitinib (eg, pemigatinib, futibatinib) for mUBC Available data with and ongoing Phase III trials of anti-PD-1/PD-L1 antibodies combined with anti-CTLA-4 antibodies with or without chemotherapy for mUBC Other promising agents and strategies under investigation for mUBC
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Journal:  γ-Core Guided Antibiotic Design Based on Human Enteric Defensin 5. (Pubmed Central) -  Jan 22, 2023   
    Molecular dynamics simulation revealed that five Arg residues, Arg1, Arg7, Arg9, Arg15, and Arg18, mediated most of the polar interactions of RC18 with the phospholipid head groups during membrane penetration. In vivo experiments indicated that RC18 decreased MRSA colonization and dramatically improved the survival of infected mice, thus demonstrating that RC18 is a promising drug candidate to treat MRSA infections.
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    New P2 trial:  A Study of Telitacicept in Lupus Nephritis (clinicaltrials.gov) -  Jan 11, 2023   
    P2,  N=120, Not yet recruiting, 
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Trial completion date, Trial primary completion date:  A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy (clinicaltrials.gov) -  Dec 22, 2022   
    P2,  N=30, Recruiting, 
    Clinical trial information: NCT04879329. Trial completion date: Sep 2022 --> Jan 2024 | Trial primary completion date: Aug 2022 --> Jul 2023
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma, Sutent (sunitinib) / Pfizer
    METABOLITES COULD BE PROGNOSTIC BIOMARKERS AND POTENTIAL DRUG TARGETS FOR ADVANCED RENAL-CELL CARCINOMA (Sapphire ABEFIJMN) -  Nov 20, 2022 - Abstract #SUO2022SUO_261;    
    Feasible ways of targeting these metabolites include stimulating or inhibiting upstream enzymes of them. The development of drug combinations that can simultaneously target tumor cells, immune cells and the metabolites in the microenvironment may represent a solution to increase therapeutic response.
  • ||||||||||  RC118 / Rongchang Pharma
    Enrollment closed, Metastases:  A Study of RC118 in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours (clinicaltrials.gov) -  Nov 18, 2022   
    P1,  N=33, Active, not recruiting, 
    The development of drug combinations that can simultaneously target tumor cells, immune cells and the metabolites in the microenvironment may represent a solution to increase therapeutic response. Recruiting --> Active, not recruiting
  • ||||||||||  Clinical, Journal:  B cell depletion and inhibition in systemic lupus erythematosus. (Pubmed Central) -  Nov 8, 2022   
    However, after more than two decades of research and over 40 randomized clinical trials, only one such therapy, belimumab, has been approved for use in SLE...Despite a lack of supporting phase III evidence, rituximab is used off-label in SLE...Successful phase II trials have recently been reported for obinutuzumab and telitacicept with larger confirmatory trials currently underway. Refinements in pharmaceutical mechanisms of action, trial design, and patient selection have resulted in recent preliminary successes, offering renewed optimism for B-cell targeted therapeutics in SLE management.
  • ||||||||||  Aidixi (disitamab vedotin) / Rongchang Pharma, Seagen
    Journal:  Disitamab vedotin, a novel HER2-directed antibody-drug conjugate in gastric cancer and other solid tumors. (Pubmed Central) -  Nov 4, 2022   
    Besides, we provide a landscape on the progression of RC48 in common malignancies, focusing on RC48 in gastric or gastroesophageal junction cancer, and a brief overview of urothelial, breast and other cancers (e.g., gynecological cancer, biliary tract cancer, non-small cell lung cancer and myometrial invasive bladder cancer). Finally, we will also discuss future challenges in the development of RC48 and future directions to improve efficacy.
  • ||||||||||  Efficacy and toxicity of HER2-targeted antibody-drug conjugates (ADCs) in the treatment of metastatic urothelial cancer (mUC): A systematic review (Exhibition / Poster Area) -  Oct 9, 2022 - Abstract #ESMOAsia2022ESMO_Asia_700;    
    The search method included the terms bladder carcinoma or urothelial carcinoma; disitamab vedotin; HER2-targeted therapy; antibody-drug conjugate...Results Ultimately, 6 phase 1 or 2 clinical trials with 236 pts were selected and 3 drugs were identified: Disatamab vedotin (DV), Trastuzumab Deruxtecan (TDXd), and MRG002...Preliminary results of DV combined with toripalimab as 1L in cis-ineligible pts or 2L treatment showed a RR of 76.7% and DCR of 96.7%...A phase 1b is testing TDXd combined with nivolumab, the ORR was 36.7%, with a median duration of response of 13.1 months...DV received FDA breakthrough therapy designation in 2020 for 2L treatment of HER2+ mUC. Confirmatory trials and better biomarker-based patient selection are needed.
  • ||||||||||  lemzoparlimab (ABBV-IMAB-TJC4) / AbbVie
    Combination of HER2 ADC and lemzoparlimab elicits enhanced efficacy in both HER2 high-and low-expressing breast and gastric cancers (Hall C) -  Oct 6, 2022 - Abstract #SITC2022SITC_1171;    
    In vivo activity of RC48 or in-house produced DS8201 analogue in combination with lemzoparlimab were investigated in CDX (HER2 0/1+/3+ by IHC) and PDX (HER2 2+ by IHC) models...Lemzoparlimab potentiated HER2 ADC mediated tumor killing by modulating NK cells and macrophage activity to increase cytotoxicity and phagocytosis. These data support future clinical investigation of lemzoparlimab and HER2 ADC combination in HER2 positive patients, especially those with HER2-low expressing tumors.
  • ||||||||||  Review, Journal, BRCA Biomarker:  From seaside to bedside: Current evidence and future perspectives in the treatment of breast cancer using marine compounds. (Pubmed Central) -  Sep 29, 2022   
    A deeper knowledge of the mechanism of action and of the potential predictive factors for response to marine-derived drugs is important for their rational and effective use, alone or in combination. In this narrative review, we discuss the role of marine-derived drugs for the treatment of BC, although most of them are not approved, and the opportunities that could arise from the potential treasure trove of the sea for novel BC therapeutics.