CEACAM5-targeted antibody-drug conjugate 
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  • ||||||||||  Review, Journal:  Diffuse interstitial lung disease induced by antibody-drug conjugates (Pubmed Central) -  May 10, 2025   
    Among the many ADCs being developed, several can cause ILD of varying grades and intensity. Knowledge of their risks, diagnostic and therapeutic modalities is required in order to quickly detect and treat ADC-induced ILD.
  • ||||||||||  Journal:  The Era of Antibody Drug Conjugates in Lung Cancer: Trick or Threat? (Pubmed Central) -  Apr 17, 2025   
    Antibody Drug Conjugates (ADCs) are a novel class of therapeutics that structurally are composed by an antibody directed to a tumour epitope connected via a linker to a cytotoxic payload, and that have shown significant antitumor activity across a range of malignancies including lung cancer. In this article we review the pharmacology and design of ADCs, as well as we describe the results of different studies evaluating ADCs in lung cancer directed to several targets including HER2, HER3, TROP2, MET, CEACAM5 and DLL3, among others.
  • ||||||||||  CEA ISAC / Bolt Biotherap
    A highly efficacious next-generation CEACAM5 (CEA)-targeted Boltbody (Section 40; Poster Board No: 25) -  Mar 25, 2025 - Abstract #AACR2025AACR_9306;    
    These findings highlight Actuximab-MMAE as a promising therapeutic option for CEACAM5-overexpressing tumors, offering a new therapeutic method for targeted cancer therapy. This pre-clinical data set demonstrates the antigen-dependent induction of a robust innate and adaptive immune response by a next-generation CEA-targeted ISAC and the potential to treat CEACAM5+ human cancers.
  • ||||||||||  Multimodal cancer therapy consisting of antibody-drug conjugates and radiotherapy in cancer treatment (Section 33; Poster Board No: 19) -  Mar 25, 2025 - Abstract #AACR2025AACR_6560;    
    Together, this study demonstrates that inherent sensitivity of tumor cells to different payload classes, DAR and TAA dynamic are of relevance for the efficacy of ADC. Informed selection of ADC exhibited synergistic effects with RT providing a novel multimodal and promising strategy for efficient cancer eradication.
  • ||||||||||  tusamitamab ravtansine (SAR408701) / Sanofi, AbbVie
    SAR408701: An anti-CEACAM5-maytansinoid antibody-drug conjugate to treat CEACAM5-positive neuroendocrine prostate cancer (NEPC) (Section 18; Poster Board No: 10) -  Mar 25, 2025 - Abstract #AACR2025AACR_5419;    
    P=N/A
    NEPC is rare de-novo (<1% of the cases) but can represent 15 to 20% of cases after failure of the treatment targeting the androgen receptor (AR) axis (such as enzalutamide, abiraterone) in. Overall, these results demonstrate the efficacy and specificity of SAR408701 against NEPC tumors harboring CEACAM5.This study provides preclinical evidence of the antitumor activity of SAR408701 in CEACAM5-positive NEPC.Funding: Gustave Roussy, Cancer Campus, Grand Paris
  • ||||||||||  precemtabart tocentecan (M9140) / EMD Serono
    Enrollment open, Pan tumor:  Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) (clinicaltrials.gov) -  Feb 20, 2025   
    P1/2,  N=250, Recruiting, 
    These data support the continued development of CEACAM5 clickable binder in combination with MMAE clickable payload for the treatment of CEACAM5 expressing cancers. Not yet recruiting --> Recruiting
  • ||||||||||  Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
    Review, Journal:  Antibody-Drug Conjugates in Non-Small Cell Lung Cancer: State of the Art and Future Perspectives. (Pubmed Central) -  Jan 12, 2025   
    To date, Trastuzumab deruxtecan is the only ADC that has been approved by the FDA for the treatment of patients with NSCLC, but several ongoing studies, both using ADCs as monotherapy and combined with other therapies, are investigating the efficacy of new ADCs. In this review, we describe the structures and mechanism of action of different ADCs; we present the evidence derived from the main clinical trials investigating ADCs' efficacy, focusing also on related toxicity; and, finally, we discuss future perspectives in terms of toxicity management, possible biomarkers, and the identification of resistance mechanisms.
  • ||||||||||  tusamitamab ravtansine (SAR408701) / Sanofi, AbbVie
    Journal:  Structural insights into epitope-paratope interactions of a monoclonal antibody targeting CEACAM5-expressing tumors. (Pubmed Central) -  Oct 31, 2024   
    Clinical studies on efficacy of novel treatment modalities such as PD-L1 inhibition or ADCs are urgently needed in this highly aggressive bladder cancer population. The antibody-drug conjugate tusamitamab ravtansine specifically recognizes the A3-B3 domains of human CEACAM5 (hCEACAM5)...The cryogenic electron microscopy structure of the hCEACAM5A3-B3- tusa Fab complex (3.11?
  • ||||||||||  Vyloy (zolbetuximab) / Astellas, bemarituzumab (AMG 552) / Amgen
    Review, Journal:  New therapeutic target molecules for gastric and gastroesophageal junction cancer. (Pubmed Central) -  Aug 26, 2024   
    Phase III and Ib/III trials of the FGFR2-targeted antibody bemarituzumab for G/GEJ cancer overexpressing FGFR2b are ongoing based on the promising result in a phase II trial, especially in cases with an FGFR2b positivity of???10%...CLDN18.2 is expressed in some G/GEJ tumors but lacks oncogenic driver potential, and the CLDN18.2-targeted antibody zolbetuximab prolonged the survival of CLDN18.2-positive G/GEJ cancer patients in phase III trials...Similarly, targeting of nondriver molecules such as DKK1, TROP2, and CEACAM5 is under investigation in early-stage clinical trials. This shift in focus from target molecules with driver potential to markers for precise drug delivery should increase the number of possible targets in G/GEJ cancer.
  • ||||||||||  Tagrisso (osimertinib) / AstraZeneca
    Analysis of Antibody-Drug Conjugate Target Expression Across Genomic Subsets of Non-Small Cell Lung Cancer (Exhibit Hall) -  Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1525;    
    We evaluated the ADC target expression in 9 paired pre- and post-osimertinib samples with EGFR mutations (exon 19 deletion, L858R, G719S/S768I, L861Q), finding no significant difference in the H-scores for MET [250 (100-291) vs 250 (0-300)], HER2 [0 (0-190) vs 3 (0-75)], TROP2 [130 (90-215) vs 115 (30-200)], CEACAM5 [40 (0-240) vs 60 (0-280)], and HER3 [0 (0-10) vs 0 (0-0)]...ADC target expression IHC H-scores in treatment-nai?ve NSCLC according to oncogene driver. H-score, Median (range) MET HER2 TROP2 CEACAM5 HER3 ALL (n=50) 220 (3-300) 15 (0-220) 152.5 (2-265) 137.5 (0-300) 0 (0-285) EGFR (n=16) 237.5 (100-295) 8.5 (0-220) 125 (5-230) 75 (0-295) 0 (0-285) ALK (n=10) 225 (160-300) 110 (15-160) 180 (137-220) 108 (0-295) 0 (0-8) ROS1 (n=9) 195 (59-290) 0 (0-170) 120 (15-210) 115 (0-210) 0 (0-0) RET (n=4) 242 (200-270) 52.5 (0-90) 90.5 (2-265) 126.5 (2-290) 3 (0-110) KRAS (n=11) 190 (2-300) 6 (0-150) 182.5 (30-205) 200 (0-300) 0 (0-10) Comparisons by oncogene driver EGFR vs KRAS p=0.183 p=0.421 p=0.635 p=0.288 p=0.305 EGFR vs fusion p=0.476 p=0.962 p=0.650 p=0.950 p=0.361 Fusion vs KRAS p=0.265 p=0.223 p=0.540 p=0.216 p=0.608 EGFR+fusion vs KRAS p=0.181 p=0.241 p=0.418 p=0.191 p=0.393
  • ||||||||||  labetuzumab govitecan (IMMU-130) / Gilead
    Journal:  CEACAM5-Targeted Immuno-PET in Androgen Receptor-Negative Prostate Cancer. (Pubmed Central) -  Jul 1, 2024   
    This review summarizes the knowledge about the efficacy and tolerance profiles of ADCs targeting TROP2, HER2, HER3, CEACAM5 and c-MET in metastatic NSCLC with and without alterations in oncogenic drivers. [89Zr]Zr-DFO-labetuzumab imaging was able to clearly delineate both neuroendocrine H660 xenografts and AR- DU145 in
  • ||||||||||  Journal:  Camelid-derived Tcell engagers harnessing human ?? T (Pubmed Central) -  May 28, 2024   
    [89Zr]Zr-DFO-labetuzumab imaging was able to clearly delineate both neuroendocrine H660 xenografts and AR- DU145 in Furthermore, restricting the activation of fresh human peripheral T
  • ||||||||||  Journal:  Expression of Potential Antibody-Drug Conjugate Targets in Cervical Cancer. (Pubmed Central) -  May 11, 2024   
    Overall, 73.1% (49/67) of cervical cancer samples are CD138-positive with 38.8% (26/67) of cervical cancer samples showing at least moderate or high expression. (4) TROP2, CEACAM5 or CD138 do seem suitable for further clinical research and the data presented here might be used to guide further clinical trials with ADCs in advanced and recurrent cervical cancer patients.
  • ||||||||||  M9140 / EMD Serono
    Trial completion date, Trial primary completion date, Metastases:  Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01) (clinicaltrials.gov) -  Mar 27, 2024   
    P1,  N=180, Recruiting, 
    The lead candidate, ATOR-4066, targets CD40 and CEACAM5 and induces superior anti-tumour activity by myeloid cell-mediated and T cell-dependent mechanisms. Trial completion date: May 2025 --> Feb 2026 | Trial primary completion date: Apr 2024 --> Feb 2026
  • ||||||||||  P329G-Engager: A novel universal antibody-based adaptor platform for cancer immunotherapy (Section 3) -  Mar 5, 2024 - Abstract #AACR2024AACR_9493;    
    Neither the individual P329G IgG nor the individual P329G-TCB induced anti-tumoral efficacy, validating the requirement for primary and secondary antibody binding for T cell engaging activity.These results provide in vitro and in vivo evidence that the universal P329G engager platform can be used as an efficacious cancer treatment. Ultimately, this modular approach may enable off-the-shelf personalization via combination of patient-specific antibodies and universal effector cell engagers based on the patient's tumor target and immune profile.
  • ||||||||||  ATOR-4066 / Alligator Biosci
    ATOR-4066, a Neo-X-Prime (Section 3) -  Mar 5, 2024 - Abstract #AACR2024AACR_8283;    
    In contrast, RNA-sequencing of peripheral blood in ATOR-4066 treated mice showed only small transcriptomic differences compared to the vehicle treated group, but distinct from mice treated with a CD40 mAb, further demonstrating the CEACAM5 dependent response of ATOR-4066. In summary, these preclinical data demonstrate that ATOR-4066 activates infiltrating myeloid cells resulting in increases in activated tumor infiltrating T cells, thus creating a pro-inflammatory tumor microenvironment, which strongly supports further development and clinical testing of ATOR-4066.
  • ||||||||||  tusamitamab ravtansine (SAR408701) / Sanofi, AbbVie
    Tusamitamab ravtansine induces immunogenic cell death and synergizes with anti-PD-1 or anti-PD-L1 antibody combination in solid tumor (Section 43) -  Mar 5, 2024 - Abstract #AACR2024AACR_5138;    
    In this model, the combination of tusamitamab ravtansine with anti-PD-1 or anti-PD-L1 antibody led to complete response and, even, tumor-free survivors at 120 days post tumor implantation while single agents were inactive or transiently active. In summary, these preclinical data show that tusamitamab ravtansine could be beneficially combined with immune checkpoint and strongly support their evaluation in clinical development.
  • ||||||||||  Recentin (cediranib) / AstraZeneca, Avastin (bevacizumab) / Roche
    Targeted proteomics and next-generation sequencing (NGS) for biomarker discovery in metastatic colorectal cancer (mCRC) (Section 39) -  Mar 5, 2024 - Abstract #AACR2024AACR_2474;    
    P2/3
    Our preliminary findings for this cohort indicate the benefit of the use of multi-modal methodologies to inform better strategies for patient stratification and precision medicine, though further assessment of proteogenomic characteristics is needed. This data may inform future clinical development and guide patient eligibility to clinical trials and possible treatment sequencing for ADCs.
  • ||||||||||  M9140 / EMD Serono
    Enrollment change, Trial completion date, Trial primary completion date, Metastases:  Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01) (clinicaltrials.gov) -  Mar 3, 2024   
    P1,  N=180, Recruiting, 
    This data may inform future clinical development and guide patient eligibility to clinical trials and possible treatment sequencing for ADCs. N=31 --> 180 | Trial completion date: Nov 2023 --> May 2025 | Trial primary completion date: Nov 2023 --> Apr 2024
  • ||||||||||  Journal:  Generation and Characterization of Iduronidase-Cleavable ADCs. (Pubmed Central) -  Dec 6, 2023   
    Finally, in vivo antitumor activity could be demonstrated for an IduA-cleavable duocarmycin ADC. The presented results emphasize the potential of iduronide linkers for ADC development and represent a tool for further balancing out tumor selectivity and safety.
  • ||||||||||  SCS-03: How CEACAM5 Expression Can Be Measured and Leveraged in NSCLC Care: Current Developments & Future Therapeutic Opportunities (Chicago Ballroom ABCD) -  Nov 29, 2023 - Abstract #IASLCNACLC2023IASLC_NACLC_93;    
    The presented results emphasize the potential of iduronide linkers for ADC development and represent a tool for further balancing out tumor selectivity and safety. Promising initial evidence demonstrates the potential of targeting CEACAM5 to provide additional therapeutic options for patients with lung cancer, and several ongoing clinical trials are evaluating CEACAM5-targeting agents across different settings in NSCLC.In this live satellite symposium, renowned experts will discuss the clinical rationale for targeting CEACAM5, explore how strategies to test for CEACAM5 fit into larger testing paradigms in NSCLC, and review ongoing research efforts to develop antibody-drug conjugates