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BIOMARKER:

CLDN6 positive

i
Other names: CLDN6, Claudin 6, Claudin-6, Skullin
Entrez ID:
Related biomarkers:
2ms
Preclinical efficacy and pharmacokinetics of an RNA-encoded T cell-engaging bispecific antibody targeting human claudin 6. (PubMed, Sci Transl Med)
No signs of adverse effects from BNT142 RNA-LNP administration were observed in mice or cynomolgus monkeys. On the basis of these and other findings, a phase 1/2 first-in-human clinical trial has been initiated to assess the safety and preliminary efficacy of BNT142 RNA-LNP in patients with CLDN6-positive advanced solid tumors (NCT05262530).
PK/PD data • Preclinical • Journal
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CLDN6 (Claudin 6)
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CLDN6 positive
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BNT142
4ms
NK-92MI Cells Engineered with Anti-claudin-6 Chimeric Antigen Receptors in Immunotherapy for Ovarian Cancer. (PubMed, Int J Biol Sci)
More importantly, CAR-NK cells combined with immune checkpoint inhibitors, anti-PD-L1, could synergistically enhance the antitumor efficacy of CLDN6-targeted CAR-NK cells. These results indicate that CLDN6-CAR NK cells possess strong antitumor activity and represent a promising immunotherapeutic modality for ovarian cancer.
Journal • PD(L)-1 Biomarker • IO biomarker
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CLDN6 (Claudin 6) • NKG2D (killer cell lectin like receptor K1)
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CLDN6 expression • CLDN6 positive
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CLDN6-CAR-NK cell therapy
5ms
CARVac: A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors (clinicaltrials.gov)
P1, N=145, Recruiting, BioNTech Cell & Gene Therapies GmbH | Phase classification: P1/2 --> P1 | Trial completion date: Sep 2037 --> Jan 2040 | Trial primary completion date: Aug 2024 --> Jan 2027
Phase classification • Trial completion date • Trial primary completion date • Metastases
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AFP (Alpha-fetoprotein) • CLDN6 (Claudin 6)
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CLDN6 expression • CLDN6 positive
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BNT211
7ms
CLDN6/GPC3/Mesothelin/AXL-CAR-NK Cell Therapy for Advanced Solid Tumors (clinicaltrials.gov)
P1, N=200, Recruiting, Second Affiliated Hospital of Guangzhou Medical University | Phase classification: P1/2 --> P1 | N=40 --> 200
Phase classification • Enrollment change • Metastases
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AXL (AXL Receptor Tyrosine Kinase) • MSLN (Mesothelin) • CLDN6 (Claudin 6) • GPC3 (Glypican 3)
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CLDN6 expression • CLDN6 positive
7ms
Trial completion date • Trial primary completion date • Metastases
|
AFP (Alpha-fetoprotein) • CLDN6 (Claudin 6)
|
CLDN6 expression • CLDN6 positive
|
BNT211
8ms
Trial completion date • Trial primary completion date • Metastases
|
CLDN6 (Claudin 6)
|
CLDN6 positive
|
BNT142
8ms
CLDN6-specific CAR-T cells plus amplifying RNA vaccine in relapsed or refractory solid tumors: the phase 1 BNT211-01 trial. (PubMed, Nat Med)
A repeat of the dose escalation is ongoing and will identify a RP2D for pivotal trials. ClinicalTrials.gov Identifier: NCT04503278 .
P1 data • Journal • CAR T-Cell Therapy
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CLDN6 (Claudin 6)
|
CLDN6 positive
|
BNT211
10ms
CARVac: A Trial to Evaluate the Safety and Efficacy of CLDN6 CAR-T +/- CLDN6 RNA-LPX (clinicaltrials.gov)
P1/2, N=114, Recruiting, BioNTech Cell & Gene Therapies GmbH | Trial completion date: Sep 2036 --> Sep 2037 | Trial primary completion date: Aug 2023 --> Aug 2024
Trial completion date • Trial primary completion date • Metastases
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AFP (Alpha-fetoprotein) • CLDN6 (Claudin 6)
|
CLDN6 expression • CLDN6 positive
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BNT211
11ms
The tight junction protein claudin 6 is a potential target for patient-individualized treatment in esophageal and gastric adenocarcinoma and is associated with poor prognosis. (PubMed, J Transl Med)
High expression of CLDN6 mRNA is associated with the dysregulation of distinct biological pathways regulating cell growth, proliferation, and cell-matrix interactions. Clinically, the expression of CLDN6 protein is a valuable adverse prognostic marker in EAC and GAC.
Journal
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CLDN6 (Claudin 6)
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CLDN6 expression • CLDN6 positive
12ms
BNT211-01: Interim results from a repeat dose escalation study of CLDN6 CAR-T cells manufactured with an automated process ± a CLDN6-encoding CAR-T cell-Amplifying RNA Vaccine (CARVac) (ESMO 2023)
The safety profile in terms of CRS, ICANS and DLTs observed is in line with previously reported observations. We intend to present data on up to 42 pts, with a data cut-off of 10.09.2023.
Late-breaking abstract • CAR T-Cell Therapy
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CLDN6 (Claudin 6)
|
CLDN6 positive
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BNT211
1year
Preclinical Efficacy of the Antibody-Drug-Conjugate CLDN6-23-ADC for the Treatment of CLDN6 Positive Solid Tumors. (PubMed, Clin Cancer Res)
We report the development of a novel antibody-drug conjugate, CLDN6-23-ADC, that selectively targets CLDN6, a potential onco-fetal-antigen which is highly expressed in ovarian and endometrial cancers. CLDN6-23-ADC exhibits robust tumor regressions in mouse models of human ovarian and endometrial cancers and is currently undergoing Phase I study.
Preclinical • Journal
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CLDN6 (Claudin 6)
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CLDN6 expression • CLDN6 positive
1year
P1/2 data • Clinical
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CLDN6 (Claudin 6)
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CLDN6 positive
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BNT142
1year
A Phase 1 Study of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=178, Recruiting, Chugai Pharmaceutical | Not yet recruiting --> Recruiting
Enrollment open • Metastases
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CLDN6 (Claudin 6)
|
CLDN6 positive
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Actemra IV (tocilizumab) • SAIL66
over1year
New P1 trial • Metastases
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CLDN6 (Claudin 6)
|
CLDN6 positive
|
Actemra IV (tocilizumab) • SAIL66
over1year
Enrollment change
|
CLDN6 (Claudin 6)
|
CLDN6 positive
|
BNT142
over1year
BNT211-01: A Trial to Evaluate the Safety and Efficacy of CLDN6 CAR-T +/- CLDN6 RNA-LPX (clinicaltrials.gov)
P1/2, N=96, Recruiting, BioNTech Cell & Gene Therapies GmbH | Trial primary completion date: Sep 2022 --> Aug 2023
Trial primary completion date • Metastases
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AFP (Alpha-fetoprotein) • CLDN6 (Claudin 6) • IL2 (Interleukin 2)
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CLDN6 expression • CLDN6 positive
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BNT211
almost2years
The role of Claudin-6 in chromophobe renal cell carcinoma. (PubMed, Histol Histopathol)
In chRCC CLDN6 expression is not associated with parameters of aggressiveness or survival. Due to the rare incidence of chRCC further studies with larger cohorts are warranted.
Journal
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CLDN6 (Claudin 6)
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CLDN6 expression • CLDN6 positive
almost2years
A phase II study assessing the safety and efficacy of ASP1650 in male patients with relapsed refractory germ cell tumors. (PubMed, Invest New Drugs)
CLDN6 expression seems ubiquitous in all elements of GCT and is worthy of investigation as a diagnostic biomarker and therapeutic target. (Clinical trial information: NCT03760081).
P2 data • Journal
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CLDN6 (Claudin 6)
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CLDN6 expression • CLDN6 positive
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ASP1650
2years
CLDN6-CAR-NK Cell Therapy for Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=40, Recruiting, Second Affiliated Hospital of Guangzhou Medical University
New P1/2 trial
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CLDN6 (Claudin 6)
|
CLDN6 expression • CLDN6 positive
|
CLDN6-CAR-NK cell therapy
2years
Enrollment change
|
IFNG (Interferon, gamma) • AFP (Alpha-fetoprotein) • CLDN6 (Claudin 6) • IL2RA (Interleukin 2 receptor, alpha) • IFNA1 (Interferon Alpha 1)
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CLDN6 expression • CLDN6 positive
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BNT211
over2years
Enrollment open
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CLDN6 (Claudin 6)
|
CLDN6 positive
|
BNT142
over2years
Discovery of a novel Claudin 6 X 4-1BB bispecific antibody with potent anti-tumor activity through conditional 4-1BB activation (AACR 2022)
Functional evaluation of CLDN6X4-1BB BsAb indicated that the activation of 4-1BB signaling was dependent on CLDN6 expression on tumor cells and the activity was stronger than reference 4-1BB monoclonal antibody urelumab...From the safety perspective, there were no significant changes in liver enzymes or liver histopathology following repeated BsAb administration, suggesting little risks for liver toxicity commonly induced by other 4-1BB agonist antibodies.Conclusions We have successfully generated a novel CLDN6-targeted 4-1BB bispecific antibody which could induce potent 4-1BB stimulation and anti-tumor activity in a CLDN6-dependent manner while minimizing the risk of liver toxicity. Taken together, these data support further development of CLDN6 X 4-1BB bispecific antibody towards IND and clinical trial in 2022.
IO biomarker
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CD8 (cluster of differentiation 8) • CLDN6 (Claudin 6) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C)
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CLDN6 expression • CLDN6 positive
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urelumab (BMS-663513)
over2years
A novel anti-CLDN6-CD137 bispecific antibody (NBL-028) for treating Claudin 6 positive solid tumors (AACR 2022)
Furthermore, NBL-028 is designed upon a proprietary molecular scaffold with superior developability features, demonstrated by stability, yield and ease to purify. NBL-028 is currently at the stage of IND-enabling activities with the aim to enter clinical studies for treating Claudin 6 positive solid tumors in 1Q 2023.
IO biomarker
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CD8 (cluster of differentiation 8) • CLDN6 (Claudin 6) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • TNFRSF9 (TNF Receptor Superfamily Member 9)
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CLDN6 expression • CLDN6 positive
over2years
BNT211: A Phase I trial to evaluate safety and efficacy of CLDN6 CAR-T cells and CARVac-mediated in vivo expansion in patients with CLDN6-positive advanced solid tumors (AACR 2022)
CLDN6 CAR-T cells ± CARVac show an acceptable safety profile at doses tested and encouraging signs of clinical activity. Data from the completed dose escalation phase will be presented. Acknowledgements: BNT211-01 is funded by BioNTech Cell & Gene Therapies GmbH.Trial registration: Clinicaltrials.gov: NCT04503278.Ethics approval: Ethics & Institutional Review Board approvals were obtained from the respective participating countries prior to initiation of the trial.
P1 data • Preclinical • CAR T-Cell Therapy
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CLDN6 (Claudin 6)
|
CLDN6 positive
|
BNT211
over2years
New P1/2 trial
|
CLDN6 (Claudin 6)
|
CLDN6 positive
|
BNT142
over2years
P1/2 data • Preclinical • Late-breaking abstract • CAR T-Cell Therapy
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IL6 (Interleukin 6) • CLDN6 (Claudin 6)
|
IL6 elevation • CLDN6 positive
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BNT211
over2years
BNT211: A phase I/II trial to evaluate safety and efficacy of CLDN6 CAR-T cells and vaccine-mediated in vivo expansion in patients with CLDN6-positive advanced solid tumors (SITC 2021)
Manageable cytokine release syndrome (CRS, grade 1-2, the latter managed with Tocilizumab) without any signs of neurotoxicity have been observed in both patients of part 1 DL2. Updated data from open cohorts and especially for combination with CARVac will be presented. Clinicaltrials gov: NCT04503278
P1/2 data • Preclinical • Late-breaking abstract • CAR T-Cell Therapy
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IL6 (Interleukin 6) • CLDN6 (Claudin 6)
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IL6 elevation • CLDN6 positive
|
Actemra IV (tocilizumab) • BNT211
almost4years
A Trial to Evaluate the Safety and Efficacy of CLDN6 CAR-T +/- CLDN6 RNA-LPX (clinicaltrials.gov)
P1/2; N=36; Not yet recruiting; Sponsor:BioNTech Cell & Gene Therapies GmbH
New P1/2 trial • Clinical
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IFNG (Interferon, gamma) • AFP (Alpha-fetoprotein) • CLDN6 (Claudin 6) • IL2RA (Interleukin 2 receptor, alpha) • IFNA1 (Interferon Alpha 1)
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CLDN6 positive