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Disease Domain	Count

Neoplasms	2
Endocrinology and Metabolic Disease	1

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saRNAs	1
Autologous CAR-T	1
Prophylactic vaccine	1

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CLDN6(Claudin 6)	2

This is a Phase I, FIH, open-label, multicenter, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of claudin 6 (CLDN6) chimeric antigen receptor T cells (CAR-T) with or without CLDN6 ribonucleic acid lipoplexes (RNA-LPX) in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

Start Date16 Sep 2020

Sponsor / Collaborator

BioNTech Cell & Gene Therapies GmbH

100 Clinical Results associated with BioNTech Cell & Gene Therapies GmbH

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12

Literatures (Medical) associated with BioNTech Cell & Gene Therapies GmbH

01 Dec 2023·Immuno-Oncology and Technology

CIMT 2023: report on the 20th Annual Meeting of the Association for Cancer Immunotherapy

Review

Author: Freitag, J ; Dallmann, J ; Khinvasara, K ; Merz, L ; Schork, M ; Peters, D ; Jung, C ; Beck, J D

The Association for Cancer Immunotherapy (CIMT) celebrated the 20th anniversary of the CIMT Annual Meeting. CIMT2023 was held 3-5 May 2023 in Mainz, Germany. 1051 academic and clinical professionals from over 30 countries attended the meeting and discussed the latest advances in cancer immunology and immunotherapy research. This report summarizes the highlights of CIMT2023.

01 Nov 2023·Nature MedicineQ1 · MEDICINE

CLDN6-specific CAR-T cells plus amplifying RNA vaccine in relapsed or refractory solid tumors: the phase 1 BNT211-01 trial

Q1 · MEDICINE

Article

Author: Türeci, Özlem ; Borchmann, Peter ; Flemmig, Carina ; Desuki, Alexander ; Mackensen, Andreas ; Preußner, Liane ; Müller, Fabian ; Alsdorf, Winfried ; Karagiannis, Panagiotis ; Smit, Eveline ; Koenecke, Christian ; He, Ying ; Schulz-Eying, Catrine ; Rengstl, Benjamin ; Wiegert, Erol ; Kutsch, Nadine ; Şahin, Uğur ; Kang-Fortner, Qing ; Hillemanns, Peter ; Wagner-Drouet, Eva ; Ho, Thang ; Schlitter, Anna Melissa ; Bokemeyer, Carsten ; Kühlcke, Klaus ; Lüke, Florian ; Haanen, John B A G ; Finlayson, Andrew ; Ferstl, Barbara ; Heudobler, Daniel ; Klobuch, Sebastian

AbstractThe oncofetal antigen Claudin 6 (CLDN6) is highly and specifically expressed in many solid tumors, and could be a promising treatment target. We report dose escalation results from the ongoing phase 1/2 BNT211-01 trial evaluating the safety and feasibility of chimeric antigen receptor (CAR) T cells targeting the CLDN6 with or without a CAR-T cell-amplifying RNA vaccine (CARVac) at two dose levels (DLs) in relapsed/refractory CLDN6-positive solid tumors. The primary endpoints were safety and tolerability, maximum tolerated dose and recommended phase 2 dose (RP2D). Secondary endpoints included objective response rate (ORR) and disease control rate. We observed manageable toxicity, with 10 out of 22 patients (46%) experiencing cytokine release syndrome including one grade 3 event and 1 out of 22 (5%) with grade 1 immune effector cell-associated neurotoxicity syndrome. Dose-limiting toxicities occurred in two patients at the higher DL, resolving without sequelae. CAR-T cell engraftment was robust, and the addition of CARVac was well tolerated. The unconfirmed ORR in 21 evaluable patients was 33% (7 of 21), including one complete response. The disease control rate was 67% (14 of 21), with stable disease in seven patients. Patients with germ cell tumors treated at the higher DL exhibited the highest response rate (ORR 57% (4 of 7)). The maximum tolerated dose and RP2D were not established as the trial has been amended to utilize an automated manufacturing process. A repeat of the dose escalation is ongoing and will identify a RP2D for pivotal trials. ClinicalTrials.gov Identifier: NCT04503278.

01 Jun 2023·Journal of Clinical Oncology

CLDN6 CAR-T cell therapy of relapsed/refractory solid tumors ± a CLDN6-encoding mRNA vaccine: Dose escalation data from the BNT211-01 phase 1 trial using an automated product.

Author: Klobuch, Sebastian ; Mackensen, Andreas ; Müller, Fabian ; Türeci, Özlem ; Haanen, John B. A. G. ; Rengstl, Benjamin ; Kutsch, Nadine ; Lüke, Florian ; Şahin, Uğur ; Desuki, Alexander ; Flemmig, Carina ; Bokemeyer, Carsten ; Heudobler, Daniel ; Koenecke, Christian ; Preußner, Liane ; Borchmann, Peter ; Wiegert, Erol ; Alsdorf, Winfried ; Schulz-Eying, Catrine ; Wagner-Drouet, Eva Maria

2518 Background: We are developing a chimeric antigen receptor (CAR)-T cell therapy targeting claudin 6 (CLDN6), an oncofetal antigen that is undetectable in healthy somatic tissue and highly expressed in various solid cancers. Autologous CLDN6 CAR-T cells are being tested alone and in combination with CLDN6-encoding CAR-T cell Amplifying RNA Vaccine (CARVac), a nanoparticulate RNA vaccine designed to stimulate and expand CLDN6 CAR-T cells. Methods: The ongoing first-in-human trial BNT211-01 evaluates the safety and feasibility of CLDN6 CAR-T cell transfer ± CARVac in lymphodepleted patients with relapsed/refractory solid tumors. Patients are pre-screened for CLDN6 expression with a cut-off of 50% positivity of intermediate or strong intensity by immunohistochemistry staining. Key endpoints are safety, tolerability, and anti-tumor activity. Pharmacokinetics of adoptively transferred CAR-T cells in peripheral blood is monitored by quantitative PCR. Dose escalation proceeds according to a classical 3+3 design, testing CLDN6 CAR-T cells at each dose level as both as monotherapy and in combination with CARVac. We previously reported results from 22 patients from 4 dose escalation cohorts with a manual CAR-T production process ± CARVac (ESMO-IO LBA38) which followed the same methodology. We observed durable responses along with a manageable safety profile, in line with commercial CAR-T products used to treat B-cell malignancies. No on-target/off-tumor toxicity and only a single case of (grade 1) neurotoxicity was observed. Given the encouraging efficacy, we have implemented an automated process to scale-up manufacturing. Accordingly, we are repeating the dose escalation with an automated CAR-T cell product, and with a modified CARVac regimen. As of 1st February 2023, 7 patients with epithelial ovarian carcinoma (EOC), 4 with testicular germ cell tumors (GCT), and a further 5 patients with tumors of various indications have been infused with CAR-T cells up to DL2. We intend to submit efficacy, safety and CAR T-cell pharmacokinetics data from 5 cohorts treated with 1x106, 1x107 or 1x108 CLDN6 CAR-T cells ± CARVac with a data cut-off of March 14th, 2023 from ≥17 treated patients as a late-breaking abstract. Clinical trial information: NCT04503278 .

100 Deals associated with BioNTech Cell & Gene Therapies GmbH

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100 Translational Medicine associated with BioNTech Cell & Gene Therapies GmbH

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Pipeline

Pipeline Snapshot as of 23 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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