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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
BNT116
i
Other names: BNT116, BNT-116, FixVac Lung
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News alerts, weekly reports and conference planners
Company:
BioNTech
Drug class:
Immunostimulant
Related drugs:
2ms
Preliminary results from LuCa-MERIT-1, a first-in-human Phase I trial evaluating the fixed antigen mRNA vaccine BNT116 + docetaxel in patients with advanced non-small cell lung cancer (AACR 2024)
BNT116 + DTX shows encouraging antitumor activity, consistent induction of immune responses, a manageable safety profile, and no signs of additive toxicity. Updated safety and clinical activity data will be presented along with additional biomarker data.
P1 data • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
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CLDN6 (Claudin 6) • MAGEA4 (Melanoma antigen family A, 4) • PRAME (Preferentially Expressed Antigen In Melanoma)
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AVENIO ctDNA Surveillance Kit
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docetaxel • BNT116
5ms
LuCa-MERIT-1: Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
P1, N=130, Recruiting, BioNTech SE
Trial completion date • Trial primary completion date • Metastases
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PD-L1 expression
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carboplatin • paclitaxel • docetaxel • Libtayo (cemiplimab-rwlc) • BNT116
7ms
LuCa-MERIT-1: Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
P1, N=130, Recruiting, BioNTech SE | N=80 --> 130 | Trial primary completion date: May 2025 --> Jan 2026
Enrollment change • Trial primary completion date • Metastases
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PD-L1 expression
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carboplatin • paclitaxel • docetaxel • Libtayo (cemiplimab-rwlc) • BNT116
10ms
A phase II study of cemiplimab plus BNT116 versus cemiplimab alone in first-line treatment of patients with advanced non-small cell lung cancer with PD-L1 expression ≥50% (ESMO 2023)
Enrollment of up to 100 patients is planned. Enrolment is ongoing.
Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker • Metastases
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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PD-L1 expression
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Libtayo (cemiplimab-rwlc) • BNT116
12ms
Safety and Efficacy of Intravenous Cemiplimab Plus BNT116 Versus Cemiplimab Alone in Advanced Non-Small Cell Lung Cancer in Adult Participants With PD-L1 ≥ 50% (clinicaltrials.gov)
P2; Not yet recruiting --> Recruiting | Phase classification: P1/2 --> P2
Combination therapy • Phase classification • Enrollment open • Metastases
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PD-L1 (Programmed death ligand 1)
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VENTANA PD-L1 (SP263) Assay
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Libtayo (cemiplimab-rwlc) • BNT116
1year
Safety and Efficacy of Intravenous Cemiplimab Plus BNT116 Versus Cemiplimab Alone in Advanced Non-Small Cell Lung Cancer in Adult Participants With PD-L1 ≥ 50% (clinicaltrials.gov)
P1/2; Trial completion date: Sep 2027 --> Jun 2027 | Trial primary completion date: Jun 2027 --> Mar 2027
Combination therapy • Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
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VENTANA PD-L1 (SP263) Assay
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Libtayo (cemiplimab-rwlc) • BNT116
over1year
LuCa-MERIT-1: First-in-human open label dose confirmation trial evaluating safety, tolerability, and efficacy of BNT116 alone and in combinations in patients with advanced non-small cell lung cancer (SITC 2022)
"BNT116 alone or in combination with either docetaxel or the PD-1 inhibitor cemiplimab (Libtayo ® ) may have synergistic anti-tumor effects, thus potentially addressing the unmet medical need of these cancer patients. The first patient was dosed in JUL 2022, with enrolment expected for approximately 12 months. The study was approved by IRB/IEC, approval numbers: 2022-03/1691 (Turkey), OGYÉI/6962-9/2022 (Hungary), and US and Spain (approval numbers for the later were not provided)."
P1 data • Clinical
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Libtayo (cemiplimab-rwlc) • BNT116
over1year
Safety and Efficacy of Intravenous Cemiplimab Plus BNT116 Versus Cemiplimab Alone in Advanced Non-Small Cell Lung Cancer in Adult Participants With PD-L1 ≥ 50% (clinicaltrials.gov)
P1/2; N=107; Not yet recruiting; Sponsor:Regeneron Pharmaceuticals
Combination therapy • New P1/2 trial
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PD-L1 (Programmed death ligand 1)
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VENTANA PD-L1 (SP263) Assay
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Libtayo (cemiplimab-rwlc) • BNT116
almost2years
LuCa-MERIT-1: First-in-human, open label, phase I dose confirmation trial evaluating the safety, tolerability, and preliminary efficacy of BNT116 alone and in combinations in patients with advanced non-small cell lung cancer (ESMO 2022)
P1 | "BNT116 alone or in combination with either docetaxel or the PD-1 inhibitor cemiplimab (Libtayo®) may have synergistic anti-tumor effects, thus potentially addressing the unmet medical need of these cancer patients. Secondary endpoints are related to clinical activity, i.e., tumor assessments, as per RECIST 1.1. The first patient is planned to be dosed in May 2022, with enrolment expected for approximately 12 months."
P1 data • Clinical
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Libtayo (cemiplimab-rwlc) • BNT116
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