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DRUG:

BNT116

i
Other names: BNT116, BNT-116, FixVac Lung, BNT 116
Associations
Company:
BioNTech
Drug class:
Immunostimulant
Related drugs:
Associations
1m
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=160, Recruiting, BioNTech SE | Trial completion date: Aug 2027 --> Nov 2028 | Trial primary completion date: Jan 2026 --> Apr 2027
Trial completion date • Trial primary completion date • Metastases
|
PD-L1 expression
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carboplatin • paclitaxel • docetaxel • Libtayo (cemiplimab-rwlc) • BNT116
8ms
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
|
CLDN6 (Claudin 6) • MAGEA4 (Melanoma antigen family A, 4) • PRAME (Preferentially Expressed Antigen In Melanoma)
|
AVENIO ctDNA Surveillance Kit
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docetaxel • BNT116
11ms
Trial completion date • Trial primary completion date • Metastases
|
PD-L1 expression
|
carboplatin • paclitaxel • docetaxel • Libtayo (cemiplimab-rwlc) • BNT116
1year
Enrollment change • Trial primary completion date • Metastases
|
PD-L1 expression
|
carboplatin • paclitaxel • docetaxel • Libtayo (cemiplimab-rwlc) • BNT116
over1year
Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
PD-L1 expression
|
Libtayo (cemiplimab-rwlc) • BNT116
over1year
Combination therapy • Phase classification • Enrollment open • Metastases
|
PD-L1 (Programmed death ligand 1)
|
VENTANA PD-L1 (SP263) Assay
|
Libtayo (cemiplimab-rwlc) • BNT116
over1year
Combination therapy • Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
VENTANA PD-L1 (SP263) Assay
|
Libtayo (cemiplimab-rwlc) • BNT116
2years
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
|
Libtayo (cemiplimab-rwlc) • BNT116
2years
Combination therapy • New P1/2 trial
|
PD-L1 (Programmed death ligand 1)
|
VENTANA PD-L1 (SP263) Assay
|
Libtayo (cemiplimab-rwlc) • BNT116
over2years
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