BNT116 / BioNTech - LARVOL DELTA

Neoadjuvant BNT116 + Cemiplimab + Carboplatin + Paclitaxel in Resectable NSCLC: Preliminary Results From a Phase I Trial (IASLC-WCLC 2026) - P1 | "Surgery was feasible and no impact of neoadjuvant treatment on postsurgical healing was detected. Longer follow-up and additional pathological response data will be presented."

Clinical • IO biomarker • P1 data • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Solid Tumor • CLDN6 • MAGEA4 • MAGEC1 • PD-L1 • PRAME

Updated results from LuCa-MERIT-1, a Phase I trial evaluating BNT116, a fixed-antigen mRNA vaccine, alone and in combination with cemiplimab across distinct advanced NSCLC cohorts (EORTC-NCI-AACR 2026) - "Abstract will be available on the day of the presentation"

Combination therapy • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Preliminary results from LuCa-MERIT-1, a phase I trial evaluating BNT116, a fixed antigen mRNA vaccine, plus cemiplimab in advanced non-small cell lung cancer after progression on PD-1 inhibition (SITC 2024) - P1 | "In conclusion, the response profile suggests BNT116+cemiplimab may induce reversion of resistance to PD-1 inhibition in NSCLC. Ethics Approval This trial received relevant Ethics & Institutional Review Board approvals in participating countries prior to initiation.View this table:View inline View popup Download powerpoint Abstract 1486 Table 1 Baseline characteristics of LuCa-MERIT-1 patients treated with BNT116+cemiplimab"

IO biomarker • Late-breaking abstract • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Phase I trial evaluating BNT116, a TAA-encoding mRNA vaccine, in combination with cemiplimab in frail patients with advanced non-small cell lung cancer (NSCLC) (AACR 2025) - "BNT116 plus cemiplimab demonstrated promising anti-tumor activity, consistent immune response induction, and a manageable safety profile in frail pts with advanced NSCLC. Updated safety and clinical activity data will be presented along with biomarker data."

Clinical • Combination therapy • IO biomarker • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CLDN6 • IFNG • MAGEA4 • MAGEC1 • PRAME

A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1) (clinicaltrials.gov) - P2 | N=51 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | N=32 ➔ 51

Enrollment change • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

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=320 | Recruiting | Sponsor: BioNTech SE | N=156 ➔ 320

Enrollment change • First-in-human • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • LAG3 • TIGIT

ctDNA as a prognostic and pharmacodynamic biomarker following first- or later-line treatment of advanced NSCLC with BNT116 + cemiplimab (AACR 2026) - P1 | "Achieving meaningful molecular responses early was associated with improved clinical outcomes after BNT116 + cemi Tx in pts with advanced NSCLC. Pts who achieved ctDNA clearance had similar outcomes to pts with undetectable ctDNA at BL. This supports use of ctDNA as a potential early efficacy surrogate in clinical trials, which can accelerate development of therapies."

Biomarker • Circulating tumor DNA • IO biomarker • Metastases • PK/PD data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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."

Clinical • First-in-human • IO biomarker • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CLDN6 • MAGEA4 • PRAME

The advantages of NK cell vaccines in solid carcinoma clinical trials: conducted by various biology strategy and technology. (PubMed, Front Med (Lausanne)) - "The study illustrated: Dendritic cell-based vaccine platforms (e.g., ilixadencel), cytokine-based vaccine platforms (e.g., ALT-803), NK receptor agonist antibodies (e.g., AFM24) and mRNA/LNP-based vaccine platforms (e.g., BNT116) It has shown early efficacy in solid tumors such as non-small cell lung cancer, triple-negative breast cancer, and glioblastoma (with partial ORR of 30-50% and DCR of 80-100%), and the safety is comparatively manageable (the incidence of grade ≥3 adverse events is less compared to T-cell therapy). In the future, combinatorial regimens (e.g., sequential application of PD-1 inhibitors) need to be optimized, an iPSC-NK universal platform developed, and perioperative application scenarios explored. NK vaccines, by reshaping the immune microenvironment, will be an attractive strategy to break the bottlenecks in the treatment of solid tumors."

Journal • Review • Brain Cancer • Breast Cancer • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Preliminary Results of the Phase I LuCa-MERIT-1 Trial: An Advanced NSCLC pt Cohort Treated With BNT116 + Cemiplimab Post CRT (IASLC-WCLC 2025) - P1 | "Promising EFS and OS rates were observed. Updated safety, clinical activity, and biomarker data will be presented."

IO biomarker • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Pneumonia • Solid Tumor • CLDN6 • MAGEA4 • MAGEC1 • PRAME

A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1) (clinicaltrials.gov) - P2 | N=51 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=100 ➔ 51 | Trial completion date: Jun 2027 ➔ May 2028 | Trial primary completion date: Mar 2027 ➔ Jan 2028

Enrollment change • Enrollment closed • Monotherapy • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Shared epitopes create safety and efficacy concerns in several cancer vaccines. (PubMed, J Immunother Cancer) - "Altogether, our analysis indicates a suboptimal design of several cancer vaccines currently in clinical development: ATP128, BNT111, BNT112, BNT116, INO-5401. We recommend that next-generation cancer vaccines should integrate rigorous epitope filtering strategies to eliminate shared sequences in TAAs."

Journal • Immunology • Oncology • ASCL2 • CLDN6 • KLK2

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=220 | Recruiting | Sponsor: BioNTech SE | N=160 ➔ 220 | Trial completion date: Nov 2028 ➔ Nov 2031 | Trial primary completion date: Apr 2027 ➔ Feb 2030

Enrollment change • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BioNTech will present data from the Phase 1 clinical trial LuCa-MERIT-1 (GlobeNewswire) - P1 | N=160 | LuCa-MERIT-1 (NCT05142189) | Sponsor: BioNTech SE | "The update includes safety and clinical activity data, along with biomarker data from a cohort of frail patients with advanced or metastatic non-small cell lung cancer ('NSCLC') who were not eligible for platinum-based chemotherapy as first-line treatment. The preliminary data showed anti-tumor activity, consistent immune response induction, and a manageable safety profile."

P1 data • Non Small Cell Lung Cancer

Groundbreaking mRNA Lung Cancer Vaccine Trials: A New Dawn in Cancer Treatment. (PubMed, Curr Cancer Drug Targets) - P1 | "Success in the BNT116 trials could redefine NSCLC treatment paradigms, offering a targeted, less cytotoxic alternative. This innovation can not only improve therapeutic outcomes, but also pave the way for preven-tive cancer vaccines, signaling a new dawn in cancer treatment."

Journal • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Novel Coronavirus Disease • Oncology • Solid Tumor

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 | Sponsor: BioNTech SE | Trial completion date: Aug 2027 ➔ Nov 2028 | Trial primary completion date: Jan 2026 ➔ Apr 2027

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Identification of Candidate Therapeutic Targets Using Single Cell RNA Sequencing in ALK-Positive Lung Cancers (IASLC-WCLC 2024) - "Second, we found support for clinical trials of solid tumor vaccines like BNT116 for ALK+ and EGFR+ LC patients because 70% of ALK+ patients and 59% of EGFR+ patients sampled express one or more among the six proteins in this mRNA vaccine...Conclusions : Taken together, we believe these types of data offer opportunities to expedite therapeutic development of improved treatments for ALK+ and other oncogene-driven LC patients. We will extend this work to include validation of transcriptome-nominated targets in tumor cells using immunohistochemistry, mass spectrometry and other protein expression assays, and in vitro and in vivo models."

IO biomarker • Lung Cancer • Oncology • Solid Tumor • Targeted Protein Degradation • ALK • EGFR

First UK patient receives innovative lung cancer vaccine (UCLH NHS) - "A lung cancer patient at UCLH is the first to receive a novel cancer vaccine designed to prime the immune system to recognise and fight cancer cells...The primary objective of this study is to determine if BNT116 is safe and well tolerated. The trial will be enrolling patients at different stages of NSCLC, from early-stage NSCLC before surgery or radiotherapy (Stage 2 and 3) to late-stage disease (Stage 4) or recurrent cancer...The trial aims to establish the safety profile and a safe dose of BNT116 monotherapy, as well as of BNT116 in combination with established treatments for NSCLC to see if BNT116 has a synergistic anti-tumour effect when given with these established chemotherapy or immunotherapy treatments....Approximately 130 participants will be enrolled in the study across 34 research sites in seven countries, with six UK sites selected."

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BNT116: “Preliminary results of BNT116 show encouraging antitumor activity and manageable safety profile in combination with docetaxel”; Non-small cell lung cancer (BioNTech) - Q1 2024 Results

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

BioNTech Announces First Quarter 2024 Financial Results and Corporate Update (GlobeNewswire) - P1 | N=130 | LuCa-MERIT-1 (NCT05142189) | Sponsor: BioNTech SE | "In April 2024, data from a Phase 1 trial cohort (NCT05142189) were presented at the AACR Annual Meeting. Patients were treated with BNT116 in combination with docetaxel after progression on a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy. Preliminary data of BNT116 in combination with docetaxel show encouraging antitumor activity, consistent induction of immune responses, a manageable safety profile, and no signs of additive toxicity. Efficacy results suggest that combination therapy with BNT116 and docetaxel was active with an overall response rate ('ORR') of 30% and a disease control rate ('DCR') of 85%."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BioNTech to Present Clinical Data Updates for Personalized mRNA-based and Targeted Oncology Candidates at AACR 2024 (GlobeNewswire) - "Highlights of BioNTech’s clinical stage programs to be presented at AACR Annual Meeting 2024: Longer-term follow-up data of activity and immune responses of the investigator-initiated first-in-human Phase 1 trial (NCT04161755) with the mRNA-based individualized neoantigen-specific immunotherapy ('iNeST') candidate autogene cevumeran (BNT122, RO7198457) in patients with resected pancreatic ductal adenocarcinoma ('PDAC') will be presented....BioNTech will present preliminary results on the LuCa-MERIT-1 Phase 1 trial (NCT05142189) with its off-the-shelf, shared tumor-associated-antigen-based mRNA therapeutic cancer vaccine candidate BNT116 in combination with docetaxel in patients with advanced unresectable or metastatic non-small cell lung cancer ('NSCLC')."

P1 data • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

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 | Sponsor: BioNTech SE

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Preliminary results from LuCa-MERIT-1, a first-in-human Phase I trial evaluating the fixed antigen RNA vaccine BNT116 in patients with advanced non-small cell lung cancer (SITC 2023) - "Methods LuCa-MERIT-1 is a first-in-human, open label, Phase I trial with cohorts to confirm the dose of BNT116 alone or as combination therapy with cemiplimab, docetaxel, and/or carboplatin/paclitaxel (21-day cycles). Conclusions In this trial, BNT116 was generally well tolerated with an expected safety profile as monotherapy and in combination with cemiplimab. Updated safety and clinical activity data will be presented along with additional biomarker data (TAA expression, PD-L1 expression, cytokines, tumor markers)."

Clinical • IO biomarker • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BioNTech to Present Multiple Program Updates Across Modalities at ESMO Congress 2023 (GlobeNewswire) - P1/2 | N=235 | NCT05438329 | Sponsor: DualityBio Inc. | "The Company will present first-in-human data of BNT325 (DB-1305) (NCT05438329), a next-generation Trop-2-targeting antibody-drug conjugate ('ADC')...Initial data with this candidate show encouraging preliminary efficacy and a manageable safety profile in patients with advanced/metastatic non-small cell lung cancer (NSCLC)....A trial in progress poster will inform on the ongoing EMPOWERVAX Lung 1 Phase 2 trial (NCT05557591)...evaluating the efficacy and safety of BioNTech’s fully-owned off-the-shelf mRNA cancer vaccine candidate BNT116 in combination with cemiplimab versus cemiplimab alone in the first-line treatment of patients with advanced NSCLC and PD-L1 expression ≥50%."

P1/2 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BioNTech to Present Clinical and Preclinical Data Updates Across Multiple Immuno-Oncology Programs at 2023 SITC Annual Meeting (BioNTech Press Release) - P1 | N=130 | LuCa-MERIT-1 (NCT05142189) | Sponsor: BioNTech SE | "First clinical data will be presented on the LuCa-MERIT-1 Phase 1 study (NCT05142189) with BioNTech’s off-the-shelf mRNA therapeutic cancer vaccine candidate BNT116 alone and in combination with cemiplimab in patients with advanced, unresectable, or metastatic NSCLC. The data show encouraging initial clinical activity in heavily pre-treated patients with advanced NSCLC and a tolerable safety profile."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor