BNT151 / BioNTech - LARVOL DELTA

BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=62 | Terminated | Sponsor: BioNTech SE | Active, not recruiting ➔ Terminated; Sponsor decision

Combination therapy • Monotherapy • Trial termination • Oncology • Solid Tumor

BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=84 | Active, not recruiting | Sponsor: BioNTech SE | Trial completion date: Jun 2026 ➔ May 2024 | Trial primary completion date: Feb 2024 ➔ May 2024

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=84 | Active, not recruiting | Sponsor: BioNTech SE | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Monotherapy • Oncology • Solid Tumor

[VIRTUAL] A rationally designed IL-2 variant with an improved receptor binding profile combines enhanced stimulation of effector T cells and natural killer cells with reduced stimulation of regulatory T cells (CIMT 2021) - P1/2 | "Owing to its optimized receptor binding characteristics, IL2var has the potential to support antitumor immunity by enhancing effector T-cell responses while limiting the immune-suppressive function of Treg cells. An open-label, Phase I/II, first-in-human trial in patients with advanced solid tumors was recently initiated to further explore the clinical safety and efficacy of IL2var RiboCytokine® (also known as BNT151) as monotherapy or in combination with other anti-cancer agents (NCT04455620)."

Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • IL2 • STAT5

[VIRTUAL] An RNA-encoded IL-2 variant with an extended half-life mediates synergistic anti-tumor activity when combined with immune checkpoint blockade (CIMT 2021) - P1/2 | "Tumor control of the combination treatment was accompanied by increased numbers of neoantigen-specific T cells and a T cell phenotype previously associated with successful cancer immunotherapy. An open-label, Phase I/II, first-in-human trial in patients with advanced solid tumors was recently initiated to further explore the clinical safety and efficacy of BNT151 as monotherapy or in combination with other anti-cancer agents (NCT04455620)."

Checkpoint inhibition • IO biomarker • Genito-urinary Cancer • Immune Modulation • Inflammation • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • CD8 • IL2

[VIRTUAL] An RNA-encoded IL-2 variant with an extended half-life enhances the anti-tumor activity of RNA-based cancer vaccines (CIMT 2021) - P1/2 | "These results demonstrate the ability of BNT151 to address the limitations of recombinant IL-2 therapy, making it a promising therapeutic agent and combination partner for cancer treatment. An open-label, Phase I/II, first-in- human trial in patients with advanced solid tumors was recently initiated to further explore the clinical safety and efficacy of BNT151 (NCT04455620)."

Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • CD8 • IL2

BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=84 | Recruiting | Sponsor: BioNTech SE | N=54 ➔ 84 | Trial completion date: Jan 2025 ➔ Jun 2026 | Trial primary completion date: Sep 2022 ➔ Feb 2024

Combination therapy • Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

[VIRTUAL] Single-cell transcriptomics reveals changes in the immune landscape following IL-2 variant and anti-PD-1 treatment in a mouse tumor model (CIMT 2021) - "In conclusion, scRNA-seq revealed that BNT151 increased the number of TILs of a less exhausted phenotype and induced the expression of genetic markers commonly associated with therapeutic success. Both effects were further enhanced by the combination with aPD-1."

IO biomarker • Preclinical • Immune Modulation • Inflammation • Oncology • CD8 • IFNG • IL2 • LAG3 • PTPRC

BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors (clinicaltrials.gov) - P1/2; N=54; Recruiting; Sponsor: BioNTech SE; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Monotherapy • Oncology • Solid Tumor

BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors (clinicaltrials.gov) - P1/2; N=54; Not yet recruiting; Sponsor: Biontech RNA Pharmaceuticals GmbH

Clinical • Combination therapy • Monotherapy • New P1/2 trial • Oncology • Solid Tumor

BioNTech announces full year 2019 financial results and corporate update (GlobeNewswire) - "BNT151 – Initiation of a Phase 1 trial in multiple solid tumors (optimized IL-2) is now expected in 1H 2021; BNT152+153 – Initiation of a Phase 1 trial in multiple solid tumors is now expected in 1H 2021."

New P1 trial