BNT411 / BioNTech - LARVOL DELTA

Updated safety, PK/PD, and efficacy results from the dose escalation part of a phase I clinical trial of BNT411, a systemic Toll-like receptor 7 agonist, in patients with advanced solid tumors (SITC 2024) - P1/2 | "Conclusions BNT411 demonstrated tolerability and a manageable safety profile in heavily pretreated patients with solid cancers at dose levels that induced immune system activation and early signals of clinical activity, warranting further clinical testing as a single agent and in combination. Final safety, PK, clinical, and biomarker data for the completed dose-escalation part and the recommended Phase 2 dose will be presented."

Clinical • IO biomarker • Metastases • P1 data • PK/PD data • Oncology • Solid Tumor

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411 (clinicaltrials.gov) - P1/2 | N=55 | Terminated | Sponsor: BioNTech SE | Active, not recruiting ➔ Terminated; Sponsor decision

Combination therapy • Monotherapy • Trial termination • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411 (clinicaltrials.gov) - P1/2 | N=55 | Active, not recruiting | Sponsor: BioNTech SE

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411 (clinicaltrials.gov) - P1/2 | N=55 | Active, not recruiting | Sponsor: BioNTech SE | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Monotherapy • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411 (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: BioNTech SE | Trial completion date: Feb 2024 ➔ Feb 2025 | Trial primary completion date: Jul 2023 ➔ Jul 2024

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Immune Modulation • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Preliminary safety, PK/PD and efficacy results from a first-in-human phase I/IIa clinical trial of BNT411, a systemic Toll-like receptor 7 agonist in patients with solid tumors (SITC 2021) - P1/2 | "Part 1A is a single-agent dose escalation (accelerated titration) of BNT411 in patients with metastatic or unresectable solid tumors that have exhausted available treatment options, with bifurcation to Part 1B, a dose escalation of BNT411 in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC), followed by expansion cohorts (Part 2). Updated data will be presented, including combination treatment in the first-line setting of ES-SCLC. Trial Registration Clinicaltrials.gov: NCT04101357"

Clinical • P1/2 data • PK/PD data • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • CD8 • IFNG

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411 (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: BioNTech SE | Trial primary completion date: Jul 2022 ➔ Jul 2023

Combination therapy • Monotherapy • Trial primary completion date • Gastrointestinal Cancer • Immune Modulation • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

BioNTech to Present New Clinical and Preclinical Data Across Multiple Immuno-Oncology Programs at 36th SITC Annual Meeting (GlobeNewswire) - "BioNTech SE....announced that new clinical and preclinical data will be presented in six posters and one presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held both in person and virtually from November 10 - 14, 2021."

Clinical data • Preclinical • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

BioNTech Announces Full Year 2020 Financial Results and Corporate Update (GlobeNewswire) - “BNT312/GEN1042 – We expect first data disclosure from the Phase 1/2a trial of BNT312 in solid tumors in the second half of 2021…BNT211…We expect a data update for this trial in the second half of 2021…BNT221 (NEO-PTC-01) – Dosing of the first patient in a Phase 1 dose escalation trial for the treatment of metastatic melanoma in patients who are refractory or unresponsive to checkpoint inhibitors is expected in the first half of 2021…BNT411…We expect a data update from this trial in the second half of 2021.”

New P1 trial • P1/2 data • Lung Cancer • Melanoma • Oncology • Skin Cancer • Small Cell Lung Cancer • Solid Tumor

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411 (clinicaltrials.gov) - P1/2; N=60; Recruiting; Sponsor: BioNTech Small Molecules GmbH; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Monotherapy • Gastrointestinal Cancer • Immune Modulation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A study to investigate the safety and efficacy of BNT411 in cancer patients with solid tumor types. The study will also assess the safety and efficacy of BNT411 when taken on its own and in combination with standard chemotherapy treatments in patients with late stage small cell lung cancer who have not taken chemotherapy before. (clinicaltrialsregister.eu) - P1/2; N=63; Ongoing; Sponsor: BioNTech Small Molecules GmbH

Clinical • Combination therapy • Monotherapy • New P1/2 trial • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

BioNTech announces first quarter 2020 financial results and corporate progress (GlobeNewswire) - "BNT131 – Data update from Phase 1/2 trial in solid tumors remains on track for 2H 2020; BNT211 – Initiation of a Phase 1/2a trial in multiple solid tumors (CLDN6) is now expected in 2H 2020; BNT311 – The expansion cohort has been initiated in the Phase 1/2 trial in multiple solid tumors for BNT311 (PD-L1x4-1BB). BioNTech expects to provide a data update, to include dose-escalation and potentially some limited expansion data from the trial in 2H 2020; BNT411 – A Phase 1/2a clinical trial of BNT411 is still expected to be initiated in multiple solid tumors in 2H 2020."

New P1/2 trial • P1/2 data • Oncology • Solid Tumor

BioNTech announces full year 2019 financial results and corporate update (GlobeNewswire) - "BNT211 – Initiation of a Phase 1/2a trial in multiple solid tumors (CLDN6) remains on track for 1H 2020; BNT411 – U.S. IND was approved in Q4 2019. A Phase 1/2a clinical trial of BNT411 is now expected to be initiated as a mono- or combination therapy in multiple solid tumors in 2H 2020; BNT141 – Initiation of a Phase 1 trial in multiple solid tumors is now expected in 1H 2021. BNT142 – Initiation of a Phase 1 trial in multiple solid tumors (CD3+CLDN6) is now expected in 1H 2021."

IND • New P1 trial • New P1/2 trial • Oncology • Solid Tumor

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411 (clinicaltrials.gov) - P1/2; N=60; Not yet recruiting; Sponsor: BioNTech Small Molecules GmbH; Trial completion date: Jul 2023 ➔ Dec 2023; Initiation date: Jan 2020 ➔ Jun 2020

Trial completion date • Trial initiation date

BioNTech SE provides update on corporate progress and third quarter 2019 financial results (GlobeNewswire) - "Filed IND for BNT411. Phase 1/2a clinical trial of BNT411 expected to be initiated as a mono- or combination therapy in solid tumors in the first half of 2020. The selective toll-like receptor 7 agonist has shown activity in numerous mouse tumor models, such as reduced tumor growth and tumor clearance."

IND • Preclinical • Trial initiation date