BNT114 / BioNTech - LARVOL DELTA

TNBC-MERIT: RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: BioNTech SE | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ May 2023

Trial completion • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

TNBC-MERIT: RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID (clinicaltrials.gov) - P1; N=42; Active, not recruiting; Sponsor: BioNTech SE; Trial completion date: Nov 2020 ➔ Dec 2023

Clinical • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

BioNTech Announces Second Quarter 2020 Financial Results and Corporate Progress (GlobeNewswire) - "BNT111 – BioNTech expects to initiate this Phase 2 trial with registrational potential in the second half of 2020. BNT113 – Planned initiation of a potentially registrational Phase 2 trial in HPV16+ head and neck cancer expected in 2H 2020. BNT114 – Planned data update from a Phase 1 trial in triple negative breast cancer (TNBC) is expected in 2H 2020....BNT122 – BioNTech expects to provide an enrollment update from the Phase 2 trial (IMCODE-001) in first line melanoma in 2H 2020 with an interim data update anticipated in 2H 2021. BNT122 –The first adjuvant Phase 2 study is currently recruiting for patients and first patient dosing is expected in 2H 2020. The trial is designed to evaluate the efficacy and safety of RO7198457 (BNT122/RG6180) plus atezolizumab compared with atezolizumab alone in patients with early and adjuvant stage non-small-cell lung cancer (NSCLC). The second Phase 2 study will be in colorectal cancer in adjuvant setting and is expected to initiate in 2H 2020."

Enrollment status • New P2 trial • P1 data • Breast Cancer • Melanoma • Oncology • Triple Negative Breast Cancer

BioNTech announces first quarter 2020 financial results and corporate progress (GlobeNewswire) - "There are currently ten oncology products in 11 ongoing trials with multiple data readouts expected in 2020....BNT111 – Data from a Phase 1 trial in advanced melanoma remains on track for publication in late 1H 2020. BioNTech expects to initiate a Phase 2 trial in advanced melanoma with registrational potential for BNT111 in 2H 2020; BNT 113 – Initiation of a Phase 2 trial in HPV+ head and neck cancer with registrational potential is on track for 2H 2020; BNT114 – Data update from a Phase 1 trial in triple negative breast cancer (TNBC) is expected in 2H 2020."

Clinical data • New P2 trial • P1 data • Breast Cancer • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

BioNTech announces full year 2019 financial results and corporate update (GlobeNewswire) - "BNT111 – Data from the ongoing Phase 1 trial in advanced melanoma remains on track for publication in late 1H 2020...the Company expects to initiate a Phase 2 trial with registrational potential for BNT111 in 2H 2020; BNT112 – The first patient was dosed in a Phase 1/2a study in patients with prostate cancer; BNT114 – Data update from a Phase 1 trial in triple negative breast cancer (TNBC) is now expected in 2H 2020."

Enrollment open • New P2 trial • P1 data

TNBC-MERIT: RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID (clinicaltrials.gov) - P1; N=39; Active, not recruiting; Sponsor: Biontech SE; Trial completion date: Apr 2020 ➔ Nov 2020; Trial primary completion date: Dec 2019 ➔ Jun 2020

Clinical • Trial completion date • Trial primary completion date • HER-2

TNBC-MERIT: RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID (clinicaltrials.gov) - P1; N=39; Active, not recruiting; Sponsor: Biontech SE; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • HER2