BNT112 / BioNTech - LARVOL DELTA

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

PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy) (clinicaltrials.gov) - P1/2 | N=75 | Terminated | Sponsor: BioNTech SE | Trial completion date: Oct 2024 ➔ Jan 2024 | Active, not recruiting ➔ Terminated; Sponsor decision

Combination therapy • Monotherapy • Trial completion date • Trial termination • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy) (clinicaltrials.gov) - P1/2 | N=75 | Active, not recruiting | Sponsor: BioNTech SE

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy) (clinicaltrials.gov) - P1/2 | N=75 | Active, not recruiting | Sponsor: BioNTech SE | Recruiting ➔ Active, not recruiting | N=115 ➔ 75 | Trial completion date: Jul 2023 ➔ Oct 2024 | Trial primary completion date: Jul 2023 ➔ Jan 2024

Combination therapy • Enrollment change • Enrollment closed • Monotherapy • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy) (clinicaltrials.gov) - P1/2 | N=115 | Recruiting | Sponsor: BioNTech SE | Active, not recruiting ➔ Recruiting

Combination therapy • Enrollment open • Monotherapy • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A first-in-human (FIH) Phase I/IIa clinical trial assessing a ribonucleic acid lipoplex (RNA-LPX) encoding shared tumor antigens for immunotherapy of prostate cancer; preliminary analysis of PRO-MERIT (SITC 2021) - P1/2 | "BNT112 is being investigated as monotherapy and in combination with cemiplimab in patients with metastatic castration-resistant prostate cancer (mCRPC) and newly diagnosed high risk localized prostate cancer (LPC). Additionally, BNT112 induces robust immune and PSA responses in patients with advanced prostate cancer. Trial Registration Clinicaltrials.gov: NCT04382898."

Clinical • P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ACPP • HOXB13 • IFNG • KLK2 • PSAP

PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy) (clinicaltrials.gov) - P1/2 | N=115 | Active, not recruiting | Sponsor: BioNTech SE | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Monotherapy • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

BioNTech Announces First Patient Dosed in Phase 2 Clinical Trial of mRNA-based BNT111 in Patients with Advanced Melanoma (GlobeNewswire) - “BioNTech…announced today that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial…The study is evaluating the Company’s therapeutic cancer vaccine candidate BNT111 in combination with Libtayo® (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma. BNT111 is the lead product candidate from BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer and is fully owned by BioNTech…The Company also plans to start randomized Phase 2 trials with mRNA vaccine product candidates in two additional programs in 2021 (FixVac: BNT113 and iNeST: BNT122).”

Trial status • Cutaneous Melanoma • Melanoma • Oncology • Skin Cancer

PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy) (clinicaltrials.gov) - P1/2; N=80; Recruiting; Sponsor: Biontech RNA Pharmaceuticals GmbH

Clinical • Combination therapy • New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy) (clinicaltrials.gov) - P1/2; N=130; Recruiting; Sponsor: BioNTech SE; N=80 ➔ 130

Clinical • Combination therapy • Enrollment change • Monotherapy • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ACPP • PSAP

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