BNT121 / BioNTech, Roche - LARVOL DELTA

Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence. (PubMed, J Immunother Cancer) - P3 | "Seviprotimut-L is very well tolerated. Exploratory efficacy model estimation supports further study in stage IIB/IIC patients, especially younger patients and those with ulcerated melanomas."

Clinical • Journal • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

[VIRTUAL] Final analysis of relapse-free survival in a multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine after resection of high-risk melanoma. (ASCO 2020) - P3 | "Seviprotimut-L is very well-tolerated. Subgroup efficacy analyses identified populations who may benefit from Seviprotimut-L: those with Stage IIB/IIC melanoma and those under age 60. These data support design of the definitive part B2 of the MAVIS phase III trial to test seviprotimut-L for stage IIB/C patients, with stratification by age and ulceration."

Clinical • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

BioNTech announces full year 2019 financial results and corporate update (GlobeNewswire, BioNTech SE) - “BNT121 (iNeST) adjuvant Phase 2 study in NSCLC to start in 2H 2020; BNT122 – BioNTech and Genentech disclosed that two additional Phase 2 clinical trials in the adjuvant setting are planned for initiation in 2020…we now expect the data update for the Phase 1/2 trial in multiple solid tumors to be presented in August 2020. BioNTech expects to provide an enrollment update1 from the Phase 2 trial in first line melanoma in 2H 2020 with an interim data update anticipated in 2021.”

Clinical • Enrollment status • New P2 trial • P1/2 data • P2 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

IVAC MUTANOME Phase I Clinical Trial (clinicaltrials.gov) - P1; N=15; Completed; Sponsor: Biontech RNA Pharmaceuticals GmbH; Active, not recruiting ➔ Completed

Clinical • Trial completion

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

IVAC MUTANOME Phase I Clinical Trial (clinicaltrials.gov) - P1; N=15; Active, not recruiting; Sponsor: Biontech RNA Pharmaceuticals GmbH; Trial completion date: Mar 2019 ➔ Oct 2019

Clinical • Trial completion date