BioNTech SE — Sponsor Intelligence | 22 EU Trials

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22 Registered trials

14 Recruiting

7 Completed trials

18 Countries active

30 Unique IMPs

100% Results reported

Phase III

Phase II

Phase I/II

Phase I

Phase III: 3 Phase II/III: 2 Phase II: 3 Phase I/II: 6 Phase I: 6 Phase I (FiH): 2

Oversight events:

1 serious breach across 1 trial

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100%

7 of 7 completed trials have published summary results (EU CTR Article 37 — 12-month obligation).

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Top indications

Non-small cell lung cancer stage IIIA 3 Non-small cell lung cancer stage III 3 Non-small cell lung cancer stage IV 3 Endometrial cancer 3 Non-small cell lung cancer metastatic 3 Non-small cell lung cancer stage IIIB 3 Non-small cell lung cancer 2 Breast cancer 2 HER2 mutant non-small cell lung cancer 1 Ovarian epithelial cancer 1 Squamous cell carcinoma of head and neck 1 Adenocarcinoma pancreas 1

Top IMPs

BNT327 9 BNT314 2 BNT326 2 DB-1303 2 PUMITAMIG 2 ATEZOLIZUMAB 1 AUTOGENE CEVUMERAN 1 BISPECIFIC ANTIBODY AGAINST VASCULAR ENDOTHELIAL GROWTH FACTOR A AND PROGRAMMED DEATH-LIGAND 1 1 BNT142 1 BNT324 1 BNT329 1 CEMIPLIMAB 1

All trials

22 total

Safety, tolerability, and efficacy of mFOLFIRINOX ±BNT321 as adjuvant therapy following curative resection in patients with pancreatic adeno… Not authorised

2023-506014-47-00 Phase I/II 4 countries FOLINIC ACID; HUMAN IGG1 MONOCLOBAL ANTIBODY AGAINST SIALYL-LEWIS A; IRINOTECAN …
ROSETTA Breast-01: The effects and safety of pumitamig in patients with triple-negative breast cancer Recruiting

2025-521884-12-00 Phase III 8 countries BNT327; PACLITAXEL ALBUMIN-BOUND
A clinical study of the anti-cancer effects of an investigational therapy or chemotherapy in patients with recurring uterine cancer Recruiting

2023-507525-42-00 Phase III 15 countries DB-1303; DOXORUBICIN HYDROCHLORIDE; PACLITAXEL
A clinical study to investigate the efficacy and safety of an investigational combination therapy with BNT324 and BNT327 in patients with ad… Recruiting

2024-520238-31-01 Phase I/II 4 countries BNT324; BNT327
A clinical trial to test if an investigational combination therapy with BNT326 and BNT327 is safe and potentially beneficial for people with… Recruiting

2024-519344-32-00 Phase I/II 4 countries BNT326; BNT327
A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known t… Recruiting

2025-522613-26-00 Phase I (FiH) 2 countries BNT329
A clinical study to find the optimal dose of an investigational treatment called BNT323 when used in combination with another investigationa… Recruiting

2024-517979-20-00 Phase I/II 3 countries BNT327; DB-1303
A clinical trial investigating the safety and biological activity of the antibody BNT351 in adults living without and with HIV Recruiting

2025-523846-29-00 Phase I 1 country
Safety and efficacy of BNT327, an investigational therapy, in combination with chemotherapy for patients with untreated small-cell lung canc… Recruiting

2024-515765-34-00 Phase III 7 countries ATEZOLIZUMAB; BNT327
A clinical study to test if an investigational treatment called BNT314 when used in combination with another investigational treatment pumit… Recruiting

2025-521768-36-00 Phase I/II 2 countries BNT314; BNT327; PUMITAMIG
A clinical study to test if an investigational treatment called BNT326 is safe and potentially beneficial when used alone or in combination … Recruiting

2024-517261-16-00 Phase I/II 4 countries BNT326; BNT327; PUMITAMIG
Safety and preliminary efficacy of pumitamig (BNT327), an investigational therapy for patients with non-small cell lung cancer in combinatio… Recruiting

2024-518279-80-00 Phase II 1 country BNT327
Safety, efficacy, and pharmacokinetics of BNT327 in combination with chemotherapy and other investigational agents for lung cancer Recruiting

2024-515764-31-00 Phase II/III 9 countries BISPECIFIC ANTIBODY AGAINST VASCULAR ENDOTHELIAL GROWTH FACTOR A AND PROGRAMMED …
Clinical trial evaluating the safety, tolerability, and preliminary efficacy of BNT116 alone and in combinations in patients with advanced n… Recruiting

2023-509283-14-00 Phase I 4 countries
A clinical trial investigating the safety, tolerability, and therapeutic effects of BNT113 in combination with pembrolizumab versus pembroli… Recruiting

2024-512671-12-00 Phase II/III 11 countries RBL015.2, RBL016.2
Safety and preliminary efficacy of BNT314 in cancer patients with malignant solid tumors Ended

2023-506053-38-00 Phase I 3 countries BNT314
A Phase II clinical trial comparing the efficacy of RO7198457 versus watchful waiting in patients with ctDNA positive, resected Stage II (hi… Ended

2023-509516-28-00 Phase II 4 countries AUTOGENE CEVUMERAN
Safety and immune responses after vaccination with two investigational RNA-based vaccines against tuberculosis in healthy volunteers Ended

2023-509515-89-00 Phase I 1 country
Dose escalation trial of BNT152+153 in patients with cancer Ended

2023-509508-13-00 Phase I 1 country
Safety and preliminary efficacy trial of BNT142 in patients with CLDN6-positive advanced ovarian, lung, or testicular cancer Ended

2024-512639-58-00 Phase I (FiH) 3 countries BNT142
A study to investigate the novel agent BNT111 and cemiplimab in combination or as single agents in patients with advanced melanoma that has … Ended

2023-509513-36-00 Phase II 4 countries CEMIPLIMAB; GINDAMERAN, VIBOSAMERAN, ENOMIMERAN, ONTASAMERAN
An open-label Phase 1 study of NEO-PTC-01 in patients with advanced or metastatic melanoma Ended

2023-508524-35-00 Phase I 3 countries

Showing 1–22 of 22 trials

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