BNT321 / BioNTech - LARVOL DELTA

Study of a New Technique for Imaging Pancreatic Cancer (clinicaltrials.gov) - P1 | N=4 | Completed | Sponsor: Memorial Sloan Kettering Cancer Center | Active, not recruiting ➔ Completed | Trial completion date: May 2025 ➔ Jan 2025 | Trial primary completion date: May 2025 ➔ Jan 2025

Trial completion • Trial completion date • Trial primary completion date • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

MV-0715-CP-001.01: Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies (clinicaltrials.gov) - P1 | N=118 | Terminated | Sponsor: BioNTech Research & Development, Inc. | Trial completion date: Oct 2026 ➔ Jan 2025 | Active, not recruiting ➔ Terminated; Sponsor decision

Trial completion date • Trial termination • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=2 | Terminated | Sponsor: BioNTech SE | N=320 ➔ 2 | Trial completion date: Jun 2031 ➔ Sep 2024 | Recruiting ➔ Terminated | Trial primary completion date: Apr 2029 ➔ Sep 2024; Sponsor decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

MV-0715-CP-001.01: Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies (clinicaltrials.gov) - P1 | N=118 | Active, not recruiting | Sponsor: BioNTech Research & Development, Inc. | Recruiting ➔ Active, not recruiting | N=264 ➔ 118

Enrollment change • Enrollment closed • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Study of a New Technique for Imaging Pancreatic Cancer (clinicaltrials.gov) - P1 | N=4 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Recruiting ➔ Active, not recruiting | N=15 ➔ 4

Enrollment change • Enrollment closed • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

MV-0715-CP-001.01: Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies (clinicaltrials.gov) - P1 | N=264 | Recruiting | Sponsor: BioNTech Research & Development, Inc. | Trial completion date: Feb 2024 ➔ Oct 2026 | Trial primary completion date: Feb 2024 ➔ Aug 2024

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

BNT321, a novel monoclonal antibody targeting sialyl Lewis A: Phase 1 monotherapy and combination with mFOLFIRINOX in patients with advanced CA19-9 expressing cancers. (ASCO-GI 2024) - P1 | "BNT321 and BNT321 + mFFX MTDs were 2 mg/kg and 1 kg/kg, respectively. DLTs were hepatic AST, ALT and T bilirubin elevations which were generally cycle 1 and did not preclude subsequent BNT321 at reduced dose. BNT321 monotherapy resulted in disease stabilization and prolonged time on study (> 90 days for > 20%) in pts with advanced line, metastatic PDAC and other CA19-9+ cancers."

Clinical • Metastases • Monotherapy • P1 data • Gastrointestinal Cancer • Oncology • CA 19-9

Study of a New Technique for Imaging Pancreatic Cancer (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: May 2024 ➔ May 2025 | Trial primary completion date: May 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies (clinicaltrials.gov) - P1 | N=264 | Recruiting | Sponsor: BioNTech Research & Development, Inc.

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=300 | Recruiting | Sponsor: BioNTech SE

Trial completion date • Trial initiation date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=300 | Recruiting | Sponsor: BioNTech SE | Not yet recruiting ➔ Recruiting | Phase classification: P2 ➔ P1/2

Enrollment open • Phase classification • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: BioNTech SE

New P2 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Study of 177Lu Human Monoclonal Antibody 5B1 (MVT-1075) in Combination With a Blocking Dose of MVT-5873 as Radioimmunotherapy (clinicaltrials.gov) - P1 | N=4 | Terminated | Sponsor: BioNTech Research & Development, Inc. | Suspended ➔ Terminated; Sponsor Decision

Combination therapy • Trial termination • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Study of a New Technique for Imaging Pancreatic Cancer (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: May 2023 ➔ May 2024 | Trial primary completion date: May 2023 ➔ May 2024

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies (clinicaltrials.gov) - P1 | N=264 | Recruiting | Sponsor: BioNTech Research & Development, Inc. | N=162 ➔ 264

Enrollment change • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CA 19-9

Study of 177Lu Human Monoclonal Antibody 5B1 (MVT-1075) in Combination With a Blocking Dose of MVT-5873 as Radioimmunotherapy (clinicaltrials.gov) - P1 | N=7 | Suspended | Sponsor: BioNTech Research & Development, Inc. | Trial completion date: Sep 2022 ➔ Feb 2023 | Trial primary completion date: Sep 2022 ➔ Feb 2023

Combination therapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CA 19-9

Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers (clinicaltrials.gov) - P2 | N=10 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jun 2022 | Trial primary completion date: Dec 2024 ➔ Jun 2022

Trial completion • Trial completion date • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Study of 177Lu Human Monoclonal Antibody 5B1 (MVT-1075) in Combination With a Blocking Dose of MVT-5873 as Radioimmunotherapy (clinicaltrials.gov) - P1 | N=7 | Suspended | Sponsor: BioNTech Research & Development, Inc. | Trial completion date: Dec 2021 ➔ Sep 2022 | Trial primary completion date: Dec 2021 ➔ Sep 2022

Combination therapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CA 19-9

Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers (clinicaltrials.gov) - P2 | N=10 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting | N=105 ➔ 10

Enrollment change • Enrollment closed • Biliary Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies (clinicaltrials.gov) - P1 | N=162 | Recruiting | Sponsor: BioNTech Research & Development, Inc. | Trial completion date: Jan 2023 ➔ Feb 2024 | Trial primary completion date: Jan 2023 ➔ Feb 2024

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Cancer antigen 19-9

Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers (clinicaltrials.gov) - P2; N=105; Recruiting; Sponsor: National Cancer Institute (NCI); Trial completion date: Dec 2023 ➔ Dec 2024; Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Phase I dose escalation study of 177Lu-HuMab-5B1 (MVT-1075) in combination with MVT-5873 as radioimmunotherapy (RIT) in subjects with relapsed / refractory pancreatic cancer or other CA19-9+ malignancies (AACR 2018) - "RIT with MVT-1075/MVT-5873 was associated with manageable hematologic toxicities, consistent with predictions. MVT-1075 demonstrated target accumulation. Accrual is ongoing and dose escalation is planned."

Clinical • Combination therapy • IO Biomarker • P1 data • Gastric Cancer • Pancreatic Cancer

HuMab-5B1 (MVT-5873), a mAb targeting sLea, in combination with first-line gemcitabine plus nab-paclitaxel (gem/nab-P) for patients with pancreatic cancer (PDAC) and other CA19-9 positive malignancies. (ASCO 2018) - P1; "MVT-5873 at 0.125 mg/kg in combination with gem/nab-P appears safe and tolerable. DLTs included reversible increases in transaminases. Initial activity is promising and is being further evaluated in an expansion cohort of 10 subjects."

Clinical • Combination therapy • Lung Cancer • Pancreatic Cancer

[VIRTUAL] Perioperative MVT-5873, a fully human monoclonal antibody against a CA 19-9 epitope, for operable CA 19-9 producing pancreatic cancers, cholangiocarcinomas, and metastatic colorectal cancers. (ASCO 2020) - P2 | "The third dose will be administered on the normally scheduled postoperative clinic visit, followed by a final dose one month after discharge from the hospital and prior to the start of adjuvant treatment. Research Funding: U.S. National Institutes of Health"

Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Ophthalmology • Pancreatic Cancer • Solid Tumor

Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With HuMab-5B1 (clinicaltrials.gov) - P1; N=15; Terminated; Sponsor: BioNTech Research & Development, Inc.; Active, not recruiting ➔ Terminated; Sponsor decision

Clinical • Trial termination • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Cancer antigen 19-9 • MRI