MVT-1075 / BioNTech - LARVOL DELTA

Novel Theranostic Tool Allows for Noninvasive Identification and Treatment of Ovarian Cancer (SSNMMI) - "A new radiotheranostic system has the ability to detect and treat ovarian cancer noninvasively, according to new research published in the April issue of The Journal of Nuclear Medicine. Combining the highly specific huAR9.6 antibody with PET and therapeutic radionuclides, this theranostic platform may provide more personalized treatment to improve health outcomes for ovarian cancer patients....In vivo studies showed that ⁸⁹Zr-DFO-huAR9.6 could effectively specify varying levels of MUC16 expression in ovarian cancer mouse models. Radioimmunotherapy studies with ¹⁷⁷Lu-CHX-A″-DTPA-huAR9.6 demonstrated improved overall survival and strong antitumor responses in highly MUC16-expressing models. Hematologic toxicity was also determined to be transient in mice treated with 177Lu-CHX-A″-DTPA-huAR9.6."

Preclinical • Gynecologic Cancers • Oncology • Ovarian 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 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

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

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

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 2020 ➔ Dec 2021; Active, not recruiting ➔ Suspended; Trial primary completion date: Dec 2020 ➔ Dec 2021

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

"$MBVX CEO David Hansen to provide a corporate overview at #BIOCEO18, including an update on the Company's two lead clinical development programs: its fully human #antibody therapeutic product MVT-5873 & antibody-based RIT MVT-1075 program. https://t.co/Vez99woGWp" (@MabVaxThera)

Clinical • Biosimilar

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; Active, not recruiting; Sponsor: BioNTech Research & Development, Inc.; Recruiting ➔ Active, not recruiting; N=22 ➔ 7; Trial completion date: Dec 2019 ➔ Dec 2020; Trial primary completion date: Dec 2019 ➔ Dec 2020

Clinical • Combination therapy • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Cancer antigen 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=22; Recruiting; Sponsor: MabVax Therapeutics, Inc.; Trial primary completion date: Dec 2018 ➔ Dec 2019

Trial primary completion date • Cancer antigen 19-9