obertamig (JNJ-6358) / J&J, Zymeworks - LARVOL DELTA

JNJ-78306358, a first-in-class bispecific T cell engaging antibody targeting CD3 and HLA-G. (PubMed, iScience) - "JNJ-78306358 also blocked the interaction of HLA-G with its receptors in vitro, indicating that immune checkpoint blocking may contribute to its anti-tumor activity. These results suggest that T cell-redirection against HLA-G could be a potent and effective treatment for a wide range of solid tumor indications."

Journal • Oncology • Solid Tumor • HLA-G

Safety and clinical activity of JNJ-78306358, a human leukocyte antigen-G (HLA-G) x CD3 bispecific antibody, for the treatment of advanced stage solid tumors. (PubMed, Cancer Immunol Immunother) - P1 | "JNJ-78306358 showed pharmacodynamic effects with induction of cytokines and T cell activation. JNJ-78306358 was associated with CRS-related toxicities including increased transaminases and pneumonitis which limited its dose escalation to potentially efficacious levels. Trial registration number ClinicalTrials.gov (No. NCT04991740)."

Journal • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Pneumonia • Renal Cell Carcinoma • Solid Tumor • HLA-G

Safety and preliminary clinical activity of JNJ-78306358 (JNJ-358), an HLA-G and CD3 bispecific antibody, for the treatment of advanced stage solid tumor (ESMO 2023) - P1 | "CRS was G1 or G2 and responded to tocilizumab. Considering the CRS-related toxicities and the ADA formation, the Sponsor decided to halt dose escalation. No recommended phase 2 dose was determined."

Clinical • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • HLA-G

JNJ-78306358: A first-in-class bispecific T cell redirecting HLA-G antibody (AACR 2022) - P1 | "JNJ-78306358’s safety, tolerability and preliminary anti-tumor activity are currently being evaluated in a first-in-human phase I study in advanced stage solid tumors with high prevalence of HLA-G protein expression (NCT04991740). This antigen-targeting approach may address an unmet medical need in patients with tumors expressing HLA-G."

Colorectal Cancer • Endometrial Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Rectal Cancer • Renal Cell Carcinoma • Solid Tumor • CD34 • CD8

A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov) - P1 | N=39 | Completed | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Feb 2023 | Trial primary completion date: Feb 2024 ➔ Feb 2023

Metastases • Trial completion • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • EGFR • MSI

A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov) - P1 | N=39 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting | N=140 ➔ 39

Enrollment change • Enrollment closed • Colorectal Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • EGFR • MSI

A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Aug 2024 ➔ Jan 2025

Trial completion date • Colorectal Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • EGFR • MSI

A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Apr 2024 ➔ Aug 2024

Trial completion date • Colorectal Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • EGFR • MSI

Zymeworks Announces Second Janssen Bispecific Antibody to Begin Clinical Development Utilizing Azymetric and EFECT Therapeutic Platforms (Businesswire) - "Zymeworks...announced that Janssen Biotech, Inc. ('Janssen') dosed the first patient with JNJ-78306358, a bispecific antibody developed using Zymeworks’ Azymetric™ and EFECT™ therapeutic platforms....Zymeworks will receive a payment in connection with this milestone under Zymeworks’ 2017 licensing agreement with Janssen."

Financing • Trial status • Oncology • Solid Tumor

A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov) - P1; N=140; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • EGFR • MSI