ISB 1302 / Harbour BioMed, Glenmark - LARVOL DELTA

Preliminary biomarker and pharmacodynamic data from a phase I study of single-agent bispecific antibody T-cell engager GBR 1302 in subjects with HER2‑positive cancers. (ASCO-SITC 2018) - P1; "Preliminary PD data indicate changes in peripheral T-cell populations and inflammatory cytokines following GBR 1302 treatment."

Biomarker • Clinical • P1 data • PK/PD data • Solid Tumor

A phase I study of the bispecific antibody T-cell engager GBR 1302 in subjects with HER2-positive cancers. (ASCO 2017) - P1; "Preclinically, GBR 1302 has demonstrated potent killing of HER2-positive human cancer cells (HER2 3+ or 2+ by IHC HercepTest), as well as growth suppression of the trastuzumab-resistant cell line JIMT-1. Due to the known cardiotoxic potential of classic HER2-targeting strategies, this study incorporates a rigorous serological and echocardiographic surveillance schedule. The effects of GBR 1302 on the adaptive immune system will also be studied at cellular and serological levels in translational research."

P1 data • Biosimilar • Oncology

Preliminary pharmacokinetic results from a phase I study of GBR 1302 in patients with HER2 positive cancers (ESMO-IO 2018) - "of the subjects evaluated so far showed positive ADA response. Editorial acknowledgement Editorial assistance was provided by Jacqueline Benjamin, PhD of Prescott Medical Communications Group, Chicago, IL."

Clinical • P1 data • PK/PD data • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

Preliminary Results from a Phase 1 Study of GBR 1302, A Bispecific Antibody T-Cell Engager, in HER2 Positive Cancers (ESMO 2018) - P1; "The combination of clinical findings and PD changes suggests T-cell activation with higher dosages of GBR 1302. Dose escalation is continuing and updated results will be presented."

P1 data • Esophageal Cancer • Thoracic Cancer

Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer (clinicaltrials.gov) - P1/2; N=1; Terminated; Sponsor: Ichnos Sciences SA; N=158 ➔ 1; Trial completion date: Jan 2022 ➔ Jul 2020; Recruiting ➔ Terminated; Trial primary completion date: Aug 2021 ➔ Jul 2020; The study was terminated during Part 1 (dose escalation), and Part 2 (expansion) of the study was not initiated. This study was voluntarily terminated due to a business decision not to proceed with the ISB 1302 asset, and not due to any safety issue.

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CD4 • CD69 • CD8 • HER-2 • IFNG • IL10 • IL2 • IL2RA • IL6 • IL7R • TMB • TNFA

Glenmark Pharmaceuticals receives FDA clearance of IND for GBR 1302-BEAT phase I trial (PRNewswire) - "Glenmark Pharmaceuticals...today announced that the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational New Drug (IND) application to initiate a phase I study of...GBR 1302-BEAT™, in patients with HER2+ cancers...Company to Initiate Phase I Clinical Study in Patients with HER2+ Cancer in 1Q 2017."

IND • New P1 trial • Oncology

Glenmark Pharmaceutical's experimental GBR 1302-BEAT demonstrates potent anti-tumor activity in preclinical data presented at the ESMO Symposium on immuno-oncology (PRNewswire) - "Glenmark Pharmaceuticals, a global pharmaceutical company, today announced preclinical findings suggesting that GBR 1302 is efficient at eliminating tumor cells and has potential for a  large therapeutic window...The company is currently recruiting patients for this Phase 1 study in Germany and plans to expand the clinical trial program to the U.S."

Conference • Enrollment status • Preclinical • Oncology

Glenmark Pharmaceuticals and Harbour BioMed sign agreement for Greater China to develop GBR 1302, a first-in-class bispecific antibody for treatment of HER2-positive cancers (PRNewswire) - P1, N=60; NCT02829372; Sponsor: Glenmark Pharmaceuticals S.A; "Glenmark Pharmaceuticals S.A. and Harbour BioMed announced today that they have entered into an exclusive license agreement for the Greater China territory to develop, manufacture and commercialize GBR 1302...The companies will collaborate on the generation of clinical data to support the registration of GBR 1302 in HER2-positive indications in their respective territories....Enrollment for the GBR 1302 clinical study is currently ongoing in the U.S. and Germany."

Enrollment status • Licensing / partnership • Oncology

Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer (clinicaltrials.gov) - P1/2; N=158; Recruiting; Sponsor: Ichnos Sciences SA; Initiation date: Aug 2019 ➔ Jan 2020

Clinical • Trial initiation date • CD8 • HER-2 • IL10 • IL2 • IL2RA • IL6 • TMB

GBR 1302-101: Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers (clinicaltrials.gov) - P1; N=36; Terminated; Sponsor: Glenmark Pharmaceuticals S.A.; Completed ➔ Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention

Clinical • Trial termination

GBR 1302-101: Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers (clinicaltrials.gov) - P1; N=36; Completed; Sponsor: Glenmark Pharmaceuticals S.A.; Terminated ➔ Completed; N=60 ➔ 36

Clinical • Enrollment change • Trial completion • HER2

GBR 1302-101: Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers (clinicaltrials.gov) - P1; N=60; Terminated; Sponsor: Glenmark Pharmaceuticals S.A.; Trial completion date: Nov 2019 ➔ May 2019; Active, not recruiting ➔ Terminated; Trial primary completion date: Nov 2019 ➔ May 2019

Clinical • Trial completion date • Trial primary completion date • Trial termination

Study of GBR 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer (clinicaltrials.gov) - P1/2; N=158; Recruiting; Sponsor: Glenmark Pharmaceuticals S.A.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Tumor Mutational Burden

Study of GBR 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer (clinicaltrials.gov) - P1/2; N=158; Not yet recruiting; Sponsor: Glenmark Pharmaceuticals S.A.

Clinical • New P1/2 trial • Tumor Mutational Burden

GBR 1302-101: Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers (clinicaltrials.gov) - P1; N=60; Active, not recruiting; Sponsor: Glenmark Pharmaceuticals S.A.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed