bafisontamab (EMB-01) / EpimAb Biotherap - LARVOL DELTA

EMB-01, an EGFR/cMET bispecific antibody, in metastatic colorectal cancer: Results from an international phase Ib/II study (AACR 2025) - P1/2 | "The median lines of prior systemic therapies were 3 (range 1-11), with 66.7% having received prior anti-EGFR therapy, 79.2% anti-VEGF therapy, and 27.1% fruquintinib, regorafenib, or trifluridine/tipiracil (TAS-102). EMB-01 demonstrated promising efficacy in heavily pretreated mCRC, including those with prior progression on anti-EGFR, with an acceptable safety profile at 1600 mg, warranting further investigation in larger cohorts.References: 1. Ren et al. Cancer Res 2020; 80(16 Suppl): Abstract 528."

Metastases • P1/2 data • Colorectal Cancer • Oncology • Solid Tumor

EpimAb Biotherapeutics Announces Four Upcoming Presentations at the 2025 American Association for Cancer Research Annual Meeting (GlobeNewswire) - "The posters will feature: 1) Clinical results for EMB-01, an EGFR x cMet bispecific antibody, in colorectal cancer; 2) Preclinical data for EM1031, a novel KLK2 x CD3 bispecific T-cell engager; 3) Preclinical data for a novel LY6G6D x CD3 bispecific T-cell engager and 4) Preclinical data for a novel TCR based bispecific platform."

P1/2 data • Preclinical • Colorectal Cancer

EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers (clinicaltrials.gov) - P1/2 | N=152 | Recruiting | Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd. | Trial completion date: Aug 2024 ➔ Dec 2025 | Trial primary completion date: Aug 2024 ➔ Dec 2025

Metastases • Trial completion date • Trial primary completion date • Carcinoid Tumor • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatocellular Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • FGFR • KRAS • NRAS • NTRK • ROS1

EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers (clinicaltrials.gov) - P1/2 | N=152 | Recruiting | Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd. | N=96 ➔ 152

Enrollment change • Metastases • Carcinoid Tumor • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatocellular Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • ALK • BRAF • EGFR • FGFR • KRAS • NRAS • NTRK • ROS1

A Dose Escalation With Expansion Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=186 | Recruiting | Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd. | Trial completion date: Mar 2023 ➔ Jan 2026 | Trial primary completion date: Mar 2023 ➔ Mar 2025

Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer (clinicaltrials.gov) - P1/2 | N=115 | Not yet recruiting | Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd. | Initiation date: Oct 2022 ➔ Jun 2023

Combination therapy • Metastases • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Integrative genomic analysis of drug resistance in MET exon 14 skipping lung cancer using patient-derived xenograft models. (PubMed, Front Oncol) - "PDX mice were then treated with MET inhibitors (crizotinib and tepotinib) and EGFR-MET bispecific antibodies (EMB-01 and amivantamab) to evaluate their drug response in vivo. We also established and characterized a pair of METex14 NSCLC PDXs, including the first crizotinib resistant METex14 PDX. And dual inhibition of MET and EGFR might be a therapeutic strategy for EGFR-driven drug resistance METex14 lung cancer."

Journal • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

EMB-01: An EGFR-cMET bispecific antibody, in advanced/metastatic solid tumors phase I results (ELCC 2022) - P1/2 | "Preliminary anti-tumor evidence suggests EMB-01 can have activity in EGFR driven NSCLC, including pts with acquired EGFR TKI resistance and EGFR exon20ins mutations. The expansion phase (Ph II) is currently enrolling biomarker selected NSCLC pts with EGFR and/or cMET aberrations as identified by next-generation sequencing in circulating tumor DNA (ctDNA) and/or tumor tissue."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer (clinicaltrials.gov) - P1/2 | N=115 | Not yet recruiting | Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.

Combination therapy • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

EpimAb Biotherapeutics Announces U.S. FDA Clearance of IND Application for Phase Ib/II Trial of EMB-01 in Combination with Tagrisso for Non-Small Cell Lung Cancer (Businesswire) - "EpimAb Biotherapeutics...announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase Ib/II study in patients with non-small cell lung cancer (NSCLC) evaluating the combination of EMB-01, a bispecific antibody designed to simultaneously target EGFR and cMET on tumor cells, and Tagrisso (osimertinib), AstraZeneca’s (LSE/STO/Nasdaq: AZN) third-generation EGFR-TKI....The planned Phase Ib/II trial will evaluate the safety and tolerability of EMB-01 in combination with Tagrisso in patients with NSCLC with EGFR mutations."

IND • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Unique Properties and Clinical Progress of Leading FIT-Ig-Based Bispecific Antibodies (PEGS 2022) - "Based on FIT-Ig, EpimAb's bispecific antibody technology, a number of therapeutic molecules have been developed and several are in clinical development, including cancer cell targeting cMET/EGFR (EMB-01) and dual check-point PD-1/LAG-3 (EMB-02). Current data reveals more aspects concerning the clinical validation of the FIT-Ig technology, as well as the synergistic mechanism of these dual-targeting bispecific antibodies."

Clinical • Oncology • EGFR • LAG3 • PD-1

EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers (clinicaltrials.gov) - P1/2; N=96; Recruiting; Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.

Clinical • New P1/2 trial • Carcinoid Tumor • Cholangiocarcinoma • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatocellular Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • EGFR • MET

A Dose Escalation With Expansion Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2; N=186; Recruiting; Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.; N=137 ➔ 186; Trial completion date: Mar 2024 ➔ Mar 2023; Trial primary completion date: Mar 2024 ➔ Mar 2023

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

EpimAb Biotherapeutics Raises $120M in Series C Financing to Advance Bispecific Programs and Broaden Clinical Pipeline (Businesswire) - "EpimAb Biotherapeutics...announced today the closing of a $120 million Series C financing round...Proceeds from the financing will be used to fund the ongoing clinical development of EMB-01, EMB-02 and EMB-06, and to expand the company’s pipeline of novel bispecific antibodies and other biologics."

Commercial • Oncology