EMB-02 / EpimAb Biotherap - LARVOL DELTA

First-in-human phase I study of EMB-02, a bispecific antibody targeting PD-1 and LAG-3 in patients with advanced solid tumors. (PubMed, Br J Cancer) - P1/2 | "EMB-02 demonstrated a favorable safety profile and early efficacy signals in multiple solid tumors, warranting further development. (NCT04618393)."

IO biomarker • Journal • P1 data • Oncology • Solid Tumor • LAG3 • PD-L1

Using Pharmacokinetic and Pharmacodynamic Analysis to Optimize the Dosing Regimens of Fanastomig (EMB-02) in Patients With Advanced Solid Tumors. (PubMed, CPT Pharmacometrics Syst Pharmacol) - P1/2 | "Based on these findings, two dosing regimens have been selected for further clinical development. Trial Registration: ClinicalTrials.gov identifier: NCT04618393."

Journal • PK/PD data • Oncology • Solid Tumor • LAG3

A Study of EMB-02 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=47 | Terminated | Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd. | Trial completion date: Dec 2025 ➔ Mar 2024 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2023 ➔ Jul 2023; Company's resource optimization and product's development change

Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

Preliminary phase I results from a first-in-human study of EMB-02, a PD-1xLAG-3 bispecific antibody, in patients (pts) with advanced solid tumors (ESMO 2023) - P1/2 | "Conclusions EMB-02 has demonstrated a tolerable safety profile and encouraging anti-tumor activity during the dose escalation phase, warranting further development. Expansion cohorts in select advanced solid tumours are ongoing."

Clinical • Metastases • P1 data • Melanoma • Oncology • Solid Tumor • LAG3

EpimAb Biotherapeutics to Present Initial First-in-human Data of EMB-02 at the 2023 ESMO Conference (Businesswire) - "EpimAb Biotherapeutics...is pleased to announce that the company will present the first-in-human results for EMB-02 as a poster display at the 2023 European Society for Medical Oncology (ESMO) Congress on October 23 (local time). This poster will feature initial safety, efficacy, and pharmacokinetic/ pharmacodynamic (PK/PD) data from the EMB-02 Phase I dose escalation study in advanced solid tumors (NCT04618393)."

P1 data • Oncology • Solid Tumor

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

EpimAb Biotherapeutics Provides Clinical Update for EMB-02 and EMB-06 (Businesswire) - "EpimAb Biotherapeutics...announced dose administration for the first patient in a Phase 1/2 clinical trial of EMB-02, a bispecific antibody targeting PD-1 and LAG-3, in patients with advanced solid tumors, as well as in a Phase 1/2 clinical trial of EMB-06, a bispecific antibody targeting B cell maturation antigen (BCMA) and cluster of differentiation 3 (CD3), in patients with recurrent and refractory multiple myeloma. The company also announced the approval of its Investigational New Drug (IND) application for EMB-02 by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA)."

Trial status • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

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

A Study of EMB-02 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=43; Recruiting; Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.; Enrolling by invitation ➔ Recruiting

Clinical • Enrollment status • Oncology • Solid Tumor

A Study of EMB-02 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=43; Enrolling by invitation; Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.; Not yet recruiting ➔ Enrolling by invitation

Clinical • Enrollment open • Oncology • Solid Tumor

A Study of EMB-02 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=43; Not yet recruiting; Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.

Clinical • New P1/2 trial • Oncology • Solid Tumor

EpimAb Biotherapeutics Announces FDA Clearance of its IND Application for EMB-02, a Bispecific Dual Checkpoint Inhibitor (Businesswire) - "EpimAb Biotherapeutics...announced that it has received 'STUDY MAY PROCEED' letter from the...FDA on an Investigational New Drug (IND) application for the Company’s second therapeutic development candidate, EMB-02. The application was submitted to the FDA to investigate the treatment of solid tumors with EpimAb’s novel bispecific antibody...EMB-02 simultaneously targets two checkpoint proteins, PD-1 and LAG-3, and has shown strong anti-tumor activities in preclinical models resistant to standard anti-PD-1 monotherapies."

IND • Oncology • Solid Tumor