ES014 / Elpiscience - LARVOL DELTA

First-in-human study of ES014, a bispecific antibody targeting CD39 and TGF-β as monotherapy in patients with advanced solid tumors (ESMO Asia 2025) - P1 | "ES014 demonstrated a good safety, tolerability, PK and PD profile in pts with advanced solid tumors. ES014 monotherapy showed preliminary antitumor activity in various tumor types including NSCLC, GIST and DT. There appears to be a correlation between CD39 expression and clinical response."

Clinical • First-in-human • Metastases • Monotherapy • P1 data • Desmoid Tumors • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • ENTPD1 • TGFB1

A Study of ES014 in Patients With Locally Advanced or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: Elpiscience (Suzhou) Biopharma, Ltd. | Trial completion date: Sep 2025 ➔ Feb 2027 | Trial primary completion date: Jun 2025 ➔ Feb 2027

Trial completion date • Trial primary completion date • Solid Tumor

ES014-IIT-01: A Study of ES014 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2024 ➔ Nov 2024

Enrollment open • Trial initiation date • Solid Tumor

A Study of ES014 in Patients With Locally Advanced or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: Elpiscience (Suzhou) Biopharma, Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Solid Tumor

A novel bi-functional antibody fusion protein for the inhibition of TGFβ pathway in cancer immunotherapy via selective delivery of TGFβ 'trap' to CD39-expressing cells (SITC 2024) - "In vitro study indicates ES014 has a role in promoting T cell fitness. ES014 exerts its functions not only on the inhibition of CD39-adenosine axis, but also on selective suppression of TGFβ signal pathway within the CD39-expressing immune cells in TME, leading to effective anti-tumor immunotherapy."

IO biomarker • Oncology • Sarcoma • Solid Tumor • CD4 • ENTPD1 • TGFB1 • VIM

A Study of ES014 in Patients With Locally Advanced or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Elpiscience (Suzhou) Biopharma, Ltd. | N=70 ➔ 120

Enrollment change • Metastases • Oncology • Solid Tumor

A Study of ES014 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=15 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Metastases • New P2 trial • Oncology • Solid Tumor

Elpiscience Announces Studies Presented at Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting (Businesswire) - "Elpiscience Biopharmaceuticals...presented studies for its innovative immunotherapeutic molecules at the SITC 2023 Annual Meeting....Our study showed that ES014, a bifunctional antibody–ligand trap which comprises an antibody targeting CD39 fused to a TGFβ receptor II ectodomain, can inhibit TGFβ activity and lead to cancer killing in ex vivo models....ES015-2 can completely block the interaction of NKG2A/CD94 with HLA-E, thereby inhibits HLA-E-induced NKG2A inhibitory signaling. Ligation of ES015-2 effectively potentiates the activation of NKG2C+ NK cells and T cells....ES008-a promotes NK cell-mediated destruction of tumor cells. ES008-a synergizes with CD47/SIRPα inhibitors in enhancing macrophage phagocytosis of tumor cells."

Preclinical • Oncology

Elpiscience Announces Three Poster Presentations at Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting (Businesswire) - "Elpiscience Biopharmaceuticals...announced it will have three poster presentations at the SITC 2023 Annual Meeting taking place November 3-5, 2023, in San Diego. The posters will highlight its studies on three innovative molecules including a first-in-class NKG2A/NKG2C dual-targeting antibody ES015, a high affinity LILRB1 specific blocking antibody ES008-a, and the first-in-class anti-CD39/TGF-βRII bifunctional fusion protein ES014 which has been proven to be able to deliver TGFβ 'trap' to CD39-expressing immune and stroma cells to reshape tumor microenvironment and rejuvenates antitumor immunity."

Preclinical • Oncology

Preclinical characterization of a novel anti-CD39/TGFβ-trap bispecific antibody that aims to modulate tumor microenvironment. (ASCO 2023) - "ES014 is a first-in-class molecule that simultaneously targeting CD39 and TGFβ. ES014 counteracts TGFβ-mediated differentiation of Tregs and adenosine-induced immune tolerance, and protected effector T cells from AICD. Treatment of ES014 resulted in significant anti-tumor effects in ex vivo and in vivo efficacy models."

IO biomarker • Preclinical • Tumor microenvironment • Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • CD163 • CD8 • CD86 • ENTPD1 • ITGAM • TGFB1

A Study of ES014 in Patients With Locally Advanced or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Elpiscience (Suzhou) Biopharma, Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Elpiscience Announces First Patient Dosed for Phase 1 Clinical Trial of First-in-Class Anti-CD39xTGF-β Bispecific Antibody ES014 (Businesswire) - "Elpiscience Biopharmaceuticals...announced that the first patient has been dosed in a Phase 1 clinical trial of ES014, a first-in-class anti-CD39xTGF-β bispecific antibody (bsAb). The principal investigator of the study is Professor Lu Shun, Director of Oncology Department of Shanghai Chest Hospital."

Trial status • Oncology • Solid Tumor

A Study of ES014 in Patients With Locally Advanced or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=70 | Not yet recruiting | Sponsor: Elpiscience (Suzhou) Biopharma, Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor

A Study of ES014 (Anti-CD39/TGF-β Bispecific Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Elpiscience Biopharma, Ltd. | N=60 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Metastases • Trial withdrawal • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Elpiscience Announces CDE IND Clearance of ES014, a First in Class Anti-CD39xTGF-β Bispecific Antibody for Patients with Advanced Solid Tumors (Businesswire) - "Elpiscience Biopharmaceuticals...announced that the Center of Drug Evaluation (CDE) has cleared Elpiscience’s Investigational New Drug Application (IND) for ES014 to initiate a Phase 1 clinical study for patients with advanced solid tumors. ES014 is a first-in-class anti-CD39xTGF-β bispecific antibody (bsAb) that simultaneously targets the CD39-adenosine and TGF-β pathways to synergistically activates T cells for ICB-resistant cancer immunotherapy."

New P1 trial • Oncology • Solid Tumor

A Study of ES014 (Anti-CD39/TGF-β Bispecific Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Elpiscience Biopharma, Ltd. | Trial completion date: Oct 2025 ➔ Apr 2026 | Initiation date: Oct 2022 ➔ Apr 2023 | Trial primary completion date: Oct 2025 ➔ Apr 2026

Trial completion date • Trial initiation date • Trial primary completion date • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of ES014 (Anti-CD39/TGF-β Bispecific Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Elpiscience Biopharma, Ltd.

New P1 trial • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Elpiscience Announces FDA IND Clearance of ES014, a First-in-Class Anti-CD39xTGF-β Bispecific Antibody for Patients with Advanced Solid Tumors (Businesswire) - "Elpiscience Biopharmaceuticals...announced that the U.S. Food and Drug Administration (FDA) has cleared Elpiscience’s ES014 Investigational New Drug (IND) Application to initiate a Phase 1 clinical study for patients with advanced solid tumors. ES014 is a first-in-class anti-CD39xTGF-β bispecific antibody (bsAb) that simultaneously targets the CD39-adenosine and TGF-β pathways, two major immunosuppressive mechanisms in the tumor microenvironment (TME)."

IND • Oncology • Solid Tumor

Creating an Immune-favorable Tumor Microenvironment by A Novel Anti-CD39/TGFβ-Trap Bispecific Antibody (SITC 2021) - "Our pre-clinical data demonstrate that ES014 counteracts TGFβ-mediated inhibitory effect and adenosine induced immune tolerance and has a unique ability to protect T cell from apoptosis. ES014 demonstrated strong efficacy in in vivo tumor growth inhibition."

Biomarker • IO biomarker • Tumor microenvironment • Oncology • CD8 • ENTPD1 • PD-1 • TGFB1

ES014: IND submission in US in Q1 2022 (Elpiscience, Jefferies 2021 Virtual Healthcare Conference (Virtual Meeting))

IND • Oncology

ES014: IND submission in US in Q1 2022 (Elpiscience, Jefferies 2021 Virtual Healthcare Conference (Virtual Meeting))

IND • Oncology