ES014 / Elpiscience - LARVOL DELTA

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