Drugs / ES014
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05381935 | Apr 2023 → Apr 2026 | neoplasm | Elpiscience Biopharma, Ltd. | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT05717348 | Feb 2023 → Feb 2027 expected | cancer, metastatic neoplasm | Elpiscience (Suzhou) Biopharma, Ltd. | Active not recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07541430 | Apr 2026 → Jan 2028 expected | desmoid tumor | Elpiscience (Suzhou) Biopharma, Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06543056 | Nov 2024 → Jun 2026 overdue | neoplasm | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-03-04 | Elpiscience Biopharma, Ltd. | Regulatory Elpiscience’s Independently Developed BsAb ES014 Receives FDA Orphan Drug Designation, Accelerating Global Development in Desmoid Tumors elpiscience.com ↗
Elpiscience announced today that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to ES014, the company’s independently developed first-in-class CD39/TGF-βbispecific antibody (BsAb), for the treatment of Desmoid Tumors (DT). |
| 2025-12-05 | Elpiscience Biopharma, Ltd. | Results Elpiscience Presents Phase I Data for First-in-Class ES014 (CD39/TGF-β Bispecific Antibody) in Oral Session at ESMO Asia elpiscience.com ↗
On December 5, 2025, Elpiscience, a clinical-stage biopharmaceutical company dedicated to developing innovative immunotherapies, presented phase I clinical trial results for its internally developed bispecific antibody, ES014, in an oral presentation at the ESMO Asia Congress. |
| 2025-11-28 | Elpiscience Biopharma, Ltd. | Results Preview | Oral Presentation at ESMO Asia 2025: First-in-Human Results of ES014, the World’s First CD39/TGF-β Bispecific Antibody, as Monotherapy in Advanced Solid Tumors to Be Unveiled elpiscience.com ↗
Data from the Phase I study, to be presented in the oral presentation at ESMO Asia 2025, shows that ES014 has exhibited a favorable safety profile and encouraging antitumor activity across multiple tumor types, including non-small cell lung cancer (NSCLC), Desmoid Tumors(DT), and gastrointestinal stromal tumors (GIST). |
| 2023-11-06 | Elpiscience Biopharma, Ltd. | Results Elpiscience Announces Studies Presented at Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting elpiscience.com ↗
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. |
| 2022-12-23 | Elpiscience Biopharma, Ltd. | Regulatory Elpiscience Announces China CDE IND Clearance of ES014, a First in Class Anti-CD39xTGF-β Bispecific Antibody for Patients with Advanced Solid Tumors elpiscience.com ↗
Elpiscience Biopharmaceuticals, Inc. (“Elpiscience”), a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapies to benefit cancer patients worldwide, today announced that the China Center of Drug Evaluation (CDE) for National Medical Products Administration has cleared Elpiscience’s Investigational New Drug Application (IND) for ES014 to initiate a Phase 1 clinical study for patients with advanced solid tumors. |
| 2022-05-09 | Elpiscience Biopharma, Ltd. | Regulatory Elpiscience Announces FDA IND Clearance of ES014, a First in Class Anti-CD39xTGF-β Bispecific Antibody for Patients with Advanced Solid Tumors elpiscience.com ↗ |
All press releases naming this drug 9 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ES014 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05381935 ↗ |
| Action | Inhibit | “ES014 simultaneously neutralizes autocrine/paracrine TGF-β and inhibits the enzymatic activity of CD39” NCT05381935 ↗ |
| Modality | Protein / enzyme biologic | “The bifunctional antibody-fusion protein ES014 was created by fusing the TGF-β receptor II ectodomain to an antibody targeting human ectonucleoside triphosphate...” NCT05381935 ↗ |
| Route | Intravenous | “ES014 is administered via intravenous infusion” NCT05381935 ↗ |
| Target | ENTPD1 | “an antibody targeting human ectonucleoside triphosphate diphosphohydrolase-1 (ENTPD1, CD39, UniprotKB: P49961)” NCT05381935 ↗ |