Top 5 Target	Count

BDCA2(C-Type lectin domain family 4 member C)	1
VSIG4(V-set and immunoglobulin domain-containing protein 4)	1
4-1BB x HER2	1
4-1BB(Tumor necrosis factor receptor superfamily member 9)	1
4-1BB x PD-1	1

Drugs associated with Eutilex Co., Ltd.

EU-101

Target

4-1BB

Mechanism

4-1BB agonists

Active Org.

Eutilex Co., Ltd.

Originator Org.

Eutilex Co., Ltd.

Active Indication

Advanced Malignant Solid Neoplasm [+2]

Inactive Indication

Colorectal Cancer [+1]

Drug Highest PhasePhase 1/2

First Approval Ctry. / Loc.-

First Approval Date-

Epstein-Barr virus induced adoptive T-cell therapy (Eutilex)

Target-

Mechanism

Immunologic cytotoxicity [+1]

Active Org.

Eutilex Co., Ltd.

Originator Org.

Eutilex Co., Ltd.

Active Indication-

Inactive Indication-

Drug Highest PhasePhase 1/2

First Approval Ctry. / Loc.-

First Approval Date-

EU-307

Target-

Mechanism

Immunologic cytotoxicity [+1]

Active Org.

Eutilex Co., Ltd.

Originator Org.

Eutilex Co., Ltd.

Active Indication

Advanced Hepatocellular Carcinoma [+2]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Eutilex Co., Ltd.

NCT05783570 / RecruitingPhase 1

A Dose-escalation, Single-arm, Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307, Autologous Glypican 3 Targeted Chimeric Antigen Receptor T Cell Therapy in Patients With GPC3 Positive Advanced Hepatocellular Carcinoma Who Have Failed Standard Therapy

To Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307, Autologous Glypican 3 (GPC3) Targeted Chimeric Antigen Receptor T cell therapy in Patients with GPC3 Positive Advanced Hepatocellular Carcinoma who Have Failed Standard Therapy

Start Date24 Aug 2023

Sponsor / Collaborator

Eutilex Co., Ltd.

NCT05798026 / RecruitingPhase 1

A Dose-escalation, Single-arm, Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EU103 in an Advanced or Metastatic Solid Tumors Who Have Failed Standard Therapy

Phase 1 (dose escalation) of this study will evaluate:
The safety and tolerability of EU103 treatment are evaluated for patients with advanced or metastatic solid tumors who have failed standard therapy to determine the maximum tolerated dose and recommended Phase 2 dose.
And preliminary efficacy (tumor response), The pharmacokinetic characteristics are evaluated, and changes are investigated.

Start Date08 Aug 2023

Sponsor / Collaborator

Eutilex Co., Ltd.

NCT04903873 / RecruitingPhase 1/2

An Open-Label, Phase 1/2 Study to Evaluate Safety, Efficacy, and Pharmacokinetics of EU101, an Agonistic Anti-CD137 (4-1BB) Monoclonal Antibody in Patients With Advanced Solid Tumors

Phase 1 (Dose Escalation) of this study will assess the safety, tolerability, dose-limiting toxicity (DLT), and will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of EU101 in participants with advanced solid tumors. Phase 2 (Dose Expansion) of the study will assess the antitumor effect of EU101 in two indications including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).

Start Date31 May 2021

Sponsor / Collaborator

Eutilex Co., Ltd.

100 Clinical Results associated with Eutilex Co., Ltd.

0 Patents (Medical) associated with Eutilex Co., Ltd.

Literatures (Medical) associated with Eutilex Co., Ltd.

01 Nov 2023·Cytotherapy

Phase 1 trial of 4-1BB-based adoptive T-cell therapy targeting human telomerase reverse transcriptase in patients with advanced refractory solid tumors.

Article

Author: Woo, Sang Myung ; Yun, Tak ; Park, Bo-Mi ; Lee, Youngjoo ; Choi, Beom K ; Lim, Myeong Cheol ; Lee, Woo Jin ; Kwon, Byoung S ; Choi, Wonyoung ; Yoo, Heon ; Kim, Young H ; Baek, Ji Yeon

BACKGROUND AIMSHuman telomerase reverse transcriptase (hTERT) is an attractive target for anti-cancer therapies. We developed an effective method for generating hTERT-specific CD8⁺ T cells (hTERT-induced natural T cells [TERTiNTs]) using peripheral blood mononuclear cells (PBMCs) from patients with solid cancers and investigated their feasibility and safety.METHODSThis was a single-center phase 1 trial using a 3 + 3 dose escalation design to evaluate six dose levels of TERTiNTs. PBMCs from each patient were screened using an hTERT peptide panel to select those that stimulated CD8⁺ T cells. The four most stimulatory peptides were used to produce autologous CD8⁺ T cells from patients refractory or intolerant to standard therapies. Eligible patients received a single intravenous infusion of TERTiNTs at different dose levels (4 × 10⁸ cells/m², 8 × 10⁸ cells/m² and 16 × 10⁸ cells/m²). Pre-conditioning chemotherapy, including cyclophosphamide alone or in combination with fludarabine, was administered to induce lymphodepletion.RESULTSFrom January 2014 to October 2019, a total of 24 patients with a median of three prior lines of therapy were enrolled. The most common adverse events were lymphopenia (79.2%), nausea (58.3%) and neutropenia (54.2%), mostly caused by pre-conditioning chemotherapy. The TERTiNT infusion was well tolerated, and dose-limiting toxicities were not observed. None of the patients showed objective responses. Seven patients (30.4%) achieved stable disease with a median progression-free survival of 3.9 months (range, 3.2-11.3). At the highest dose level (16 × 10⁸ cells/m²), four of five patients showed disease stabilization.CONCLUSIONSThe generation of TERTiNTs was feasible and safe and provided an interesting disease control rate in heavily pre-treated cancer patients.

01 Sep 2023·Cellular & molecular immunology

4-1BB-4-1BBL cis-interaction contributes to the survival of self-reactive CD8⁺ T cell.

Letter

Author: Kim, Young H ; Singh, Rohit ; Choi, Beom K ; Han, Chungyong ; Han, Seongeun ; Kwon, Byoung S ; Cho, Eunjung ; Nam, Ki Taek ; Kim, Seon-Hee ; Shin, Dong Hoon ; Park, Bo-Mi ; Kim, Kwang H

01 Jun 2023·Journal of Clinical Oncology

Therapeutic effect of a VSIG4-specific mAb EU103 in a preclinical model of patient-derived ascites of ovarian cancer.

Author: Kim, Byoung-Gie ; Shin, Jeamin ; Kwon, Byoung S. S ; Lee, Joong Won ; Jeong, Joseph H. ; Kim, Hye Jeong ; Park, Sang-Yoon ; Kang, Kyung-Jung

e14516 Background: V-set and immunoglobulin domain-containing 4 (VSIG4) is one of the B7 family-related proteins that includes PD-L1, VISTA, and CTLA4 ligand. VSIG4 overexpression is correlated with poor prognosis in patients with ovarian cancer, lung cancer, gastric cancer, high-grade glioma, and multiple myeloma. VSIG4 is also known to function as a receptor for complements and the negative regulation of T cell proliferation. Although VSIG4 is highly expressed in tissue-resident macrophages and tumor-associated macrophages (TAM), its role in the tumor microenvironment (TME) is not fully elucidated. Methods: We previously developed a therapeutic antibody, EU103, in a humanized form of a VSIG4-specific antibody. Most importantly, we demonstrated that EU103 directly acts on the tumor-associated macrophages (TAM) and mechanistically induces repolarization of TAM to tumor killing M1 macrophages and blocks VSIG4-mediated T cell suppression, eventually leading to CD8+ T cell proliferation and tumor suppression in a PBMC-humanized human lung cancer mouse model. Results: Expanding our previous findings with the therapeutic potential of EU103 in a non-small cell lung carcinoma (NSCLC), here, we also proved its therapeutic effect in human ovarian cancer. Firstly, TAMs isolated from ovarian cancer patients express high levels of VSIG4 with immunosuppressive M2 macrophage phenotype. Secondly, EU103 treatment of the TAMs in in vitro studies induces M2-to-M1 conversion and activation of T cells in the ascites leading to ovarian tumor cell killing in a dose-dependent manner. Thirdly, in vivo therapeutic efficacy of EU103 in ovarian cancer, especially through M2-to-M1 conversion, is also verified in both CD34+ cell and peripheral blood mononuclear cell (PBMC) humanized mouse models. Finally, we validate the results above by treating ovarian cancer patient-derived ascites with EU103. Conclusions: Almost 300,000 women are diagnosed with ovarian cancer worldwide each year, and ovarian cancer ranks fifth in cancer deaths among women. In the United States alone, we expect approximately 20,000 new diagnoses and more than 12,000 deaths for this year. Given our findings in this study and clinical significance, we propose here the therapeutic potential of EU103, previously developed by our proprietary antibody discovery and engineering technology, in ovarian cancer.

News (Medical) associated with Eutilex Co., Ltd.

26 Jan 2021

·www.biospace.com

Samsung Biologics, National OncoVenture, and Eutilex Obtain IND Approval from FDA

INCHEON, South Korea, Jan. 26, 2021 /PRNewswire/ -- Samsung Biologics (KRX: 207940.KS) announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company's track record as a premiere CDO service provider in the global market. In late 2018, National OncoVenture (NOV), a government-funded virtual oncology drug development program in South Korea, approached Samsung Biologics for the development of EU101(NOV1801), an anti-4-1BB therapeutic monoclonal antibody provided by Eutilex (KOSDAQ:263050). Studied by NOV and Eutilex with humanized mice, EU101(NOV1801), effectively eradicated human tumors and showed synergistic anti-tumor activity with immune checkpoint blockade. "We are extremely glad to be notified of EU101(NOV1801)'s IND approval from the FDA," said John Rim, CEO of Samsung Biologics. "This is our third IND approval demonstrating our unparalleled quality and speed, and as our CDO business continues to expand geographically in the next decade, we look forward to assisting many more clients in bringing their products to market faster and better as the most qualified CDMO partner." Young-Whan Park, president of NOV, said, "In order to conduct the domestic and global clinical trials of EU101(NOV1801) in parallel, we plan to IND with the Ministry of Food and Drug Safety in South Korea within the first half of this year, working together with Samsung Biologics." Dr. Soo Young Choi, COO of Eutilex, added, "In the US, we will be able to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) through Phase I of clinical trials within the first half of the year." Samsung Biologics' CDO business has shown rapid growth and success since its business expansion, signing over 60 CDO contracts within two years to obtain three IND approvals by the FDA as well as one Clinical Trial Application (CTA) approval by the EMA. Leveraging Samsung Biologics' extensive expertise for the submission process, the successful IND was achieved with no further significant comments from the regulatory agency. About Samsung Biologics Co., Ltd. Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit . About Eutilex, Ltd. Eutilex (KOSDAQ:263050) is a biotechnology company focused on the research and development of three in-house immunotherapeutic platforms, including innovative T cell receptor (TCR) T cell therapy, chimeric antigen receptor (CAR) T cell therapy and immunomodulatory antibody therapeutics, to help lead the fight against incurable diseases such as cancers. The mission of Eutilex is a dedication to develop and deliver innovative immune-oncology therapeutics to patients in desperate need. Samsung Biologics Press Contact Claire Kim cair.kim@samsung.com Company Codes: Korea:207940

AntibodyCell TherapyImmunotherapy

100 Deals associated with Eutilex Co., Ltd.

100 Translational Medicine associated with Eutilex Co., Ltd.

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Pipeline

Pipeline Snapshot as of 23 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

Phase 1 Clinical

Phase 2 Clinical

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

EU-101 ( 4-1BB )	Metastatic Renal Cell Carcinoma More	Phase 2 Clinical
Epstein-Barr virus induced adoptive T-cell therapy (Eutilex)	-	Phase 2 Clinical
EU-307	Advanced Hepatocellular Carcinoma More	Phase 1
EU-103 ( VSIG4 )	Metastatic Solid Tumor More	Phase 1
EU-505 ( 4-1BB x PD-1 )	Neoplasms More	Preclinical

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