EU101 / Eutilex, Zhejiang Huahai Pharma, National OncoVenture - LARVOL DELTA

A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=110 | Recruiting | Sponsor: Eutilex | Trial completion date: Feb 2025 ➔ Dec 2025 | Trial primary completion date: Sep 2023 ➔ Sep 2025

Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • ALK • MSI • ROS1

A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=96; Recruiting; Sponsor: Eutilex; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • MSI • ROS1

[VIRTUAL] Eutilex (BIO 2021) - "EU101: Fully humanized anti-human 4-1BB monoclonal antibody...Toxicity study will be started in the 1st half of 2021. IND submission to Korea FDA (MFDS) and China FDA (NMPA) will be done in early 2022."

Oncology • IL18

A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=96; Not yet recruiting; Sponsor: Eutilex

Clinical • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • MSI • ROS1

Utilex, applied for phase 1/2 clinical trial by the Ministry of Food and Drug Safety for immuno-cancer drug'EU101 [Google translation] (The Value News) - “On the 18th, Utilex, an immunotherapy development company, announced that it applied for a phase 1/2 clinical trial plan of its immune anticancer drug'EU101' to the Ministry of Food and Drug Safety. 'EU101' is a solid cancer indication antibody treatment targeting the T cell activating factor '4-1BB'…Utilex has already been approved for Phase 1/2 of the US clinical trial of'EU101' by the FDA. At the time, Utilex announced that it was planning to apply for'EU101' to the Korean Food and Drug Administration as MRCT (multi-regional clinical).”

IND • Non-US regulatory • Oncology

Samsung Biologics, National OncoVenture, and Eutilex Obtain IND Approval from FDA (PRNewswire) - "Samsung Biologics...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...Studied by NOV and Eutilex with humanized mice, EU101(NOV1801), effectively eradicated human tumors and showed synergistic anti-tumor activity with immune checkpoint blockade."

IND • Oncology

Eutilex (263050) R&D momentum to grow stronger, corporate value rise (Maekyung Media Group) - "Antibody therapy EU101 US Phase 1 clinical trial IND application On the 18th, Eutilex applied for IND for phase 1/2 global multinational clinical trial of anti-CD137(4-1BB) monoclonal antibody EU101. It is planned to evaluate safety, efficacy, pharmacokinetics, pharmacokinetics, etc. by administering EU101 to patients with advanced solid cancer...EU101 signed a technology export contract with Huahai Pharm for development rights and copyrights for all regions of China. Expected to start medication for patients in the US and in the first half of 21."

IND • Licensing / partnership • New P1 trial • Oncology • Solid Tumor

Transcription factor Atf1 regulates expression of cellulase and xylanase genes during solid-state fermentation of ascomycetes. (PubMed, Appl Environ Microbiol) - "Here, we employed RNA-sequencing and genetic analyses to investigate transcriptomes of Penicillium oxalicum strain EU2101 cultured on media containing different carbon sources and to identify and characterize transcription factors for regulating the expression of cellulase and xylanase genes during SSF. The results generated will provide novel insights into genetic engineering/improvement of filamentous fungi to further increase enzyme production."

Journal

Eutilex’s cancer therapy won Canadian patent (Korea Biomedical Review) - "Eutilex, a biotechnology firm specializing in cancer immunotherapy, said Friday that it obtained Canadian patent for its antibody treatment EU101, which targets 4-1BB, a co-stimulatory receptor of T cells. The patent registration guarantees technology's exclusive rights for EU101 antibodies and antigen-binding sites in Canada until 2038."

Patent • Oncology

Newly added product (Eutilex Press Release) - Preclinical, Oncology

Pipeline update • Oncology