acrixolimab (YBL-006) / Y-Biologics - LARVOL DELTA

Safety and efficacy of YBL-006, a novel anti-PD-1 antibody, in advanced solid tumors including G3 NET/NEC: results from a phase 1/2A study (SITC 2023) - P1/2 | "Y-biologics Inc would like to thank all the participating patients, dedicated clinical trial investigators and their team members who have helped to bring this novel therapy to the clinic. This research was supported by Korea Drug Development Fund funded by Ministry of Science and ICT, Ministry of Trade, Industry, and Energy, and Ministry of Health and Welfare (HN21C1391, Republic of Korea)."

Clinical • IO biomarker • Metastases • P1/2 data • Tumor mutational burden • Anal Carcinoma • Endocrine Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Microsatellite Instability • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Oncology • Penile Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Thyroid Gland Carcinoma • Thyroid Gland Hurthle Cell Carcinoma • MSI • TMB

Derivation of Breast Cancer Patient Derived Human Induced Pluripotent Stem Cell Line (YBLi006-A) with FANC-BRCA Gene Mutations: A Resource for Precision & Personalized Medicine. (PubMed, Stem Cell Res) - "We generated an iPSC line (YBLi006-A) from peripheral blood mononuclear cells (PBMCs) of a patient carrying a mutation in FANCIgene (NM_001376911.1, NM_001376910.1, NM_001113378.2; c.80G > T, c.257C > T, c.2225G > C; p.Gly27Val, p.Ala86Val, p.Cys742Ser) using non-integrating Sendai virus technology. This unique breast cancer patient-derived-iPSC line will be resourceful to analyze the entire coding sequence and splicing sites ofFANCIin high-risk familial breast cancer."

Journal • Preclinical • Breast Cancer • Hematological Disorders • Oncology • Solid Tumor • Targeted Protein Degradation • BRCA • FANCI

Safety and efficacy of YBL-006, an anti-PD-1 monoclonal antibody in advanced solid tumors: A phase I study. (ASCO 2022) - P1 | "Interim analysis of phase I trial of YBL-006 shows a tolerable safety profile and clinical activity. Notable anti-tumor efficacy was observed in inflamed immune phenotype."

Clinical • IO biomarker • P1 data • Anal Carcinoma • Dermatology • Endocrine Cancer • Endocrine Disorders • Fatigue • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Inflammation • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Oncology • Otorhinolaryngology • Penile Cancer • Pneumonia • Pruritus • Solid Tumor • Squamous Cell Carcinoma • Thyroid Gland Carcinoma • Thyroid Gland Hurthle Cell Carcinoma

YBL006C101: Dose Escalation/Dose Expansion Study of YBL-006 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=90 | Active, not recruiting | Sponsor: Y Biologics Inc. | Recruiting ➔ Active, not recruiting | Phase classification: P1 ➔ P1/2 | Trial primary completion date: Sep 2022 ➔ Mar 2023

Enrollment closed • Phase classification • Trial primary completion date • Endometrial Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • ALK • EGFR • MSI • PD-L1 • TMB

[VIRTUAL] Interim results of phase I dose escalation study of YBL-006: A novel anti-PD-1 monoclonal antibody in advanced solid tumors (ESMO 2021) - P1 | "YBL-006 is well tolerated, and AEs are manageable with the of no DLTs occurred and the maximum tolerated dose was not reached until progressing to the 10 mpk. Dose expansion cohort using flat dosing is planned."

IO biomarker • P1 data • Anal Carcinoma • Gastrointestinal Cancer • Oncology • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma • IFNG • TMB

Korean cancer drug developers on lookout for chance at ASCO 2022 (Korea Biomedical Review) - P1 | N=90 | NCT04450901 | Sponsor: Y Biologics Inc. | "Y-Biologics will also unveil new interim results of YBL-006, the first Korean-made anti-programmed death-1 (PD-1) antibody....Y-Biologics confirmed stability, pharmacokinetics (PK), and ORR in the phase 1 dose-escalation and dose-expansion cohorts. The company evaluated efficacy in 52 of 67 patients with solid cancer, and the biomarker-based ORR was 62.5 percent. In addition, the company did not find any dose-limiting toxicity (DLT)."

P1 data • Oncology • Solid Tumor

YBL006C101: Dose Escalation/Dose Expansion Study of YBL-006 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=90; Recruiting; Sponsor: Y Biologics Inc.; Trial completion date: Sep 2022 ➔ May 2023

Clinical • Trial completion date • Endometrial Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • MSI • PCR • PD-L1 • TMB

[VIRTUAL] Interim analysis of first-in-human phase 1 study to assess safety and efficacy of YBL-006, an anti-PD-1 antibody in advanced solid tumor with exploratory biomarker analysis of tumor mutational burden and artificial intelligence (AI)-powered spatial analysis of tumor-infiltrating lymphocytes. (ASCO 2021) - P1 | "Interim analysis of phase I study showed that YBL-006 is well tolerated and preliminary biomarker analysis showed that the TMB, and intratumoral TIL infiltration are potentially related to the response to YBL-006."

Biomarker • Clinical • IO biomarker • P1 data • Anal Carcinoma • Endocrine Disorders • Fatigue • Gastrointestinal Cancer • Inflammation • Oncology • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma • IFNG • TMB

Lunit AI Applied to Clinical Trial for Drug Development for the First Time--Findings Presented at ESMO 2021 (PRNewswire) - P1, N=80; NCT04450901; Sponsor: Y Biologics; "A leading medical AI provider Lunit...announced that its AI for tissue analysis has been applied in a clinical trial for drug development, accurately predicting the patients' response to immunotherapy. Including this major finding, the company presented three studies at European Society for Medical Oncology(ESMO) Congress 2021...The highlight of Lunit at ESMO 2021 is its announcement that Lunit SCOPE IO—one of Lunit SCOPE product lines—has been applied to a phase 1 clinical trial of a new drug for the first time."

P1 data • Oncology • Solid Tumor

YBiologics begins phase 1 dose expansion trial for immunotherapy 'YBL-006' in Australia [Google translation] (MedigateNews) - "YBiologics, a company specializing in antibody drug development, announced on the 29th that it had started the first dose of its Dose Expansion cohort for its immuno-oncology candidate 'YBL-006' in Australia. Following dose escalation, a dose escalation cohort will also be initiated at Macquarie University Hospital….The dose expansion trial started in Australia this time is a global clinical trial including Korea and Thailand, and the goal is to evaluate the optimal dose of the drug by verifying the safety and efficacy of YBL-006 for solid cancer treatment in various carcinomas. This dose expansion clinical trial will be conducted on about 70 solid cancer patients."

Trial status • Oncology • Solid Tumor

Dose Escalation/Dose Expansion Study of YBL-006 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Y Biologics Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • MSI • PCR • PD-L1

[VIRTUAL] Preclinical characterization of YBL-006, a fully human anti-PD-1 antibody being ready for clinical studies (AACR-II 2020) - "When affinity to recombinant PD-1 of various species was measured using surface plasmon response system, KD of YBL-006 was 0.372 nM to human PD-1 & 0.070 nM to cynomolgus monkey PD-1 which is higher affinity than nivolumab (1.37 nM & 2.50 nM) & pembrolizumab (1.44 nM & 0.817 nM). YBL-006 is an anti-PD-1 antibody with high affinity, promising anti-tumor activity in animal models, & favorable safety profile. First-in-human phase I trial to investigate the safety & efficacy of YBL-006 in advanced solid cancer will be held in 2020."

Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • IFNG • PDCD1LG2

Dose Escalation/Dose Expansion Study of YBL-006 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=80; Not yet recruiting; Sponsor: Y Biologics Inc.

Clinical • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer

Y-Biologics approved clinical trial (thebell) - "YBIOLOGICS will conduct Phase I clinical trials in Korea for 'YBL-006', an anti-cancer drug. Starting next month, patients will be enrolled in patients with solid cancer, such as lung cancer…YBIOLOGICS announced on the 22nd that YBL-006 was approved for clinical trial (IND) by the Ministry of Food and Drug Safety….In clinical trials in Korea, safety and tolerability are evaluated for cancer patients such as lung cancer, melanoma, and head and neck cancer. Clinical trials will be conducted at Seoul National University Hospital and Seoul National University Bundang Hospital."

Enrollment status • New P1 trial • Non-US regulatory • Oncology • Solid Tumor

Y-Bio, self-developed 'PD-1 antibody' "Australia 1st approval" (Biospectator) - "YBIOLOGICS announced on the 8th that it has been approved for the clinical trial in Australia for the PD-1 antibody immune anticancer drug 'YBL-006'. YBL-006 is the first domestically developed PD-1 antibody to enter clinical trials. It is an immune anti-cancer agent with a mechanism that effectively inhibits the growth of cancer by blocking the immune evasion function of cancer cells by combining with PD-1 receptor of T cells and promoting the immune activity of T cells."

Non-US regulatory • Oncology

Biocure signs a collaboration agreement with Y biologics (Yahoo Finance) - "BPK and YB agreed to collaborate in the following areas to verify combined therapy of YBL-006 and anti-CD19 CAR T-cell therapy; (1) Plan and implement pre-clinical trial(animal) for combined therapy. (2) Conduct a study of action mechanism and bio marker of combined therapy. (3) Development of anticancer treatment (4) And exchange of information and other essential items to fulfill the intended goal of the agreement."

Licensing / partnership