YH003 / Biocytogen - LARVOL DELTA

YH003004: A Study to Assess YH003 in Combination with Toripalimab(anti-PD-1 MAb) Injection in Patients with Cancers (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Active, not recruiting ➔ Completed | N=129 ➔ 40

Enrollment change • Trial completion • Melanoma • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

A Study to Evaluate the Combination of YH003, YH001 and Pembrolizumab in Subjects with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=5 | Completed | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Recruiting ➔ Completed | N=44 ➔ 5

Enrollment change • Trial completion • Oncology • Solid Tumor

A Study to Assess YH003 in Combination with Pebolizumab and Albumin Paclitaxel Injection in Subjects with Unresectable/metastatic Mucosal Melanoma (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Recruiting ➔ Completed | N=43 ➔ 20 | Trial completion date: Sep 2025 ➔ Mar 2024 | Trial primary completion date: Dec 2023 ➔ Mar 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

A phase II, multi-center, open-label study to evaluate the safety and efficacy of YH003 in combination with toripalimab (anti-PD-1 mAb) in patients with unresectable/metastatic pancreatic ductal adenocarcinoma (PDAC). (ASCO 2024) - P2 | "In the 1L Cohort, patients without any prior systemic treatment were enrolled and received 0.3 mg/kg YH003 plus 240 mg Toripalimab plus nab-paclitaxel + gemcitabine, iv, every 21 days. The results of the phase II study have shown that YH003 plus Toripalimab with/without chemotherapy, as 1L or 2L treatment in patients with u/m PDAC have promising antitumor activity and response durability, especially in the Caucasian subgroups. Both treatment regimens are well tolerated."

Clinical • Combination therapy • Metastases • P2 data • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

A multicenter, single-arm, open-label phase II study to evaluate the efficacy and safety of YH003 in combination with pembrolizumab and nab-paclitaxel in the first-line treatment of patients with unresectable/metastatic mucosal melanoma. (ASCO 2024) - P2 | "The results of the phase II study have shown that YH003 in combination with pembrolizumab and nab-paclitaxel, as 1L treatment in patients with unresectable/metastatic mucosal melanoma have promising antitumor activity and response durability and well tolerated. Clinical trial information: NCT05420324."

Clinical • Combination therapy • Metastases • P2 data • Eye Cancer • Melanoma • Mucosal Melanoma • Ocular Melanoma • Oncology • Solid Tumor

ASCO 2024 | Biocytogen/Eucure Biopharma to Present Two Phase II Clinical Studies of CD40 Agonistic Antibody YH003 (Biocytogen Press Release) - "Biocytogen’s...today announced that the company will present two phase II clinical studies of YH003, a humanized anti-CD40 agonistic monoclonal antibody, at the American Society of Clinical Oncology (ASCO) annual meeting, taking place in Chicago, US, from May 31-June 4, 2024."

P2 data • Gastrointestinal Cancer • Melanoma • Mucosal Melanoma • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Skin Cancer • Solid Tumor

ANNOUNCEMENT OF ANNUAL RESULTS FOR THE YEAR ENDED DECEMBER 31, 2023 (HKEXnews) - P2 | N=129 | NCT05031494 | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | "As of December 31, 2023, a total of 92 PDAC subjects were enrolled and received at least one dose of any study drug, including 47 subjects in the first line treatment group and 45 subjects in the second and later line treatment group. During the study, YH003 in combination with toripalimab, with or without chemotherapy, are well tolerated and achieved promising clinical efficacy. The study is ongoing and the results are expected to be reported in first half of 2024."

P2 data • Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

ANNOUNCEMENT OF ANNUAL RESULTS FOR THE YEAR ENDED DECEMBER 31, 2023 (HKEXnews) - P1 | N=26 | NCT04481009 | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | "The Phase I clinical trial of YH003 in combination with PD-1 in Australia is now completed. A total of 26 patients (20 in part I dose escalation stage and 6 in part II expansion stage) were enrolled and received at least 1 dose of study treatment. Subjects in part I dose escalation stage received YH003 at 0.03, 0.1, 0.3, 1 and 3mg/kg and Toripalimab at a fixed dose of 240mg, iv q3W. Among the 26 enrolled patients, three patients achieved PR and six patients achieved SD."

P1 data • Oncology • Solid Tumor

BIO-Europe Spring 2024 | BIOcyto invites you for a 1-on-1 appointment [Google translation] (Biocytogen Press Release) - "Biocytogen's Antibody Drug Business (BDL) team will participate in the BIO-Europe Spring conference to be held in Barcelona, ​​Spain, from March 18 to 20, 2024, and participate in 1-on-1 appointments and exchanges...Antibodies and antibody-like molecules available for cooperation include: 40+ PCC stage antibody molecules: B7-H3, Siglec-15, TNFR2, MUC16, NKG2D, ROR1, TIGIT, IL-2RA, AMHR2, CD73, CD40 (antagonist) antibodies, etc...60+ fully human GPCR single/double antibody projects: CCR8, GPRC5D, LGR5, CCR2, etc...The five clinical-stage antibody molecules available for collaboration are: YH008...YH003 (CD40 agonist monoclonal antibody)...YH001 (CTLA-4 monoclonal antibody)...YH002...YH004 (4-1BB monoclonal antibody)....The antibody molecules in Biocytogen's antibody library can be directly provided to global pharmaceutical companies and biotechnology companies for evaluation and licensing cooperation."

Licensing / partnership • Hematological Malignancies • Melanoma • Mucosal Melanoma • Oncology • Sarcoma • Skin Cancer • Soft Tissue Sarcoma • Solid Tumor

A Study to Evaluate YH003 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | N=16 ➔ 10 | Trial completion date: Jul 2023 ➔ Mar 2023 | Trial primary completion date: Jul 2023 ➔ Mar 2023

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Phase I open-label, dose escalation and expansion study of YH003, an anti-CD40 agonist monoclonal antibody in combination with toripalimab in patients (pts) with advanced solid tumours (ESMO 2023) - P1/2 | "Conclusions YH003 was well tolerated up to 3.0 mg/kg dose levels when combined with Toripalimab, and 0.3mg/kg was deemed the RP2D. YH003 has shown encouraging antitumour activity in patients with advanced solid tumours."

Clinical • Combination therapy • Metastases • P1 data • Eye Cancer • Melanoma • Ocular Melanoma • Oncology • Solid Tumor • CD40

Biocytogen/Eucure Biopharma to Present Complete Clinical Data from YH003 (anti-CD40 mAb) Phase I Trial at ESMO 2023 (Businesswire) - "Eucure Biopharma...will attend and present a poster at the ESMO Congress 2023, taking place in Madrid, Spain from October 20-24, 2023. The poster will summarize data from a completed phase I study of YH003, an independently developed anti-CD40 monoclonal antibody (mAb)."

P1 data • Oncology • Solid Tumor

A Study to Evaluate YH003 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Active, not recruiting ➔ Completed | Trial completion date: Mar 2023 ➔ Jul 2023 | Trial primary completion date: Dec 2022 ➔ Jul 2023

Metastases • Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study to Assess YH003 in Combination With Toripalimab(Anti-PD-1 mAb) Injection in Patients With Cancers (clinicaltrials.gov) - P2 | N=129 | Active, not recruiting | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Trial completion date: Mar 2023 ➔ Jan 2024 | Trial primary completion date: Jan 2023 ➔ Jan 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Melanoma • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

A Study to Evaluate the Combination of YH003, YH001 and Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Trial primary completion date: Jan 2023 ➔ Dec 2023

Metastases • Trial primary completion date • Oncology • Solid Tumor

A Study to Evaluate YH003 in Combination With Toripalimab (Anti-PD-1 mAb) in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=26 | Completed | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Active, not recruiting ➔ Completed | N=60 ➔ 26 | Trial completion date: Dec 2022 ➔ May 2022

Combination therapy • Enrollment change • Trial completion • Trial completion date • Melanoma • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • BRAF

A Study to Assess YH003 in Combination With Toripalimab(Anti-PD-1 mAb) Injection in Patients With Cancers (clinicaltrials.gov) - P2 | N=129 | Active, not recruiting | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Melanoma • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

A Study to Evaluate YH003 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Recruiting ➔ Active, not recruiting | N=30 ➔ 16

Enrollment change • Enrollment closed • Oncology • Solid Tumor

A phase I open-label, dose escalation of YH003, an anti-CD40 monoclonal antibody, in combination with toripalimab (anti-PD-1 mAb) in patients with advanced solid tumors. (ASCO 2022) - P1/2 | "YH003 was well tolerated up to 3.0 mg/kg dose levels when combined with Toripalimab and has shown encouraging antitumor activity in patients with advanced solid tumors."

Clinical • Combination therapy • P1 data • Eye Cancer • Fatigue • Hematological Disorders • Hepatology • Immune Modulation • Inflammation • Lung Cancer • Melanoma • Neutropenia • Non Small Cell Lung Cancer • Ocular Melanoma • Oncology • Solid Tumor

Eucure Biopharma, a Subsidiary of Biocytogen, Announces Partnership with ISU ABXIS for the Development of Tri-specific Antibodies using YH003 Antibody Sequence (Businesswire) - "Eucure Biopharma...announced today that it has entered into a collaborative agreement with ISU ABXIS Co., Ltd. (KOSDAQ: 086890), a Korea-based clinical stage company developing immuno-oncology drugs. Under the terms of the agreement, ISU ABXIS will utilize the sequence of YH003, Biocytogen’s humanized agonistic anti-CD40 antibody currently in phase II clinical trials, to construct a few groups of tri-specific antibodies and develop cancer drugs for multiple indications using its technology platform. Eucure Biopharma will receive an upfront payment, milestone payments and royalties....'YH003’s phase I clinical trials indicate good tolerability and safety profiles, as well as encouraging antitumor activities against several tumor types, including malignant melanoma and pancreatic cancer'."

Licensing / partnership • Gastrointestinal Cancer • Melanoma • Oncology • Pancreatic Cancer • Skin Cancer • Solid Tumor

A Study to Assess YH003 in Combination With Pebolizumab and Albumin Paclitaxel Injection in Subjects With Unresectable/Metastatic Mucosal Melanoma (clinicaltrials.gov) - P2 | N=43 | Recruiting | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

A Study to Evaluate YH003 in Combination With Toripalimab (Anti-PD-1 mAb) in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=60 | Active, not recruiting | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Trial completion date: Mar 2023 ➔ Dec 2022

Combination therapy • Trial completion date • Melanoma • Oncology • Solid Tumor • BRAF

A Study to Assess YH003 in Combination With Toripalimab(Anti-PD-1 mAb) Injection in Patients With Cancers (clinicaltrials.gov) - P2 | N=129 | Recruiting | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Trial completion date: Dec 2023 ➔ Mar 2023

Combination therapy • Trial completion date • Melanoma • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Biocytogen to Participate in BioJapan2022 to Showcase Innovative R&D Platform, Bispecific ADC Program and Pipeline Progress [Google Translation] (Businesswire) - "Biocytogen Pharmaceuticals...will hold a seminar at the BioJapan 2022 conference on October 14 ( will be held on Friday). The seminar will be divided into three parts and will cover the following topics: Five fully human antibody drug discovery platforms based on RenMice TM: monoclonal antibody platform based on RenMab TM, bispecific antibody platform and bispecific ADC platform based on RenLite ^® , TCR mimic platform, GPCR platform; Progress of 'Project Integrum,' a large-scale project to develop antibody therapeutics against more than 1000 targets by evidence-based in vivo high-throughput screening; Key Assets of Bispecific ADCs Targeting HER2 x TROP2 and EGFR x c-MET (YH012 and YH013, respectively); Phase 1 Results of the Agonistic CD40 Monoclonal Antibody YH003, an Ongoing Multinational Phase 2 Clinical Trial in Patients with Unresectable/Metastatic PDAC."

Clinical • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Biocytogen IPO raises HK$471.1M to back cancer candidates (Bioworld) - "Biocytogen Pharmaceuticals Co. Ltd. has raised HK$471.1 million (US$60 million) in net proceeds through an initial public offering on the Hong Kong Stock Exchange Sept. 1. It plans to use about three-quarters of the proceeds to advance clinical trials of two of its core anticancer candidates, YH-003 and YH-001. Company shares (HKEX:2315), initially offered at HK$25.22 each, closed at HK$26 on their first trading day."

Financing • Oncology