YH001 / Biocytogen, Tracon Pharma - LARVOL DELTA

EXCEPTIONAL RESPONSE TO COMBINATION IMMUNOTHERAPY WITH YH001 AND ENVAFOLIMAB IN METASTATIC SARCOMA. (CTOS 2025) - "Data from a group of patients at a single institution enrolled in a prematurely discontinued clinical trial are presented, focusing on one patient who showed an exceptional response. This discontinued phase 1/2 open-label study was designed to investigate the combination of YH001 (recombinant humanized anti-CTLA-4 IgG1 monoclonal antibody) and envafolimab (KN035, an anti-PD-L1 agent approved in China) in advanced sarcomas. A sustained disease response was identified in a patient with metastatic fibrosarcoma refractory to chemotherapy and TKI, after PD-L1/CTLA-4 treatment, underscoring potential for combined immunotherapeutics in sarcoma and the need for predictive biomarker identification beyond TMB and PD-L1."

IO biomarker • Metastases • Tumor mutational burden • Fibrosarcoma • Leiomyosarcoma • Liposarcoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • TMB

A Study to Assess YH002 in Combination with YH001 in Subjects with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Recruiting ➔ Completed | N=44 ➔ 6

Enrollment change • Trial completion • Oncology • 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 clinical study to evaluate the efficacy and safety of YH001 capsule in patients with vitiligo (ChiCTR) - P=N/A | N=20 | Not yet recruiting | Sponsor: TaiHe Hospital; TaiHe Hospital

New trial • Dermatology • Immunology • Vitiligo

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

PHASE 1/2 STUDY OF YH001, A CTLA-4 ANTIBODY WITH THE SUBCUTANEOUSLY ADMINISTERED PD-L1 ANTIBODY ENVAFOLIMAB, WITH OR WITHOUT DOXORUBICIN IN PATIENTS WITH ADVANCED OR METASTATIC SOFT TISSUE SARCOMA (CTOS 2023) - "YH001 has been tolerable with envafolimab with or without doxorubicin and evidence of activity has been observed for doublet and triplet therapy."

Clinical • Metastases • P1/2 data • Angiosarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma (clinicaltrials.gov) - P1/2 | N=15 | Active, not recruiting | Sponsor: Tracon Pharmaceuticals Inc. | Recruiting ➔ Active, not recruiting | N=176 ➔ 15

Combination therapy • Enrollment change • Enrollment closed • Metastases • Oncology • Sarcoma • Soft Tissue Sarcoma • 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 YH001 in Combination With Toripalimab in Subjects With Advanced NSCLC and HCC (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | N=80 ➔ 0 | Not yet recruiting ➔ Withdrawn

Combination therapy • Enrollment change • Metastases • Trial withdrawal • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

TRACON Pharmaceuticals Reports Fourth Quarter and Year-End 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "Report the second and final interim efficacy analysis from the ENVASARC pivotal trial following the review of more than 12 weeks of efficacy data (including two on-study CT scans) by the independent data monitoring committee from 46 patients who receive envafolimab as a single agent and 46 patients who receive envafolimab in combination with Yervoy, which we expect in the third quarter of 2023. Complete full accrual of the ENVASARC pivotal trial before the end of 2023. Report Phase 1 data from the Phase 1/2 clinical trial of YH001 in combination with envafolimab and doxorubicin in patients with soft tissue sarcoma, which we expect in the second half of 2023."

P1 data • P2 data • Oncology • Sarcoma • Solid Tumor

A Study to Assess YH001 in Combination With Toripalimab Injection in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=29 | Completed | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Recruiting ➔ Completed | N=42 ➔ 29

Combination therapy • Enrollment change • Metastases • Trial completion • Oncology • Solid Tumor

YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma (clinicaltrials.gov) - P1/2 | N=176 | Recruiting | Sponsor: Tracon Pharmaceuticals Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

A Study to Evaluate YH001 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Recruiting ➔ Completed | N=37 ➔ 17

Enrollment change • Trial completion • Gastrointestinal Cancer • Oncology • Solid Tumor

TRACON Pharmaceuticals Announces Dosing of First Patient in Phase 1/2 Trial of YH001 in Combination with Envafolimab and Doxorubicin in Front Line Sarcoma (GlobeNewswire) - "TRACON Pharmaceuticals...announced dosing of the first patient in a Phase 1/2 trial evaluating the Company’s CTLA-4 antibody, YH001, in combination with its PD-L1 antibody envafolimab and with doxorubicin in front line therapy in patients with sarcoma (NCT 05448820). The Phase 1/2 trial will assess the safety and efficacy of the triplet combination of YH001, envafolimab and doxorubicin in the common sarcoma subtypes of leiomyosarcoma and dedifferentiated liposarcoma....'At the time in 2024 when we expect to seek accelerated approval from the FDA for envafolimab in the refractory sarcoma subtypes of UPS and MFS based on data from our ongoing ENVASARC clinical trial, we expect to be enrolling a Phase 3 trial for the full approval of envafolimab with YH001 in front line sarcoma patients'."

New P3 trial • sBLA • Trial status • Oncology • Sarcoma • Solid Tumor

A Study to Evaluate YH001 in Combination With Toripalimab in Subjects With Advanced NSCLC and HCC (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Trial completion date: Jun 2023 ➔ Mar 2025 | Initiation date: Dec 2022 ➔ Jun 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2024

Combination therapy • Trial completion date • Trial initiation date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A first-in-human phase I dose escalation of YH001, an anti-CTLA-4 monoclonal antibody (mAb), in combination with toripalimab (anti-PD-1 mAb) in patients with advanced solid tumors. (ASCO 2022) - P1 | "YH001 was well tolerated up to 4 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 • Dermatology • Esophageal Cancer • Gastric Cancer • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Gynecologic Cancers • Hematological Disorders • Hepatology • Immunology • Inflammation • Oncology • Pruritus • Sarcoma • Solid Tumor • Thrombocytopenia • Urothelial Cancer • Vulvar Cancer

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

TRACON Pharmaceuticals Announces Approval of IND for CTLA-4 Antibody YH001 for the Treatment of Front-line Sarcoma Patients in Combination with Envafolimab (GlobeNewswire) - "TRACON Pharmaceuticals, Inc...announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for the initiation of a Phase 1/2 clinical trial of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy....The Phase 1/2 trial will assess the safety and efficacy of YH001 and envafolimab in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma."

IND • Leiomyosarcoma • Liposarcoma • Oncology • Sarcoma • Solid Tumor

TRACON Pharmaceuticals Announces Submission of IND Application for CTLA-4 Antibody YH001 for the Treatment of Front-line Sarcoma Patients in Combination with Envafolimab (GlobeNewswire) - "TRACON Pharmaceuticals...announced that the company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1/2 clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy. The Phase 1/2 trial will assess the safety and efficacy of YH001 and envafolimab with or without doxorubicin in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma and in the common sarcoma subtypes of leiomyosarcoma and dedifferentiated liposarcoma...'we look forward to initiating the trial before end of this year'..."

IND • Trial status • Oncology • Sarcoma

A Study to Evaluate YH001 in Combination With Toripalimab in Subjects With Advanced NSCLC and HCC (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Initiation date: Mar 2022 ➔ Dec 2022

Combination therapy • Trial initiation date • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma (clinicaltrials.gov) - P1/2 | N=176 | Not yet recruiting | Sponsor: Tracon Pharmaceuticals Inc.

Combination therapy • New P1/2 trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

A Study to Assess YH002 in Combination With YH001 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Oncology • Solid Tumor

Biocytogen/Eucure Biopharma to Present Clinical Data from YH003 (anti-CD40 mAb) and YH001 (anti-CTLA-4 mAb) Trials at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (PRNewswire-Asia) - "Eucure Biopharma...announced that it will present two posters at the 2022 ASCO Annual Meeting, taking place in Chicago, IL and virtually from June 3-7, 2022. The posters describe updates from two phase I clinical studies in Australia for internally developed monoclonal antibodies (mAbs) YH003 (anti-CD40, abstract # 2603) and YH001 (anti-CTLA-4, abstract # 2602). Both YH003 and YH001 demonstrate favorable safety and tolerability profiles and preliminary efficacy when administered in combination with anti-PD-1 mAb to patients with advanced solid tumors."

P1 data • Oncology • Solid Tumor

A Study to Assess YH001 in Combination With Toripalimab Injection in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Eucure (Beijing) Biopharma Co., Ltd | Trial completion date: May 2022 ➔ Dec 2022 | Trial primary completion date: Jan 2022 ➔ Dec 2022

Combination therapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Biocytogen Subsidiary Eucure Biopharma Completes First Patient Dosing for Phase I Clinical Trial of YH003 (Anti-CD40 mAb) Triple Combination Therapy (Canada Newswire) - "Biocytogen subsidiary Eucure Biopharma announced the first patient dosing for a phase I clinical trial (No. YH003005) of YH003 (anti-CD40 monoclonal antibody, mAb) in combination with YH001 (anti-CTLA-4 mAb) and pembrolizumab (anti-PD-1 mAb) in Australia. The study is an open-label, dose-escalation study designed to evaluate the safety, tolerability and efficacy of YH003 in combination with YH001 and pembrolizumab in patients with advanced solid tumors."

Trial status • Oncology • Solid Tumor