YH008 / Biocytogen, Chipscreen - LARVOL DELTA

A Study of NWY001 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=196 | Recruiting | Sponsor: Chipscreen Biosciences, Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2023 ➔ Jan 2024

Enrollment open • Metastases • Trial initiation date • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • HER-2 • MSI

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

Chipscreen NewWay: First Patient Dosed in Phase 1 Trial of the Bispecific Antibody NWY001, a Next-generation Tumor Immunotherapy in Patients with Advanced Solid Tumors (PRNewswire) - "Chengdu Chipscreen NewWay Biosciences...announced that on January 5, 2024, the dosing of the first patient for a phase I clinical trial of a PD-1/CD40 bispecific antibody (bsAb), NWY001, at Sun Yat-Sen University Cancer Center in China, the trial-leading institution. The trial is a multi-center, non-randomized, open-label, multi-dose phase I clinical trial designed to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic properties, and potential biomarkers associated with NWY001 treatment in patients with advanced solid tumors."

Trial status • Solid Tumor

Biocytogen’s Subsidiary Eucure Biopharma and Chipscreen Biosciences’ Holding Subsidiary Chipscreen NewWay Biosciences Enter into Greater China License Agreement for Bispecific Antibody YH008 (Businesswire) - "Biocytogen Pharmaceuticals (Beijing) Co., Ltd...announced that its wholly owned subsidiary, Eucure (Beijing) Biopharma Co., Ltd. ('Eucure Biopharma'), has reached an exclusive licensing agreement with Chipscreen NewWay Biosciences ('Chipscreen NewWay'), a holding subsidiary of Shenzhen Chipscreen Biosciences Co., Ltd. ('Chipscreen Biosciences', SSE: 688321) for the clinical development and commercialization of bispecific antibody YH008 in Greater China (including Mainland China, Hong Kong, Macau and Taiwan). Eucure Biopharma retains YH008’s global rights to develop and commercialize YH008 outside Greater China. Under the agreement, Chipscreen NewWay will pay Eucure Biopharma an upfront payment of 40 million RMB, a potential development milestone payment of up to 360 million RMB, a potential sales milestone payment of up to 196 million RMB, as well as tiered royalties on net sales."

Licensing / partnership • Oncology • Solid Tumor

Biocytogen Announces FDA Clearance of IND Application for Bispecific Antibody YH008 (Businesswire) - "Biocytogen Pharmaceuticals (Beijing)...announced that the US FDA has approved the Investigational New Drug (IND) application for a phase I study of YH008, an internally developed first-in-class PD-1 x CD40 bispecific antibody (bsAb). The IND application was completed by Biocytogen’s wholly owned subsidiary Eucure Biopharma. The trial is an open-label, dose-escalation study (No. YH008101) that will evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YH008 monotherapy in patients with PD-(L)1-resistant advanced solid tumors or hematological malignancies."

IND • New P1 trial • Hematological Malignancies • Oncology • Solid Tumor

[VIRTUAL] A novel PD1-CD40 bispecific antibody YH008 induces potent anti-tumor activity in vivo by PD1 dependent activation of CD40 signaling (AACR 2021) - "Furthermore, YH008 did not elevate liver enzymes of MC38 bearingB-hPD1/hCD40 mice at dose as high as 26 mg/kg, demonstrating improved liver safety profile than selicrelumab. Taken together, these data demonstrated that YH008 is a promising new immunotherapeutic candidate in cancer treatment."

Preclinical • Oncology • CD40 • PD-1