BIOCYTOGEN-PHARMA
19.12.2022 14:56:41 CET | Business Wire | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) today 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.
YH008 exerts antagonistic and agonistic activities on PD-1 and CD40, respectively. In vitro and in vivo studies indicate that activation of the CD40 signaling pathway is dependent on PD-1 expression. Therefore, YH008 can conditionally activate the CD40 pathway in the tumor microenvironment where tumor specific PD-1+ T cells are enriched, without systemic CD40 non-specific activation. Additionally, YH008 was engineered with an Fc-silent IgG1 isotype to avoid Fc-receptor-mediated non-specific immune activation. YH008 demonstrated superior anti-tumor activity than parental monoclonal antibodies (mAbs) or combination therapy in vivo. Moreover, the anti-tumor activity of YH008 was also superior to benchmark PD-1 mAbs and PD-L1 x CD40 bsAbs in syngeneic models. In vivo pharmacodynamic studies indicate that YH008 can activate tumor-infiltrating DCs and T cells. In addition, both in vivo studies and GLP toxicology studies indicate improved safety of YH008 compared with benchmark CD40 mAbs.
“The CD40 agonistic activity of YH008 is PD-1-dependent, which allows for more targeted immune cell activation and synergies,” said Dr. Yi Yang, Chief Scientific Officer (CSO) of Biocytogen. “These characteristics prevent occurrence of liver toxicity, even at high doses, while enhancing anti-tumor activity, giving YH008 high clinical potential.”
“YH008 is a first-in-class bispecific antibody discovered through large-scale in vivo efficacy screening, where it demonstrated excellent anti-tumor activity, even in cold tumors,” said Dr. Rong Chen, CEO and CMO of Eucure Biopharma, VP of Biocytogen. “With this IND clearance for YH008, the company will have more products with diversified modalities entering the clinic to benefit patients.”
About Eucure Biopharma
As a wholly owned subsidiary of Biocytogen, Eucure Biopharma undertakes the mission of clinical development for Biocytogen’s R&D pipelines. Relying on a strong clinical development team and extensive clinical development experience, Eucure Biopharma focuses on antibody drug therapy for oncology and other indications. The company has established a product pipeline for more than 10 targets, with two products in launched phase II multi-regional clinical trials (MRCT) and two in phase I. For details, please visit https://www.eucure.com/en/index.
About Biocytogen
Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Using its proprietary RenMab™ /RenLite® mice platforms for fully human monoclonal and bispecific antibody development, Biocytogen has integrated its in vivo drug efficacy screening platforms and strong clinical development expertise to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop antibody drugs for more than 1000 targets, known as Project Integrum. This project has resulted in 28 drug co-development agreements and 16 RenMice™ licensing agreements with companies around the world, including several partnerships with multinational pharmaceutical companies (MNCs). Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai, Boston, USA and Heidelberg, Germany. For more information, please visit http://en.biocytogen.com.cn.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221219005464/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Brenus Pharma Announces FDA Acceptance of IND Application for STC-1010 (BreAK-CRC001) in MSS Metastatic Colorectal Cancer (mCRC)27.5.2026 08:49:00 CEST | Press release
STC-1010 is a first-in-class allogeneic in vivo immunotherapy for which the FDA has authorized clinical evaluation in the U.S. under the BreAK-CRC001 study. This strategic milestone enables the company to execute a global clinical strategy following European regulatory approvals (ANSM, AFMPS), first patients dosed with preliminary results and good tolerability observed in early Phase Ia. First data are expected to be presented during ESMO annual congress 2026. Brenus Pharma, a clinical stage biotechnology company developing novel in vivo immunotherapies for solid tumors, announced that the U.S. Food and Drug Administration (FDA) has accept the company's Investigational New Drug (IND) application for its first drug candidate, STC-1010, in microsatellite stable (MSS) metastatic colorectal cancer (mCRC). STC-1010 is designed to address a critical unmet need worldwide. Approximately 95% of mCRC patients have MSS tumors, which demonstrate minimal response to standard immunotherapies. The FD
Tide Crosses 2 Million Members Worldwide - Big Step Forward in Mission to Support and Grow Small Businesses27.5.2026 08:00:00 CEST | Press release
Continuing to grow in the UK and internationally, with India seeing especially strong member growth in the last 12 months In the UK, Tide has 15% market share and has helped small businesses access over £1.75bn in credit Rapid roll out of products; from admin, accounting and tax tools; subscription options; payment solutions; government registrations; bill payments and credit Tide, the UK’s leading business management platform, today announces it has crossed 2 million members globally, with India in particular seeing strong growth. More than 1.1 million small businesses joined Tide in India since the company launched there in December 2022. This makes India Tide’s fastest-growing market by member acquisition. The UK is Tide’s home market, with 900,000 SMEs, 15% market share, and the majority of the company’s revenue. Tide’s steadily expanding its presence in Europe, with Germany and France, where the platform is gaining strong traction, thanks to millions of small businesses turning to
Alfasigma presents first data on filgotinib from the Phase 3 OLINGUITO trial in axial spondyloarthritis at EULAR 202627.5.2026 08:00:00 CEST | Press release
The information contained within this press release is for the purpose of scientific exchange.It is intended for scientific and investor media only.In the OLINGUITO Phase 3 study in radiographic (r) and non-radiographic (nr) axial spondyloarthritis (axSpA) a significantly greater proportion of patients achieved the prespecified primary endpoint of ASAS40 with filgotinib compared with placebo at week 16.The improvements in signs and symptoms of axSpA with filgotinib, an oral, once-daily JAK1 preferential inhibitor, were observed as early as week 1 and maintained over 52 weeks of treatment.In the r-axSpA and nr-axSpA filgotinib groups, of those achieving a response in the prespecified primary endpoint of ASAS40 at week 16, 84.6% and 78.0% maintained their responses to week 52, respectively.In OLINGUITO no new safety signals were observedfor filgotinib over 52 weeks, and the safety profile was consistent with the known overall safety profile.Primary results from the Phase 3 OLINGUITO tria
Royal London Asset Management Expands Relationship with SS&C to Service New Australian Funds27.5.2026 00:00:00 CEST | Press release
SS&C Technologies Holdings, Inc. (Nasdaq: SSNC) today announced that Royal London Asset Management, a leading U.K. fund management company, has extended its relationship with SS&C. SS&C Global Investor & Distribution Solutions will provide fund administration and unit registry services for its new range of Australian active funds, including: Royal London Global Equity Diversified Fund Royal London Global Equity Enhanced Fund Royal London Global Equity Select Fund Royal London Short Duration Global High Yield Bond Fund RLAM is part of Royal London, the U.K.’s largest mutual life, pensions and investment company. SS&C services approximately £72bn in assets under management across its U.K. fund range. Equity Trustees will serve as the Responsible Entity for RLAM’s new funds, which have launched with around AUD $1 billion in AUM. The unit trusts are structured as feeder funds, providing investors with indirect exposure to RLAM’s range of Dublin-domiciled Undertakings for Collective Investm
SLB Announces Date for Second-Quarter 2026 Results Conference Call26.5.2026 19:00:00 CEST | Press release
SLB (NYSE: SLB) will hold a conference call on July 24, 2026, to discuss the results for the second quarter ending June 30, 2026. The conference call is scheduled to begin at 9:30 a.m. U.S. Eastern time and a press release regarding the results will be issued at 7:00 a.m. U.S. Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (800) 715-9871 within North America or +1 (646) 307-1963 outside of North America approximately 10 minutes prior to the start of the call and the access code is 3440360. A webcast of the conference call will be broadcast simultaneously at https://events.q4inc.com/attendee/157027565 on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until July 31, 2026, and can be accessed by dialing +1 (800) 770-2030 within North America or +1
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom