US FDA Approval of IND for CTLA-4 Antibody YH001 for the Treatment of Front-line Sarcoma Patients in Combination with Envafolimab
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen") and TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), today jointly 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 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 in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma and assess the safety and efficacy of the combination of YH001, envafolimab and doxorubicin in the common sarcoma subtypes of leiomyosarcoma and dedifferentiated liposarcoma.
“YH001 was discovered using Biocytogen’s evidence-based in vivo drug efficacy screening platform and has demonstrated a favorable safety profile and promising anti-tumor activity in combination with a PD-1 antibody in an earlier phase 1 clinical study,” said Rong Chen, M.D., Ph.D., VP of Biocytogen, CEO and CMO of Eucure Biopharma. “As an antibody targeting the validated checkpoint CTLA-4, YH001 is expected to play a very important role in immune-oncology therapy. We are glad to learn that the combination therapy of YH001 + envafolimab and doxorubicin received IND approval by the FDA.”
“We are pleased to receive approval from the FDA to initiate our triplet combination therapy study in sarcoma, which includes our potentially best-in-class CTLA-4 antibody YH001 and the only subcutaneous checkpoint inhibitor approved anywhere in the world, envafolimab,” said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. “We look forward to enrolling patients in this study and giving patients additional options for their sarcoma treatment.”
About YH001
YH001 is an IgG1 antibody targeting CTLA-4 that was invented by Biocytogen, the parent company of Eucure Biopharma, and licensed by TRACON. YH001 has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro when compared with ipilimumab. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab as a single agent and when combined with a PD-(L)1 antibody in human transgenic mouse tumor models. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 has been dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).
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 www.eucure.com.
About Biocytogen
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Using its proprietary RenMabTM /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, and has entered ongoing collaborations with dozens of partners worldwide to produce a variety of antibody drugs. The company's pipeline includes 12 core products, among which two products are in phase II multi-regional clinical trials and two products are in phase I. Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai and Boston, USA. For more information, please visit www.biocytogen.com.cn.
About TRACON
TRACON is a clinical-stage biopharmaceutical company utilizing a cost-efficient, CRO-independent, product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies. The Company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships through a profit-share or revenue-share partnership, or through franchising TRACON’s product development platform. TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the United States or who wish to become CRO-independent. To learn more about TRACON and its product pipeline, visit TRACON’s website at www.traconpharma.com.
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/20220829005548/en/
Contact information
Biocytogen
Drug Assets: BD-Licensing@biocytogen.com
Media: pr@bbctg.com.cn
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Grid Dynamics Signs Strategic Collaboration Agreement with AWS to Advance Data Foundations for Generative AI9.12.2025 16:15:00 EET | Press release
Grid Dynamics Holdings, Inc. (NASDAQ: GDYN) (Grid Dynamics), a premier IT consulting and digital services provider, today announced it has entered into a multi-year strategic collaboration agreement (SCA) with Amazon Web Services (AWS). The agreement focuses on enabling and scaling generative AI journeys for enterprise companies, extending a 15-year relationship between the companies. The collaboration provides Grid Dynamics access to the AWS Data Foundations for Generative AI Program, established to help organizations build the robust, governed, and high-quality data infrastructures required to adopt and scale AI. By combining the AWS suite of cloud-native data and AI services and Grid Dynamics’ deep expertise in data engineering, analytics, and AI/ML, enterprises can accelerate their progress in AI from experimentation to full-scale production. As a recognized AWS Partner with deep technical expertise and proven customer success, Grid Dynamics expects to play a pivotal role in enabli
Indero Named Best Employer by Mercer9.12.2025 16:00:00 EET | Press release
Indero, a global CRO specializing in dermatology and rheumatology, has been honored by Mercer, recognizing its excellence as a Best Employer. Indero is proud of its long-term commitment to building a workplace culture defined by trust, fairness, and meaningful employee experiences and believes this distinction reflects its positive impact in 2025. The Best Employers in Canada – Powered by Mercer certification program recognizes organizations that consistently deliver a positive and engaging employee experience, based on employee feedback. The degree of employee engagement is a crucial factor for both current and prospective clients and partners, since motivated and committed employees are more likely to excel in their roles and ensure the highest standards in the organization’s products and services. Formerly known as the Kincentric Best Employers, the program has highlighted Canada’s top workplaces for over 25 years and now benefits from Mercer’s expanded global reach and one of the m
Gulf Oil Selects DataXstream’s OMS+ Portal to Power LATAM Digital Transformation9.12.2025 15:33:00 EET | Press release
DataXstream LLC, an SAP® Endorsed App partner developing innovative solutions for SAP sales and distribution, today announced that Gulf Oil, a globally recognized lubricant company with operations in more than 25 countries, has selected OMS+ Portal to modernize and unify the company’s customer-facing sales platform across Latin America. The project is part of a broader initiative to streamline operations, enhance scalability and deliver a seamless buying experience that is fully integrated with SAP S/4HANA. As Gulf Oil continues its footprint across LATAM, the company needed a solution that would not only elevate the customer experience, but also provide the flexibility and performance needed to scale. OMS+ Portal will serve as the central platform for Gulf’s distributor network, offering a unified, SAP-embedded environment for self-service ordering and real-time collaboration. “We chose OMS+ Portal because it is a certified SAP partner that will help us to scale the customer portal ac
Guardant Health and Policlinico Gemelli Launch In-House Liquid Biopsy Testing Service in Italy9.12.2025 15:05:00 EET | Press release
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the successful launch of FPG 360, an in-house liquid biopsy testing service at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Policlinico Gemelli) in Rome, Italy. This partnership is the latest in a series of public-private partnerships Guardant Health has formed with top-tier European academic and research hospitals that embed its groundbreaking technology with existing care pathways to expand access to more cancer patients. Policlinico Gemelli will offer on-site liquid biopsy testing based on Guardant360® CDx technology. The collaboration expands access to precision oncology diagnostics and supports both routine care and clinical research. FPG 360 is one of the first dedicated liquid biopsy testing facilities in Italy housed within a hospital system. Policlinico Gemelli, one of Italy's largest and most renowned hospitals, serves thousands of cancer patients each year at its com
Avia Expands to Europe with New German Subsidiary9.12.2025 15:00:00 EET | Press release
AviaGames, a leading global mobile skill-based gaming platform, today announced the establishment of a new subsidiary in Germany. Games industry veteran Michelle Zou has been appointed to head the new entity, overseeing market expansion and investment initiatives across Europe. This move marks a significant milestone in AviaGames’ global growth strategy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251209920028/en/ Games industry veteran Michelle Zou has been appointed to head the AviaGames German subsidiary, overseeing market expansion and investment initiatives across Europe. AviaGames has rapidly emerged as one of the most prominent interactive entertainment companies worldwide, with a global user base of tens of millions of players across North America, and Europe, spanning North America and beyond. The company is especially recognized for its popularity among female players and for delivering high-quality, skill-based
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