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
TNG Digital and EPOS Launch EPOS360 and EPOS360 BlueTap in Malaysia to Help Local SMEs Grow with AI and Unique Payment Capabilities15.1.2026 12:23:00 EET | Press release
TNG Digital Sdn. Bhd. (“TNG Digital”), the operator of Malaysia’s leading digital financial services and lifestyle app, TNG eWallet, and EPOS, the all-in-one SME transformation platform of Ant International, have jointly announced the launch of EPOS360 in Malaysia, with a suite of AI-powered growth tools and unique payment capabilities to support the digitalisation of Malaysian businesses, particularly SMEs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260115763131/en/ [From left] Mr. Sarveswaran Raja Gopal, Chief Commercial Officer of TNG Digital; Mr. Alan Ni, Chief Executive Officer of TNG Digital; [middle] En. Anuar Fariz Fadzil, Chief Executive Officer of Malaysia Digital Economy Corporation (MDEC); Mr. Gary Liu, Chief Executive Officer of Antom and Senior Vice President of Ant International; and Mr. Alan Wang, Chief Executive Officer of EPOS and Vice President of Ant International, at the launch of EPOS360 and EPOS360
OPEX® Corporation Presented with Multiple DM Awards by Document Manager Magazine15.1.2026 11:00:00 EET | Press release
OPEX® Corporation, a global leader in Next Generation Automation providing innovative solutions for warehouse, document and mail automation, has been recognized by Document Manager magazine with multiple DM Awards. At the 2025 awards ceremony held recently in London, OPEX was named the winner in two categories―Imaging Product of the Year: High Volume and Hardware Product of the Year―for its Falcon+® document imaging solution. OPEX also received runners-up accolades, in partnership with Iron Mountain, in the category of Project of the Year: Public Sector, for their NHS Medical Scanning project. “OPEX is honored to receive such prestigious recognition from Document Manager magazine,” said Alban Collas, Director of EMEA Operations, OPEX. “Our team is committed to developing solutions that enable clients to transform how business is conducted. For our imaging solutions to be recognized in this way means so much to us. We’re especially pleased that the DM Awards honored our partnership with
SAP and Syngenta Announce Partnership to Scale AI-Assisted Agriculture15.1.2026 10:00:00 EET | Press release
SAP SE (NYSE: SAP) and Syngenta, a global leader in agricultural innovation, today announced a multi-year strategic technology partnership to accelerate AI-assisted innovation across Syngenta’s global operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260115682130/en/ Jeff Rowe - CEO of Syngenta Group (left) and Christian Klein - CEO of SAP (right) The partnership will embed artificial intelligence at the core of Syngenta’s enterprise, modernizing operations and enabling accelerated innovation through advanced data analytics across the business — from manufacturing and supply chain to grower-facing products and services. Agriculture continues to navigate challenges driven by climate variability, supply chain complexity, and global uncertainty. By deploying AI-assisted tools enterprise-wide, this partnership positions Syngenta to meet the challenge of feeding a projected 10 billion people by 2050, while unlocking fast
NTT DATA Recognized as a Global Top Employer for Third Consecutive Year15.1.2026 10:00:00 EET | Press release
NTT DATA, a global leader in AI, digital business and technology services, today announces it has been certified as a Global Top Employer for 2026 by the Top Employers Institute. Recognized for the third year in a row, this prestigious honor places NTT DATA among a select group of just 17 organizations worldwide honored for consistently delivering a high-performing people strategy across its global operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260115418660/en/ NTT DATA recognized as a Global Top Employer In addition to its global recognition, NTT DATA has also earned four Top Employer 2026 regional seals and 37 country and region seals across North America, Latin America, Asia Pacific, Europe and Africa. The Global Certification is the highest level of recognition offered by the Top Employers Institute and underscores NTT DATA’s ability to align its leadership, leverage data-driven insights and apply validated b
Advanced Sterilization Products (ASP) Announces CE Mark for ULTRA GI™ Cycle for Duodenoscopes in Partnership with FUJIFILM Healthcare Europe15.1.2026 10:00:00 EET | Press release
ASP International GmbH (“ASP”), a division of Fortive (NYSE: FTV), in collaboration with FUJIFILM Healthcare Europe GmbH, proudly announces that the ULTRA GI™ Cycle has received CE mark approval. The ULTRA GI™ Cycle is the latest innovation for the STERRAD™ 100NX Sterilizer with ALLClear™ Technology. The ULTRA GI™ Cycle’s receipt of the CE mark represents a pivotal advancement in elevating patient safety across healthcare facilities and addressing the complex challenges associated with traditional reprocessing methods. “This is a meaningful step forward in our mission to make duodenoscope reprocessing safer across Europe,” said Chad Rohrer, President, ASP. “By bringing hydrogen peroxide gas plasma sterilization into routine practice, we’re giving clinicians greater confidence to focus on what matters most – their patients.” ASP’s immediate focus is to work with medical device manufacturers to ensure that new duodenoscope models are designed to be compatible with hydrogen peroxide. The
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