CA-BIOCYTOGEN
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/
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
26th UN Tourism General Assembly kicks off in Riyadh7.11.2025 22:13:00 CET | Press release
UN Tourism marks 50 years of global cooperation as leaders from across the industry gather to shape the future of tourism. His Excellency Ahmed Al Khateeb, Minister of Tourism – “The Kingdom will play an integral part in ensuring one of the world’s most powerful generators of jobs and GDP grows in harmony with the Sustainable Development Goals.” UN Tourism Secretary-General ZurabPololikashvili – “The UN Tourism General Assembly brings together tourism leaders from across the world to set the agenda and build a more innovative and inclusive sector. From Riyadh, we will set the agenda for tourism for the years ahead.” The 26th session of the UN Tourism General Assembly opened today in Riyadh, marking a historic first for the Gulf Cooperation Council (GCC) region and the largest Assembly since UN Tourism was founded 50 years ago. Around 160 delegations from member states including ministers, senior officials, and leaders from across industry and civil society are coming together to celebr
Xsolla Partners With Deloitte Turkiye and Lorien Accelerator as Category Sponsor for Gaming Awards at Fast 50 Türkiye 2025 Program7.11.2025 19:11:00 CET | Press release
Celebrating Turkey’s Gaming Industry with High-Impact Sponsorship and Industry Panel Xsolla, a leading global video game commerce company that helps developers launch, grow, and monetize their games, is proud to announce its sponsorship of the Gaming Awards segment at the Deloitte Technology Fast 50 Türkiye 2025 Program, organized in collaboration with Lorien Accelerator. The event will take place on December 10, 2025, and will recognize Turkey’s top high-growth companies across various industries, with a special focus on the dynamic gaming sector. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251107671030/en/ Graphic: Xsolla As the Gaming Awards category sponsor, Xsolla will receive significant brand exposure through prominent logo placements across all event materials, including digital platforms, official event signage, and other promotional materials. In addition to this visibility, Xsolla’s participation includes an ex
Takeda Presents New Data Showing Mezagitamab (TAK-079) Sustained Effect on Kidney Function 18 Months After Treatment in Primary IgA Nephropathy7.11.2025 17:00:00 CET | Press release
− Phase 1b, Open-Label Study Follow Up Shows Stable Kidney Function (eGFR) in Patients Treated with Investigational Mezagitamab Through Week 96 – 18 Months After Last Dose1− Rapid Reductions in Proteinuria and Serum Gd-IgA1 Levels Were Sustained Through Week 961− No Serious Adverse Events or Opportunistic Infections Were Observed Through Week 961− Takeda Initiated Pivotal Phase 3 Clinical Trials Evaluating Mezagitamab in Primary IgA Nephropathy and Immune Thrombocytopenia with Patient Enrollment Ongoing Takeda (TSE:4502/NYSE:TAK) today announced new interim data from the Phase 1b, open-label, proof-of-concept study of subcutaneous mezagitamab (TAK-079), an anti-CD38 monoclonal antibody with disease-modifying potential, in primary immunoglobulin A (IgA) nephropathy. Data from the study showed that kidney function (eGFR) remained stable in patients with IgA nephropathy through Week 96 – up to 18 months after the last mezagitamab dose.1 The results were presented at the American Society o
Oremus Corporate Services Expands into Europe with Launch in Finland7.11.2025 16:23:00 CET | Press release
CEO, Lalit Ananth Chawla, to Attend Slush 2025 in Helsinki Oremus Corporate Services Private Limited, a multinational Finance and Accounting Advisory firm having its offices in the USA, India and the UK, has announced the extension of its services to Finland, marking the company’s foray into the European market. With over two decades of expertise in accounting, payroll, tax compliance, and advisory services, Oremus has earned trust as a technology-driven finance partner serving clients across geographies. Oremus is an ISAE 3402, ISO 27001, GDPR & DPDP Compliant Company, adhering to International Quality and Security Standards. “Finland isn’t just a new market for us — it’s the gateway to meaningful, growth-driven partnerships across Europe”. said Lalit Ananth Chawla, CEO of Oremus. Having established a strong reputation for delivering reliable Accounting and Advisory solutions to scale-ups and growing businesses, we seek to collaborate with like-minded firms and investors to build a tr
Experian Named a Leader in IDC MarketScape: Worldwide Identity Verification in Financial Services 2025 Vendor Assessment7.11.2025 15:00:00 CET | Press release
Advanced fraud prevention, multi-layered verification and innovative data-driven security solutions are core to Experian’s Ascend Platform™ Experian today announced it has been named a leader in the IDC MarketScape: Worldwide Identity Verification in Financial Services 2025 Vendor Assessment (doc # US52985325, September 2025). The report evaluates vendors on the depth and breadth of their identity verification capabilities and on how effectively they align with current and future customer needs. The IDC MarketScape methodology for this assessment involved two key measures of success: capabilities that reflect Experian’s current menu of services and how well aligned they are to its customer needs as well as strategies that indicate how well Experian’s future strategy aligns with what customers will require in three to five years. “This assessment offers a 360-degree view of our identity-verification solutions, and we’re very proud to be recognized as a leader,” said Keith Little, Presid
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