CA-BIOCYTOGEN
30.8.2022 02:01:34 CEST | Business Wire | Press release
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
Sharjah Advocates More Dominant Role for Women in Technology under 2050 Roadmap24.9.2026 18:38:00 CEST | Press release
As artificial intelligence reshapes global economies, the UAE is placing women at the heart of its global ambitions positioning them not only as participants, but as key contributors to the AI future. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260924186173/en/ Women leaders and technology experts during a session at the Women in Technology 2026 Forum in Sharjah (Photo: AETOSWire) The message was echoed by Her Highness Sheikha Bodour bint Sultan Al Qasimi, Chairperson of the Sharjah Research, Technology and Innovation Park (SPARK), who urged women to move beyond participation in technology to playing a leading role in shaping the future. Addressing the seventh edition of the Women in Technology 2026 Forum, hosted by SPARK on the theme “The 2050 Mindset,” HH Sheikha Bodour said: “2050 may seem far away, but it is being shaped by the decisions we make, the research we fund and the technologies we develop today. Women must t
MultiBank Group Founder and Chairman Naser Taher Named Financial Leader of the Year at Gulf Business Awards 202624.9.2026 17:39:00 CEST | Press release
Recognition highlights Taher’s leadership in building MultiBank Group into a global financial institution Naser Taher, Founder and Chairman of MultiBank Group, one of the world’s largest financial derivatives institutions, was named Financial Leader of the Year at the Gulf Business Awards 2026. Presented during a ceremony held on 23 September at The Ritz-Carlton JBR, Dubai, the award was part of the Editor’s Choice category. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260924454616/en/ Naser Taher, Founder and Chairman of MultiBank Group, one of the world’s largest financial derivatives institutions, was named Financial Leader of the Year at the Gulf Business Awards 2026 The recognition comes after Taher lead the expansion of MultiBank Group for more than two decades, from its founding in 2005 to a financial institution serving more than four million clients across 100 countries today. Under his leadership, the Group has b
Multiple Industry Honors Reinforce CSG/Netcracker Leadership in Customer Journey Orchestration and AI Innovation24.9.2026 17:05:00 CEST | Press release
Customer engagement platform recognized for ability to orchestrate connected, AI-driven customer experiences The next phase of customer experience hinges on how well brands turn customer data into relevant communications, real-time action, and responsible, proven AI use. CSG® and Netcracker Technology today announced that CSG has been named a Leader in The Forrester Wave™: Customer Journey Orchestration Platforms, Q3 2026, with the highest possible scores in 19 of 23 Forrester Wave™ criteria. CSG Xponent, a best-in-class customer engagement platform, helps brands land timelier, more relevant communications that drive customer action, secure loyalty, and bolster measurable business results. The Forrester Wave™: Customer Journey Orchestration Platforms states that, “CSG earns superior scores across the core journey intelligence and orchestration capabilities that define this market. Its excellent journey simulation, predictive intelligence, and decisioning capabilities help organizations
VasionⓇ Enhances Global Partner Program to Accelerate AI-Powered Automation24.9.2026 16:05:00 CEST | Press release
A refreshed rewards structure, new Partner Academy, and rebuilt partner portal give partners a clearer path to sell and support agentic print and document workflows. VasionⓇ, the Intelligent Print Automation platform trusted by more than 14,000 organizations worldwide, today unveiled a comprehensive refresh of its Global Partner Program. The program delivers the resources partners expect from Vasion: always-on incentives, structured onboarding, elevated enablement, and a rebuilt portal experience, all engineered to help partners scale, compete, and deliver stronger customer outcomes as agentic AI reshapes how enterprises automate work. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260924791639/en/ Agentic print and document workflow environments remain an overlooked channel opportunity, as enterprises race toward agentic automation. IDC forecasts that by 2026, 40% of all Global 2000 job roles will involve working with AI ag
The Only AI Crypto Lead Prioritization Solution Built With Law Enforcement, for Law Enforcement: Elliptic Launches Pulse24.9.2026 15:15:00 CEST | Press release
Pulse delivers actionable leads in seconds, no crypto expertise required, enabling decisions in the field Elliptic, the global leader in on-chain risk, today launched Pulse. Pulse puts crypto lead prioritization directly in the hands of every frontline law enforcement and government officer. Crypto now touches every part of law enforcement, from the patrol officer on the street to the detective assigned to investigate the case. Pulse gives each of them a quick, accurate financial summary and a starting point: whether that's a crypto address on a suspect's phone, in a scam ATM victim's receipt, uncovered during a vehicle or pocket search, or found at the scene of an overdose, an arrest, or a seizure. An officer can input anything that looks like a wallet address or transaction hash. Pulse identifies it, reasons over the result, and returns a summary in plain language, enough for the officer to decide on the spot whether the case needs escalation. If a case needs further investigation, o
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