US FDA Approval of IND for CTLA-4 Antibody YH001 for the Treatment of Front-line Sarcoma Patients in Combination with Envafolimab
14.9.2022 18:51:00 EEST | 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/
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
Estithmar Holding Net Profit Surges 122% to QAR 938 Million; Revenue Rises 54% to QAR 6.4 Billion for the Year Ended 31 December 202510.3.2026 23:52:00 EET | Press release
Estithmar Holding Q.P.S.C. has announced its financial results for the year ended 31 December 2025. The group reported a 54% increase in revenue to QAR 6.4 billion, compared with QAR 4.2 billion in 2024. Gross profit rose to QAR 2.1 billion, up from QAR 1 billion in 2024, representing growth of 111%. EBITDA reached QAR 1.5 billion, an increase of 102% year-on-year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310410214/en/ Estithmar Holding Net Profit Surges 122% to QAR 938 Million; Revenue Rises 54% to QAR 6.4 Billion for the Year Ended 31 December 2025 (Photo: AETOSWire) Net profit climbed 122% compared with 2024, reaching QAR 938 million. Earnings per share increased by 145% to QAR 0.264. The growth in net profit was primarily driven by higher revenues, particularly from the specialized contracting and healthcare sectors. The results reflect the group’s ability to convert operational growth into sustainable profitabi
IFF Expands Latin American Footprint With New Enzyme Hub, Brazil Application Lab10.3.2026 22:30:00 EET | Press release
IFF (NYSE: IFF) — a global leader in flavors, fragrances, food ingredients and health & biosciences — is enhancing regional production and innovation capabilities to better support the continued growth of its Health & Biosciences (H&B) business in Latin America, one of the fastest-growing markets for the company. The effort includes the transformation of the Arroyito site in Argentina into IFF’s first full fermentation‑based enzyme production hub in the region and the opening of a household care application laboratory at IFF’s Innovation Center in Brazil. Together, these enhancements expand IFF’s regional footprint and are expected to improve speed, reliability and locally relevant solutions for markets including brewing, animal nutrition, biofuels and home care. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310253993/en/ IFF's home care application lab in Brazil. “This is about turning science into impact where it matte
Xtep-Sponsored Chinese Teenage Dancer Claims World Championship at Juste Debout Street Dance World Finals10.3.2026 20:46:00 EET | Press release
Xtep, a well-known sportswear brand from China, proudly announced that Xtep-sponsored Chinese teenage dancers delivered an electrifying performance at the Juste Debout Street Dance World Finals in Paris on Sunday, March 8, 2026, claiming top honors and showcasing a unique fusion of traditional Chinese culture with modern street dance. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310519224/en/ Chinese Teens Dance to Glory at Juste Debout World Finals Li Yongqiu, a 14-year-old from Southwestern China’s Chongqing Municipality, made history by winning the Global Championship in the Junior Dance Tour, becoming the third Chinese dancer to achieve this feat. His explosive power and technical mastery, honed through years of training that integrates Kungfu elements, captivated judges and audiences alike. The Chinese contingent's success didn't stop there. Zhang Xinlan and Zhang Chuyi secured a Top 8 finish in the Popping Adult D
ATLAS Infrastructure Invests in H2O America, Backs Long-Term Growth Strategy10.3.2026 19:29:00 EET | Press release
ATLAS Infrastructure (“ATLAS”) is a specialist Global Listed Infrastructure investor managing funds on behalf of long-term infrastructure clients. Following the recent equity placement, ATLAS’s actively managed accounts hold ~10.8% voting and economic interest in H2O America (“H2O”). ATLAS was pleased to support H2Os long‑term strategy to invest in local water and wastewater utility operations through our participation in the recent equity raise. ATLAS recognises the disciplined approach from H2O management which focuses on organic investment in existing businesses alongside targeted and accretive transactions such as the acquisition of Quadvest which materially expands H2O’s regulated water footprint in a premium high‑growth jurisdiction. The upsized equity raise, anchored by ATLAS, supports the company strategy through providing significant balance sheet capacity and financial flexibility well into the Company’s 2026-2030 CapEx plan. “Increased investment in water utilities is essent
Svante and Integrated Packaging Company Advance U.S. Biogenic CDR Project to Feasibility10.3.2026 15:57:00 EET | Press release
Svante Technologies Inc. (“Svante”) announced today that its bioenergy with carbon capture and storage (BECCS) project at a paper mill in the Southeast U.S. has progressed to the feasibility study phase. The project is being developed in partnership with an integrated sustainable packaging company, following an extensive screening and pre-feasibility study conducted across several of the partner’s mills. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310319382/en/ During the feasibility study phase, the companies will complete further engineering and design activities, cost and schedule estimates, and risk assessments required to evaluate commercial viability ahead of a future engineering study leading to final investment decision (FID). Svante’s subsidiary, Svante Development Inc., is co-investing in this phase with the mill owner. The project is designed to capture and permanently store more than 500,000 tonnes per year
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