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
Reply Achieves the AWS Advertising and Marketing Technology Competency Thanks to the Contribution of the Data Reply and Storm Reply Teams16.9.2025 10:40:00 CEST | Press release
Reply [EXM, STAR: REY] has achieved the AWS Advertising and Marketing Technology Competency, the official recognition from Amazon Web Services certifying advanced technical and project expertise in the design and delivery of advertising and marketing solutions on AWS. This milestone was made possible thanks to the joint contribution of Storm Reply and Data Reply, both part of the Reply Group, with solid expertise in implementing cloud-native and data-driven solutions on the AWS platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250916374888/en/ With this certification, Reply’s companies specialized in AWS services further consolidate their role as trusted technology partners for organizations looking to evolve their marketing and communication strategies through the advanced use of AWS cloud and AI technologies. The AWS Advertising and Marketing Technology Competency validates the ability of AWS Partners to deliver hig
PayPay Is Now Accepted in South Korea via Ant International’s Alipay+16.9.2025 10:26:00 CEST | Press release
Connecting 70 million PayPay users to over 2 million South Korean merchants A milestone in PayPay’s overseas expansion Starting from late September 2025, Japan's leading cashless payment service PayPay will be accepted at over 2 million merchants across South Korea through Alipay+, a global wallet gateway service operated by Ant International. This will allow its 70 million registered users to make seamless payments during their visit, wherever the Alipay+ logo is displayed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250915612411/en/ Starting from late September 2025, Japanese travellers will be able to use PayPay to make payments in South Korea at stores displaying the Alipay+ logo. PayPay will show users the payment amount in Korean won and its yen equivalent in real time. This marks a new chapter in PayPay’s overseas expansion. From K-beauty stores and convenience chains to local eateries and cultural hotspots, from m
Talent shortages and AI pressures drive shifting dynamics in global technology leadership, According to Expereo16.9.2025 10:00:00 CEST | Press release
Skills gaps in networking, cybersecurity, and AI are delaying growth and forcing businesses to rethink leadership, training, and investment strategies Global businesses are facing mounting challenges in their growth ambitions due to persistent skills shortages in critical technology areas. As AI becomes more deeply embedded in business strategy, organisations are struggling to find or retain talent in key domains such as networking (39%), cybersecurity (40%), and Data/AI/automation (33%). The findings come from an IDC InfoBrief commissioned by Expereo, titled “Enterprise Horizons 2025: Technology Leaders Priorities: Achieving Digital Agility.” The report reveals that 39% of organisations are struggling to find or retain networking talent, while 33% report similar challenges in data, AI, and automation - figures that remain consistent with 2024 findings. These shortages are not only slowing down AI adoption but also reshaping leadership dynamics and workforce strategies across enterpris
Infobip Achieves GSMA Open Gateway Certifications for Network APIs16.9.2025 10:00:00 CEST | Press release
New credentials strengthen Infobip's role in the global telco ecosystem Global communications platform Infobiphas received two new Network API certifications from the GSMA, as part of the CAMARA project. The SIM Swap and Number Verification certifications demonstrate Infobip's commitment to advancing global standards for Network APIs through the GSMA Open Gateway initiative. The certifications mark a significant milestone for Infobip and its telco partners worldwide. The certifications validate Infobip's expertise and support mobile network operators (MNOs) in achieving their own certifications as part of GSMA's global standardization efforts. Viktorija Radman, Telecom Growth & Strategy Director at Infobip, said:"Achieving GSMA certifications for SIM Swap and Number Verification demonstrates our commitment to building secure, scalable solutions for operators worldwide. As a CPaaS enabler, Infobip is dedicated to helping telcos embrace new global standards and bring the benefits of Netw
Groundbreaking New Sensor Transforms How Europe Tracks Pollution, Smoke and Cloud From Space16.9.2025 09:00:00 CEST | Press release
The first images from the Multi-Viewing, Multi-Channel, Multi-Polarisation Imager, presented at the 2025 EUMETSAT Conference, reveal the brand-new instrument’s exceptional ability to monitor the Earth’s atmosphere from multiple perspectives, to support improved forecasts and air pollution and climate monitoring. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250915322837/en/ 3MI’s very first image, captured between 10:59 and 11:03 CEST on 28 August 2025, confirmed the instrument is already performing well as it delivers its preliminary data streams. The left panel shows a standard view using natural light, highlighting clouds and land surfaces. The right panel, based on polarised light measurements, reveals much finer detail of the atmosphere’s composition – such as subtle cloud structures over Italy and wildfire smoke on the right edge of the image, over Greece. When sunlight interacts with particles in the air, like drople
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