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
CORRECTING and REPLACING Yamaha to Acquire Disguise, Expanding Its Capabilities in Integrated Audio, Video, Lighting and Media13.11.2026 19:10:00 EET | Press release
Please replace the release issued Nov. 12, 2026, at 11:00 p.m. PT/Nov. 13, 2026, at 2:00 a.m. ET with the following corrected version due to multiple revisions in the third paragraph. This release has been updated to ensure the accuracy of certain references in the original version. The updated release reads: YAMAHA TO ACQUIRE DISGUISE, EXPANDING ITS CAPABILITIES IN INTEGRATED AUDIO, VIDEO, LIGHTING AND MEDIA Acquisition combines Yamaha’s audio expertise with Disguise’s software and media server technologies Yamaha Corporation today announced an agreement to acquire Disguise Technologies Limited (“Disguise”), a London-based provider of software and media server technologies for live and immersive experiences. Yamaha will acquire the company by purchasing all shares in its parent, Butterfly Topco Limited. The acquisition will expand Yamaha’s capabilities beyond audio into integrated audio, video, lighting and media solutions, in line with its strategy to expand beyond hardware into soft
VELOCIFERO Takes Action Against Counterfeiting in China13.11.2026 18:32:00 EET | Press release
VELOCIFERO is taking action against counterfeiting in China. White s.r.o., the exclusive owner of the VELOCIFERO brand and its related intellectual property rights, has launched decisive measures to protect its creative and industrial assets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261113797570/en/ Photo courtesy of White s.r.o. “Vehicle sealed in Chongqing as part of actions undertaken to protect VELOCIFERO’s intellectual property rights.” The matter originated in June 2026 when, according to the company’s complaint, computers were removed from the technical office of Taizhou Siweiluo, the company appointed to manufacture VELOCIFERO products. White s.r.o. subsequently became aware of the promotion and sale of vehicles that it believes were produced in violation of its intellectual property rights. White s.r.o. therefore decided to take direct action in China, entrusting the protection of its rights to Shanghai-based
LangChain Raises $300M to Enable Every Company to Own Their Intelligence13.11.2026 17:53:00 EET | Press release
LangChain today announced it has raised $300 million in new funding at a $3 billion valuation, bringing total funding to date to $460 million. The round was led by existing investor CapitalG, with significant participation from new investors GIC and DFJ Growth and existing investors IVP and Sapphire Ventures. LangChain is advancing its mission to help every company own its intelligence. As agents transform the economy, companies are building domain-specific agents differentiated by their knowledge, data, and user experience. These agents will power new products and transform internal company operations, creating lasting competitive advantages for the companies that control them. "Agents are going to transform how companies operate and the products they deliver. The companies that control these systems will build lasting competitive advantages," said Harrison Chase, Co-Founder and CEO of LangChain. "Every company should be free to choose the best models for its needs, control its data a
Kinaxis Named a Leader in Five 2026 IDC MarketScapes for Worldwide Supply Chain Planning13.11.2026 14:00:00 EET | Press release
Kinaxis® Inc. (TSX:KXS), a global leader in end-to-end supply chain planning and orchestration, today announced it has been named a Leader in five 2026 IDC MarketScape vendor assessments for worldwide supply chain planning. The recognition spans the overall market and four industries - discrete industries, process industries, consumer packaged goods and life sciences industries - all served by a single platform, Kinaxis Maestro®, the company's AI-powered supply chain orchestration platform. "Supply chain leaders don't need a better forecast once a month. They need to know what changed this morning, what it means across the business, and what to do about it," said Andrew Bell, Chief Product Officer of Kinaxis. "I believe being named a Leader across five IDC MarketScape vendor assessments, in industries that plan in very different ways, shows that a single concurrent platform is the right foundation for that. Operational orchestration builds on it by connecting planning, decisions and ex
SBC Medical Announces Capital and Business Alliance with NeuroBrain Dynamics to Advance Clinic Profitability Through Medical AI13.11.2026 13:30:00 EET | Press release
SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“The Company” or “SBC Medical”), a Medical Services Organization (MSO) providing management support across a wide range of healthcare fields, today announced a strategic capital and business alliance agreement with NeuroBrain Dynamics Inc. (“NBD”), a Taipei-based company dedicated to enterprise generative AI solutions. As part of the agreement executed on November 13, 2026, SBC Medical has made a minority equity investment in NBD. Through this alliance, SBC Medical plans to introduce two complementary suites of generative AI solutions across its network of 287 clinics in Japan and overseas*: “revenue-growth AI,” to elevate average revenue per visit and customer retention through personalized customer guidance, and “cost-reduction AI,” to streamline medical documentation, staff scheduling, and promotional workflows. These initiatives are designed to improve per-clinic profitability. Furthermore, SBC Medical has secured priority sale
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