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
Klarna Expands Its Partnership With H&M in Romania and Hungary23.3.2026 11:46:00 EET | Press release
Klarna, a global digital bank and provider of flexible payment solutions, and H&M, one of the world's largest fashion retailers, announce the expansion of their partnership in Romania and Hungary as a strategic step that strengthens the long-standing global collaboration between the two companies. Klarna is now available as a payment method for H&M customers in both markets, offering a smooth, more predictable checkout experience and payment options tailored to the different needs of shoppers. The integration of Klarna into H&M online stores is an important feature for customers, who will thus be able to access interest-free flexible payment options. More flexibility at checkout By integrating Klarna into the payment process, H&M customers shopping online in Romania and Hungary can benefit from a full range of deferred payment options, flexible solutions with no interest or fees if payment is made on time. Depending on eligibility, customers can choose between paying in full with Klarn
Recyclable Packaging and Responsible Water Management: Barilla’s Commitment to a More Sustainable Future23.3.2026 11:30:00 EET | Press release
With 99.8% of the packaging designed to be recyclable and a 45% increase in water recycled and reused in 2024 compared to 2022, Barilla continues to strengthen its commitment to the responsible management of resources. The company is reaffirming this commitment on the occasion of Global Recycling Day (March 18) and World Water Day (March 22), two moments that highlight the importance of increasingly sustainable production models – from efficient water management to the design of more circular packaging solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260320294356/en/ Barilla Group's Rubbiano Plant (PR) WATER AS A STRATEGIC RESOURCE TO PROTECT A fundamental resource for pasta production and for the balance of ecosystems, water is a central element in Barilla’s management of its operations. The company works to progressively reduce water consumption in its production processes, promoting the responsible use of this re
Massive Gaming Secures MGA B2B License to Expand Global iGaming Partnerships23.3.2026 11:13:00 EET | Press release
Massive Gaming (MVG), a global iGaming content provider with headquarters in Australia, has secured a B2B Gaming License from the Malta Gaming Authority (MGA), marking a key milestone in the company’s expansion into regulated international markets. The MGA license enables Massive Gaming to supply its gaming content and solutions to operators licensed under the Malta regulatory framework, strengthening the company’s ability to collaborate with partners across Europe and other regulated jurisdictions. To support its regulatory expansion, Massive Gaming established MVG Malta, a dedicated entity created as part of the licensing process, and which supports the company’s broader strategy to strengthen its presence within the European iGaming ecosystem. Massive Gaming develops its gaming portfolio across three studios - Slot Mart, Whale House and Blitzcrown. All three deliver a range of gaming experiences spanning traditional slot titles, regulated market content and emerging non-traditional
LTM Expands BlueVerse ™ Tech with AppIQ, AgentIQ and FusionIQ to Accelerate AI‑Led Engineering23.3.2026 10:30:00 EET | Press release
LTM – the Business Creativity partner to the world’s largest enterprises, today announced the expansion of BlueVerseTM Tech, its AI‑led engineering platform, with the launch of AppIQ, AgentIQ and FusionIQ—three purpose‑built platforms designed to help enterprises modernize applications, orchestrate AI‑first software delivery, and engineer quality at scale. As software development evolves from human‑only execution to human + intelligent agents, traditional effort‑driven engineering and QA models are increasingly unable to keep pace. These BlueVerseTM platforms embed agentic, engineering‑aware AI across the software development lifecycle (SDLC), enabling enterprises to move faster from legacy complexity to modern, resilient, and high‑quality digital systems. AppIQ — Modernize Legacy Applications, Faster AppIQ applies AI to read and understand legacy codebases, generate documentation, map functional workflows, and produce actionable specifications for forward engineering. What previously
Galderma Receives U.S. FDA Approval for Restylane ® Contour™ for the Correction of Temple Hollowing23.3.2026 08:00:00 EET | Press release
Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the U.S. FDA has approved Restylane Contour for the correction of temple hollowing in patients over the age of 21.1,2 This builds on its previous approvals for cheek augmentation and midface contour deficiencies, helping injectors address volume loss across key structural areas.1-3 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260322108467/en/ With the broadest Injectable Aesthetics portfolio in the industry, this follows the recent U.S. approval of Restylane Lyft for augmentation of the chin region, adding to its indications to treat the midface, facial folds and wrinkles, back of hands, and the chin.4,5 Together, these approvals demonstrate Galderma’s ongoing commitment to evolving the versatile Restylane portfolio to deliver personalized, natural-looking outcomes that meet diverse patient needs.1,4,6,7 The volume of the temples can dimi
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