US FDA Approval of IND for CTLA-4 Antibody YH001 for the Treatment of Front-line Sarcoma Patients in Combination with Envafolimab
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
CorriXR Therapeutics, InhaTarget Therapeutics, and Merxin Ltd Announce Strategic Collaboration for the Development of Inhaled Lung Cancer Treatment2.12.2025 15:30:00 EET | Press release
CorriXR Therapeutics, an oncology-focused biotherapeutics company pioneering a ground-breaking gene editing platform technology, InhaTarget Therapeutics, a company dedicated to the early development and clinical validation of innovative treatments of pulmonary diseases by inhalation, and Merxin Ltd, a designer and supplier of inhaler devices, have entered a strategic collaboration to develop a pioneering inhaled genetic therapy targeting lung cancer. The partnership draws upon CorriXR’s proprietary CRISPR-based gene editing platform targeting NRF2, InhaTarget’s proprietary formulation platform and strong experience in pulmonary drug development, and Merxin Ltd’s advanced inhalation device technology. Through their combined expertise, they aim to create a patient-friendly inhaled therapy that delivers targeted treatment directly to lung tumors, maximizing efficacy, minimizing systemic side effects, and offering new hope for patients facing one of the world’s deadliest cancers. Innovativ
AdvanCell Initiates Phase 2 Expansion Trial of ADVC001, a Novel Targeted Alpha Therapy for Prostate Cancer2.12.2025 15:00:00 EET | Press release
AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, today announced the initiation of the TheraPb Phase 2 expansion trial (NCT05720130) evaluating its lead investigational candidate, ADVC001, in metastatic prostate cancer. The news follows the encouraging Phase 1b dose escalation results presented at the European Society for Medical Oncology (ESMO) 2025 congress that showed a favorable safety profile and compelling anti-tumor activity for ADVC001 in patients with mCRPC (see press release). ADVC001 is a first-in-class 212Pb-PSMA RLT in clinical development, with early data indicating a differentiated and competitive profile both within and beyond its class. Development is advancing rapidly; the Phase 1b therapeutic cohorts were enrolled within ten months, and the commencement of Phase 2 expansion sustains this strong program momentum. The TheraPb Phase 2 expansion will evaluate ADVC001 at two therapeutic dose levels – 160 MB
Luma AI Opens for International Business With Former WPP Executive Jason Day Leading New London Office2.12.2025 15:00:00 EET | Press release
Luma AI, the frontier artificial intelligence company building multimodal AGI intelligence and known for its flagship product Dream Machine, today announced a major step in its global expansion with the opening of its first international office in London, UK. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251202217704/en/ LUMA AI OPENS FOR INTERNATIONAL BUSINESS WITH FORMER WPP EXECUTIVE JASON DAY LEADING NEW LONDON OFFICE As creative economies decentralize and new production hubs emerge across EMEA, Luma AI is positioning its capabilities where creative work is increasingly being produced - not just consumed. To build intelligence that truly serves global creators, Luma AI will work alongside them in their markets, cultures, and workflows. London is the first step in that strategy, as it has the unique position as a global center of advertising, brands, and entertainment. “With this Series C raise and the upcoming build-out
Aurigene Oncology Limited Announces Encouraging Initial Data From 1 st Two Cohorts of Phase 1 Study of AUR112, an Oral Small Molecule Inhibitor of MALT1, in Relapsed/Refractory Lymphoid Malignancies2.12.2025 15:00:00 EET | Press release
Aurigene Oncology Limited, a clinical-stage biopharmaceutical company developing novel therapies in oncology,today announced initial clinical results from 1st two cohorts of its ongoing Phase 1 clinical trial evaluating AUR112 in patients with relapsed or refractory lymphoid malignancies. Early findings show that AUR112 is safe, well tolerated, demonstrating meaningful clinical activity, with objective responses observed across multiple lymphoma subtypes, including Mantle Cell Lymphoma (MCL) and Marginal Zone Lymphoma (MZL). “We are very encouraged by the early results of the first two cohorts from our Phase 1 study of AUR112,” said Dr. Murali Ramachandra, CEO. “AUR112 has shown a promising initial clinical profile, achieving an overall response rate of 63.6% in the efficacy-evaluable population and 58.3% in the intent-to-treat group. These strong early data, combined with its distinct preclinical and safety characteristics, reinforce our belief that AUR112 has the potential to become
Eventbrite Enters into Definitive Agreement to Be Acquired by Bending Spoons for Roughly $500 Million to Accelerate Eventbrite’s Next Phase of Growth2.12.2025 14:30:00 EET | Press release
Eventbrite, Inc. (NYSE: EB), the leading global marketplace for shared experiences, announced today that it has entered into a definitive agreement to be acquired by Bending Spoons, in an all-cash transaction valued at approximately $500 million. The acquisition is subject to customary closing conditions and approvals, including regulatory approvals and approval by Eventbrite’s stockholders. “For two decades, Eventbrite has stood at the forefront of the experience economy, helping tens of millions to create, discover, and attend unforgettable events,” said Luca Ferrari, Bending Spoons CEO and Co-Founder. “Joining forces with Bending Spoons will accelerate innovation and strengthen Eventbrite’s tools and resources to bring even more people together through shared live experiences for many years to come. As longstanding fans, we’ve identified a few opportunities that we’re excited about exploring with the Eventbrite team after closing the transaction. These include building a dedicated m
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