CA-BIOCYTOGEN
30.8.2022 02:01:34 CEST | 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/
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
Phase 3 RAINIER Results Supporting Best-in-Class Potential of Povetacicept in IgA Nephropathy Published in the New England Journal of Medicine and Presented at the American Society of Nephrology Kidney Week 202623.10.2026 19:42:00 CEST | Press release
- Vertex is on track for the U.S. FDA Prescription Drug User Fee Act (PDUFA) date of November 30 for potential accelerated approval of povetacicept –- Data published in NEJM and presented at ASN highlight povetacicept’s unique trifecta of efficacy, favorable safety, and the simplicity of dosing at-home every 4 weeks with a low-volume autoinjector –- Data presented at ASN include a qualitative study examining patient perspectives on current and emerging IgAN therapies, showing that 96% of participants preferred an autoinjector over a prefilled syringe, and 80% of participants preferred dosing every 4 weeks versus weekly dosing - - New clinical studies of povetacicept underway including a study evaluating patient experience on povetacicept administered via autoinjector - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the publication of Phase 3 RAINIER results for povetacicept in the New England Journal of Medicine (NEJM), presentation of these data at the American Soc
BeOne Medicines Reports Sustained Survival Benefit with TEVIMBRA-ZIIHERA Combination in First-Line HER2+ Gastroesophageal Cancer23.10.2026 16:15:00 CEST | Press release
New data from HERIZON-GEA-01 Phase 3 trial show 36-month overall survival of nearly 40% with TEVIMBRA plus ZIIHERA and chemotherapy, and median OS reaching 27 monthsTEVIMBRA-containing arm was associated with a four-month longer median OS compared with ZIIHERA plus chemotherapy BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new survival results from the planned second interim analysis (IA2) and final formal analysis of the Phase 3 HERIZON-GEA-01 trial, further confirming the benefit of TEVIMBRA® (tislelizumab) plus ZIIHERA® (zanidatamab) and chemotherapy as first-line treatment for patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). The results will be presented today as a late-breaking abstract during a rapid oral session at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain (LBA79). Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne,
Lifezone Metals Confirms Advanced Negotiations with Orion CMC on Kabanga Nickel Project23.10.2026 16:10:00 CEST | Press release
Lifezone Metals Limited (NYSE: LZM) notes comments made today by Oskar Lewnowski, Founder and Group Chief Executive of Orion Resource Partners, in an interview with Bloomberg Television regarding the Company’s Kabanga Nickel Project in Tanzania. In response to inbound inquiries from media outlets and investors following the interview, the Company can confirm that negotiations with Orion Critical Mineral Consortium (Orion CMC) regarding a significant equity investment into the Kabanga Nickel Project are at an advanced stage. The Orion CMC is a global investment platform launched by Orion Resource Partners in partnership with the U.S. International Development Finance Corporation (DFC) and Abu Dhabi's sovereign investor ADQ. As previously announced, the Company has been running a competitive process, led by Standard Chartered Bank, to secure a strategic investment into the Kabanga Nickel Project. Social Media LinkedIn | X | YouTube About Lifezone Metals Lifezone Metals (NYSE: LZM) is com
inDrive and Pony.ai Announce Collaboration to Explore Autonomous Mobility in Kazakhstan Built on NVIDIA Hyperion23.10.2026 15:00:00 CEST | Press release
Collaboration will establish the roadmap for bringing Pony.ai robotaxis to Kazakhstan on the inDrive ride-hailing platform, leveraging the NVIDIA Hyperion and the NVIDIA Halos safety system. inDrive, the global mobility and delivery platform, today announced it has signed a memorandum of understanding (MOU) with NVIDIA and Pony.ai, a global leader in the large-scale commercialization of autonomous driving technology, to explore the future of autonomous ride-hailing. Kazakhstan will serve as the first test market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261023143469/en/ inDrive partners with Pony.ai and NVIDIA to explore autonomous mobility in Kazakhstan Kazakhstan was chosen first for its regulatory readiness following the creation of the country’s first structured legal framework for driverless transport, as part of its “Year of Digitalization and Artificial Intelligence.” Combined with Kazakhstan’s position as a lea
Brenus Pharma's Novel In Vivo Immunotherapy STC-1010 Shows Safety, Activating T Cells in First-Line MSS Metastatic Colorectal Cancers With 2 Complete Responses.23.10.2026 14:50:00 CEST | Press release
Phase Ia BreAK CRC-001 at ESMO 2026: 43% of patients, all initially unresectable, became eligible for surgery Poster 1023P – Developmental Therapeutics Brenus Pharma, a clinical-stage biotech company, announced first data from the Phase Ia dose escalation of BreAK CRC-001. Nine unresectable patients were treated; 89% had liver metastases and 89% KRAS-mutant tumors, a population refractory to immunotherapy. Median follow-up: 8 months (1–14; data cut-off 6/08/2026). 95% of metastatic colorectal cancers are pMMR/MSS tumors, poorly immunogenic and resistant to immunotherapy. STC-1010, the company’s lead in vivo DC-engager, is designed to make these “cold” tumors visible to immune cells. Safety: no dose-limiting toxicity, only grade 1–2 related adverse events. Clinical activity (seven evaluable patients, RECIST 1.1): 100% disease control, 57% objective response rate (4/7). 43% of patients became operable (3/7): two with no evidence of disease afterward. Molecular profile: ctDNA dropped by u
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