Beijing, China & San Diego, United States:
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”) and TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), right this moment collectively introduced that the U.S. Food and Drug Administration (FDA) has authorised the Investigational New Drug (IND) utility for the initiation of a Phase 1/2 medical examine of YH001 in mixture with envafolimab and doxorubicin for the therapy of sarcoma sufferers, together with sufferers who haven’t acquired prior remedy.
The Phase 1/2 trial will assess the security and efficacy of YH001 and envafolimab in sufferers with the uncommon sarcoma subtypes of alveolar tender half sarcoma and chondrosarcoma and assess the security and efficacy of the mixture of YH001, envafolimab and doxorubicin in the widespread 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,” mentioned 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,” mentioned 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 concentrating on CTLA-4 that was invented by Biocytogen, the mother or father firm of Eucure Biopharma, and licensed by TRACON. YH001 has proven enhanced antibody dependent mobile cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro compared with ipilimumab. In preclinical research YH001 demonstrated superior T cell activation and superior tumor development inhibition exercise in comparison with ipilimumab as a single agent and when mixed with a PD-(L)1 antibody in human transgenic mouse tumor fashions. In these fashions, single agent YH001 depleted regulatory T cells and elevated CD8+ T cells in tumor tissue. YH001 has been dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in mixture with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).
About Eucure Biopharma
As an entirely owned subsidiary of Biocytogen, Eucure Biopharma undertakes the mission of medical growth for Biocytogen’s R&D pipelines. Relying on a robust medical growth staff and in depth medical growth expertise, Eucure Biopharma focuses on antibody drug remedy for oncology and different indications. The firm has established a product pipeline for greater than 10 targets, with two merchandise in launched section II multi-regional medical trials (MRCT) and two in section I. For particulars, please go to www.eucure.com.
About Biocytogen
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. is a worldwide biotechnology firm that drives the analysis and growth of novel antibody-based medicine with revolutionary applied sciences. Using its proprietary RenMabTM /RenLite® mice platforms for absolutely human monoclonal and bispecific antibody growth, Biocytogen has built-in its in vivo drug efficacy screening platforms and powerful medical growth experience to streamline the complete drug growth course of. Biocytogen is enterprise a large-scale mission to develop antibody medicine for greater than 1000 targets, referred to as Project Integrum, and has entered ongoing collaborations with dozens of companions worldwide to provide a range of antibody medicine. The firm’s pipeline consists of 12 core merchandise, amongst which two merchandise are in section II multi-regional medical trials and two merchandise are in section I. Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai and Boston, USA. For extra info, please go to www.biocytogen.com.cn.
About TRACON
TRACON is a clinical-stage biopharmaceutical firm using a cost-efficient, CRO-independent, product growth platform to advance its pipeline of novel focused most cancers therapeutics and to associate with different life science firms. The Company’s clinical-stage pipeline consists of: Envafolimab, a PD-L1 single-domain antibody given by speedy subcutaneous injection that’s being studied in the pivotal ENVASARC trial for sarcoma; YH001, a possible best-in-class CTLA-4 antibody in Phase 1 growth; TRC102, a Phase 2 small molecule drug candidate for the therapy of lung most cancers; and TJ004309, a CD73 antibody in Phase 1 growth for the therapy of superior stable tumors. TRACON is actively searching for further company partnerships by way of a profit-share or revenue-share partnership, or by way of franchising TRACON’s product growth platform. TRACON believes it may possibly function an answer for firms with out medical and industrial capabilities in the United States or who want to grow to be CRO-independent. To be taught extra about TRACON and its product pipeline, go to TRACON’s web site at www.traconpharma.com.
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