First Patient Dosed in Phase 1/2 Trial Evaluating YH001 in Combination with Envafolimab and Doxorubicin in Front Line Sarcoma Patients
Beijing, China and San Diego, CA, November 21, 2022 – Eucure (Beijing) Biopharma Co., Ltd. (“Eucure Biopharma”), a wholly owned subsidiary of Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”) and TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), today jointly announced dosing of the first patient in a Phase 1/2 Trial that studies its CTLA-4 antibody YH001 in combination with its PD-L1 antibody envafolimab and with doxorubicin in front line sarcoma patients (NCT 05448820).
The Phase 1/2 trial will assess the safety and efficacy of the triplet combination of YH001, envafolimab and doxorubicin in the common sarcoma subtypes of leiomyosarcoma and dedifferentiated liposarcoma. In addition, the trial will assess the safety and efficacy of the doublet combination of YH001 and envafolimab in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma.
“We are pleased that YH001 in combination with PD-L1 antibody (and standard chemotherapy) for the treatment of sarcoma made rapid progress and dosed the first patient,” said Rong Chen, M.D., Ph.D., CEO and CMO of Eucure Biopharma, VP of Biocytogen. “There are high unmet medical needs in the treatment of sarcoma. We look forward to enrolling patients in this study and giving patients additional options for their sarcoma treatment.”
“At the time of the expected accelerated approval of envafolimab in the refractory sarcoma subtypes of UPS and MFS based on data from our ongoing ENVASARC clinical trial, we expect to be enrolling a Phase 3 trial for the full approval of envafolimab with YH001 in front line sarcoma patients,” said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. “Dosing the first patient in a trial that studies envafolimab with YH001 in front line sarcoma patients, including in combination with standard of care doxorubicin, is an important step to inform as to the subtypes of sarcoma which should enroll in the front line Phase 3 trial.”
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.
Biocytogen (HKEX: 02315) 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. This project has resulted in 28 drug co-development agreements and 16 RenMiceTM licensing agreements with companies around the world, including several partnerships with multinational pharmaceutical companies (MNCs). Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai, Boston, USA and Heidelberg, Germany. For more information, please visit http://en.biocytogen.com.cn.
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.
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