Key Highlights

- Clinical trial to evaluate the safety and efficacy of YK012 in primary membranous nephropathy

- Globally, this is the first bispecific CD19-directed CD3 T cell engager immunotherapy for this autoimmune disease

- Milder T cell activation than Blincyto and Target cell-dependent T cell activation

- Multiple CR cases observed in ongoing r/r NHL Phase Ia trial and r/r ALL Phase Ib/II trial

HONG KONG, May 29, 2025 - (ACN Newswire) – Excyte, a global clinical-stage biotechnology company, announced first patient has been dosed for YK012, the world’s first patient T cell engager that entered into clinical trial for primary membranous nephropathy (pMN). The patient remained well after administration with no adverse reactions witnessed to date.

pMN is an autoimmune disease caused by the attack of autoantibodies against podocyte antigens leading to the in situ production of immune complexes. pMN is the most common cause of primary nephrotic syndrome in non-diabetic adults worldwide, accounting for 20% to 37% of affected individuals, and as high as 40% in adults over 60 years of age (1). Currently, 20-30% of pMN cases are resistant to current therapies like rituximab and cyclophosphamide and relapse rates can be high (2).

A clear regulatory pathway in this orphan disease in US could make YK012 one of the first approved TCE in the autoimmune space with many other autoimmune and oncology indications to follow. Excyte would file for US investigational new drug (IND) application imminently.

The study aims to evaluate the safety, tolerability, and preliminary efficacy of YK012 in PMN patients. Led by Professor Minghui Zhao and Prof Zhao Cui from Peking University First Hospital, the trial is planned to be conducted across multiple centers in China. The clinical trial for this indication in the United States will be collaboratively executed by Excyte and its international partners.

“YK012 is a T-cell engaging bispecific antibody targeting both CD19 and CD3, activating T-cell immunity via CD3 while targeting CD19—the most widely expressed tissue-specific marker during B-cell development and thereby enabling B-cell reset. Our data illustrated YK012 mediated significant B cell depletion and have illustrated in current clinical studies extended half-life and limited cytokine release in patients,” said Mr. Andrew Meng, chairman and COO at Excyte. “We look forward to collaborating with regulatory authorities to make YK012 available to this  patient population with a high unmet medical need."

In December 2024, YK012 obtained Clinical Trial Approval Notice (No. CXSL2400727) from China's National Medical Products Administration (NMPA) and was registered on ClinicalTrials.gov (NCT06982729). With the first patient dosed in pMN, Excyte now has a global presence in autoimmune diseases in additional to oncology indications such as NHL and ALL. Earlier this year, Excyte also secured clinical trial approval for systemic lupus erythematosus (SLE), with Professor Xiaofeng Zeng from Peking Union Medical College Hospital serving as Principal Investigator.

About Excyte Biopharma Ltd.

Excyte Ltd. was co-founded by Dr Qing’an Yuan and Mr Andrew Meng , biotech industry veterans with decades of antibody engineering experiences. The company has also established a U.S.-based wholly-owned subsidiary, Excyte LLC, forming a dual-engine drug R&D hub spanning China and the U.S. Excyte is dedicated to developing innovative bispecific antibody drugs for hematologic cancers, multiple myeloma, solid tumors, autoimmune diseases, and other conditions. Excyte’s FIST platform and next generation assets possess features such as long-acting, low-toxicity, and high-yield technological innovations. For more information, please visit https://www.iExcyte.com/

Business Development Contact
Ying Liu, liuying@iExcyte.com

References:

1.William G Couser, Primary Membranous Nephropathy, Clin J Am Soc Nephrol. 2017 May 26;12(6):983–997.
2.Elham Ahmadian, Seyed Mahdi Hosseiniyan Khatibi, Sepideh Zununi Vahed, Mohammadreza Ardalan, Novel treatment options in rituximab-resistant membranous nephropathy patients, International Immunopharmacology, Volume 107, 2022, 108635, ISSN 1567-5769.

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