Another milestone! Xinkanghe XKH002 has officially submitted its clinical trial application (IND) to the US FDA.

In Beijing, China, on January 10, 2023, XinKangHe Bio, an innovative drug development company, announced that its independently developed innovative drug B7S1 blocking antibody XKH002 for the treatment of tumors has officially submitted its clinical trial application (IND) to the U.S. FDA. Prior to this, the product also completed Pre-IND communication with China's NMPA. This will be XinKangHe Bio's first tumor treatment drug to enter clinical trials.

B7S1, also known as B7-H4, B7x, or VTCN1, is a negative regulatory molecule in the B7 family with significant immunosuppressive effects. The discovery of this important molecule was simultaneously reported by three laboratories led by XinKangHe's founders Dong Chen and Chen Lieping, along with Professor James P. Allison in 2003. As a new immune checkpoint, B7S1 is highly expressed in some tumors and can negatively regulate T cell immune function by inhibiting T cell proliferation, cytokine production, the cytotoxicity of killer T cells, and promoting T cell exhaustion. Although some B7S1 clearing antibodies have entered clinical stages, XKH002 is the first to restore and enhance anti-tumor immune responses by blocking the B7S1 immune checkpoint, and can be used as a monotherapy or in combination therapy for various tumors. B7S1 exhibits its own uniqueness in expression patterns and anti-tumor immune regulatory mechanisms, and can regulate tumor immune responses through various mechanisms related to adaptive and innate immunity. Therefore, XKH002, as a "first-in-class" B7S1 blocking antibody, has great development potential, especially for patients who do not respond to or develop resistance to PD-1/PD-L1 antibody therapies.

"Following the entry of the two inflammation projects XKH004 and XKH001 into clinical trials, the company team efficiently collaborated to complete all research for the IND applications of XKH002 in China and the U.S. with high quality. As the company's first tumor immune project, the submission of this IND signifies that XinKangHe's innovative drug development for tumor diseases has reached a new important milestone, further validating and affirming XinKangHe's independent innovation capabilities," said Mr. Wang Yaning, CEO of XinKangHe Bio. "This drug will provide a new immune treatment option for cancer patients worldwide. We will rapidly advance the clinical development of XKH002 to meet patient needs as soon as possible."

As a Chinese original innovative drug development company, XinKangHe Bio has multiple BIC and FIC innovative pipeline products and new indications entering clinical stages. The company will continue to focus on areas of unmet clinical needs in inflammation/autoinflammatory diseases and tumor immunotherapy, and looks forward to deep cooperation with innovative pharmaceutical companies both domestically and internationally.

About XKH002

XKH002 is a recombinant humanized IgG4 monoclonal antibody that blocks B7S1, independently developed by XinKangHe Bio. XKH002 can specifically bind to B7S1 and effectively block the immunosuppressive effects mediated by B7S1 on T cell proliferation and immune responses. XKH002 helps restore and enhance the body's anti-tumor immune responses and has broad-spectrum anti-cancer potential.

About XinKangHe Bio

XinKangHe Bio was established in 2015, founded by Academician Dong Chen, who is the director of the Shanghai Immunotherapy Innovation Research Institute, a professor at Shanghai Jiao Tong University School of Medicine, and a professor at Tsinghua University School of Medicine, as well as an internationally renowned immunologist. The company is committed to developing macromolecular drugs in the fields of autoimmune diseases and immuno-oncology, based on cutting-edge international immunology research, aiming to create innovative drugs with independent intellectual property rights that originate from China and target the global market, providing patients with globally pioneering or best-in-class treatment options. The company adheres to the R&D philosophy of "innovation, precision, quality, and focus," and through solid basic science combined with translational medicine, has multiple R&D projects with global independent intellectual property rights, covering a rich array of indications in the fields of autoimmune diseases and tumors.