JunTuo Bio's Live Biotherapeutic Product KEX02 Receives FDA IND Clearance for NSCLC in Combination with PD-1 Inhibitor

Shenzhen Juntuo Biotechnology Co., Ltd. (hereinafter referred to as “Juntuo Bio”) announced that on August 12 (U.S. time), its drug pipeline involving the KEX02 live biotherapeutic product in combination with a PD-1 inhibitor for the treatment of non-small cell lung cancer officially received Investigational New Drug (IND) clearance from the U.S. FDA, allowing it to enter the clinical trial phase. Public information shows that,This is one of the first live biotherapeutic product (LBP) pipelines in China to obtain clinical trial approval from the U.S. FDA.Juntuo Biotechnology is a joint venture subsidiary of Shenzhen Xbiome Biotechnology Co., Ltd. (hereinafter referred to as “Xbiome”) and Beijing Chuangtong Hengtong Biotechnology Co., Ltd. (SZ 300858, hereinafter referred to as “Chuangtong Biotech”).

KEX02 is a live biotherapeutic product (LBP) derived from the gut microbiota of healthy children. Leveraging KT Biotech’s lactic acid bacteria germplasm resource library, UnknownYou’s multi-dimensional screening platform, and KT Biotech’s strain development and manufacturing platform, the R&D team at Juntuo Biopharmaceutical discovered that KEX02 exhibits potent immune-activating capabilities. In combination with PD-1 antibodies, KEX02 demonstrated significant tumor-suppressive effects and markedly prolonged survival in tumor-bearing mice. Mechanistically, KEX02 activates dendritic cells, enhances the cytotoxic function of effector T cells, and significantly improves response rates to immunotherapy.

KeTuo Biology Possesses Asia’s Largest Strain Resource Bank, Facilitating the Development of KEX02 Drug

Dr. Leng Bingfeng, Project Leader at Juntuo BiologicsIntroduction: Leveraging the respective platform advantages of Xbiome and Ketuo Biology, the project team has made unremitting efforts over the past two years. The approval of KEX02 marks a significant milestone for Juntuo Biopharma and signifies that China’s R&D capabilities in Live Biotherapeutic Products (LBPs) are now aligned with international standards. Moving forward, KEX02 will actively advance clinical activities and expedite domestic clinical trial applications. The R&D team will also continue to explore the therapeutic potential of KEX02 for various other diseases beyond its currently approved indications.

Liu Xiaojun, President of Ketuo BiologyIt was stated that since its establishment in 2003, Ketuo Biology has consistently adhered to the principle that science and technology are the primary productive forces. The company has continuously developed and refined its basic research, scientific evidence-based studies, and advanced production processes, diligently laying a solid foundation to ensure steady and long-term growth, as well as significant achievements, in the probiotic industry. Notably, Juntuo Biology’s KEX02 is the first live biotherapeutic product (LBP) pipeline to obtain clinical trial approval from the U.S. FDA. This milestone not only enhances the functional validation of probiotics at the drug development level but also serves as an affirmation and encouragement of the company’s two-decade commitment to scientific research and medical evidence-based practices.

Dr. Tan Yan, Co-founder and CEO of Xbiomestated that the human gut microbiota is closely linked to human health. The approval of the Investigational New Drug (IND) application for KEX02 marks a solid step forward for Xbiome in scientifically, rigorously, and standardly evaluating the clinical functions of microbiota, and also signifies that Xbiome’s live biotherapeutic product development has aligned with international advanced standards.Dr. Yin Yiming, Vice President of R&D at XbiomeIt was stated that, as a drug with a novel mechanism of action, the clinical development of KEX02 will bring new hope to numerous cancer patients. Furthermore, Xbiome has multiple pipelines in clinical and preclinical development, and its AI+BT platform is poised to enter a period of accelerated growth.

Shanghai Juntuo Biopharmaceutical Technology Co., Ltd. was established in September 2019 as a joint venture subsidiary of Shenzhen Unknown Biotechnology Co., Ltd. and Beijing KT Biotech Co., Ltd. Leveraging its parent companies’ drug R&D platform, probiotic strain library, and GMP-compliant probiotic manufacturing platform, the company focuses on the clinical development of probiotic therapeutics for oncology, gastrointestinal disorders, and other indications. It also provides probiotic drug R&D and manufacturing services to domestic and international live biotherapeutic product (LBP) companies and research institutions. Committed to integrating independent innovation with the adoption of advanced external technologies, the company aims to build a world-class probiotic therapeutic platform to serve human health.

Founded in Huairou, Beijing in 2003, Ketuo Biology is a national high-tech enterprise engaged in the R&D, production, and sales of probiotics and microecological preparations for animals and plants, as well as providing comprehensive product solutions. It is a strategic partner of the Training Bureau of the General Administration of Sport of China. Its products are widely applied in fields such as the food industry, healthcare, livestock breeding, and agricultural cultivation. Ketuo Biology successfully listed on the ChiNext board of China’s A-share market in July 2020. Collaborating with numerous domestic universities, research institutes, and enterprises, Ketuo Biology has isolated, identified, and preserved 21,268 strains of lactic acid bacteria from naturally fermented foods across Asia, as well as from the intestines and breast milk of healthy individuals, establishing Asia’s largest germplasm resource bank for lactic acid bacteria. In cooperation with more than ten Grade III Class A hospitals in China, Ketuo Biology has conducted over 60 clinical trials to evaluate the efficacy of probiotics, achieving effective research outcomes. As of 2022, Ketuo Biology had filed more than 120 patents and published over 300 scientific papers.

Founded in 2017, Xbiome is a leading AI-driven innovative therapeutics drug development company, equipped with an advanced AI+BT microbiome research and product development platform. Leveraging artificial intelligence and biotechnology, Xbiome develops targeted microbiome-based drugs tailored to the specific gut microbiota profiles of patients with different indications. The company boasts a pipeline of over 10 drug candidates, three of which have entered clinical trials. In June 2021, the U.S. FDA officially approved the Investigational New Drug (IND) application for Xbiome’s fecal microbiota transplantation (FMT) drug candidate, XBI-302. According to public information, this marks the first FMT live biotherapeutic product pipeline from Asia to receive FDA clearance for clinical trials. In 2020, Xbiome was recognized as a “National High-Tech Enterprise” and was named one of the “50 Smartest Companies” by MIT Technology Review. It was also listed among the “Top 50 Most Innovative Companies in China” by Fast Company and has been consecutively honored as one of the “Top 50 Innovative Biotech Enterprises in the Greater Bay Area.”