Tiantian Bio and Genexine announced that TJ107 has been approved for Clinical Phase 2 trials

Heavenly Creatures (the "Company")
, a clinically focused biopharmace companies in the field of tumor and autoimmune diseases, and Genexine Inc., a biopharmaceers company in the clinical stage dedicated to the development of innovative immunotherapy and new long-acting biologics, today announced that China's national The Drug Administration has approved the new long-acting recombinant human leukocyte interleukin 7 (rhIL-7) TJ107 / HyLeukin-7™ (Efineptakin alfa) to conduct Phase 2 clinical studies in newly diagnosed patients with glioblastoma with reduced lymphocytes. In addition, the two companies will expand their partnership to jointly advance the development of the TJ107 / HyLeukin-7 ™ for the adaptive disease.The approval and support of China's State Drug Administration is based on the approval of the clinical development program for Tiantian Bio before the declaration of clinical trials of new drugs (pre-IND). With the approval of the Drug Administration, Tiantian Bio and Genexine can launch phase 2 clinical studies in TJ107 / HyLeukin-7™glioblastoma in China without having to submit a new clinical trial application."Innovative therapies are an urgent medical need for patients with glioblastoma," said Dr. Sein Huajun, ceo of Tiantian Bio. This is one of the most invasive brain tumors, and the prognostication of patients has not improved significantly due to limited treatment options. Tiantian Bio and Genexine are very grateful to the Chinese Drug Administration for its accelerated review and support for the development of this innovative drug".“ This further expansion of our partnership with Genexine speaks volumes about our fruitful partnership and the excellent progress we have made so far. This will enable us to better collaborate on the mission of bringing a new generation of cancer immunologic drugs to patients," Added Shen.Under the agreement, Tiantian Bio will be primarily responsible for the implementation of the glioblastoma Phase 2 clinical study in China, while Genexine will share relevant development strategies, data and cost-sharing that will contribute to the success of the clinical study. Financial terms were not disclosed.“ The standard treatment for glioblastoma induces long-lasting lymphocyte reduction in most patients. As a potential therapeutic drug, TJ107 / HyLeukin-7™ has been shown to be effective in inducing T cells, especially initial T cells and memory T cells, and to treat lymphocyte reduction in patients with advanced solid tumors. We are excited to work with Tiantian Bio to develop this promising new therapy," said Dr. Jung Won Woo, Executive Vice President and Chief Development Officer of Genexine.Genexine presented the results of phase 1b clinical trials (clinical trial registration number: NCT03478995) at the 34th Annual Meeting of the Society for Cancer Immunotherapy (SITC) in 2019, showing the ability of TJ107/HyLeukin-7™ to repair functionally defective T cells™ In the study group of 21 patients with advanced solid tumors, the results showed that TJ107/HyLeukin-7™ had good tolerance and no dose-limiting toxicity and cytokine release syndrome. Absolute lymphocyte counts and T-cell sub-groups (non-regulatory T-cells) showed increased dose dependence. The results showed that TJ107/HyLeukin-7™ by increasing the number of T lymphocytes to enhance anti-tumor action, indicating that TJ107/HyLeukin-7™ can be combined with chemotherapy, cancer vaccine and immuno-checkpoint inhibitors (such as anti-PD-1/PD-L1 antibodies) to achieve synergetic anti-tumor effects.Tiantian Bio is currently conducting a Phase 1b clinical study (clinical trial registration number: NCT04001075) in patients with advanced solid tumors in China to assess the safety, toerability, pharmacodynamics, pharmacodynamics and determine the recommended Phase 2 dosage (RP2D™ for TJ107 / HyLeukin-7™
According to data released by GLOBOCAN 2018, an international cancer research organization of the World Health Organization, there are 76,494 new cases of brain and nervous system cancer in China, of which about 17% are glioblastomas. The annual incidence of glioblastoma in China is 5 to 8 people per 100,000 people/year.[1] Ostrom Q T, Gittleman H, Liao P, et al. CBTRUS statistical report: primary brain and other central nervous system tumors diagnosed in the United States in 2010–2014[J]. Neuro-oncology, 2017, 19(suppl_5): v1-v88.About TJ107 / HyLeukin-7™ TJ107/HyLeukin-7™ (Efineptakin alfa) is the world's first and only long-acting recombinant human leukocyte mesokin-7 (rhIL-7), which can promote T lymphocyte proliferation by increasing the number of T lymphocytes and improving T-cell function. The product uses Genexine's patented technology platform hyFc ®-acting biologics developed in the world. Tiantian Bio has obtained an exclusive license from TJ107/HyLeukin ™ clinical development and commercialization in Greater China. TJ107/HyLeukin-7™ may play a role in the reduction of lymphocytes associated with cancer treatment (lower levels of exothermic blood lymphocytes). Lymphocyte reduction is a common phenomenon in cancer patients after chemotherapy or radiotherapy, and there is currently no approved targeted treatment. TJ107/HyLeukin-7™ may also be shown in various tumor animal models to produce synergies with PD-1 antibodies by increasing T cell activation and proliferation.About Tiantian BioTiantian Bio is a dynamic international biotechnology company, focusing on the research and development of differentiated innovative biopharmaceers in the field of tumor immunity and autoimmune diseases, with the mission of "continuously developing innovative biopharmaceians to truly change the lives of patients". Driven by a two-wheel strategy of "fast product launch" and "fast proof of concept", Tiantian Bio has rapidly established more than a dozen innovative drug research and development pipelines with global competitiveness through diversified models such as independent research and development and global cooperation. Tiantian Bio is rapidly growing into an integrated global biopharmaceutical company covering the entire industry chain, thanks to its excellent pharmaceutical research and development team, recognized preclinical and clinical development capabilities, and world-class GMP production capacity. Tiantian Life has offices in Beijing, Shanghai, Hong Kong and Maryland, USA. For more informationabout Genexine, Inc.Genexine, Inc., listed on the Korea GEM Market (KOSDAQ:095700) since 2009, is a leading biopharmaceutical company focused on immuno-oncology and rare diseases. Genexine's goal is to develop innovative biotherapies to save the lives of seriously ill patients. Genexine has a rich clinical-stage product line, such as Hyleukin-7™ (GX-I7), HyTropin (GX-H9), Papitrol (GX-188E) and other drugs based on long-acting Fc fusion technology and DNA vaccine technology. Hyleukin-7 ™ currently in phase 1b or 2 clinical trials of monotherapy or combination therapies for several cancers. Papitrol, a therapeutic DNA vaccine for human papillomavirus (HPV)-related diseases, is currently being used in phase 2 trials with Mercadon Keytruda for advanced relapsed cervical cancer. Genexine has completed a cross-country Phase 2 clinical study of HyTropin (long-acting human growth hormone, hGH-hyFc) on growth hormone deficiency in children and growth hormone deficiency in adults. Founded in 1999, Genexine has more than 160 employees, half of whom are scientists with M.S.S. or Ph.D. degrees. Genexine is located in the Technology Valley of The Boardbridge near Seoul, South Korea.Forward-Looking Statements information disclosed in this press release contains "forward-looking statements." Forward-looking statements contain statements such as "anticipate" and "anticipate". Forward-looking statements are based on the current expectations and assumptions of Heavenly Life. Forward-looking statements relate to future events and are subject to uncertainties, risks and changes in circumstances that may differ materially from those anticipated in the forward-looking statements. Forward-looking statements are not statements of historical fact and are not warranties or confirmations of future performance. The filings with the U.S. Securities and Exchange Commission list important factors that could cause actual results to differ materially from forward-looking statements. Unless otherwise required by law, Tianseon is under no obligation to publicly update or revise any forward-looking statements as a result of new information, future events or otherwise.
(Heavenly Biology Website)