Aurora B

SHENZHEN, China, Nov. 1, 2024 /PRNewswire/ -- On November 1, Shenzhen Chipscreen Biosciences Co., Ltd. (hereinafter referred to as "Chipscreen Biosciences") and its wholly-owned subsidiary Chengdu Chipscreen Pharmaceutical Ltd., received the "Drug Clinical Trial Approval Notice" approved by the National Medical Products Administration. The company's self-developed original new drug, Chiauranib, combined with PD - (L) 1 monoclonal antibody and standard chemotherapy for the first-line treatment of extensive stage small cell lung cancer, has been approved for phase III clinical trials. Extensive disease small cell lung cancer (ES-SCLC), as a highly aggressive subtype of lung cancer, has long been a huge challenge in the field of treatment. In recent years, chemo-immunotherapy has greatly improved the survival outcomes of patients with small cell lung cancer. However, compared to other types of tumors, there is still great room for improvement in the long-term survival of patients with small cell lung cancer. Chiauranib has a multi pathway pharmacological mechanism and has unique anti-tumor activity against neuroendocrine tumors such as small cell lung cancer. At the same time, it can produce synergistic effects with immunotherapy and chemotherapy through its dual effects of anti-angiogenesis and immune regulatory activity. On the basis of first-line chemo-immunotherapy, the introduction of the new regimen of Chiauranib is expected to further improve the long-term survival of patients with extensive stage small cell lung cancer, demonstrating enormous clinical treatment potential. In addition to the approved Phase III clinical trial, the phase III clinical trial of Chiauranib monotherapy for the later-line treatment of small cell lung cancer has been completed and the Pre NDA is currently under communication. The phase III clinical trial of Chiauranib combined with chemotherapy for ovarian cancer, and the phase II clinical trial of single or combined treatment for triple negative breast cancer, soft tissue sarcoma and pancreatic cancer are also being progressed. In terms of overseas clinical trials, the phase Ib/II clinical trial of Chiauranib monotherapy for small cell lung cancer / solid tumor is in progress in the United States. About Chiauranib Chiauranib is a novel molecular entity independently designed and developed by the Chipscreen Biosciences, with global patent protection. It is a selective inhibitor of Aurora B, a key mitotic regulator. Additionally, Chiauranib targets VEGFR to inhibit tumor angiogenesis, and blocks CSF1R and DDR1 pathways to reduce the infiltration and activity of immunosuppressive cells, thereby enhancing tumor immune microenvironment. Its unique Aurora B inhibitory activity specifically targets neuroendocrine tumors, such as SCLC, making it a novel small molecule anti-tumor drug candidate. Chiauranib exerts a comprehensive anti-tumor effect by a triple-pathway mechanism that simultaneously inhibits tumor angiogenesis, prevents tumor cell mitosis, and modulates the tumor microenvironment. Chiauranib has outperformed drugs with a similar mechanism in overall efficacy and safety profile. About Chipscreen Chipscreen Biosciences is an innovative drug company driven by core technologies with globally competitive pipelines. As a pioneer in drug innovation & development in China, adhering to the concept of "Constant Innovation for Life", we focus on developing revolutionary innovative drugs with new mechanisms of action, to address patients' pressing clinical needs. Our complete industry chain that covers early exploratory discovery through commercialization allows us to provide innovative Chinese drugs for patients worldwide. With a global development strategy based on early-stage research in China, Chipscreen Biosciences has leveraged the top scientists and teams with extensive experience in related fields from the Shenzhen Small Molecule Early R&D Center and Chengdu Small Molecule Early R&D Center to create an integrated technology platform based on AI-driven design and chemical genomics, which spanned the whole process from basic science to clinical translation. We have successfully developed first-in-class and best-in-class innovative drugs. Currently, 2 drugs with 6 indications have been marketed worldwide. In addition, we have launched a number of R&D projects with differentiated advantages and global competitiveness in the five major areas, including malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antivirals. Chipscreen Biosciences has formed a global industrial layout consisting of Shenzhen Head Office/R&D Center/GMP production base, Chengdu Regional Head Office/R&D Center/GMP production base, Beijing Branch, Shanghai Branch, and Chipscreen Biosciences (USA) Co., Ltd. Meanwhile, as one of the first batches of national "innovative drug incubation bases" and national high-tech enterprises, Chipscreen Biosciences has independently undertaken many national "863" plans and national major science and technology projects, such as "10th five-year plan", "11th five-year plan", "12th five-year plan" and "13th five-year plan", and National Science and Technology primary Project for Innovative Drug Development. We have filed over 680 invention patents in China and worldwide, with over 200 granted. SOURCE Shenzhen Chipscreen Biosciences Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

REYKJAVIK, Iceland, Oct. 29, 2024 /PRNewswire/ --Scientists at deCODE genetics/Amgen, and their collaborators have discovered six novel genes with rare germline variants that associate with cancer risk. The findings are published today in Nature Genetics under the title "Gene-based burden tests of rare germline variants identify six cancer susceptibility genes". Continue Reading Kari Stefansson senior author of the paper, “Gene-based burden tests of rare germline variants identify six cancer susceptibility genes”, published today in Nature Genetics, discusses the paper with Erna V. Ivarsdottir first author on the paper. Kari Stefansson CEO of deCODE genetics and senior author on the paper in Nature Genetics, with Erna V. Ivarsdottir scientists at deCODE genetics and first author. A subset of cancers arises in individuals who are born with rare sequence variants that significantly alter their cancer risk. The discovery of such variants, like those in the BRCA1- and BRCA2 genes, has led to improved early cancer detection and the development of targeted therapies, ultimately reducing the cancer burden and improving prognosis of those carrying these mutations. In this study, the scientists analysed three large genetic datasets from individuals of European descent, including 130,991 cancer patients and 733,486 controls. Through a gene-based burden association analysis across 22 different cancer types, they found four novel genes associated with a risk of developing cancer; the pro-apoptotic BIK for prostate cancer, the autophagy involved ATG12 for colorectal cancer, TG for thyroid cancer, and CMTR2 for both lung cancer and cutaneous melanoma. The relative increase in cancer risk conferred by these variants was substantial (90-295%), but it should be noted that the design of the study does not allow accurate assessment of absolute lifetime cancer risk. Additionally, the researchers found the first genes with rare variants that are associated with a decreased risk of cancer. Specifically, loss of AURKB was found to protect against any cancer type, and loss of PPP1R15A was associated with 53% lower risk of breast cancer. This suggests that inhibition of PPP1R15A may be a therapeutic option for breast cancer. The study revealed new insight into the biological mechanisms involved in cancer predisposition that will hopefully lead to better screening and treatment strategies. Video - Photo - SOURCE deCODE genetics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

RSS Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Lupkynis® (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus, an autoimmune disease. Lupkynis is a novel, oral immunosuppressive agent developed for the treatment of LN. It suppresses the immune system by inhibiting calcineurin, an enzyme that is crucial for the proliferation and activation of T cells, an important element of the immune system. In the U.S., Aurinia Pharmaceuticals Inc. (Aurinia) received FDA marketing approval in January 2021 for Lupkynis as a treatment for active LN in adults. In September 2022 Otsuka received European Commission (EC) approval for Lupkynis as the treatment for active LN in EU member countries. Otsuka has subsequently received reimbursement in several EU countries as well as in the UK. In December 2020, Otsuka and Aurinia announced that they entered into a collaboration and license agreement for the development and commercialization of oral voclosporin for the treatment of LN in Japan, the European Union (EU), and the UK, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine. Otsuka Pharmaceutical has been committed to research and development that contributes to patients and their families in order to meet unmet medical needs worldwide, focusing on cardiovascular, renal and autoimmune diseases as one of which are among our priority areas. About lupus nephritis Lupus nephritis (LN) is an inflammation of the kidneys caused by systemic lupus erythematosus (SLE). The kidneys are vital organs, and LN is an irreversible and progressive condition that puts them at risk for long-term complications. If left untreated, this kidney inflammation impairs kidney function and can lead to permanent kidney damage and even kidney failure, known as end-stage renal disease (ESRD). LN is one of the most serious complications of SLE. In Japan, the number of SLE patients is estimated to be between 60,000 and 100,000, with women accounting for 90% of cases. It is particularly prevalent among women aged 20 to 40.1 Asians have a higher incidence of renal involvement compared to Caucasians, with 21% to 65% of Asian patients (living in Asia) with SLE having developed LN by the time of diagnosis, and 40% to 82% developing it over time.2 The development of LN in SLE patients often occurs at a relatively young age and is believed to increase the risk of end-stage renal failure, leading to a deterioration in life expectancy. The challenge is to achieve rapid remission of glomerulonephritis with reduction in proteinuria, while avoiding long-term use of high doses of steroid medication. About the clinical trials AURORA 1 and AURORA 23, 4 The MHLW approval is based on data from clinical trials, including AURORA 1 and AURORA 2. The AURORA 1 international phase 3 trial was conducted with the primary endpoint of renal response at 52 weeks. A total of 357 patients with active LN from age 18 to 75 were enrolled in the trial, of whom 179 patients and 178 patients were randomly assigned to the voclosporin and placebo groups, respectively. Both the voclosporin group and the placebo group were co-administered with mycophenolic mofetil and oral steroids during the trial, with a regimen to reduce the dose of steroids. The proportion of patients achieving renal response at 52 weeks was significantly higher in the voclosporin group at 40.8% compared to 22.5% in the placebo group (p＜0.001). AURORA 2 evaluated the long-term safety, tolerability, and efficacy of voclosporin compared to placebo in 216 patients with LN (116 in the voclosporin group and 100 in the placebo group) who received an additional 2 years of treatment following completion of AURORA 1. The long-term safety and tolerability was assessed and no new or unexpected safety signals were observed. Reference 1. Information Center for Rare Diseases https://www.nanbyou.or.jp/entry/53 (as of September 2024) 2. Jakes, RW. et al.:Arthritis Care Res. 2012; 64(2): 159-168 3. Brad H Rovin, Y K Onno Teng, et al. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-bling, randomized, multicenter, placebo-controlled, phase 3 trial. Lancet 2021; 397: 2070-80 4. Amit Saxena, Ellen M. Ginzler, et al. Safety and efficacy of long-term voclosporin treatment for lupus nephritis in the phase 3 AURORA 2 clinical trial. Arthritis & Rheumatology Vol. 76, No. 1, January 2024, pp 59-67