DDR1

WOBURN, Mass., Nov. 14, 2024 /PRNewswire/ -- Azurity Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved Danziten™, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adult patients with chronic phase (CP) and acute phase (AP) resistant or intolerant to prior therapy that included imatinib. "Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna®, but without the fasting requirements of Tasigna," said Richard Blackburn, CEO of Azurity Pharmaceuticals, Inc. "Unlike Tasigna, the boxed warning on the Danziten label has no requirement for patients to take their medication in a fasted state, liberating CML patients from mealtime restrictions." Tasigna has established efficacy in adults with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP.1 However, Tasigna has variable bioavailability that considerably increases when taken with food. In a concentration dependent manner, Tasigna may significantly prolong QT interval on surface electrocardiogram (ECG) when inappropriately taken with food. As such, strict fasting with Tasigna is crucial to avoid cardiotoxicity.2 Danziten is a re-engineered formulation of nilotinib without mealtime restrictions that offers equivalent efficacy to Tasigna but with improved bioavailability, allowing for a lower dose.1,3,4 Danziten demonstrates consistent pharmacokinetics, with no clinically significant differences in nilotinib exposure regardless of fasting state or meal type, while offering the proven efficacy expected from nilotinib.1,5,6 With optimal tyrosine kinase inhibitor (TKI) therapy, patients can achieve deep molecular responses, and some may even attain treatment-free remission.7 The life expectancy of newly diagnosed CP-CML patients who have responded to appropriate treatment is now approaching that of the general population. However, challenges remain, including patient adherence to treatment. Danziten has the potential to improve adherence due to the removal of fasting requirements.7,8 Danziten will be available in the coming weeks through Biologics by McKesson and Limited Specialty Distribution. For full prescribing information including boxed warning, please visit . Azurity will offer patient support through DanzitenCONNECT™, a comprehensive program, subject to terms and conditions, that includes Prior Authorization support and Benefits Investigation, a free first month of Danziten, a co-pay of as little as $0, and a Patient Assistance Program (PAP). About Azurity Pharmaceuticals, Inc. Azurity specializes in providing innovative, high-quality medicines that serve overlooked patients. We supply a large number of products to treat a wide range of medical conditions. These include anti-infective, cardiovascular/cardiology, central nervous system/cerebrovascular, endocrinology, gastrointestinal, immunology, and oncology medicines. Many of our medicines are dose-form innovations for patients with needs that are not met by other available products. Our medicines have benefited millions of people. For more information, visit . Sources: DANZITEN [prescribing information]: Woburn, MA: Azurity Pharmaceuticals, Inc; 2024. Tasigna [prescribing information]: East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2024. Radich J, Mauro M, Jain P , et al. Population pharmacokinetic (PopPK) modeling for a novel nilotinib formulation. Presented at: SOHO 2024 Annual World; September 4-7 , 2024; Houston, TX. Tan BK, Tan SB, Chen L. Medication-related issues associated with adherence to long-term tyrosine kinase inhibitors for controlling chronic myeloid leukemia: a qualitative study . Patient Prefer Adherence. 2017;11:1027-1034. Hochhaus A, Masszi T , Giles FJ, et al. Treatment-free remission following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the ENESTfreedom study . Leukemia. 2017;31(7):1525-1531. Hughes TP , Saglio G, Kantarjian HM, et al. Early molecular response predicts outcomes in patients with chronic myeloid leukemia in chronic phase treated with frontline nilotinib or imatinib. Blood. 2014;123(9):1353-1360. Chronic Myeloid Leukemia. Leukemia & Lymphoma Society; 2023. Accessed October 29, 2024. Hochhaus A, Baccarani M, Silver RT, et al. European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia. Leukemia. 2020;34(4):966-984. PP-DAN-US-0080 SOURCE Azurity Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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

Phase 1c study of PRTH-101 alone or in combination with KEYTRUDA® in patients with advanced or metastatic solid tumors will inform optimal design of the Phase 2/3 study PRTH-101 demonstrated favorable safety profile in Phase 1a and 1b studies CAMBRIDGE, MA, USA I September 10, 2024 I Incendia Therapeutics , a precision oncology company discovering and developing a novel class of therapies that reprogram the tumor microenvironment (TME), today announced that the first patient has been enrolled in the Phase 1c study of PRTH-101 for the treatment of patients with advanced or metastatic solid tumors. “In our Phase 1a and 1b studies, we were able to select an optimal dose and identify potential biomarkers to carry forward” said Irena Webster, SVP Development and Operations of Incendia. “The data from this study will inform the design of the Phase 2/3 program, for which planning and global feasibility are currently underway.” Dr. Joseph Paul Eder, CMO, added “Incendia, with its outstanding team of investigators and investigative sites, has determined a recommended Phase 2 dose of PRTH 101. PRTH 101 has shown consistent safety as a single agent and in combination with pembrolizumab. We will now focus on tumor types that have demonstrated signs of clinical activity and patient benefits.” The Phase 1c study will evaluate the safety, tolerability and anti-tumor activity of PRTH-101 as both a monotherapy and in combination with KEYTRUDA® (pembrolizumab). About PRTH-101 PRTH-101 is a therapeutic antibody that targets DDR1, a collagen binding protein and kinase present on epithelial cells. Some tumor cells are believed to co-opt DDR1 – collagen binding to build an impenetrable barrier around the tumor. By allosterically disabling DDR1, PRTH-101 disrupts tumor associated collagen alignment to permit immune cell access into the tumor core. In preclinical experiments, PRTH-101 mediated DDR1 blockade has demonstrated both single agent anti-tumor activity as well as marked augmentation of checkpoint inhibitor function. Tumor types that express high levels of DDR1-associated collagen barriers include thymic, colorectal, pancreatic, ovarian, glioma, and non-small cell lung cancer. Currently, there are no approved drugs that target DDR1. About the Phase 1 Trial The Phase 1 trial ( NCT05753722 ) is a multi-center, open-label, dose escalation and dose expansion study that is expected to enroll up to 270 patients in the US with advanced or metastatic solid tumors. The goals of the study are to assess safety and tolerability of PRTH-101, evaluate anti-tumor activity in select indications alone and in combination with anti-PD-1 inhibitors, and determine dosing regimens for the Phase 2 clinical program. In addition to examining the clinical profile of PRTH-101, the trial will evaluate DDR1 and pathway-related proteins as predictive biomarkers for patients whose tumors respond to treatment. About Incendia Therapeutics Incendia Therapeutics is discovering and developing a novel class of experimental therapeutics that reprogram the tumor microenvironment (TME). Incendia’s platform is based on rigorous, groundbreaking research involving spatial characterization of the tumor microenvironment, multi-omics data integration, and extensive preclinical testing. The Company’s most advanced experimental molecule, PRTH-101, is in a Phase 1c clinical trial for the treatment of patients with advanced solid tumors. For more information visit incendia.com and LinkedIn . SOURCE: Incendia Therapeutics