LTα

CAMBRIDGE, Mass., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the appointment of Jane Grogan, Ph.D., as Executive Vice President, Head of Research effective 2 October 2023. Dr. Grogan will be a member of Biogen’s Executive Committee reporting to Christopher A. Viehbacher, President and Chief Executive Officer. “Dr. Grogan is a pioneering scientist whose groundbreaking discoveries at Genentech helped pave the way for development of targeted autoimmune and oncology therapies. I believe Jane will be a strong asset to Biogen as we seek to bring a greater number of innovative medicines to market faster and more effectively,” said Mr. Viehbacher. “Together with Dr. Priya Singhal, EVP and Head of Development, she will determine the company’s portfolio strategy with the aim of creating value and making decisions aligned with our scientific expertise and translational capabilities.” Jane Grogan brings nearly two decades of experience leading biotech research, including fifteen years with Genentech. Dr. Grogan most recently served as the Chief Scientific Officer at Graphite Bio, a cell and gene editing company. Prior to this, she served as Chief Scientific Officer at ArsenalBio, a privately held programmable T cell therapy company, responsible for research, discovery and preclinical pipeline, including development for the company’s first product candidate. During her time at Genentech, Dr. Grogan served in a number of increasingly senior roles across Immunology and Immuno-oncology, covering research strategies and drug development across RA, Lupus, MS, IBD and Cancer. As Head of Adaptive Tumor Immunity and Principal Scientist in Cancer Immunology Discovery Research at Genentech, Dr. Grogan’s research primarily delved into mechanisms of T cell activation, tolerance-induction, and epigenetic modifiers, adopting an integrative methodology combining bioinformatics, biology, and diagnostics. Her laboratory identified crucial regulators of both effector and regulatory T cells and progressed several targets into clinical trials for autoimmune and oncology indications, such as anti-lymphotoxin alpha for rheumatoid arthritis and anti-TIGIT for cancer immunotherapy. At Genentech, Dr. Grogan also integrated strategy between Early Discovery Research, Clinical Development, and Business Development and was project leader for engineered T cell therapies. During her career, Dr. Grogan has published more than 60 papers in a wide array of journals and is listed as inventor on more than 20 patents. She received her Bachelor of Science at the University of Melbourne, Australia, earned her PhD in Immunology from Leiden University, The Netherlands, and underwent post-doctoral training as an Alexander von Humboldt Fellow at the DRFZ in Berlin and as a Howard Hughes Fellow at the University of California, San Francisco. About BiogenFounded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world. We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - X, LinkedIn, Facebook, YouTube. Biogen Safe Harbor This news release contains forward-looking statements, including statements relating to our business activities; our strategy and plans and the potential of our commercial business and pipeline programs; capital allocation and investment strategy. These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will” and other words and terms of similar meaning. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our dependence on sales from our products; uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; failure to compete effectively due to significant product competition in the markets for our products; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; our dependence on collaborators, joint venture partners, and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; the potential impact of the conflict in Ukraine; risks associated with current and potential future healthcare reforms; risks related to commercialization of biosimilars; risks relating to the distribution and sale by third parties of counterfeit or unfit versions of our products; risks relating to the use of social media for our business; failure to obtain, protect, and enforce our data, intellectual property, and other proprietary rights and the risks and uncertainties relating to intellectual property claims and challenges; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; risks relating to technology failures or breaches; problems with our manufacturing processes; risks relating to management and personnel changes, including attracting and retaining personnel; failure to comply with legal and regulatory requirements; the risks of doing business internationally, including currency exchange rate fluctuations; risks relating to investment in our manufacturing capacity; the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations, and financial condition; fluctuations in our operating results; risks related to investment in properties; the market, interest, and credit risks associated with our investment portfolio; risks relating to share repurchase programs; risks relating to access to capital and credit markets; risks related to indebtedness; change in control provisions in certain of our collaboration agreements; fluctuations in our effective tax rate; environmental risks; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission. This news release speaks only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements. MEDIA CONTACT:BiogenJack Cox+ 1 781 464 3260public.affairs@biogen.comINVESTOR CONTACT:BiogenChuck Triano+1 781 464 2442IR@biogen.com

A few months ago, Takeda paid $4 billion to buy the psoriasis drug TAK-279 from startup Nimbus Therapeutics. Recently, Takeda announces the positive results in Phase 2b study of the drug, at the highest dose of TAK-279, 46% of patients achieved PASI 90 and 33% achieved PASI 100 at 12 Weeks, Indicating a near-total or total clearance of skin lesions. It hasn’t been previously shown with an oral pill and approaches that of more potent injectable drugs. What is TAK-279? TAK-279 is one of many medicines in development that target TYK2, an enzyme involved in cell signaling pathways that are implicated in inflammation. These treatments have become highly coveted by drugmakers because of their potential to be oral alternatives to top-selling, injectable medicines like Humira. Last September, the Food and Drug Administration made Sotyku the first TYK2 inhibitor approved, clearing it for psoriasis. TAK-279 is a small molecule drug developed by Nimbus Therapeutics LLC that targets TYK2, a member of the Janus kinase (JAK) family involved in the signaling pathways of various cytokines. TAK-279 functions as a TYK2 inhibitor and is being investigated for its potential therapeutic applications in autoimmune diseases such as plaque psoriasis and psoriasis. This drug aims to interrupt the JAK/STAT signaling pathway, which plays a crucial role in immune cell function and has been implicated in a range of autoimmune diseases. Currently, TAK-279 has reached phase 2 clinical trials, the second highest phase of clinical development. The progress made thus far in developing TAK-279 suggests its potential as a promising therapeutic option for patients with autoimmune diseases. About Psoriasis Psoriasis is a chronic, immune-mediated disorder with cutaneous and systemic manifestations and substantial negative effects on patient quality of life. Psoriasis has a strong, albeit polygenic, genetic basis. Whereas approximately half of the accountable genetic effect of psoriasis maps to the major histocompatibility complex, >70 other loci have been identified, many of which implicate nuclear factor-κB, interferon signalling and the IL-23–IL-23 receptor axis. Search the drug intelligence database: Synapse, a total of 970 drugs and 3509 clinical trials were found for the treatment of psoriasis. For this indication, the top three research and development organizations are Pfizer, Novartis and Amgen, the major R&D targets are focused on TNF-α、GR and LTα. The top three types of drug development for this indication are Small molecule drug, Monoclonal antibody, and Biosimilar. Finally Takeda Will Evaluate TAK-279 in Additional Immune-Mediated Diseases Including Systemic Lupus Erythematosus (SLE) and Inflammatory Bowel Disease (IBD), and Explore Further Indications in the Future. If you’re interested in learning more about this space or keeping track of drug development and clinical trials, sign up for Synapse（synapse.patsnap.com）, our freemium product offering.

LA JOLLA, Calif., Dec. 06, 2022 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that MediciNova’s Chief Medical Officer, Kazuko Matsuda, MD PhD MPH, presented positive results from a subgroup analysis of the completed Phase 2 clinical trial which evaluated MN-001 (tipelukast) for the treatment of hypertriglyceridemia at the International Diabetes Federation (IDF) World Diabetes Congress 2022 held online December 5 - 8, 2022. In the completed Phase 2 study, MN-001 (tipelukast) significantly reduced serum triglycerides in participants with non-alcoholic fatty liver disease (NAFLD) and hypertriglyceridemia (HTG). Subsequent in vitro results revealed that MN-001 (tipelukast) downregulated CD36 and upregulated ABCG1 mRNA expression, both of which are highly associated with Type 2 diabetes mellitus (T2DM). Hypothesizing that MN-001 (tipelukast) might be more effective at reducing serum triglycerides in participants with a dual diagnosis of NAFLD and Type 2 diabetes mellitus (T2DM), a subgroup analysis was conducted in participants with and without T2DM. In the presentation entitled, “Improvement of Serum Lipid Panel by Tipelukast (MN-001) in Type 2 Diabetes Mellitus and Non-alcoholic Fatty Liver Disease Patients" (Abstract #LI2022-1192) the following results were announced: Compared to subjects without T2DM, the T2DM group showed a greater reduction in serum triglyceride levels at Week 8 (50.8% reduction for with T2DM versus 17.8% reduction for without T2DM, p=0.098).Mean HDL increase was significantly greater in subjects with T2DM than subjects without T2DM at Week 8 (15.8% versus 1.0%, p<0.0002). In comparison to subjects without T2DM, the T2DM group showed a greater reduction in serum LDL levels at Week 8 (15.4% versus 6.7%). Kazuko Matsuda, M.D. Ph.D., M.P.H., Chief Medical Officer, MediciNova, Inc., commented, “We are very pleased to present this subgroup analysis of the results of our completed Phase 2 trial in individuals diagnosed with NAFLD and hypertriglyceridemia. Those participants with T2DM/prediabetes showed greater improvement in the serum lipid profile than participants without T2DM. These findings suggest that MN-001 is a potential treatment for patients with dyslipidemia and NAFLD due to T2DM. A trial to evaluate the efficacy and safety of MN-001 in patients with T2DM, NAFLD, and HTG is currently ongoing.” About NAFLD, Type 2 Diabetes Mellitus (T2DM), and Hypertriglyceridemia NAFLD is considered the hepatic manifestation of metabolic syndrome; studies have reported that 50% of patients with metabolic syndrome also have NAFLD. There is sufficient clinical and epidemiological evidence supporting the assertion that NAFLD is strongly associated with an increased prevalence and incidence of cardiovascular disease, T2DM, chronic kidney disease, and malignancy. The presence of dyslipidemia (hypercholesterolemia, hypertriglyceridemia, or both) is reported in 20 - 80% of NAFLD cases. About MN-001 MN-001 (tipelukast) is a novel, orally bioavailable, small molecule compound thought to exert its effects through several mechanisms to produce its anti-inflammatory and anti-fibrotic activity in preclinical models, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). The 5-LO/LT pathway has been postulated as a pathogenic factor in fibrosis development, and MN-001's inhibitory effect on 5-LO and the 5-LO/LT pathway is a novel approach to treat fibrosis. MN-001 has been shown to down-regulate expression of genes that promote fibrosis including LOXL2, Collagen Type 1 and TIMP-1. MN-001 has also been shown to down-regulate expression of genes that promote inflammation including CCR2 and MCP-1. In addition, MN-001 was found to inhibit triglyceride synthesis in hepatocytes by inhibiting arachidonic acid uptake. About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in glioblastoma and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2021 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT: Geoff O'Brien Vice President MediciNova, Inc. info@medicinova.com