Cosentyx shows efficacy in key manifestations of psoriatic arthritis

pharmatimes | June 12, 2019

Novartis has announced that its drug Cosentyx (secukinumab) has been found to show efficacy and safety of a biologic in the management of axial manifestations of psoriatic arthritis, in first-of-its kind data. The company announced that the ongoing 52-week Phase IIIb trial met both its primary and key secondary endpoint with 63.1% of Cosentyx 300 mg and 66.3% of Cosentyx 150 mg patients achieving ASAS20 at week 12, compared to 31.3% for placebo. Dr Antonio Mera Varela, head of rheumatology at Hospital Clínico Universitario de Santiago de Compostela explained that the data marks the "First time we've seen the efficacy of a biologic in the axial manifestations of psoriatic arthritis at 12 weeks.” Dr Antonio continued, ”As a physician, it's highly important that there is something that can help manage all aspects of my patients' psoriatic arthritis, including inflammation of the spine, joints, enthesitis, dactylitis and psoriasis of the skin and nails.” The company says that the results strengthen unique position of Cosentyx as a rapid, comprehensive treatment of spondyloarthritis and psoriatic disease, with over 200,000 patients treated worldwide.

Spotlight

Chronic immune activation and elevated numbers of circulating activated monocytes (CD16) are implicated in HIV-associated neuroinflammation. The objective was to compare the level of circulating CD16 monocytes and IFN-γ-inducible protein 10 (IP-10) between HIV-infected cannabis users (HIV+MJ+) and noncannabis users (HIV+MJ-) and determine whether in-vitro Δ-Tetrahydrocannabinol (THC), a constituent of cannabis, affected CD16 expression as well as IP-10 production by monocytes.


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BUSINESS INSIGHTS

invoX Pharma to Acquire F-star Therapeutics, Inc. a Pioneering Next Generation Bispecific Discovery Platform and Clinical Programs

F-star Therapeutics, Inc. | June 24, 2022

invoX Pharma a wholly owned subsidiary of Sino Biopharmaceutical Limited focused on research and development and business development activities outside of China, and F-star Therapeutics, Inc. a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives, today announced that the companies have entered into a definitive agreement whereby invoX will acquire all of the issued and outstanding shares of F-star common stock for $7.12 per share. The proposed acquisition values F-star at approximately $161 million. The transaction has been unanimously approved by the invoX and F-star Boards of Directors and is expected to close in the second half of 2022. F-star’s proprietary platform technology pioneers the use of tetravalent (2+2) bispecific antibodies that enable the simultaneous targeting of two different antigens and a unique set of pharmacology to deliver focused, potent and safe immune activation in the tumor microenvironment. Four programs are progressing in clinic, three based on F-star’s tetravalent platform and one next generation STING agonist, with multiple further undisclosed programs in development. These programs represent potentially first- and best-in-class drug candidates for many areas of unmet medical need, including patients with cancer and other serious diseases who have few other options available. Leveraging its modular antibody technology, F-star has forged collaborations with major international biopharma companies across a wide range of therapeutic areas including oncology, immunology and neurology. invoX, established in 2021 in the United Kingdom, is Sino Biopharm’s international expansion platform, focusing on R&D and business development activities outside of China, with a core focus on oncology and respiratory therapeutics. F-star will form a key element of invoX’s strategy to accelerate Sino Biopharm’s development of innovative medicines to transform the lives of patients worldwide, complementing its existing R&D platforms and pipeline. “Today’s proposed acquisition is aligned with invoX’s strategy to become a fully integrated biopharmaceutical company with an advancing pipeline of innovative products addressing unmet healthcare needs, worldwide. We are excited to welcome F-star employees and look forward to working with them as we invest in the company to progress and grow its clinical pipeline to realize the full potential of the platform.” Ben Toogood, Chief Executive Officer of invoX Eliot Forster, Chief Executive Officer of F-star said: “We believe our tetravalent bispecifics offer the best approach to tackle hard-to-treat cancers and other serious diseases, with the ambition to deliver longer and improved lives for patients. Today’s announcement is good news for F-star, for our shareholders and, of course, for patients. This transaction enables greater and longer-term opportunities to develop the F-star platform and accelerate delivery of our novel medicines as we work together towards a future free from cancer and other serious diseases. I’d like to thank the fantastic team at F-star as well as our partners for all their hard work, support and dedication and I’m delighted to share this exciting development.” About invoX Pharma invoX Pharma was incorporated in March 2021 and is a wholly owned subsidiary of Sino Biopharm, a global top 40 pharmaceutical company with more than 24,000 employees. United Kingdom-based invoX is Sino Biopharm’s international expansion platform, focusing on R&D and business development activities outside of China, with a core focus on oncology and respiratory therapeutics. At its core, the Company aspires to improve patients’ lives by creating access to innovative medicine. About Sino Biopharm Sino Biopharm, together with its subsidiaries, is a leading, innovative research and development driven pharmaceutical conglomerate in China, with a business scope that is vertically integrated including research and development, manufacturing and sales and marketing infrastructure. The Company’s product offerings include a variety of biologics and small molecule drugs, and in therapy areas that include hepatology, oncology, cardiovascular and cerebrovascular diseases, orthopaedics, digestive and immune and respiratory diseases. About F-star Therapeutics, Inc. F-star Therapeutics, Inc. is a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives. F-star is committed to working towards a future free from cancer and other serious diseases, through the use of tetravalent (2+2) bispecific antibodies to create a paradigm shift in treatments. The Company has four second-generation immuno-oncology therapeutics in the clinic, each directed against some of the most promising IO targets in drug development, including LAG-3 and CD137. F-star’s proprietary antibody discovery platform is protected by an extensive intellectual property estate. F-star has over 500 granted patents and pending patent applications relating to its platform technology and product pipeline. The Company has attracted multiple partnerships with biopharma targeting significant unmet needs across several disease areas, including oncology, immunology, and CNS.

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BUSINESS INSIGHTS

Iktos Announces Collaboration With Galapagos in AI For Drug Design

Iktos, | June 29, 2022

Iktos, a company specialized in Artificial Intelligence for new drug design, announced a collaboration with Galapagos, a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines, to apply Iktos’s generative modelling artificial intelligence (AI) technology in one of Galapagos drug discovery programs. Under the agreement, Iktos will apply its de novo ligand and structure-based generative modelling technologies and software Makya™, its AI-based retrosynthesis analysis and planning tool Spaya™, and its know-how in computational drug design to expedite the identification of potential pre-clinical candidates and to identify additional novel chemical matter with suitable properties. Galapagos scientists will benefit from direct access to Makya™ and Spaya™ as part of the collaboration. Iktos’s AI technology, based on deep generative models, helps to bring new insights and directions into the drug discovery process based on a comprehensive data-driven chemical structure generation technology. This technology automatically designs virtual novel molecules with all of the characteristics of a successful drug molecule. This approach, validated through multiple collaborations, is a novel solution to one of the key challenges in drug design: rapid identification of molecules that simultaneously satisfy multiple parameters, such as potency, selectivity, safety, and project-specific properties. This approach uniquely enables the exploration of chemical space and produces innovative molecule designs with greater freedom to operate. Iktos has also diversified its R&D efforts into the development of an AI technology for retrosynthesis and has developed the AI-based retrosynthesis analysis and planning tool Spaya™ enabling systematic exploration and prioritisation of synthetic routes for a desired compound in minutes. “We are thrilled and proud to join forces with Galapagos with the aim to discover optimised lead compounds for one of Galapagos undisclosed small molecule drug discovery projects. Pleased to have earned Galapagos trust, we are confident that together with Galapagos established R&D team, we will be able to identify promising novel chemical matter and solve complex multiparametric optimisation problems. The insights and feedback from Galapagos research team will be highly valuable to guide us into improving our technology and products.” Yann Gaston-Mathé, President and CEO of Iktos About Iktos Incorporated in October 2016, Iktos is a French start-up company specialized in the development of artificial intelligence solutions applied to chemical research, more specifically medicinal chemistry and new drug design. Iktos is developing a proprietary and innovative solution based on deep learning generative models, which enables, using existing data, to design molecules that are optimized in silico to meet all the success criteria of a small molecule discovery project. The use of Iktos technology enables major productivity gains in upstream pharmaceutical R&D. Iktos offers its technology both as professional services and as a SaaS software platform, Makya™. Iktos is also developing Spaya™, a synthesis planning software based upon Iktos’s proprietary AI technology for retrosynthesis.

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LexisNexis® Reed Tech™ and Schlafender Hase® Alliance Provides Mutual Customer Benefits for Pharmaceutical and Medical Device Companies

LexisNexis Reed Tech | April 27, 2022

Reed Technology and Information Services Inc. a leading provider of data management and analytics solutions for the life sciences industry, announced an alliance with Schlafender Hase®, the market leader for intelligent, automated proofreading software and services for regulated industries. Current and prospective customers of both companies can leverage exclusive benefits as part of this new alliance ecosystem. Pharmaceutical labelers who have regulatory deadlines for US FDA can benefit from the expert conversion and submission services offered by Reed Tech while ensuring reduced risk and greater accuracy in the proofreading process for drug labels and related documentation with Schlafender Hase's TVT®, the Text Verification Tool®. "Schlafender Hase is already a trusted ally as part of our pharmaceutical SPL conversion process. By offering our UDI and pharma customers the benefits of TVT, we continue advancing our mission of providing innovation for the unique workflows of these specialty manufacturers. Ensuring the accuracy of labels, barcodes, graphics and IFU language is essential. With TVT®, regulatory team members around the world benefit from superior, automated proofreading in order to reduce risk and meet the compliance requirements of local health authorities," Arshad Rahman, General Manager of the Reed Tech Life Sciences division "Schlafender Hase is pleased to recognize Reed Tech as an industry-leading, core SPL conversion service provider. It will be productive for our customers to have access to their deep understanding of regulatory submission requirements for drug manufacturers and distributors," said Peter Muller, Sales Director, North America at Schlafender Hase. Those manufacturers bringing new products to market or maintaining existing portfolios will benefit from the subject-matter expertise offered by Reed Tech." Both the pharmaceutical and medical device industries are continually upgrading processes and preparing for multiple global health authority requirements. The complementary solutions and services between Reed Tech and Schlafender Hase offer critical efficiency gains in managing the product life cycle. About LexisNexis Legal & Professional LexisNexis® Legal & Professional provides legal, regulatory, and business information and analytics that help customers increase their productivity, improve decision-making, achieve better outcomes, and advance the rule of law around the world. As a digital pioneer, the company was the first to bring legal and business information online with its Lexis® and Nexis® services. LexisNexis Legal & Professional, which serves customers in more than 150 countries with 10,500 employees worldwide, is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers. Reed Tech serves manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles by delivering better outcomes for the collection, transformation, submission and analysis of regulatory data. Our solutions support the innovation ecosystem and enable you to achieve regulatory compliance and improved product data management contributing to impactful innovations to our world. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis® company. About Schlafender Hase Schlafender Hase leads the way in intelligent, automated text and graphic proofreading solutions. With its flagship product, TVT®, the Text Verification Tool®, users can quickly compare source content with output formats, detecting changes and deviations prior to publication. Schlafender Hase serves regulated industries across the globe. Clients include the world's leading pharmaceutical and medical device companies, as well as healthcare regulatory bodies. The continued success of Schlafender Hase is based on delivering quality products and a strong understanding of customer pain points. Easy to use, our products reduce proofreading workloads, assure the quality of printed and online materials, and mitigate the risk of costly errors.

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PHARMA TECH

Aquavit Further Prevails Against Counterfeiters in U S Following its Recent Victory in Europe

Aquavit Pharmaceuticals, Inc | March 22, 2022

Aquavit Pharmaceuticals, Inc continues to succeed in its intellectual property cases against counterfeiters both domestically and abroad. Following a recent win against counterfeiter U-BioMed, Inc. across the European Union, the U.S. Southern District Court of New York adopted Judge Lehrburger's recommendations that any sanctions related to U-BioMed's deletion of its Instagram account, which blatantly exploited Aquavit's AQUAGOLD product illegally, be folded into the pre-existing sanctions requiring U-BioMed to pay Aquavit's reasonable legal fees and costs associated with the sanctions-related motions. The Court further reinforced Lehrburger's preview award ordering U-BioMed to pay attorney fees and costs to Aquavit in compensatory damages. U-BioMed's continuous violation of the court's order in 2019 has to date accumulated the court's coercive sanction to millions of dollars. "The depths to which counterfeiters have gone to exploit Aquavit's patented technology, confuse customers, and attempt to trick the legal system(s) is criminal, especially with FDA regulated medical devices. It is of the utmost importance that we protect our physicians from liability and misinformation and continue to keep our patients safe." Sobin Chang, CEO of Aquavit Aquavit's victorious claim against U-BioMed with the European Union Intellectual Property Office (EUIPO) has set a significant milestone. The court acknowledged that U-BioMed knowingly and intentionally filed an infringing trademark application with the EUIPO for the mark "AQUAGOLD Fine Touch". "The counterfeits appear almost identical to the naked eye; however, they do not contain the microchannels as they claim and are often made of regular steel that are not biocompatible under the FDA's medical device material guidelines. Furthemore, they infringe on our 'repeated motion' drug delivery utility patent (U.S. Patent No . 10,980,865) for any drugs, components or biologics." says Dr. David Shafer, Aquavit's Chief Medical Technology Officer. The EUIPO has declared U-BioMed's actions to be willful and done purposefully in an effort to confuse consumers with Aquavit's already existing AQUAGOLD products being sold globally. The EUIPO issued a cancellation of U-BioMed's infringing mark, upheld Aquavit's application for a declaration of invalidity, and held U-Biomed accountable for the legal costs in the European Union. About Aquavit Aquavit is a high-tech pharmaceutical company that provides a comprehensive range of innovative pharmaceutical, biotech and medical device technologies. Aquavit focuses on personalized medicine to improv.

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Spotlight

Chronic immune activation and elevated numbers of circulating activated monocytes (CD16) are implicated in HIV-associated neuroinflammation. The objective was to compare the level of circulating CD16 monocytes and IFN-γ-inducible protein 10 (IP-10) between HIV-infected cannabis users (HIV+MJ+) and noncannabis users (HIV+MJ-) and determine whether in-vitro Δ-Tetrahydrocannabinol (THC), a constituent of cannabis, affected CD16 expression as well as IP-10 production by monocytes.

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