Following Lab Test, Eagle Pharma Looks to Test MH Drug Ryanodex Against COVID-19

BioSpace | April 16, 2020

Following Lab Test, Eagle Pharma Looks to Test MH Drug Ryanodex Against COVID-19
In a controlled laboratory test, Eagle Pharmaceuticals’ malignant hyperthermia treatment Ryanodex (dantrolene sodium) inhibited the growth of SARS-CoV-2, the virus causing the COVID-19 pandemic. Now the company hopes to launch a clinical trial testing the efficacy of the drug in patients. In the in vitro tests, Ryanodex demonstrated antiviral activity and a lack of cytotoxicity. Two days after dosing, the in vitro results showed an absence of cytopathic effects in the infected cells. This morning, New Jersey-based Eagle Pharmaceutical submitted its Investigational New Drug Application to the U.S. Food and Drug Administration to launch a Phase II trial in partnership with Hackensack University Medical Center to evaluate the efficacy of Ryanodex in patients infected with SARS-CoV-2. The company said it has been in contact with the FDA’s Coronavirus Treatment Acceleration Program to request a potential expedited review of the IND application and aims to begin the clinical trial as soon as possible.

Spotlight

Different types of clinical studies are used in different circumstances. Depending on what is known and what isn’t, scientists may even study the same research question using different kinds of studies and in different groups of people. Here are different types of clinical studies and why they might be used.


Other News
BUSINESS INSIGHTS

Deargen Annonuces Patent Application for a TNBC Target Novel Drug Candidate Using AI

Deargen Inc. | December 23, 2021

Deargen, a company specializing in the development of novel NCE drugs using artificial intelligence, announced on the 22rd that it had discovered and synthesized a new anticancer target compound using its own AI platform and had already applied for a patent for it. Deargen has the technology to predict candidates for a novel drug without the 3D structure data of proteins. Deargen's technology, which uses amino acid sequence data rather than the structure information of proteins, possesses global-level differentiated artificial intelligence technology that enables the rapid development of novel drugs even for proteins whose 3D structure has not yet been identified. "The new compound for which we have applied for a patent this time is a first-in-class candidate, and we plan to develop a therapeutic agent targeting triple-negative breast cancer. TNBC is an area where there are few novel drugs available and it is difficult to find innovative targets, so it is a disease with a high demand for new therapeutics…Deargen confirmed the efficacy of the new compound discovered through in-vitro experiments." An official from Deargen Also, the substance that Deargen discovered through this study is an NCE. An NCE refers to a new chemically synthesized drug, which requires a great deal of time and money because it is difficult to develop such a drug that has not been previously approved by the FDA. However, it is within an area with high needs by many global pharmaceutical companies as it has the advantage of being able to receive market monopoly rights for 5 years in the U.S. and 10 years in Europe after product approval. In particular, Deargen's achievements are significant in that it discovered the new compound in a shorter time than the existing novel drug discovery process through its collaboration of advanced AI and in-house experts for novel drug development. The target discovery and substance design process, which usually takes about 3 to 4 years in the existing traditional drug development process, was carried out in just 10 weeks, and it took merely 2 weeks for target discovery and 8 weeks for substance design and synthesis. Currently, Deargen is establishing a large-scale R&D center. With this R&D center, the plan is to further shorten the period of the discovery of candidates by efficiently managing the time required for designing and synthesizing substances. The R&D center will be in charge of fast verification of substances by conducting the design and synthesis verification of substances under joint research with Deargen's internal pipeline, along with the production of high-quality data. Daniel Bae, Chief Business Officer of Deargen said : "We plan to continuously derive new substances with patentability through our synthesis research center, which will be established in the first half of next year. We plan to not only build our own pipeline centered on anticancer drugs, but also to introduce various business models with our partners that go beyond the existing joint research contracts." He also said, "Deargen plans to establish its position among global AI drug developers as a company specializing in NCE drug development, from target discovery to compound design and synthesis." About Deargen Inc. Established in December 2016, Deargen is an AI-based drug discovery and development company. In February 2020, the company released study results on predicting the development of COVID-19 treatments. Candidate compounds for treating COVID-19 predicted by Deargen include remdesivir, which was first approved as an emergency therapy. The company conducts research on and owns core AI technologies in-silico, such as 'prediction of bio-markers', 'selection of disease targets', and 'extraction of candidate substances for new drugs', utilizing techniques of meta analysis of genome big data and its unique AI technologies. Building on these outcomes, the company is developing new drugs in collaboration with multiple pharmaceutical companies and research institutions, demonstrating its outstanding technology capabilities as being named as top awardees at the ILSVRC, a world-prominent deep-learning competition, and Dream Challenge, an international AI-based new drug development competition.

Read More

PHARMA TECH

IACTA Pharmaceuticals and TALLC Corporation Announce Strategic Collaboration to Utilize Novel SmartCelle Topical Delivery Technology

IACTA Pharmaceuticals, Inc. | December 16, 2021

IACTA Pharmaceuticals, Inc. an innovation leader in ophthalmic therapeutics, and TALLC Corporation Inc. a pioneering ophthalmology company focused on the growing unmet needs of patients with corneal and retinal conditions, announced that they are entering into a strategic collaboration and licensing agreement. The agreement grants IACTA the use of TALLC’s proprietary SmartCelle™ micellar technology, a novel platform for pan-ocular drug delivery, for future clinical development. IACTA plans to utilize TALLC’s SmartCelle technology to deliver one or more of its novel ophthalmic therapeutics, as well as co-develop new ophthalmology therapeutic candidates that leverage IACTA’s formulation and clinical expertise with TALLC’s novel delivery technology. The collaboration also includes an option agreement, granting IACTA exclusive rights to negotiate a separate license agreement for the right to co-develop TALLC’s lead product candidate TA-A001, a novel anti-inflammatory anti-angiogenic molecule with analgesic properties in various disease state models. “I am thrilled to be able to partner with TALLC, a company with a shared vision focused on addressing the growing and significantly underserved ocular pain market. IACTA was formed with the mission of developing and commercializing innovative ocular therapies through novel compounds and utilizing leading drug delivery technologies, and we view this collaboration as the perfect synergy to realize the full potential of our ophthalmology pipeline. We are excited to explore how best to deploy the SmartCelle technology within our current pipeline, as well as the future co-development opportunities this partnership provides.” Damon Burrows, Chief Executive Officer of IACTA Pharmaceuticals TALLC’s proprietary SmartCelle pan-ocular drug delivery technology employs 30nm micelles that enable delivery of difficult to formulate drugs into corneal and retinal tissues after topical delivery. The company’s pipeline is led by SmartCelle TA-A001, a novel CB2 receptor activator, delivered topically to treat the effects of dry eye syndrome and age-related macular degeneration. “We are delighted to partner with the IACTA team for this important program. IACTA, with its in depth scientific and commercial understanding of the ophthalmic space is an ideal partner for TALLC as we drive towards further commercialization of the SmartCelle platform and TA-A001,” said Damon Smith, Ph.D., Chief Executive Officer of TALLC. “We look forward to working closely with the IACTA team and to co-developing SmartCelle versions of the IACTA pipeline.” About TALLC, Inc. TALLC is a Montreal-based developer of ophthalmic medicines actively engaged in the commercialization of SmartCelle TA-A001, and its pipeline of SmartCelle-delivered drug candidates, as treatments for acute and chronic inflammation. Focused initially on unmet needs in inflammatory front of eye indications, TALLC plans also to develop SmartCelle TA-A002 and TA-A003 in other chronic conditions including macular degeneration and glaucoma. SmartCelle enables pan ocular delivery of drug candidates by topical application directly to the ocular surface, by injection or by insufflation. About IACTA Pharmaceuticals, Inc. IACTA is an innovation leader in ophthalmic therapeutics, led by former top executives from one of the leading eye care companies in the world. The company currently has four products in development for major market opportunities. IC 800 is a novel, non-opioid, dual enkephalinase inhibitor, being studied for the treatment of acute ocular pain. In addition, IACTA’s IC 265, is a SYK kinase inhibitor being developed as a potential novel treatment for dry eye disease.

Read More

BUSINESS INSIGHTS

Iktos and The University of Dundee, Drug Discovery Unit (DDU) Announce a Collaboration to Use AI for Drug Design and Retrosyntheis

Iktos | December 20, 2021

Iktos, a company specialized in Artificial Intelligence for new drug design, and The Drug Discovery Unit (DDU), School of Life Sciences, The University of Dundee, focused on the discovery of therapeutics for neglected diseases and the translation of novel biology through small molecule drug discovery, announced entering a collaboration to apply Iktos’s generative modelling artificial intelligence (AI) technology in one of DDU’s drug discovery programs. Under the agreement, Iktos will apply its de novo ligand and structure-based generative modelling technologies, its AI-based retrosynthesis analysis and planning tool Spaya™, and know-how complementing DDU’s drug discovery capabilities to expedite the identification of potential pre-clinical candidates and to identify additional novel chemical matter with suitable properties. The DDU was established in 2006 to respond to a lack of drug targets identified for neglected tropical diseases being translated into therapeutics for diseases impacting the poorest people in the world. The DDU translates basic science into lead compounds to validate putative drug targets, to use as tools to investigate disease pathways and, when appropriate, advance to pre-clinical drug candidates for multiple diseases, e.g. TB and cancer. 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 Iktos’s other 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 recently diversified its R&D efforts into the development of an AI technology for retrosynthesis. Identifying and selecting synthetic pathways is one of the most challenging and time-consuming tasks in synthetic and medicinal chemistry. Iktos has developed AI based retrosynthesis analysis and planning tool Spaya™ by harnessing the power of data-driven retrosynthesis algorithm for systematic exploration and prioritisation of synthetic routes for a desired compound in minutes. “We are thrilled to be working with Iktos to drive our projects towards drug candidates. Iktos AI platform combined with our own in-house computational and medicinal chemistry design teams provide a powerful combination for innovative new drug design.” Professor Paul Wyatt, Head of the DDU “We are thrilled and proud to join forces with DDU with the aim to help in the discovery of therapeutics for neglected diseases and the translation of novel biology through small molecule drug discovery,” commented Yann Gaston-Mathé, President and CEO of Iktos. “Pleased to have earned DDU’s trust, we are confident that together with DDU and their established R&D partners, we will be able to identify promising novel chemical matter and solve complex multiparametric optimisation problems. The feedback from DDU’s research team will be highly valuable as we improve our product offerings. Our strategy has always been to tackle challenging problems alongside our collaborators where we can demonstrate value generation for new and on-going drug discovery projects.” About DDU The Drug Discovery Unit (DDU) (est. 2006) within the School of Life Sciences at The University of Dundee is a fully integrated, Biotech-style, drug discovery centre working across multiple disease areas. The DDU collaborates with partners to translate world-class biology research into novel drug targets and candidate drugs to address unmet medical need. 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.

Read More

BUSINESS INSIGHTS

Agilent Announces the Innovative Seahorse XF Pro Analyzer

Agilent Technologies Inc. | January 25, 2022

Agilent Technologies Inc. announced the release of the Agilent Seahorse XF Pro Analyzer, featuring new pharma-oriented workflow solutions incorporating advanced experimental design and analysis tools. With enhanced performance, more robust and efficient workflows, and an optimized user experience, the XF Pro enables operators at any skill level to access the most advanced cellular metabolism analysis technology for understanding cellular fate, fitness, and function. Preclinical therapeutic discovery workflows place high demands on cellular analysis, with immunology and disease researchers increasingly using rare, ex vivo, and genetically engineered cells to build better disease models. To address the increasing interest in monitoring live cells in real-time, the new XF Pro Analyzer incorporates a suite of hardware and software enhancements that improve measurement performance and data interpretation. These enhancements will make it easier to identify novel drug targets, validate target effect on cellular function, optimize disease models, and determine drug safety and antitumor potential of T cell therapies. “With dedicated workflow solutions the XF Pro provides enhanced performance and customer experience, particularly within pharma and biopharma therapeutic development, and toxicity programs. This underlines Agilent’s commitment towards developing intentional end-to-end solution-focused innovations that continue to lead the way for applied analytical and research applications, including direct metabolic analysis.” Richard Fernandes, associate vice president and general manager of Agilent’s Cell Analysis, Seahorse, Luxcel, and microplates businesses "The launch of the XF Pro is very much a customer-driven event. Through collaboration and intentional conversations with our customers and key opinion leaders, we recognized the need for a live-cell metabolic analysis platform which makes sophisticated analysis even more accessible for both experienced users as well as novices,” added Chris Braun, associate vice president of Marketing for Agilent’s Cell Analysis Division. “Primarily targeting the pharma/biopharma sector, but beneficial to all our customers, the XF Pro incorporates critical metabolic insights into researchers’ discovery workflows to facilitate even higher quality data where it matters most.” The XF Pro Analyzer is expected to enhance critical aspects of live-cell analysis, particularly for researchers working in immunotherapy, early drug discovery, and preclinical safety assessment. By delivering better precision at a low oxygen consumption rate (OCR), the XF Pro Analyzer allows analysts to confidently interrogate more immune cell types, as well as cell types that are bioenergetically compromised. The instrument also features pharma-tailored workflows for harnessing robust cellular metabolism measurements while handling suspension cell types, along with simplified automation enablement and analytical instrument qualification (AIQ). About Agilent Technologies Agilent Technologies Inc. is a global leader in the life sciences, diagnostics, and applied chemical markets, delivering insight and innovation that advance the quality of life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.32 billion in fiscal 2021 and employs 17,000 people worldwide.

Read More

Spotlight

Different types of clinical studies are used in different circumstances. Depending on what is known and what isn’t, scientists may even study the same research question using different kinds of studies and in different groups of people. Here are different types of clinical studies and why they might be used.

Resources