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 and The University
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.


Spotlight

What are drugs? What do they do? How do they do what they do? These questions are part of the field of pharmacology, and over this series we will learn all about a wide variety of different drugs that have clinical use. This will require a lot of prerequisite knowledge in other fields, so make sure to check out some of my other playlists as well, but when you're ready, let's dive into the world of drugs!


Other News
PHARMACY MARKET

IAMA Therapeutics Announces Initiation of Preclinical Development Studies in Drug-resistant Epilepsy Under a Service Agreement with Psychogenics

IAMA Therapeutics | July 26, 2022

IAMA Therapeutics, a preclinical-stage pharmaceutical company focused on the discovery, development, and commercialization of novel medicines to make a difference in the lives of individuals suffering from brain disorders, and PsychoGenics Inc., a leader in AI-enabled phenotypic drug discovery and preclinical CRO services, today announced that the companies have entered into a service agreement to identify the efficacy of novel drug candidates in drug-resistant epilepsy. Under the terms of the agreement, PsychoGenics will evaluate the preclinical anti-seizure efficacy of first-in-class selective-NKCC1 inhibitors, which aims to reduce intracellular chloride concentration and restore the physiological hyperpolarizing and inhibitory GABAergic transmission in an animal model of refractory epilepsy. "PsychoGenics is a leader in preclinical behavioral neurobiology with a successful track record of anti-epilepsy drug testing through translational EEG approaches, including electrographic and behavioral identification of seizure. We look forward to leveraging our collective expertise in neuroscience drug development to identify and evaluate the anti-seizure efficacy of new drug candidates, to enhance further and complement our pipeline of differentiated therapeutic opportunities for epilepsy, neurodevelopmental and cognitive disorders." Andrea P. Malizia, Ph.D., MBA, Chief Executive Officer of IAMA Therapeutics “We are excited to embark of these studies with IAMA Therapeutics” said Stephen Morairty, Ph.D., Vice President of Translational Neuroscience at PsychoGenics. “Using our pre-clinical MTLE model, will carefully evaluate the efficacy of these first-in-class selective-NKCC1 inhibitors.” About IAMA Therapeutics IAMA Therapeutics is a preclinical-stage pharmaceutical company focused on discovering, developing, and commercializing novel medicines to make a difference in the lives of children and adults suffering from epilepsy, neurodevelopmental and cognitive disorders. IAMA Therapeutics couples emerging advances in drug discovery and neurobiology to build a leading, next-generation neuroscience pipeline to selectively inhibit the sodium-potassium chloride cotransporter and other therapeutic targets relevant to brain disorders characterized by neuronal imbalance. The company's preclinical pipeline consists of the lead candidate IAMA-6 for the treatment of idiopathic autism, IAMA-097 for the treatment of secondary and rare forms of autism, and other compounds for treating refractory epilepsy and other brain disorders. About PsychoGenics Inc. PsychoGenics is a leader in vivo phenotypic drug discovery. The company applies its proprietary technology platforms in partnership with pharmaceutical and biotechnology companies to discover the next generation of drugs for neuropsychiatric disorders. PsychoGenics' capabilities include standard behavioral testing, electrophysiology, translational EEG, molecular biology, and state-of-the-art microdialysis. In addition, the company offers a variety of in-licensed transgenic mouse models that support research in areas such as Huntington's disease, Autism spectrum disorders, psychosis/schizophrenia, Alzheimer's disease, Parkinson's disease, sleep, and Spinal Muscular Atrophy muscular dystrophy and other muscle disorders.

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BUSINESS INSIGHTS

Aquestive Therapeutics Receives FDA Tentative Approval for Libervant™ (diazepam) Buccal Film

Aquestive Therapeutics, Inc. | August 31, 2022

Aquestive Therapeutics, Inc. a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, announced today that the U.S. Food & Drug Administration has granted tentative approval for Libervant™ Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older. "Tentative approval" means the FDA has concluded that Libervant has met all required quality, safety, and efficacy standards for approval but, due to an existing FDA regulatory grant of orphan drug market exclusivity for Valtoco®, a diazepam nasal spray product, Libervant is not yet eligible for marketing in the United States. As a result of the FDA determination, the Agency cannot give final approval for Libervant until the expiration or inapplicability of the orphan drug market exclusivity, including, for example, by court order, a selective waiver of the orphan drug exclusivity, or a reversal of the FDA’s decision and determination that Libervant is “clinically superior” to Valtoco. “The FDA’s decision provides welcome clarity to our business. The tentative approval of Libervant is a significant achievement that brings us one step closer to bringing this important medicine to patients who are unable or choose not to use the current standards of care. Libervant has the potential to offer these patients a treatment option that is simple, portable, and precise. A significant unmet need exists for additional alternate delivery options given the ongoing shortage of diazepam rectal gel, which continues to represent a substantial portion of the current diazepam rescue market. This FDA action further validates our ability to gain FDA approval of our pipeline programs. We look forward to continuing the rapid progression of AQST-109 for the treatment of severe allergic reactions, including anaphylaxis, towards a filing with the FDA.” Daniel Barber, Chief Executive Officer of Aquestive “We continue to examine the FDA’s determination on Libervant market access and plan to request a meeting with the Agency as soon as possible. We disagree with the FDA’s determination on the various points presented by the Agency and believe that, particularly in the case of our submitted studies on the effect of food on the absorption of diazepam formulations, Libervant has the distinct advantage of being able to be readily administered when needed without regard to food, providing an important benefit to patients. This is important to patients as rapid and extensive drug absorption is critical in a rescue situation. We will continue to vigorously engage with the FDA on the need for these data to be carefully considered.” During the review process, the Company submitted to the FDA the results of a 2021 Aquestive sponsored randomized, open-label, two-sequence, two-period, two-treatment crossover study to evaluate the effect of food on the pharmacokinetics of Valtoco in healthy adult subjects. The results of this study indicated that, when Valtoco is administered after a high fat meal, the maximum drug concentration (Cmax) was reduced by 48% compared to Valtoco administered to subjects in a fasted state. The study also showed that the time to maximum drug concentration (Tmax) of Valtoco doubled from 2 hours to 4 hours when administered after a high fat meal. Aquestive provided the data along with a cross-study comparison to a similar study performed with Libervant, to FDA during the review process. The FDA’s decision concluded that the information Aquestive submitted was not sufficient to overturn the Agency's previous conclusion regarding the lack of food effect for Valtoco. Specifically, the FDA stated that “[a] cross-study comparison is not considered [by the reviewer] to be a suitable approach for making a quantitative comparison of plasma concentrations between different products because of the lack of a common reference standard between the two studies.” Aquestive will seek to gain alignment with the Agency on a reasonable path to appropriately characterize the food effect of Valtoco including potentially conducting a comparative study as indicated by the FDA. About Libervant Libervant™ is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. Approximately 1.0 million patients with epilepsy suffer from uncontrolled refractory seizures, approximately 85% of whom will not interact with the available treatments. About Aquestive Therapeutics Aquestive Therapeutics, Inc. is a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products on the U.S. market, four licensed products and one stand-alone proprietary product to date, Sympazan® (clobazam) oral film for the treatment of seizures associated with Lennox-Gastaut syndrome. Our licensees market their products in the U.S. and around the world. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system, or CNS, and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis.

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BUSINESS INSIGHTS

Hyfe Joins Forces with Merck to Deploy Its Artificial Intelligence-Powered Cough Detection and Counting Technology

Hyfe, Inc. | July 20, 2022

Hyfe, Inc., the global leader in AI-powered cough detection, tracking and classification, has entered into an agreement with Merck, known as MSD outside the United States and Canada, to integrate its artificial intelligence-powered (AI) cough tracker technology into Merck’s consumer disease educational efforts.. Hyfe’s AI-powered technology passively and remotely monitors the number of times a person coughs and the sound of the cough through any smart device, such as a mobile phone. This data collected over time provides the user with helpful information by revealing patterns and potential triggers like seasonal allergies that may be causing the cough that would otherwise go unnoticed or unaddressed. “The overwhelming majority of people cannot even come close to accurately estimating the number of times they cough per day. In order to help diagnose and treat patients, cough frequency and sound should be monitored and measured with the same accuracy as blood pressure, temperature, heartbeat and other biomarkers that are essential for assessing health and medical conditions.” Peter Small, M.D., chief medical officer of Hyfe, Inc Users of the app will be able to determine when and how long to track their coughing. The AI-powered technology records cough-related sounds and allows the user to compare the frequency and quality of their coughs against their own benchmark. This personalized approach provides users with more detailed information and confidential data about their individual situations to share with their health care providers. Hyfe, Inc. is the global leader in AI-powered cough detection and classification that provides insight into cough patterns and correlations that can greatly improve treatment and prevention. With more than 280 million samples, Hyfe maintains the largest cough dataset in the world enabling the building of powerful models to track, manage and diagnose respiratory illnesses. Hyfe provides platforms and data for pharmaceutical companies, medical researchers, government agencies, health care providers and patients and has partnerships with leading academic institutions including Johns Hopkins University and the University of California at San Francisco. The company was founded in 2020 and is headquartered in Wilmington, Delaware.

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BUSINESS INSIGHTS

PCI Pharma Services Selects Thoughtworks for Digital Platform Transformation with Agile Approach

Thoughtworks | July 11, 2022

Thoughtworks a global technology consultancy that integrates strategy, design and engineering to drive digital innovation, today announced the signing of a multi-year agreement with PCI Pharma Services, a leading global contract development and manufacturing organization. Thoughtworks will help PCI in its journey to digitize its supply chain, with the goal of accelerating the time it takes to bring clients’ life-changing therapies to market for patients. By co-developing tools for digital business modernization, Thoughtworks will help PCI improve client visibility into its clinical and commercial drug supply chains for pharmaceutical and biotech companies of all sizes in 100+ countries. By digitizing the supply chain, Thoughtworks will help PCI deliver greater insights to clients to increase their overall efficiency, support their business goals and ultimately produce high quality treatments for patients. The agreement includes expanding and adapting pci | bridge, an industry first-of-its-kind, end-to-end data platform that provides real-time status of projects, automatically identifies risks, spots trends and provides business analytics insights. With this modern application programming interface (API), clients have the ability to seamlessly integrate their systems with PCI’s, creating greater transparency and a more simplified process for decision-making. “Digital transformation has been a key differentiating factor for PCI’s business strategy, and the evolution of pci | bridge will be critical to increasing client engagement and maximizing the value of data and analytics for PCI and our external partners. With Thoughtworks’ 28+ years of experience at the forefront of innovation, we look forward to making our clients’ lives easier through this partnership." Wayne Hull, Chief Digital and Technology Officer, PCI Pharma Services With a shared commitment to customer-centricity, the Thoughtworks and PCI product and engineering teams will create a new level of intuitive self-service solutions for clients. The partnership will also simplify the collection and analysis of information to reach business insights faster and streamline processes to develop useful new products for clients. The teams will do this by working side-by-side using agile development methods, including pair programming, test-driven development and continuous integration/continuous delivery (CI/CD) automation. “Recognized as a leader in global CDMO services, PCI Pharma Services is well on its digital transformation journey, providing clients with sophisticated supply chain solutions and a digitally integrated experience unlike anything else in the industry,” said Chris Murphy, Chief Executive Officer, Thoughtworks North America. “We are thrilled to partner with PCI Pharma Services as it empowers its clients to make even more powerful, life-impacting decisions through their expansive data and analytics ecosystems.” About PCI Pharma Services PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries and over 4,300 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives. For more information, please visit pci.com About Thoughtworks Thoughtworks is a global technology consultancy that integrates strategy, design and engineering to drive digital innovation. We are 11,000+ people strong across 49 offices in 17 countries. Over the last 25+ years, we’ve delivered extraordinary impact together with our clients by helping them solve complex business problems with technology as the differentiator.

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Spotlight

What are drugs? What do they do? How do they do what they do? These questions are part of the field of pharmacology, and over this series we will learn all about a wide variety of different drugs that have clinical use. This will require a lot of prerequisite knowledge in other fields, so make sure to check out some of my other playlists as well, but when you're ready, let's dive into the world of drugs!

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