Lipid nanoparticles used to deliver RNA in vaccines

European Pharmaceutical Review | September 30, 2019

Researchers have developed a series of lipid nanoparticles, which encapsulate RNA, for effective and improved vaccine delivery. Researchers have developed a series of lipid nanoparticles to deliver RNA vaccines accurately, to ensure the therapy reaches the correct immune cells and produces sufficient amounts of the encoded protein. A team from the Massachusetts Institute of Technology (MIT), US conducted the research into the vaccine. They say it also behaves like an “adjuvant”, boosting the effectiveness of the treatment. Using mouse models, the researchers showed that the RNA vaccine is successful in inhibiting the growth of melanoma tumours. “One of the key discoveries of this paper is that you can build RNA delivery lipids that can also activate the immune system in important ways,” says Daniel Anderson, an associate professor at MIT and the senior author of the study. Anderson’s lab has previously developed lipid nanoparticles for delivering RNA and DNA for a variety of applications. These lipid particles form tiny droplets that protect the RNA molecules and carry them to their destinations.

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Insider Exclusive Host and Executive Producer Steve Murphy interviews Stephen A. Sheller, Founding Partner of Sheller, P.C. about the practice of industry whistleblowers exposing illegal marketing of "off label" prescribed drugs. Sheller details how the effect on consumers, both in their own health as well as consumer fraud perpetrated on the U.S. Government at taxpayer expense.


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MedAvail Announces Pricing of $50 Million Private Placement

MedAvail | April 01, 2022

MedAvail Holdings, Inc. a technology-enabled retail pharmacy company, announced it has entered into a definitive securities purchase agreement for the sale of common stock and warrants to purchase common stock in a private placement with certain institutional and other accredited investors for gross proceeds to MedAvail of $50 million, before deducting placement agent commissions and other offering expenses. Pursuant to the terms of the securities purchase agreement and following the completion of all closings of the private placement, MedAvail will issue approximately 47.1 million shares of common stock and warrants to purchase approximately 23.5 million shares of common stock. The shares of common stock will be sold for a price of $1.0625 per share. Each purchaser will also receive a warrant to purchase 50% of the number of shares purchased under the securities purchase agreement by such purchaser. The warrants will have a per share exercise price of $1.25 and will be exercisable by the holder at any time on or after the issuance date for a period of five years. In addition, the warrant terms provide MedAvail with a call option to force the warrant holders to exercise up to two-thirds of the warrant shares subject to each warrant, with one-third of the warrant shares being callable beginning on each of the 12 month and 24 month anniversaries of the warrant issuance dates, in each case until the expiration of the warrants, and subject to the satisfaction of certain pricing conditions relating to the trading of MedAvail’s shares. If all warrants that are sold and issued in the private placement following the completion of all closings are fully exercised, then MedAvail would receive gross proceeds of approximately $29.4 million. The private placement is expected to have a first close on or about April 1, 2022, subject to the satisfaction of customary closing conditions. Additional details regarding the private placement will be included in a Form 8-K to be filed by MedAvail with the Securities and Exchange Commission. MedAvail intends to utilize the net proceeds for general corporate purposes and to fund its strategic initiatives. The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended or any state or other jurisdiction’s securities laws, and may not be resold absent registration under, or exemption from registration under, the Securities Act. MedAvail has agreed to file a registration statement with the SEC registering the resale of the shares of common stock to be issued and sold in the private placement, together with the shares of common stock underlying the warrants issued in the private placement, within 60 days of the applicable closing of the private placement in which such securities were purchased. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Cowen acted as the placement agent for the private placement. Lake Street acted as financial advisor. About MedAvail MedAvail Holdings, Inc. is a technology-enabled pharmacy organization, providing turnkey in-clinic pharmacy services through its proprietary robotic dispensing platform, the MedAvail MedCenter, and home delivery operations, to Medicare clinics. MedAvail helps patients to optimize drug adherence, resulting in better health outcomes.

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Cedars-Sinai Medical Center and AIkido Pharma Inc. to Codevelop Novel Immuno-Oncology Cancer Treatment

AIkido Pharma Inc. | March 15, 2022

AIkido Pharma Inc. announced that the Company and Cedars-Sinai Medical Center have agreed under their Master Collaboration Agreement to co-fund and codevelop a novel immuno-oncology treatment designed to promote the destruction of cancer cells by a patient's own "killer" T-cells. The Company and Cedars-Sinai will share costs, expenses and management of the drug co-development and will leverage the talent of Cedars-Sinai Technology Ventures and the lead scientists who originated the novel treatment. The parties will also share in the proceeds of any commercialization of the treatment. The compounds to be codeveloped target the cellular pathway that causes CD8+ T-cells to enter an "exhausted state," rendering them ineffective against cancer cells. The new treatment targets and blocks recently discovered transcription factors essential for T-cells to enter the "exhausted state," the goal of which is to strengthen the ability of a patient's T-cells to retain their capacity to destroy cancer cells. "Our agreement with Cedars-Sinai to collaborate in the funding and monetization of novel disease treatments is a major step for the Company. I am thrilled that Cedars-Sinai will be co-funding this project and providing its exceptional staff of scientists to advance this new cancer treatment, which I believe speaks volumes about its potential." Anthony Hayes, CEO of AIkido About AIkido Pharma Inc. AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics. The Company's platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV MERS-CoV, Ebolavirus and Marburg virus.

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Ultivue Announces Co-Marketing Agreement with Aignostics for Unique Spatial AI-Powered Imaging Solutions for Translational Medicine

Ultivue, Inc., | March 10, 2022

Ultivue, Inc., an industry leader in multiplexing tools and novel image analysis solutions for tissue biomarker studies, and Aignostics GmbH, a global leader in Artificial Intelligence (AI) powered precision diagnostics focused on pathology to assist with research, clinical trials and CDx development, announced a partnership to collaborate on the co-development of AI-powered spatial multiplexed immunophenotype solutions for translational research groups and Biopharma. The companies have already been working together since early 2021 to adapt Aignostics’ client platform to support visualization and analysis for some of Ultivue’s products and services, as well as provisioning of results and corresponding reports. The resulting co-developed platform will now be made available to joint clients. Additionally, proof of concept work conducted on the Ultivue 12-plex Immunophenotyping biomarker panel in over 1,000 clinical NSCLC cases has demonstrated encouraging results for the capacity of AI-based analysis of multiplexed images for more consistent and reproducible readouts at scale. These results will be published later this year and respective AI models made available via the platform. The companies are now expanding their relationship under a co-marketing agreement to offer the multiplex immunofluorescence (mIF) platform to their respective biotech and pharma clients, initially for research use, with a GCP-compliant version to follow later this year. Moreover, Ultivue and Aignostics will offer AI-powered image analysis services within the platform via Aignostics “Explainable AI” approach for the consistent and precise analysis of mIF cohorts at scale, for both translational research and clinical trial research services in Ultivue’s CLIA accredited clinical research laboratory. “We are excited to extend our workflow offering to include mIF AI for highly automated image analysis by partnering with Aignostics,” says Florian Leiss, VP Digital Health at Ultivue. “Improved viewing capabilities enable us to interactively explore the interplay of mIF-labeled cell populations in the histological context of same-slide H&E.” “We believe that development of Ultivue’s assays with our AI-powered image analysis will create insights from data at scale that are unprecedented in spatial biology today. We are excited to start offering this approach to our clients for translational science and clinical trials,” Viktor Matyas, CEO of Aignostics Besides offering research and development services to its clients, Ultivue and Aignostics will also develop products for standardized analysis of certain Ultivue products, paving the way for more widespread use of these technologies in both clinical trials and clinical routine. About Ultivue Ultivue provides researchers and scientists in translational medicine with multiplex biomarker assays for tissue phenotyping and digital pathology. Its proprietary InSituPlex® technology enables advanced exploration and interrogation of tissue samples for precision medicine research. These highly customizable solutions coupled with our scientific consultative approach strengthen and accelerate biomarker discovery and drug development programs. About Aignostics Aignostics, a Berlin based company with offices in the US, is a digital pathology company dedicated to novel precision diagnostics through the use of a proprietary “Explainable AI” platform in pre-clinical and translational research and clinical trials. The use of such technology is expected to be crucial to implementation of AI-powered algorithms in routine diagnostics in order to verify (explain) the model’s decision outputs. Additionally, through its close alignment to Charité and TU Berlin amongst other collaborators, only Aignostics offers the combination of data access, sample testing and pathology expertise to develop digital pathology algorithms spanning multi-modal biomarker assay detection systems such as H&E, IHC and mIF, amongst others.

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Iktos and Teijin Pharma to Co-Develop New Technology for Small Molecule Drug Discovery

Iktos | April 07, 2022

Iktos, a company specialized in Artificial Intelligence for new drug design, and Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business that provides comprehensive healthcare services to improve the quality of life, today announced a strategic collaboration agreement in Artificial Intelligence for new drug design. Under the agreement, Iktos generative modelling technology will be implemented and applied to several Teijin Pharma’s small molecule drug discovery projects to expedite the identification of potential pre-clinical candidates. Iktos and Teijin Pharma will collaborate in developing new AI technology aiming to bring further improvement and speed to the drug design process, leveraging Iktos’ proprietary know-how in AI for Computer Aided Drug Design (CADD) and complementing Teijin’s research and development capabilities. In the recent years, Iktos has emerged as one of the world leaders in AI for drug design, establishing multiple collaborations with renowned pharmaceutical companies and successfully developing the AI software platforms Makya™ for new drug design and Spaya™ for synthesis planning. Iktos’ generative AI technology, based on deep generative models, automatically designs virtual novel molecules presenting the desirable characteristics specified by the researchers. This approach brings unprecedented efficiency in the exploration of chemical space and produces innovative molecule designs with greater freedom to operate. It is a novel solution, validated through many collaborations, to one of the key challenges in drug design: the rapid identification of molecules that simultaneously satisfy multiple parameters, such as potency, selectivity, safety, and project-specific properties. Based on the recent drastic demographic change and increased health consciousness, Teijin Pharma is committed to providing healthcare solutions in the priority fields of bone, joint, rehabilitation, neurology, respiratory, cardiovascular and metabolic diseases. Creating innovative drugs is one of the company’s core business strategies and Teijin Pharma is now focusing on strengthening technological foundation for small molecule drugs that play major roles among the drug modalities for innovative drug discovery. "We are thrilled and proud to announce a strategic collaboration with Teijin Pharma, a leading company that contributes to society by providing advanced healthcare solutions. It is a major recognition for Iktos to be selected by Teijin Pharma as a strategic partner for implementation, development, and application of generative modeling technology for new drug design. Iktos has been a pioneer in the application of generative models for drug discovery and is recognized as a world leader in the technology space that has the potential to disrupt the way new therapeutics are designed.’’ “Our ultimate objective is to expedite drug discovery and achieve time and cost efficiencies for our global collaborators by using Iktos’s proprietary AI platform and know-how. We are confident that together with our Teijin collaborators, we will be able to develop new technology to bring further speed and efficiency to drug discovery.” Yann Gaston-Mathé, Co-founder and CEO of Iktos “We are delighted to create innovative new small molecule drugs together with Iktos,” said Ichiro Watanabe, President of Teijin Pharma. “We provide solutions in the field of demographic change and increased health consciousness and are focusing on the launch of new drugs. Iktos’ proprietary AI technology will dramatically accelerate our small molecule drug discovery. We continue to enhance patients' quality of life by providing new treatment options for diseases with high unmet needs.” About Iktos Incorporated in October 2016, Iktos is a start-up company specializing 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, the design of 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. About the Teijin Group Teijin is a technology-driven global group offering advanced solutions in the fields of environmental value; safety, security and disaster mitigation; and demographic change and increased health consciousness. Originally established as Japan's first rayon manufacturer in 1918, Teijin has evolved into a unique enterprise encompassing three core business domains: high-performance materials including aramid, carbon fibers and composites, and also resin and plastic processing, films, polyester fibers and products converting; healthcare including pharmaceuticals and home healthcare equipment for bone/joint, respiratory and cardiovascular/metabolic diseases, nursing care and pre-symptomatic healthcare; and IT including B2B solutions for medical, corporate and public systems as well as packaged software and B2C online services for digital entertainment. Deeply committed to its stakeholders, as expressed in the brand statement “Human Chemistry, Human Solutions,” Teijin aims to be a company that supports the society of the future. The group comprises more than 170 companies and employs some 20,000 people across 20 countries worldwide. Teijin posted consolidated sales of JPY 836.5 billion and total assets of JPY 1,036.4 billion in the fiscal year that ended on March 31, 2021.

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Spotlight

Insider Exclusive Host and Executive Producer Steve Murphy interviews Stephen A. Sheller, Founding Partner of Sheller, P.C. about the practice of industry whistleblowers exposing illegal marketing of "off label" prescribed drugs. Sheller details how the effect on consumers, both in their own health as well as consumer fraud perpetrated on the U.S. Government at taxpayer expense.

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