AI Outperformed Humans in Cervical Precancer ID

Techonology Networks | January 10, 2019

AI Outperformed Humans in Cervical Precancer ID
A research team led by investigators from the National Institutes of Health and Global Good has developed a computer algorithm that can analyze digital images of a woman’s cervix and accurately identify precancerous changes that require medical attention. This artificial intelligence (AI) approach, called automated visual evaluation, has the potential to revolutionize cervical cancer screening, particularly in low-resource settings. To develop the method, researchers used comprehensive datasets to "train" a deep, or machine, learning algorithm to recognize patterns in complex visual inputs, such as medical images. The approach was created collaboratively by investigators at the National Cancer Institute (NCI) and Global Good (link is external), a fund at Intellectual Ventures, and the findings were confirmed independently by experts at the National Library of Medicine (NLM). The results appeared in the Journal of the National Cancer Institute on January 10, 2019. NCI and NLM are parts of NIH.

Spotlight

VisionGate founder, chairman and CEO Dr. Alan Nelson explains to Mike Ward, Informa Pharma Insights global director of content, what has motivated the company to migrate from being a diagnostics business to one having a therapeutics focus. Having developed a non-invasive test for lung cancer, LuCED, which also has indicated an ability to detect various tumor types and stages of lung cancer, including Stage I and even dysplasia, VisionGate acquired exclusive rights to the University of Colorado’s patent for the use of the drug Iloprost, a drug currently used to treat various lung diseases such as pulmonary arterial hypertension, in the prevention of lung cancer.

Spotlight

VisionGate founder, chairman and CEO Dr. Alan Nelson explains to Mike Ward, Informa Pharma Insights global director of content, what has motivated the company to migrate from being a diagnostics business to one having a therapeutics focus. Having developed a non-invasive test for lung cancer, LuCED, which also has indicated an ability to detect various tumor types and stages of lung cancer, including Stage I and even dysplasia, VisionGate acquired exclusive rights to the University of Colorado’s patent for the use of the drug Iloprost, a drug currently used to treat various lung diseases such as pulmonary arterial hypertension, in the prevention of lung cancer.

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CELL AND GENE THERAPY

Gritstone bio and CEPI Expand Vaccine Agreement to Tackle Omicron Variant

Gritstone bio | December 07, 2021

Gritstone bio, Inc. a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, and CEPI, the Coalition for Epidemic Preparedness Innovations, announced the expansion of their agreement in order to support the development of a self-amplifying mRNA vaccine designed to tackle the Omicron COVID-19 variant. CEPI will provide up to $5 million in additional funding to conduct a Phase 1 clinical trial of Gritstone’s Omicron vaccine candidate in South Africa, where a CEPI-funded clinical trial of Gritstone’s Beta variant COVID-19 vaccine is due to begin shortly. The SARS-CoV-2 T cell epitopes administered within Gritstone’s SAM COVID-19 vaccines are minimally impacted by mutations found within the Omicron variant, reinforcing the platform’s potential to address both Omicron and future variants of concern. CEPI is already funding up to $20.6 million to support preclinical studies, manufacturing process optimization, and a Phase 1 trial of Gritstone’s Beta variant vaccine candidate which will be initiated by South Africa’s University of the Witwatersrand in the coming weeks. The funding announced today will expand the Phase 1 trial to include additional arms to evaluate an Omicron-specific version of the vaccine. Gritstone has commenced manufacturing its SAM vaccine to specifically target the Omicron variant, and the Omicron arms of the Phase 1 trial are expected to begin in Q2 2022, subject to regulatory approval. The recently described Omicron variant, first identified in South Africa on November 9, 2021, was designated a variant of concern by the World Health Organization (WHO) on November 26, 2021. Early evidence suggests that Omicron carries an increased risk of re-infection, and sequence analysis has revealed many mutations in Spike, which may reduce clinical effectiveness of existing vaccines and/or therapeutic antibodies. Enabling equitable access CEPI is committed to global equitable access to COVID-19 vaccines so, through this agreement, CEPI and Gritstone have agreed that this Omicron vaccine candidate will be made available to the COVAX Facility for procurement and allocation, if it is proven to be safe and effective. The COVAX Facility aims to deliver equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate. “While key questions are yet to be answered about Omicron, its transmissibility, and its potential ability to evade our current vaccines, the stakes are too high to delay developing Omicron-specific vaccine candidates. Given the uncertainties, we must accelerate crucial R&D so vaccines are available to tackle Omicron as soon as possible – just in case we need them. There is no time to lose, so I’m pleased that within 10 days of Omicron being declared a Variant of Concern by the WHO, CEPI is expanding its partnership with Gritstone to support a new Omicron vaccine candidate which can be made globally accessible through COVAX.” Dr Richard Hatchett, CEO of CEPI “Our vaccine platforms are built on the premise that a best-in-class vaccine against a virus will drive strong neutralizing antibodies directed to surface antigens such as Spike, and strong cytotoxic T cell responses against other conserved viral antigens to eliminate virally infected cells. This broad immune response would, in principle, provide superior protection against a virus that is mutating its surface protein. Omicron is an example of a novel SARS-CoV-2 variant that may escape clinical protection conferred by vaccines that only afford narrow, Spike-specific immunity,” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone. “Our SAM technology provides an innovative platform likely capable of delivering on the attractive concept of broad, durable immunity. We are thrilled to be quickly expanding our relationship with CEPI in our shared goal of finding new vaccine solutions to battle this deadly virus on a global scale and help prevent current and perhaps future COVID outbreaks.” Self-amplifying mRNA vaccines As with the mRNA-based COVID-19 vaccines that are now in global use, self-amplifying mRNA vaccines use the body’s own machinery to make antigenic protein itself rather than injecting the antigen directly into the body. However, in self-amplifying mRNA vaccines, viral RNA is adapted in a way that allows only the genetic sequence for a specific antigen to be expressed, while keeping the part of the RNA that allows it to produce multiple copies of itself—the self-amplification machinery. The benefit of this approach is that the dose of RNA can be reduced while maintaining the potency of the vaccine. Gritstone’s vaccine candidate may also elicit T-cell immune responses against non-Spike gene fragments, which are slower to mutate than the genes associated with the SARS-CoV-2 Spike protein and could potentially provide broad protection against other SARS-CoV-2 strains. About CEPI CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19 CEPI’s work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus – it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens. During the current pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale and access. These programmes leverage the rapid response platforms developed by CEPI’s partners prior to the emergence of COVID-19 as well as new collaborations. The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation to these vaccines worldwide through COVAX. CEPI’s 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a universal vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens. About the CORAL Program Gritstone’s CORAL program is a second-generation SARS-CoV-2 vaccine platform delivering spike and additional SARS-CoV-2 T cell epitopes, offering the potential for more durable protection and broader immunity against SARS-CoV-2 variants. Delivery vectors can comprise a chimpanzee adenovirus, self-amplifying mRNA or both (mix and match). The program is supported by several key relationships: Bill & Melinda Gates Foundation, National Institute of Allergy and Infectious Disease (NIAID), and the Coalition for Epidemic Preparedness Innovations (CEPI). An ongoing Gritstone-sponsored Phase 1 trial is evaluating SAM as a boost and immunogenicity enhancer of AstraZeneca's first-generation COVID-19 vaccine AZD1222 (Vaxzevria) in healthy adults ≥ 60 years in the UK. A two-dose SAM regimen is also being evaluated in an ongoing clinical trial sponsored by the National Institute of Health (NIH) Division of Microbiology and Infectious Disease and in the Coalition for Epidemic Preparedness Innovations-funded, Gritstone-sponsored clinical trial in South Africa expected to begin by year end 2021. About Gritstone Gritstone bio, Inc. a clinical-stage biotechnology company, is developing the next generation of immunotherapies against multiple cancer types and infectious diseases. Gritstone develops its products by leveraging two key pillars—first, a proprietary machine learning-based platform, Gritstone EDGETM, which is designed to predict antigens that are presented on the surface of cells, such as tumor or virally-infected cells, that can be seen by the immune system; and, second, the ability to develop and manufacture potent immunotherapies utilizing these antigens to potentially drive the patient’s immune system to specifically attack and destroy disease-causing cells. The company’s lead oncology programs include an individualized neoantigen-based immunotherapy, GRANITE, and an “off-the-shelf” shared neoantigen-based immunotherapy, SLATE, which are being evaluated in clinical studies. Within its infectious disease pipeline, Gritstone is advancing CORAL, a COVID-19 program to develop a second-generation vaccine, with support from departments within the National Institutes of Health (NIH), the Bill & Melinda Gates Foundation, the Coalition for Epidemic Preparedness Innovations (CEPI) and through a license agreement with La Jolla Institute for Immunology (LJI). Additionally, the company has a global collaboration for the development of a therapeutic HIV vaccine with Gilead Sciences. About COVAX COVAX, the vaccines pillar of the Access to COVID-19 Tools Accelerator, is co-convened by CEPI, Gavi, the Vaccine Alliance Gavi) and the World Health Organization – working in partnership with UNICEF as key implementing partner, developed and developing country vaccine manufacturers, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.

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MEDTECH

Medtronic Expands Minimally Invasive Spine Surgery Ecosystem with Next-Generation Spinal Technologies

Medtronic plc | October 01, 2021

Medtronic plc, the global leader in medical technology, today announced the latest additions to its minimally invasive spine surgery ecosystem, making it the only company to combine spinal implants, biologics, navigation, robotics, and AI-powered data to surgeons and patients. New additions to the Medtronic MIS+ portfolio include: Catalyft™ PL and PL40, the first releases in the new Catalyft™ Expandable Interbody System. Catalyft™ PL and PL40 feature a unique design for anterior rim engagement, a beveled tip for ease of insertion, seamless integration with StealthStation™ Navigation, simplified bone graft delivery, and active expansion at the precise angle and lift that surgeons need for minimally invasive, patient-specific solutions to meet sagittal alignment goals. The Space-D™ Access System, which enables pedicle-screw-based distraction, retraction and compression, compatible with Medtronic's leading MIS screw system, CD Horizon™ Solera™ Voyager™, enabling simpler, all-in-one access for surgeons, making procedures more efficient and reproducible. Accelerate™ Graft Delivery System with Grafton™ DBF enables more controlled and efficient delivery of graft material into the disc space or other locations. Accelerate enables placement of more bone graft2 to facilitate fusion and is nine-times faster than traditional graft delivery methods.3 Bone grafting is also more controlled and easier for surgeons to visualize. At Medtronic, we continue to raise the bar in minimally invasive spine surgery through our commitment to driving innovation and expanding our MIS capabilities, Our seamless integration of implants, instrumentation, and enabling technologies into a single ecosystem is helping surgeons remove variability in the surgical procedure, streamline and personalize care, and enable better patient outcomes. - Carlton Weatherby, vice president and general manager of Spine & Biologics within the Cranial & Spinal Technologies business Advancing Care with MIS+ TLIF More than 450,000 spinal fusion procedures4 are performed in the United States each year to reduce pain, improve stability, or correct deformities of the spine. About 200,000 are lower or lumbar fusion procedures,5 which treat conditions such as degenerative disc disease, herniated disc, fractured vertebrae, spinal stenosis, and other conditions. One of the most common spinal fusion procedures is transforaminal lumbar interbody fusion (TLIF). During a TLIF procedure, a disc is removed from the lumbar spine, and two vertebrae are joined together using screws or rods. An interbody fusion spacer is inserted into the space, and a bone graft or bone substitute is placed into the space. As the bone heals, it fuses the vertebrae together to form one bone. The new additions to Medtronic's MIS+ portfolio create the most complete MIS+ TLIF solution available for surgeons. A complete procedural solution allows surgeons to provide the benefits of minimally invasive spine care – including lower infection and complication rates,1 less blood loss,1 smaller incisions, reduced hospital stays,1 and less pain6 – to more patients. Compared to open TLIF, MIS+TLIF requires a smaller incision and less muscle and tissue disruption, which can mean a faster recovery time after the operation.7, 8, 9 Together, these technologies improve clinical and economic value while reducing OR time with a fully streamlined procedure1. About Medtronic Medtronic plc, headquartered in Dublin, Ireland, is among the world's largest medical technology, services, and solutions companies alleviating pain, restoring health, and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals, and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

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Amagma Therapeutics Announces Strategic Partnership with Innovent Biologics in Inflammatory Diseases

Amagma Therapeutics | January 19, 2022

Amagma Therapeutics, a biotechnology company developing antibody therapeutics for inflammatory diseases, announced a license option agreement with Innovent Biologics, Inc. for up to three enzyme specific inhibitors derived from Amagma’s proprietary SEIZMIC™ Platform. Amagma’s SEIZMIC™ Platform leverages a structure-based approach to identify highly selective antibodies which inhibit dysregulated proteases and other enzymes of interest. The collaboration will allow Innovent to access novel, first-in-class molecules for inflammatory disorders with little to no existing treatment options. Amagma will secure clinical manufacturing for its lead programs and gain a proven regional partner with extensive expertise in protein engineering and manufacturing. Under the terms of the agreement, Innovent will be responsible for the manufacture of the three programs through a Phase 2 study and, if Innovent exercises its option, research, development, and commercialization of each program in Greater China. Amagma will continue to be responsible for global research and development prior to option exercise and ex-China research, development and commercialization thereafter. Amagma is eligible to receive development, approval, and commercial milestones if Innovent exercises the options. Amagma may also receive royalties on net sales of any commercial products in the territory. “This transaction highlights an innovative approach to securing manufacturing expertise in exchange for insights into novel disease biology from our SEIZMIC™ platform. Innovent has demonstrated themselves to be an excellent partner with robust capabilities and strong execution. We look forward to working with Innovent to potentially advance these novel therapies.” Tillman Gerngross, Ph.D., Co-founder, Chairman, Amagma Therapeutics About Amagma Therapeutics Amagma Therapeutics is developing precision antibody therapeutics against inflammatory diseases which have proven to be intractable by other approaches. A number of these serious illnesses are driven by overactive extracellular proteases which can compromise organ function and fuel inflammation. The Company’s SEIZMIC proprietary discovery platform enables screening and development of highly selective antibodies that can inhibit dysfunctional enzyme activity. Amagma was founded in 2019 by serial entrepreneur scientists Leonard Zon and Tillman Gerngross. Amagma is based in Waltham, MA.

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