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Artsakh Human Rights Defender: Azerbaijan's Criminal and Impudent Behavior is a Slap in the Face to All Civilized Humanity - Hetq Online
DO | The Social Limelight – Cornell University The Cornell Daily Sun
There is a very specific feeling of dread that often overtakes me in uncomfortable social settings. My blood begins to churn and immense pressure builds up in my chest. I cant quite think straight and the usual screening process between emotion and action is infiltrated by panic and an impulse to escape. As much as I might try to behave normally, my mind is scrambling to find some way out of my imagined spotlight.
These episodes are a regular occurrence for me. As you can imagine, it gets exhausting always being front and center on a stage that youve completely fabricated for yourself. Im unable to do much of anything without also considering how the people around me are likely to perceive it. Every twitch in my facial expression, every touch of my hair, every small shift in my intonation has been thoroughly envisioned, assessed and cleared by my inner self-critic. Anything that risks alienating me from the group is a no-go and any grab for attention, no matter how small, must first be assessed through every doomsday scenario imaginable.
My outlook is fueled by two very conflicting feelings. The first is the outside gaze, the judgments that the people around me are surely making at all times. Their assessments of my appearance, my personality and the way I carry myself. No action goes unnoticed and every little insecurity Im zoomed in on must be a blaring siren alerting everyone that I should be avoided at all costs.
Accompanying my adolescent egocentrism is the second reason for my insecurity-driven social complex, which is the fear of being alone. I assume this worry stems somehow from evolutionary adaptations for group survival and the reproductive advantages of attracting a mate by being similar to everyone else. In the 21st century, this amounts to feelings of estrangement like Im a pariah in any social circle I attempt to wedge my way into. My place in the group is justified by happenstance and my presence would never be missed or even noticed if I happened to slip out quietly, as is my tendency when faced with the slightest bit of discomfort.
I feel at once like the center of attention and a forgettable wisp of a personality. In my mind, everyones always participating in the nitpicking and the badmouthing, but never doing anything to challenge those assumptions about me. Its always my job to prove my social worth to get others to talk to me, a task far too exhausting to beat out a solo night of watching Korean rom-coms, accompanied by a bubbling pot of instant ramen.
I could point to multiple origins in my life that could be potentially responsible for my paradoxical unease. When I was a child, I was always extremely aware of how adults were judging my actions whether they were impressed by my shows of maturity or bursting out into amused, but nevertheless hurtful, fits of laughter at the blunders that children make out of simply not knowing enough about socially acceptable human behavior. Anytime I misused a punchline I heard from a TV show or unknowingly violated some unspoken social norm, I made sure to quickly scan how the adults were reacting. Any indication that I was doing something even slightly out of line was motivation for me to just keep it to myself the next time. I never understood that their reactions were merely out of amusement and not a judgment on me.
Another possible source lies in my position in my family. As the eldest son in a small Asian family, I never had to vie much for attention when I was younger. I received praise and affection for the smallest accomplishments and grew up convinced that I deserved to be part of the group just for being me. Attending gifted programs from the 2nd to 12th grade meant that I kept the same circle of friends for most of my childhood, never having to fend for myself in an environment where I didnt already know several people I could fall back on.
College completely disrupted the safety nets I grew up cherishing so much. Gone are the doting family members who hang onto my every word and the friends who dont need some compelling reason to give me their time of day. I have no anchor to rely on, no reason to believe that I will be welcomed into the crowd with open arms.
All I want is some sense of security. The ability to interact with others without the expectation to prove that Im a friend-worthy person. I dont want to feel like I have to nitpick every last thing I do because I dont trust that the people around me arent internally badmouthing me.
Too often do I live in service of my imagined sense of others perceptions. I become convinced that negating any potentially embarrassing parts of my personality is the easiest way to get others to like me, when the truth is usually the complete opposite. My constant search for signs of alienation or disinterest in the people I interact with exhausts the little decision-making chimp in my brain to the point where avoiding the interaction altogether is the most attractive choice.
The magnifying glass that I feel constantly pointed at me, no matter how self-imposed it may be, restrains all the most distinctive elements of my personality. Behind the wall of insecurities and timid small talk is, in my opinion, a perceptive, curious, open-minded and incredibly humble individual. The only one preventing him from emerging more frequently is almost always me.
Noah Do is a sophomore in the College of Human Ecology. He can be reached at [emailprotected] Noahs Arc runs every other Monday this semester.
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DO | The Social Limelight - Cornell University The Cornell Daily Sun
New infosec products of the week: March 25, 2022 – Help Net Security
Heres a look at the most interesting products from the past week, featuring releases from AvePoint, DTEX Systems, ExtraHop, NICE Actimize, and Sonrai Security.
NICE Actimizes X-Sight Entity Risk solution delivers data intelligence from a variety of data sources to ensure an entity profile is always accurate and analyzes entity networks and behaviors to provide a single entity trust score which informs detection and prevention systems to power their analytic precision.
Sonrai Security announced its expansion into Cloud Workload Protection (CWPP), with new capabilities that enable enterprise companies to appropriately react to host-based threats according to their immediate severity and business impact.
AvePoints new enhancements automate retention and disposal rules, and provide safe information access retrieval, so that organizations can easily meet requirements and reduce storage overages at the same time.
Reveal(x) 360 Cloud Threat Defense for AWS is purpose-built to stop advanced threats like ransomware, software supply chain attacks, and more. This new offering includes VPC Flow Logs and additional protocol analysis, providing both depth and breadth of visibility for threats in AWS.
The behavioral, contextual workforce intelligence provided by DTEX InTERCEPT extends the capabilities of the Microsoft 365 E5 modules to detect and capture intentional data loss incidents, stop intellectual property theft, pinpoint human behavior attribution as well as malware root cause, and prevents the use and misuse of unsanctioned and sanctioned SaaS applications.
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New infosec products of the week: March 25, 2022 - Help Net Security
Human Population Collapse May Be Closer Than We Think – E/The Environmental Magazine
Courtesy of TRT World Fair Use
Greenhouse gas emissions continued unabated in 2021, and there is no sign that countries are going to honor their commitments to lower them anytime soon. This is evident as the West scrambles for ways to replace Russian fossil fuel supplies as quickly as possible. This means that fossil fuel emissions will not abate, and that we will reach a global mean surface temperature 1.5 degrees Celsius higher than the preindustrial level decades sooner than had previously been predicted. Indeed, 1.5 degrees is the threshold that climate science tells us spells the point at which the effects of global warming will become irreversible and devastating, and will have profound consequences to global ecosystems and to our global civilization.
These impacts are already bad and rapidly worsening. More and hotter heat waves, more frequent and worsening storms, catastrophic flooding, prolonged droughts, wildfires of unprecedented frequency and scale, continuing acidification of the oceans and consequent destruction of marine ecosystems, and a species extinction rate 1,000 times higher than the normal background rate are already wreaking havoc with planetary ecosystems and will only get worse. Feedback loops reinforce these devastating trends, and tipping points threaten to make then suddenly and rapidly turn even more deadly.
All of this promises that, rather than a gradual effect on humankind, the impact of global warming on human population may be rapid and catastrophic. The main compounding factor will be human migration. As heat begins to become an existential threat to the populations in the tropic and subtropic zones, up to three billion people will migrate towards the temperate zones. This is 40% of the human population, and its movement will present an existential threat to the populations in the temperate zones. The inevitable consequence will be conflict on a scale that dwarfs anything in human history.
This conflict, which will manifest itself on national borders across the world, may unleash the use of nuclear weapons that will make the loss of life even more devastating. The deteriorating climate and this unparalleled level of conflict will reduce food production and distribution, and this will further exacerbate the loss of life. As the pace of climate change continues to accelerate, this scenario is likely to play out in a matter of years, not decades, and consequently, the decrease in the human population will be sudden rather than gradual. The following graph shows a potential scenario.
This graph shows two population scenarios. The blue line is the UNs low population scenario. The orange line is a scenario that anticipates a draconian impact of climate change on the human population. It envisions global population peaking in 2030. During the subsequent decade, the scenario projects that population will decrease by one billion as the reproduction rate even in developing countries turns negative, and as the global mortality rate begins to climb. Between 2040 and 2050, this scenario envisions the global human population falling by over six billion people as the human mortality rate soars due to the catastrophic effects of global warming, the reduction of food supplies, global warfare, and the destruction of the infrastructure and communication on which our global civilization depends.
This is speculation. There is no certainty that this scenario will play itself out. But it is not unreasonable speculation. Without a rapid and dramatic change in human behavior on a planetary scale, there is no reason to assume that we are immune from such a horrendous fate.
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Human Population Collapse May Be Closer Than We Think - E/The Environmental Magazine
Women’s body image more likely to be impacted by pornography if they are high in anxious attachment – PsyPost
Does pornography usage make women more self-conscious about their bodies? A study published in the Computers in Human Behavior journal suggests that this relationship may be related to attachment style to romantic partners.
Body image self-consciousness is something many women struggle with for a myriad of reasons, including the strict societal beauty standards placed on women. Being self-conscious about ones own body is associated with negative body satisfaction, lower sexual self-esteem, and lower self-perceived attractiveness. Body image self-consciousness during sexual activity can lead to a less fulfilling sex life, with decreased sexual functioning and pleasure and increased shame and anxiety.
Attachment theory posters that people seek support and proximity when faced with a threat, and that the level of responsiveness they receive from a caregiver in childhood can have implications for romantic relationships later in life. Attachment theory and body image self-consciousness have not been significantly studied together, and the new research seeks to address that, as well as examine a potential mediating role of pornography usage.
Study author Ateret Gewirtz-Meydan and colleagues conducted an online survey of 1,001 Israeli women ranging from 18 to 56 years of age. Participants completed a demographic survey, an attachment orientation scale, answered how often they consume pornographic content, and completed a measure on body image. Gerwitz-Meydan and colleagues sought to measure if pornography usage mediated the relationship between attachment and body image self-consciousness in this study.
Results showed significant group differences between participants in romantic relationships and participants not in romantic relationships. People in romantic relationships showed lower levels of anxious and avoidant attachment styles and reported lower body-image insecurities and pornography usage. Pornography usage was not a mediator between attachment and body image for women who were not in a romantic relationship and was a significant mediator only for women in a romantic relationship who showed an anxious attachment style. This is consistent with previous research that shows that anxious attachment, not avoidant attachment, predicts body dissatisfaction and insecurity.
This study has implications for treating body image issues by working on attachment style. Despite this advantage, the study has some limitations to speak of. Regarding the sample, it was a convenience sample gathered through social media, which may limit generalizability. This research also focused purely on women, and future research could focus on if similar relationships are found in men. Gerwitz-Meydan and colleagues also left pornography usage as a pretty vague variable, and the relationship may be affected by what type or medium of pornography is consumed.
The findings of the present study extend the literature by utilizing attachment theory to gain a better understanding of how women develop body image self-consciousness during intimate relations, the researchers concluded. Specifically, the findings suggest that women may be more susceptible to the influence of pornography use on their body image self-consciousness when they are anxiously attached and in a romantic relationship.
The study, Attachment insecurities and body image self-consciousness along women: The mediating role of pornography use, was authored by Ateret Gewirtz-Meydan, Kimberly J. Mitchell, Zohar Spivak-Lavi, and Shane W. Kraus.
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Women's body image more likely to be impacted by pornography if they are high in anxious attachment - PsyPost
LatticeFlow: The Venture Leader Technology that enables robust and trustworthy AI – Venturelab
28.03.2022 07:00, Isabelle Mitchell
The Venture Leaders Technology expert jury had their work cut out for them this year: They had to look through 180 applications to choose the 10 members of the Swiss National Startup team that will travel to Silicon Valley in April. Before the 10 entrepreneurs meet with international investors and industry leaders to strengthen their business network and advance their globalization, we want to introduce you to each of the 10 Venture Leaders Technology 2022: Meet Petar Tsankov, the co-founder and CEO of LatticeFlow.
Name: Petar TsankovLocation: ZurichNationality: Bulgaria/USAGraduated from: ETH PhD in CS, 2017Job title: Co-founder and CEO of LatticeFlow Number of employees: 12Money raised: USD 2.8 millionFirst touchpoint with Venturelab:In 2022, for theVenture Leaders programPetar, can you summarize what LatticeFlow does?We empower ML [machine learning] teams to deliver robust and performant AI systems, solving a major roadblock to the widespread adoption of AI in our daily lives.How and where did you come up with the idea for your startup?I was reading a Stanford research paper on verifying the correctness of AI models at my ETH office when I realized how we could develop a massively more scalable approach by leveraging techniques from classic program analysis. This idea led to building the worlds first scalable robust AI platform that works on large deep learning models, which form the foundations of modern AI systems. These results triggered significant interest across the industry that was actively looking into solutions that enable safe, robust, and reliable adoption of recent AI advances.What do you expect from the Venture Leaders Technology roadshow, and how will it help you achieve your vision?A fun fact is that it all actually started in San Francisco for us. In early 2020, right before the pandemic hit, I was on a three-week solo roadshow in the US, looking to get feedback from entrepreneurs and investors on our product and business model. The Venture Leaders roadshow is an exciting opportunity to go back and meet these people again. More generally, to build our global brand and become the world leader in robust and trustworthy AI, we need also to win the US market. I expect that the Venture Leaders roadshow will accelerate our expansion into the US market.What is one thing not many people know about you?I had my first professional IT gig when I was 14 years old. A friend of mine took me to his brother-in-laws company to set up a couple of brand new computers and printers in the office. Initially, the company staff was skeptical because of my youthful appearance, but ultimately, I got the work done and was then compensated with an ice cream. They actually took me to my favorite ice cream shop, and I cant say I wasnt thrilled.What is your favorite podcast?Currently, I love Lex Fridmans podcast. Lex is a master at asking simple, direct questions, offering an excellent opportunity to pick into the brains of great minds in business and science. I also enjoy Andrew Hubermans podcast, bringing knowledge about the latest advances in neuroscience, human behavior, and beyond.
What is always in your fridge? Lemons. I always start my day with freshly squeezed lemon in warm water.What are you most proud of? Receiving the John Atanasoff Award from the President of Bulgaria, given once per year to a computer scientist for major research contributions in the domain. I know some of the prior awardees and am proud to have my name next to theirs.How did you come up with the name of your startup?The first startup I co-founded was ChainSecurity, which focused on blockchain security. This time, I wanted a less obvious name that is not directly related to the companys business. My co-founder, Prof. Martin Vechev, came up with LatticeFlow. We always wanted to plug in the term Lattice somewhere, which is the abstract mathematical structure that underpins the theory behind our robust AI platform that initiated all our work on safe, robust, and trustworthy AI.What is your favorite productivity hack?Do what you love with people you admire and are proud to work with. Thats the main hack. Also, work on big problems that matter; this is essential to persevere during difficult times.How and where do you clear your mind to stay productive?I run in the mountains for about 40-50 minutes in the morning. This is the best way to detach from technology, pop up from the daily routine to reflect on what is happening around me, and plan the time ahead. Most of my decisions about what to focus on and prioritize happen while running.What is your greatest professional failure, and what did you learn from it?I forgot about a clients deadlinea security review of a crypto token that was about to launchand received a reminder from the client on Christmas Eve. This happened in the early days of my previous company when I was still reluctant to adopt a calendar to manage my time (I do use a calendar today). My co-founder and I spent Christmas reviewing the code of the crypto token, which ultimately had a successful launch and right now ranks among the most-valued cryptocurrencies on the market with a valuation of nearly USD 500 million.For more information and updates on LatticeFlow and the Venture Leaders Technology 2022, follow#VLeadersTechon social media and onwww.venture-leaders.ch/technology.
The Venture Leaders Technology 2022 program is organized by Venturelab and supported by dpd Switzerland, EPF Lausanne, ETH Zurich, Kellerhals Carrard, Rothschild & Co, and the Canton of Vaud.
LatticeFlow (https://latticeflow.ai/) is an award-winning deep-tech spin-off and creator of the worlds first platform for robust AI models. The company was founded in 2020 by globally leading AI rese... Read more
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LatticeFlow: The Venture Leader Technology that enables robust and trustworthy AI - Venturelab
Press Release: Sanofi continues on path to industry leadership in Immunology with Dupixent (dupilumab) as key driver – Yahoo Finance
Sanofi - Aventis Groupe
Sanofi continues on path to industry leadership in Immunology with Dupixent (dupilumab) as key driver
Dupixent peak sales ambition raised to more than 13 billion
Chronic obstructive pulmonary disease 2023 pivotal readouts provide potential for additional Dupixent sales ambition upgrade
13 potential new medicines currently in the clinic to treat chronic inflammatory diseases, with 17 readouts expected by the end of 2024
Paris, March 28, 2022. Tomorrow, Sanofi will host an Immunology Investor Event with key members of the leadership team providing updates on how the company is advancing its Immunology strategy, including the ambition to more than quadruple Immunology franchise sales by the end of the decade. The focus of the event is on Dupixent (dupilumab), a key growth driver, and Sanofis rapidly advancing pipeline, highlighting dermatological, respiratory and gastrointestinal diseases as priority therapeutic areas. Sanofi has raised the Dupixent sales peak ambition to more than 13 billion. This new ambition does not include potential for additional sales ambition upgrade from chronic obstructive pulmonary disease (COPD), with pivotal readouts anticipated in 2023.
For more than a decade Sanofi, in collaboration with Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), has been advancing the science of diseases driven by type 2 inflammation. Dupixent is now a market leader and more than 400,000 patients with certain types of atopic dermatitis (AD), asthma and chronic rhinosinusitis with nasal polyposis have been treated globally. By 2025, Dupixent is expected to generate an additional 11 new regulatory submissions across indications and age groups.
Bill SiboldExecutive Vice President, Head of Global Specialty Care, SanofiIn the five years since launch, Dupixent has excelled in improving the lives of patients with diseases driven by type 2 inflammation. This truly unique medicine is only at the beginning of its journey to helping potentially millions of patients. Beyond Dupixent, we are committed to delivering the next generation of novel medicines that we hope will change the practice of medicine in chronic inflammatory diseases beyond type 2 inflammation. We are committed to moving with the utmost urgency to bring new medicines to patients that address their individual needs, offering choice and hope.
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Sanofis novel pipeline is comprised of 13 next-generation medicines designed to target mechanisms beyond type 2 inflammation. Our Research & Development (R&D) teams are following the science to control chronic inflammation and collaborating with leading experts across all sectors to address both urgent and growing patient needs. We are focused on targets with the most potential to alter the course of immune-based diseases, from the mildest to the most severe, using novel technologies that unlock previously inaccessible biology. These drug discovery platforms, for example, synthetic biology, TAILORED COVALENCY chemistry, and multispecific NANOBODY molecules, are allowing Sanofi to pursue both injectable and oral therapeutics. Sanofis attack in immunological diseases also entails precision medicine approaches that aim to remove the guess-work from clinical practice by treating the right patients, with the right medicines, at the right time.
John Reed, M.D., Ph.D.Global Head of Research and Development, SanofiOur long-term strategy goes well beyond Dupixent to deliver best-in-class medicines that break efficacy ceilings and help patients with chronic inflammatory diseases achieve long-term disease modification. We are pursuing this ambition through precision medicine approaches that leverage our proprietary technologies, such as our NANOBODY platform that can help us address multiple therapeutic targets with one medicine. With approximately 21 clinical readouts expected across our promising immunology pipeline by the end of next year, it is an exciting time for our team working in Immunology R&D.
Sanofi will highlight the following assets in its growing R&D pipeline:
Three candidates for AD, complementing Dupixents position in AD driven by type 2 inflammation, spanning all severities of disease as well as topical, oral and injectable administration. These drug development programs include our acceleration of priority asset amlitelimab, an anti-OX40L antibody that aims to restore immune homeostasis between pro-inflammatory and anti-inflammatory T cells.
Two complementary candidates for COPD, developed in collaboration with Regeneron, targeting distinct subpopulations.
A broad Phase 1 clinical program of small molecules and biologics. These candidate medicines include oral small molecules, degraders, synthetic cytokines, and several NANOBODY molecules, designed to simultaneously tackle two proven targets, thus aiming to break efficacy ceilings.
Immunology Investor Event Details
The hybrid Immunology Investor Event will take place on Tuesday, March 29 from 2 p.m. to 6 p.m. CEST / 8 a.m. to noon EDT (webcast, in-person meeting at Sanofis Cambridge office).
For background slides and webcast information, please refer to the following link. The information will be available beginning Tuesday, March 29 at 1 p.m. CEST / 7 a.m. EDT.https://www.sanofi.com/en/investors/financial-results-and-events/investor-presentations/Immunology-Investor-Event-2022
About Our Inflammatory Pipeline
Through world-class R&D and a laser focus on patients, Sanofi discovers, develops and delivers best-in-class treatments that improve the lives of people living with chronic inflammatory diseases. The Immunology pipeline consists of 7 potential new medicines in Phase 1 clinical development, 5 in Phase 2 clinical development, and 1 in Phase 3 clinical development. These programs include potential treatments across a wide range of inflammatory conditions. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. In addition to the 3 currently approved indications, Sanofi and Regeneron are studying dupilumab in nearly a dozen other diseases.
About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comSally Bain | + 1 617 834 6026 | sally.bain@sanofi.com
Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.comArnaud Delpine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comPriya Nanduri | +1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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Press Release: Sanofi continues on path to industry leadership in Immunology with Dupixent (dupilumab) as key driver - Yahoo Finance
Pharming Announces Presentation of Positive Results of Phase III Leniolisib Trial in APDS at Clinical Immunology Society 2022 Annual Meeting – Yahoo…
Principal Investigator Dr. V. Koneti Rao Will Share Data Supporting the Investigational Treatment for Activated PI3K Delta Syndrome (APDS)
LEIDEN, Netherlands, March 28, 2022 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) (NASDAQ: PHAR) announces that Principal Investigator V. Koneti Rao, MD, FRCPA, a staff physician in the Primary Immune Deficiency Clinic at the National Institutes of Health in Bethesda, Maryland, will present positive findings from the Phase III pivotal clinical trial of leniolisib for patients with activated phosphoinositide 3-kinase delta (PI3K) syndrome (APDS) at the Clinical Immunology Society (CIS) 2022 Annual Meeting in Charlotte, North Carolina.
Pharming_Group_NV_Logo
The presentation for healthcare practitioners and other experts will take place on April 1, 2022, from 11:30 to 11:45 ET/17:30 to 17:45 CET and will be accessible on site and virtually. To attend, please register here:
https://cis.clinimmsoc.org/education/meetings/am22/program/amprogram
Leniolisib is being developed for the targeted treatment of APDS, a rare primary immunodeficiency caused by genetic variants that currently has no approved therapy. On February 2, 2022, Pharming announced that the Phase III trial of leniolisib, sponsored by Novartis, has met both of its co-primary endpoints by demonstrating improvements in lymphoproliferation and immunophenotype correction, and that the treatment was well tolerated by patients.
Pharming plans to begin submitting global regulatory filings for leniolisib, a small-molecule PI3K inhibitor, in the first half of 2022 and, subject to approval, launching the treatment in the U.S. in the first quarter of 2023 and starting a series of European launches in the second half of 2023.
Nicholas Hartog, MD, FAAAAI, FACAAI, a specialist in allergy and immunology at Spectrum Health Helen Devos Children's Hospital in Grand Rapids, Michigan, said: "I'm eager to learn more about the positive results of this Phase III study of leniolisib in patients with APDS. A promising therapy for this rare and challenging disease sparks hope in physicians like me, who are dedicated to improving care for affected patients and reducing their symptoms. I could not be more excited about the opportunity for a personalized and precision-based therapy on the horizon for this patient population."
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Anurag Relan, Chief Medical Officer of Pharming, commented: "Pharming is committed to bringing new therapies to people with rare diseases and will work closely with regulatory authorities across the globe in an effort to make this innovative option available to physicians who care for patients with primary immunodeficiencies. We are excited to be pursuing a development program that aims to bring patients the first targeted therapy option for APDS, as this disease significantly impacts their lives, yet treatment has been limited to supportive therapies such as antibiotics and immunoglobulin replacement therapy."
In his presentation during a plenary session titled "Precision Medicine for Hyperinflammatory Disorders," Dr. Rao will explain the study's design, share its primary and secondary findings, and detail patient disposition and safety results. The annual CIS meeting will be dedicated to exploring immune deficiency and dysregulation.
About Activated Phosphoinositide 3-Kinase Syndrome (APDS)
APDS is a rare primary immunodeficiency that affects approximately one to two people per million. Also known as PASLI, it is caused by variants in either of two genes, PIK3CD or PIK3R1, that regulate maturation of white blood cells. Variants of these genes lead to hyperactivity of the PI3K (phosphoinositide 3-kinase delta) pathway.1,2 Balanced signaling in the PI3K pathway is essential for physiological immune function. When this pathway is hyperactive, immune cells fail to mature and function properly, leading to immunodeficiency and dysregulation.1,3 APDS is characterized by severe, recurrent sinopulmonary infections, lymphoproliferation, autoimmunity, and enteropathy.4,5 Because these symptoms can be associated with a variety of conditions, including other primary immunodeficiencies, people with APDS are frequently misdiagnosed and suffer a median 7-year diagnostic delay.6 As APDS is a progressive disease, this delay may lead to an accumulation of damage over time, including permanent lung damage and lymphoma.4-7 The only way to definitively diagnose this condition is through genetic testing.
About leniolisib
Leniolisib is a small-molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K with immunomodulating and potentially anti-neoplastic activities. Leniolisib inhibits the production of phosphatidylinositol-3-4-5-trisphosphate (PIP3). PIP3 serves as an important cellular messenger specifically activating AKT (via PDK1) and regulates a multitude of cell functions such as proliferation, differentiation, cytokine production, cell survival, angiogenesis, and metabolism. Unlike PI3K and PI3K, which are ubiquitously expressed, PI3K and PI3K are expressed primarily in cells of hematopoietic origin. The central role of PI3K in regulating numerous cellular functions of the adaptive immune system (B-cells and, to a lesser extent, T cells) as well as the innate immune system (neutrophils, mast cells, and macrophages) strongly indicates that PI3K is a valid and potentially effective therapeutic target for several immune diseases.
To date, leniolisib has been well tolerated during both the Phase 1 first-in-human trial in healthy subjects and the Phase II/III registration-enabling study.
About the Phase II/III leniolisib Trial
Sponsored by Novartis, the Phase II/III registration-enabling study was composed of two parts, the first being a 12-week open-label dose escalation part that included six patients with APDS and determined the dose of leniolisib to be given in the Phase III part.
The Phase III part consisted of a randomized, placebo-controlled, blinded trial of leniolisib that enrolled 31 patients who had APDS and were age 12 or older. The patients were randomly assigned according to a 2:1 ratio to receive either leniolisib 70mg twice daily or placebo for 12 weeks. The co-primary endpoints of the randomized study evaluated reduction in lymph node size and correction of immunodeficiency as shown by an increase in nave B cells. Following study treatment, patients were permitted to roll over to an open-label extension study evaluating long-term safety, tolerability, and efficacy.
About Pharming Group N.V.
Pharming Group N.V. is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs.
The flagship of our portfolio is our recombinant human C1 esterase inhibitor (rhC1INH) franchise. C1INH is a naturally occurring protein that down regulates the complement and contact cascades in order to control inflammation in affected tissues.
Our lead product, RUCONEST, is the first and only plasma-free rhC1INH protein replacement therapy. It is approved for the treatment of acute hereditary angioedema (HAE) attacks. We are commercializing RUCONEST in the United States, the European Union and the United Kingdom through our own sales and marketing organization, and the rest of the world through our distribution network.
In addition, we are investigating the clinical efficacy of rhC1INH in the treatment of further indications, including pre-eclampsia, acute kidney injury and severe pneumonia as a result of COVID-19 infections.
We are also studying our oral precision medicine, leniolisib (a phosphoinositide 3-kinase delta, or PI3K delta, inhibitor), for the treatment of activated PI3K delta syndrome, or APDS. World-wide rights for leniolisib were licensed from Novartis AG in 2019. Leniolisib met both of its primary end points in a registration enabling Phase 2/3 study in the United States and Europe. We are targeting global regulatory filings for leniolisib from Q2 2022 onwards.
Additionally, we entered into a strategic collaboration with Orchard Therapeutics to research, develop, manufacture and commercialize OTL-105, a newly disclosed investigational ex-vivo autologous hematopoietic stem cell (HSC) gene therapy for the treatment of HAE.
Furthermore, we are leveraging our transgenic manufacturing technology to develop next-generation protein replacement therapies, most notably for Pompe disease, which is currently in preclinical development.
Forward-looking Statements
This press release contains forward-looking statements, including with respect to timing and progress of Pharming's preclinical studies and clinical trials of its product candidates, Pharming's clinical and commercial prospects, Pharming's ability to overcome the challenges posed by the COVID-19 pandemic to the conduct of its business, and Pharming's expectations regarding its projected working capital requirements and cash resources. These statements are subject to a number of risks, uncertainties and assumptions, including but not limited to: the scope, progress and expansion of Pharming's clinical trials and ramifications for the cost thereof; and clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in Pharming's 2020 Annual Report and the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission, the events and circumstances discussed in such forward-looking statements may not occur, and Pharming's actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Pharming as of the date of this release.
Inside Information
This press release relates to the disclosure of information that qualifies, or may have qualified, as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation.
References:
1. Lucas CL, et al. Nat Immunol. 2014;15:88-97.
2. Elkaim E, et al. J Allergy Clin Immunol. 2016;138(1):210-218.
3. Nunes-Santos C, Uzel G, Rosenzweig SD. J Allergy Clin Immunol. 2019;143(5):1676-1687.
4. Coulter TI, et al. J Allergy Clin Immunol. 2017;139(2):597-606.
5. Maccari ME, et al. Front Immunol. 2018;9:543.
6. Jamee M, et al. Clin Rev Allergy Immunol. 2019;May 21.
7. Condliffe AM, Chandra A. Front Immunol. 2018;9:338.
For further public information, contact:
Pharming Group, Leiden, The Netherlands Sijmen de Vries, CEO: T: +31 71 524 7400 Susanne Embleton, Investor Relations Manager: T: +31 71 524 7400 E: investor@pharming.com
FTI Consulting, London, UK Victoria Foster Mitchell/Alex Shaw T: +44 203 727 1000
FTI Consulting, USA Jim Polson T: +1 (312) 553-6730
LifeSpring Life Sciences Communication, Amsterdam, The Netherlands Leon Melens T: +31 6 53 81 64 27 E: pharming@lifespring.nl
US PR: Emily VanLare E: Emily.VanLare@precisionvh.com T: +1 (203) 985 5596
EU PR: Dan Caley E: Dan.caley@aprilsix.com T: +44 (0) 787 546 8942
Logo: https://mma.prnewswire.com/media/1454235/Pharming_Group_NV_Logo.jpg
DICE Therapeutics Expands Management Team and Board of Directors – Yahoo Finance
DICE Therapeutics, Inc.
Mary Riley, J.D., appointed as general counsel
Lisa Bowers, MHSA, and Mittie Doyle, M.D., FACR, join board of directors
SOUTH SAN FRANCISCO, Calif., March 28, 2022 (GLOBE NEWSWIRE) -- DICE Therapeutics, Inc. (Nasdaq: DICE), a biopharmaceutical company leveraging its proprietary technology platform to build a pipeline of novel oral therapeutic candidates to treat chronic diseases in immunology and other therapeutic areas, today announced the appointment of Mary Riley as general counsel and the additions of Lisa Bowers and Mittie Doyle, M.D., FACR, to DICEs board of directors. Concurrently, Stephen Zachary, Ph.D., will be stepping down from the Companys board.
Mary, Lisa and Mittie are excellent additions to the DICE team with extensive biopharmaceutical industry experience and expertise in their respective fields, said Kevin Judice, Ph.D., CEO of DICE Therapeutics. We are pleased to welcome them to DICE during this important time in the Companys growth and evolution. We would also like to thank Stephen for his many contributions during his time on our board, including during the early stages of the Companys formation.
Mary Riley, J.D., as general counselMs. Riley joins DICE following a 15-year tenure at Genentech, most recently serving as vice president, litigation, where she served on the legal leadership team and was responsible for managing a wide range of legal matters. She also previously led Genentechs business law group and employment law group, where she served as a member of the human resources leadership team. Before joining Genentech, Mary was a partner at Heller Ehrman LLP and held roles at other corporate law firms. Mary received a J.D. from Fordham University School of Law and a B.A. from College of the Holy Cross.
Lisa Bowers, MHSA, to board of directorsMs. Bowers is the chief commercial officer of Day One Biopharmaceuticals, a clinical-stage biopharmaceutical company founded to address a critical unmet need, the lack of therapeutic development in pediatric cancer. Prior to joining Day One, Lisa served as the chief executive officer and founder of Rhia Ventures, a social venture investment organization focused on reproductive health. She was also the chief operating officer of the Tara Health Foundation and had an extensive career at Genentech/Roche, where she held P&L accountability for Genentechs cystic fibrosis business and was the head of the North American supply chain region, accountable for more than $20 billion of medicine across the U.S. and Canada. Prior to these roles, Ms. Bowers led Genentechs patient access services and the companys strategic marketing function for managed care organizations. Ms. Bowers has been a board observer for Cadence Health and is a member of the board for Planned Parenthood Mar Monte. She received a Master of Health Services Administration from the University of Michigan School of Public Health and a B.A. from Yale University.
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Mittie Doyle, M.D., FACR, to board of directorsDr. Doyle is a proven research physician who has held numerous leadership roles in clinical development. She currently serves as chief medical officer of Aro Biotherapeutics, a biotechnology company pioneering the development of tissue-targeted genetic medicines. Prior to joining Aro, Dr. Doyle served as vice president, global therapeutic area head, immunology at CSL Behring. Prior to her time at CSL, Dr. Doyle held senior level roles at Shire Pharmaceuticals, Flexion Therapeutics and Alexion Pharmaceuticals. During her career, she has led clinical development across a broad range of immune mediated and orphan diseases and led teams with responsibilities for design and execution of first-in-human through Phase 2 and 3 trials, resulting in several global regulatory approvals. Dr. Doyle received an M.D. from Yale Medical School and completed her postdoctoral training at Harvard Medical School including a residency in internal medicine at Massachusetts General Hospital and clinical/research fellowship in rheumatology and immunology at Brigham and Womens Hospital. She received a B.A. from Princeton University.
About DICE Therapeutics, Inc.DICE Therapeutics, Inc. is a biopharmaceutical company leveraging its proprietary technology platform to build a pipeline of novel oral therapeutic candidates to treat chronic diseases in immunology and other therapeutic areas. DICE is initially focused on developing oral therapeutics against well-validated targets in immunology, with the goal of achieving comparable potency to their systemic biologic counterparts, which have demonstrated the greatest therapeutic benefit to date in these disease areas. The Companys DELSCAPE platform is designed to discover selective oral small molecules with the potential to modulate protein-protein interactions (PPIs) as effectively as systemic biologics. DICEs lead therapeutic candidates are oral antagonists of the pro-inflammatory signaling molecule, IL-17, which is a validated drug target implicated in a variety of immunology indications. DICE is also developing oral therapeutic candidates targeting 47 integrin and V1/V6 integrin for the treatment of inflammatory bowel disease and idiopathic pulmonary fibrosis, respectively.
Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the Companys future plans and prospects, the Companys current cash position and anticipated runway, and the anticipated therapeutic properties and potential of the Companys therapeutic candidates. In addition, when or if used in this press release, the words may, could, should, anticipate, believe, estimate, expect, intend, plan, predict and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Companys forward-looking statements due to a variety of factors, including risks and uncertainties related to the Companys ability to advance DC-806, DC-853 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the Companys therapeutic candidates, the timing and results of preclinical and clinical trials, our ability to fund development activities and achieve development goals, the impact of the COVID-19 pandemic on the Companys business, its ability to protect its intellectual property and other risks and uncertainties described under the heading Risk Factors in the Companys annual report on Form 10-K filed on March 28, 2022, and its other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein.
Contact:Katie Engleman, 1ABkatie@1abmedia.com
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DICE Therapeutics Expands Management Team and Board of Directors - Yahoo Finance
Allergen immunotherapy during the COVID-19 pandemic-A survey of the German Society for Allergy and Clinical Immunology – DocWire News
This article was originally published here
Clin Transl Allergy. 2022 Mar;12(3):e12134. doi: 10.1002/clt2.12134.
ABSTRACT
BACKGROUND: When the coronavirus pandemic 2019 (COVID-19) emerged, concerns were also raised regarding the safety of allergen immunotherapy (AIT). The German Society for Allergology and Clinical Immunology (DGAKI) conducted a survey to collect real-world data on the daily routine of administering subcutaneous AIT (SCIT) and sublingual AIT (SLIT) during the COVID-19 pandemic.
METHODS: A web-based retrospective survey using the online platform survio with 26 standardized questions was used to survey physicians treating allergic patients during the pandemic.
RESULTS: Three hundred and forty-five physicians who regularly offer and perform AIT in German-speaking countries responded to the questions. 70.4% of the respondents stated that they regularly initiated and dosed up SCIT for inhalant allergies (41.4% venom-SCIT, 73.6% SLIT), and 85.2% of the respondents stated that they continued SCIT for inhalant allergies during the maintenance phase in a regular way (59.1% venom-SCIT, 90.4% SLIT) in healthy patients without current symptoms indicating an infection with COVID-19. With regard to tolerability, there was no evidence for increased occurrence of adverse events in patients without current symptoms of COVID-19 infection during the pandemic.
CONCLUSIONS: This retrospective study demonstrated adherence to national and international position papers of AIT during the COVID-19 pandemic in German-speaking countries. Besides, the survey has confirmed a good tolerability of AIT for both SCIT and SLIT.
PMID:35344300 | DOI:10.1002/clt2.12134