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Microtissue system allows study of deadly lung disease

WASHINGTON, November 16, 2021 — Idiopathic pulmonary fibrosis (IPF) is a deadly and rapidly progressing disease with no cure. Credit: Katherine Cummins WASHINGTON, November 16, 2021 — Idiopathic pulmonary fibrosis (IPF) is a deadly and rapidly progressing

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WASHINGTON, November 16, 2021 — Idiopathic pulmonary fibrosis (IPF) is a deadly and rapidly progressing disease with no cure.

Credit: Katherine Cummins

WASHINGTON, November 16, 2021 — Idiopathic pulmonary fibrosis (IPF) is a deadly and rapidly progressing disease with no cure.

The disease involves abnormal interactions between lung cells, including fibroblasts, and their surrounding environment. Because of this, standard 2D cell culture models used for drug screening tend to perform poorly when predicting response to potential therapies.

Amid the COVID-19 pandemic and rising air pollution levels, incidence of IPF is anticipated to rise, urgently increasing the need for strong model systems.  

In APL Bioengineering, from AIP Publishing, researchers from the University of Minnesota-Twin Cities and Mayo Clinic in Rochester, Minnesota, describe a 3D cell culturing platform that allows study of lung fibroblasts and their microenvironment. The platform enables measurement of cell behaviors and microenvironment changes involved in the disease progression of IPF, and the platform’s size and simplicity make it suitable for use in high-throughput drug screening protocols.

“IPF is a horrible disease that drastically impacts a patient’s life and eventually causes them to die from lack of oxygen,” said co-author Katherine Cummins. “It’s really important to have lab tools and models that create and control the microenvironment in which the cells sit, because this may be key to preclinical identification of possible treatments.”

Unlike rodent IPF models that do not mimic progressive disease and other cell culture systems that lack the surrounding microenvironment, their microtissue platform allows study of fibroblasts within an extracellular matrix (ECM). Changes in the ECM are a hallmark of IPF, so the system allows more relevant functional outputs. Moreover, its simplicity and tunability make it easy to use.

“Many organoid and lab-on-a-chip platforms can be hard to use,” said co-author David Wood. “What’s exciting is that this system is very easy to use. We’ve already disseminated it to two other labs who are using it completely independent of us.”

Validation of the system’s functioning focused primarily on ECM remodeling (i.e., cell-driven changes to the microenvironment) and cell contractility, which increases in activated, diseased fibroblasts.

Multiple tests for each of these two functions demonstrated the system robustly quantifies key aspects of fibrosis. These results were reproduced using patient-donated cells as well, indicating the system could be used for personalized medicine.

Moreover, the system’s versatility allows it to be used with different cell types and other matrix components, so it could be adapted for use in the study of other diseases where cell-microenvironment interactions contribute to disease. The research team has already used the system to study liver toxicity and anticipates it could be used across multiple solid organ systems, including in the study of cancer progression and metastasis.

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The article “A scalable 3D tissue culture pipeline to enable functional therapeutic screening for pulmonary fibrosis” is authored by David K. Wood, Katherine A. Cummins, Peter B. Bitterman, and Daniel Tschumperlin. The article will appear in APL Bioengineering on Nov. 16, 2021 (DOI: 10.1063/5.0054967). After that date, it can be accessed at https://aip.scitation.org/doi/full/10.1063/5.0054967.

ABOUT THE JOURNAL

APL Bioengineering is an open access journal publishing significant discoveries specific to the understanding and advancement of physics and engineering of biological systems. See http://aip.scitation.org/journal/apb.

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Monkeypox cases are rising. Should we be worried?

The World Health Organization has said the current outbreak of monkeypox is the largest ever recorded outside sub-Saharan
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The World Health Organization has said the current outbreak of monkeypox is the largest ever recorded outside sub-Saharan Africa, with cases rising above the 100-mark a few days ago and the UK top of the table with 56 as of yesterday.

Top of the list of concerns is how the virus – which does not spread easily between humans and requires skin-to-skin contact – is spreading so quickly in so many countries in Europe, the Americas and Australia where the disease is not endemic.

There is speculation that monkeypox may be being spread between sexual partners, even though it is not normally considered a sexually-transmitted infection. Thankfully, there have been no deaths reported so far, although the WHO notes monkeypox has a fatality rate of between 3% and 6%.

While health authorities are on alert, the WHO said it thinks the outbreak can be contained and that the overall risk to the population remains low. It also stressed there is no evidence that a viral mutation is responsible for the unusual pattern of infections.

Monkeypox is considered less likely to mutate quickly because it is a DNA virus rather than an RNA virus like influenza or COVID-19.

Several countries including Belgium and the UK are already advising a three-week quarantine period for anyone who contracts the virus and their close contacts.

The increasing case numbers in the current monkeypox outbreak are certainly concerning,” commented Dr Charlotte Hammer, an expert in emerging infectious diseases based at the University of Cambridge in the UK.

“It is very unusual to see community transmission in Europe – previous monkeypox cases have been in returning travellers with limited ongoing spread. However, based on the number of cases that were already discovered across Europe and the UK in the previous days, it is not unexpected that additional cases are now being and will be found, especially with the contact tracing that is now happening.”

Vaccines and drugs are available

Meanwhile, attention is now being turned to other measures to control the outbreak, including the use of vaccines against smallpox – a related virus – in a ‘ring vaccination’ approach designed to control the spread among contacts.

Vaccines used during the smallpox eradication programme can provide around 85% protection against monkeypox, according to the WHO, which notes that one newer vaccine – Bavarian Nordic’s Jyneos – has been approved by the FDA for prevention against both viruses.

There’s also a licensed antiviral drug for monkeypox. SIGA Technologies’ oral drug Tpoxx (tecovirimat) is approved for smallpox, monkeypox and cowpox in Europe, and in the US and Canada for smallpox, although it can be used off-label for the other disease. The US FDA also approved a new intravenous form of the drug last week.

The WHO says there is no need for widespread vaccination, as other control measures like isolation of patients should be enough to curb the spread and in any case supplies of vaccines are limited.

Monkeypox causes symptoms similar to but milder than smallpox, typically beginning with fever, headache, muscle aches and exhaustion. It is transmitted to people from various wild animals, such as rodents and primates, and is usually a self-limited disease with symptoms lasting from two to four weeks.

In 2003, the US experienced an outbreak of monkeypox, which was the first time human monkeypox was reported outside of Africa. The Centers for Disease Control and Prevention (CDC) is making some Jyneos vaccine reserves available for close contact inoculations, including healthcare workers tending to patients.

The UK Health Security Agency (UKHSA) said yesterday it had identified 36 additional cases of monkeypox in England, and that vaccination of high-risk contacts of cases is already underway.

“A notable proportion of recent cases in the UK and Europe have been found in gay and bisexual men so we are particularly encouraging these men to be alert to the symptoms,” said the agency’s chief medical advisor Dr Susan Hopkins.

“Because the virus spreads through close contact, we are urging everyone to be aware of any unusual rashes or lesions and to contact a sexual health service if they have any symptoms.”

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What does good cybersecurity look like in 2022?

The pharma industry is becoming an increasingly hot commodity for cybercriminals. In recent years, digital adoption has accelerated
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The pharma industry is becoming an increasingly hot commodity for cybercriminals. In recent years, digital adoption has accelerated at a rapid pace, with companies racing to integrate cloud-based platforms and telehealth services to expand the delivery of modern healthcare. Combined with the sudden arrival of COVID-19, this perfect storm of events handed cybercriminals an opportunity to exploit weaknesses in fledging systems and processes.

Pharma companies hold masses of vital data sets, from classified intellectual property to proprietary information about drugs and clinical trial developments. The value of such data is not lost on cybercriminals. This was illustrated in 2021, amid growing awareness of the pharma industries’ efforts to develop and distribute COVID-19 vaccines. According to cybersecurity firm Critical Insights, the number of cybersecurity breaches in healthcare reached an all-time high in 2021, exposing an unprecedented amount of protected health information.

Cyber attacks can be highly damaging, both financially and to a company’s reputation. Therefore, it is essential that necessary steps are taken, both at a company and individual level, to understand and prevent the risk of cyber threats. But what does good cybersecurity actually look like? To help navigate the complex world of digital crime, Adarma’s threat consultant Mike Varley, KnowBe4 lead security awareness advocate Javvad Malik, CEO and founder of CyberSmart Jamie Akhtar, and senior engineer at Trend Micro Simon Walsh offer their insights into key trends and best practises for pharma companies.

Why is the healthcare industry a particular target for cyberattacks?

Javvad Malik (JM): Historically cybercriminals were after money, so they often ignored healthcare providers. However, with increasing sophistication within the criminal economies and the ability to monetise data through ransomware, other means of extortion, or resale, healthcare providers have become an almost ideal target for criminals.

Simon Walsh (SW): Despite statements from would-be attackers to the contrary, the healthcare and pharma industries became prime targets during the COVID pandemic, particularly for ransomware operators, as we saw during the breach of the Irish Healthcare Service Executive in May 2021.

There are several reasons for this: they’re seen as easy targets because of their relative lack of security maturity; the COVID pandemic-induced strain they’re already under makes them more likely to pay the ransom; and the fact that the data they hold – patient records – is extremely valuable and opens additional paths to extortion.

Jamie Akhtar (JA): Many healthcare providers have weak or limited defences. These range from poor staff awareness of threats to creaking, outdated operating systems and tech, but whatever the reason, cybercriminals are aware that many healthcare providers make for easy pickings.

Mike Varley (MV): We can expect to see a rising number of ransomware attacks on the healthcare sector. Healthcare is recognised as national critical infrastructure, which makes it an attractive target to malicious foreign entities looking to create chaos and harm. Similarly, when human life is put at risk by an attack, organisations are more likely to pay up, so attackers often view these structures as a quick pay-day.

Where do you see the most mistakes being made in healthcare when it comes to addressing cyber threats?

JM: Perhaps the biggest mistakes or challenges healthcare faces when addressing cyber threats are having outdated or unpatched software running, being too quick to purchase or adopt internet-connected devices without demanding rigorous security testing, and, finally, the lack of security awareness and training amongst IT staff.

SW: Security maturity and the ability to successfully detect and withstand attacks comes from understanding cyber risk and building and developing a cyber security strategy around that understanding. This of course needs to be adopted and driven by the board and C-level executives and too often this is not the case, with a lack of understanding and investment resulting in a weakened security posture.

Over-reliance on security technology without adequate human oversight further weakens this posture. The Irish hospitals who successfully prevented the attack in May 2021 were those who not just detected stages of the attack but also understood what those detections meant and acted as a result.

Developing a human oversight function – for example a Security Operations Centre – in house is costly, difficult, and takes time. So, for many in the healthcare/pharma industry, the quickest route to success on this front is working with the correct partner who will provide that function.

JA: There are two areas in which most organisations, not just healthcare providers, could be doing better. Many aren’t doing the simple things that can thwart most cyber-attacks. For example, regularly updating software and operating systems, using strong passwords and MFA, developing clear policies for staff to follow, and ensuring security tools are configured properly.

On top of this, employee awareness of cyber threats just isn’t widespread enough. An organisation can have the best cybersecurity software around but, if an employee doesn’t know what a phishing email looks like and clicks a malicious link, it’ll be hacked just the same. The way to counter this is basic cybersecurity training. It doesn’t have to be comprehensive, just enough to help your people make informed choices.

“Perhaps the biggest mistakes or challenges healthcare faces when addressing cyber threats are having outdated or unpatched software running, being too quick to purchase or adopt internet-connected devices without demanding rigorous security testing, and, finally, the lack of security awareness and training amongst IT staff.”

 

What trends are you seeing in cybersecurity at the moment?

JA: The most worrying trend is the rise in supply chain attacks. Cybercriminals have worked out that the best way to target large enterprises with solid defences, is to attack a smaller, less well-defended supplier who can give them a backdoor in. As a result, we’re seeing more major attacks originate in this way.

Alongside this, phishing continues to be the single most common form of attack. Due to the general lack of awareness in the working population, many organisations are still struggling to contain the threat.

MV: Increasingly I think we will see healthcare sector organisations turning to managed security service providers who have the expertise, capability, and technology to deal with an increasingly complex and harmful cyber landscape.

The healthcare sector is expected to provide an elevated level of cyber protection and with a shortage of cyber talent and the prohibitive cost of establishing a Security Operations Centre internally, organisations will need a trusted security partner that can provide that level of proactive protection.

What advice would you give to companies looking to improve their cybersecurity policies, both on a company-wide scale and individual basis?

JA: Above all, make them clear and easy to follow. Avoid technical jargon, where possible, as this will only disengage people. And, explain why the company has adopted the policies it has; your staff will find it much easier to follow them if they know why. Also, store them somewhere that’s easy to access from anywhere. There’s little use in a policy if it’s buried deep in a shared drive where nobody reads it.

MV: Cybersecurity policies should be informed by a threat-led approach. Regular threat modelling will highlight what threats you are facing and how adversaries are likely to target your organisation. With this information on areas of commonality, your security teams can focus on implementing layered security and monitoring.

Your policy should consider asset awareness. As basic as it sounds, it can be easy for a small handful of assets to fall under the radar within vast enterprises, which leads to out-of-date operating systems and software.

JM: Organisations should look to take a data-driven approach. That means, that in addition to following what is occurring externally in terms of attacks, they should look through a year or two worth of internal security logs to see what was the root cause of the incidents during this time period.

Once the root causes have been identified, they should be prioritised, and then controls be put in place to address those specific root causes. Those should inform the cybersecurity policies and tailor them to the specific risks the organisation is facing.

SW: For companies, start at the top and ensure that the board and C-level executives are capable of understanding and assessing risk. This will drive investment in cyber strategy and improve your chances of mitigating that risk. Human oversight of security-related activity in the organisation is also fundamental.

For individuals, heightened awareness and ongoing education are key. We all have a role to play in cyber-security as 100% reliance on technology is unfortunately never enough.

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CytoDyn Inc (OTCMKTS: CYDY) On the Comeback Trail (HIV Leronlimab Update)

CytoDyn Inc (OTCMKTS: CYDY) continues to move steadily higher in recent trading since hitting lows of $0.231 after the FDA placed a partial clinical hold…

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CytoDyn Inc (OTCMKTS: CYDY) continues to move steadily higher in recent trading since hitting lows of $0.231 after the FDA placed a partial clinical hold on the Company’s HIV program and a full clinical hold on its COVID-19 program in the United States. CYDY was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share and MIcrocapdaily covered the stock regularly back in those exciting times. Since than CYDY has been downward bound, first suffering from the Citron short attack and more recently the March 30 drop after the FDA hold. Further, CytoDyn elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and is in the process of reevaluating the timing of its HIV BLA resubmission. CYDY saw further declines after the Company’s CEO and registered public accounting firm, Warren Averett LLC, both resigned. 

On May 23 CYDY reached a non-cash settlement with its former Chief Medical Officer, Dr. Richard Pestell. The Company will release to Dr. Pestell 8.3 million shares of CYDY held in escrow, transfer to Dr. Pestell the assets acquired from ProstaGene LLC and subsequently written-off by the Company and issue a warrant at an exercise price of $0.37 per share to Dr. Pestell for seven million shares of the Company’s common stock. Dr. Pestell and the Company are also exploring ways in which Dr. Pestell can reengage with the Company to help realize Leronlimab’s full potential in oncology. This is an important step forward for CytoDyn as any potential suitor would want the current management to clear the deck of lawsuits before initiating a buyout or partnership. Also, an all-stock settlement shows a lot of faith in the Company from Dr. Pestell who make come back. At this point Cytodyn must find a sponsor or partner to get Leronmilab back on track for HIV. 

The underlying science of Leronmilab has not changed; leronlimab has demonstrated significant potential to attack a number of diseases including cancer, and HIV.  Considering how fast CYDY dropped the bounce potential here is significant and when CYDY does make a definitive move northbound the stock could make rapid gains in a very shorty time period. Management remains hopeful the FDA will review the case and stop the hold of Leronlimab. 

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CytoDyn Inc (OTCMKTS: CYDY) is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn is studying leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions. 

In January Cytodyn reported positive results from the 350 mg weekly dose of its Phase 2 NASH clinical trial. The trial was conducted in two parts. Part 1 compared a 700 mg weekly dose and placebo in a double-blind randomized manner and Part 2 evaluated a 350 mg weekly dose as an open label study compared to the same placebo blinded arm. Results of the topline report will be announced when available.  

The pre-clinical and clinical development of PRO 140 was led by Progenics Pharmaceuticals, Inc. through 2011. The Company acquired the asset from Progenics in October 2012. In February 2018, CYDY announced it had met the primary endpoint in its Phase 3 trial for leronlimab as a combination therapy with HAART for highly treatment-experienced HIV patients and first submitted the non-clinical portion of the Company’s Biologics License Application (“BLA”) to the FDA in March 2019.  

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Cytodyns current business strategy is to resubmit its BLA to the FDA as soon as possible, to finalize with the FDA our submitted protocol for a pivotal Phase 3 clinical trial with leronlimab as a monotherapy for HIV patients, to seek emergency use authorization and approval for leronlimab as a potential therapeutic benefit for COVID-19 patients with mild-to-moderate, severe-to-critical, and long-haulers indications in the U.S., Brazil, and other countries, to advance the Company’s clinical trials with leronlimab for various forms of cancer, including, among others, the Phase 2 clinical trial for metastatic triple-negative breast cancer and Phase 2 basket trial for 22 solid tumor cancers, to complete the Phase 2 trial for liver fibrosis associated with nonalcoholic steatohepatitis (“NASH”), and to explore other cancer and immunologic indications for leronlimab.  

On May 23 CYDY announced it has reached a non-cash settlement with its former Chief Medical Officer, Dr. Richard Pestell, concerning an ongoing legal dispute related to his former employment with the Company. 

Under the terms of the agreement, the parties will release each other of all claims, and the Company will release to Dr. Pestell 8.3 million shares of the Company’s common stock held in escrow, transfer to Dr. Pestell the assets acquired from ProstaGene LLC and subsequently written-off by the Company and issue a warrant at an exercise price of $0.37 per share to Dr. Pestell for seven million shares of the Company’s common stock. Dr. Pestell and the Company are also exploring ways in which Dr. Pestell can reengage with the Company to help realize leronlimab’s full potential in oncology. CytoDyn regrets Dr. Pestell’s departure from the Company and the subsequent public statements made by its former CEO about Dr. Pestell. 

Dr. Pestell has published more than 600 works, is the most frequently cited scientist in the field of cell-cycle control and was appointed an Officer of the Order of Australia in the 2019 Queen’s Birthday Honours for distinguished service to medicine and medical education. He has served on editorial boards of six journals, was the Director of two NCI-designated Cancer Centers and has founded several biotechnology companies. He serves as an advisor and reviewer for a number of domestic and international research centers, including NCI cancer centers. 

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Currently trading at a $226 million market valuation CYDY is an SEC filer and is fully reporting OTCQB. The Company has close to $100 million in assets and about that in debt. At current price levels CYDY is worth a close look; CYDY was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share. While there are plenty of ricks not to mention the CEO and accounting firm resigning CYDY is moving northbound now and looks to be coming back. The underlying science has not changed; Leronlimab has demonstrated significant potential to attack a number of diseases including cancer and HIV.  Considering how fast CYDY dropped the bounce potential here is significant and when CYDY does make a definitive move northbound the stock could make rapid gains in a very shorty time period. Management remains hopeful the FDA will review the case and stop the hold of Leronlimab. We will be updating on CYDY when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CYDY.

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Disclosure: we hold no position in CYDY either long or short and we have not been compensated for this article.

The post CytoDyn Inc (OTCMKTS: CYDY) On the Comeback Trail (HIV Leronlimab Update) first appeared on Micro Cap Daily.

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