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Quotient Sciences and CytoAgents Accelerate Potential Treatment for COVID-19 Cytokine Storm

Collaboration Expedites Human Clinical Trials for COVID-19 Drug Candidate

Nottingham, U.K., and Pittsburgh–(BUSINESS WIRE)–A collaboration to accelerate the development of a lead COVID-19 drug candidate into human clinical trials was announced today by Quotient Sciences, a leading provider of innovative drug development and manufacturing solutions, and CytoAgents, Inc., a privately held biotechnology company focused on the development of pharmaceutical products for the treatment of viral infectious diseases. The partnership will focus on utilizing Quotient’s integrated service portfolio to support the rapid development of CytoAgents’ lead COVID-19 drug candidate, GP1681, for Phase I and II in 2020.

“Our mission is to create a powerful, lasting solution, not just for the current crisis but for any respiratory epidemic, thereby saving lives and reducing the strain on healthcare facilities”

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Scientific consensus is building that severe illness caused by COVID-19 and other infectious diseases is triggered by a phenomenon known as “cytokine storm,” an excessive immune response that attacks the body. GP1681 is a small molecule inhibitor of cytokine release in activated human immune cells and has been shown to safely modulate the natural immune response by tamping down various cytokines. GP1681 addresses an unmet need for therapeutic treatment by targeting the underlying cause of life-threatening symptoms associated with cytokine storm, which can cause more harm than the virus itself.

“Our mission is to create a powerful, lasting solution, not just for the current crisis but for any respiratory epidemic, thereby saving lives and reducing the strain on healthcare facilities,” said Teresa Whalen, RPh, CEO, CytoAgents. “Working with Quotient Sciences is a major milestone for CytoAgents in its accelerated path for a universal treatment for COVID-19-related or any respiratory epidemic.”

Mark Egerton, Ph.D., CEO, Quotient Sciences, said, “The COVID-19 pandemic has caught humanity off guard, and we need to act swiftly to bring new medicines to patients around the world. We are delighted to support CytoAgents with the product development of GP1681.”

Under the scope of the agreement, CytoAgents will access Quotient’s formulation and manufacturing expertise to develop and rapidly supply drug product for Phase I and II testing in 2020. In parallel, Quotient will work to develop a scalable solid oral dosage form for larger patient trials and commercialization. The program will be conducted at Quotient’s facility in Garnet Valley, PA, which has specialized drug handling and containment suitable for highly potent drug candidates.

About Quotient Sciences
Quotient Sciences is an innovative global pharmaceutical development, clinical and commercial manufacturing organization providing services to the pharmaceutical and biotech industries. A combination of specialized skills and agile integrated processes enables Quotient Sciences to develop customized solutions which dramatically reduce the time and cost of getting drugs to market. Everything we do is driven by a deeply held belief, shared across the entire organization, that molecules need to become cures — fast.

About CytoAgents
CytoAgents is a privately held biotechnology company focused on the development of innovative pharmaceutical products for the treatment of COVID-19, influenza, viral infectious diseases and conditions that cause acute respiratory distress. Using a novel, host-directed approach, our lead compound, GP1681, targets the underlying cause of life-threatening respiratory distress, cytokine release syndrome, by modulating the body’s natural immune response to sickness or disease. We are committed to developing first-in-class, best-in-class products that meet a major medical need now and into the future.

Contacts

Jane Byram for Quotient Sciences
SCORR Marketing
(512) 626-2758
jane@scorrmarketing.com

Kelley Skoloda for CytoAgents
KS Consulting & Capital
(412) 897-3369
kelley.skoloda@ksconsultingandcapital.com

Niche Raises $35 Million to Rival School Directory Review Sites

By Wade Tyler Millward     Apr 29, 2020

 With campuses closed around the world, aspiring college students may well depend on digital tools to decide where to attend. Some schools have invested in virtual tours to give students and parents a peek, but families may also fall back on old-fashioned online reviews.

Some people already refer to U.S. News & World Report’s school rankings or nonprofit GreatSchools’ directory. There’s also Niche, which hopes to compete for the attention of parents as they research and decide where to send their kids to school.

And now, thanks to a $35 million Series C investment round that closed before the outbreak, Niche hopes to raise its profile and partner with thousands of additional schools nationwide to add more information to the existing 130,000 K-12 schools, colleges and universities on its website. “These are the most important decisions of your life,” says Niche founder and CEO Luke Skurman.

Radian Capital led the round. Salesforce Ventures, Allen & Co. and Tim Armstrong participated. Founded in 2002 and based in Pittsburgh, Niche has raised a total of about $45 million in venture capital.

Skurman’s company originally focused on college ratings under the name College Prowler. In 2013, the company rebranded as Niche and added K-12 and neighborhood data.

Niche claims its directory has 140 million ratings and reviews for schools and colleges, not to mention quality of life metrics for various U.S. cities. It ranks schools by different measures and categories. K-12 schools are sortable by public or private, religious affiliation and whether they offer gifted programs, among other measures. College categories include four-year or two-year, average costs after financial aid and level of selectivity.

If you’re curious about the latest results, Niche’s best college in America is Massachusetts Institute of Technology. The best public high school is Thomas Jefferson High School for Science and Technology in Alexandria, Va., and the best private high school is Phillips Exeter Academy in Exeter, N.H.

The best city to live in? Arlington, Va., per Niche.

Niche.com CEO Luke Skurman shares company history.

The company relies on data from the Department of Education, U.S Census and FBI, along with other resources. The company also uses survey data from millions of students, parents and alumni to inform its profiles. It excludes schools and places missing data for 50 percent or more of the factors it weighs the most.

For its 2020 college rankings, for example, academic factors like acceptance rates and student and alumni surveys on academics at the school received the most weight, while factors like median rent and local crime rates received the lowest weight. For K-12 schools, academics received the highest weight while the number of sports and survey responses on athletics and athletic facilities from students and parents were weighed less.

Niche claims that about 21 million people a year research K-12 schools on its platform. Another 20 million research colleges and 11 million people research places to live. Skurman says his company has about 120 full-time employees.

The website is free to use for students and parents. The company makes money from advertising and charging schools to upgrade their profiles on their site. Institutions can access the already-created profiles for free and receive monthly insight reports and update their information. Niche has about 15,000 such accounts.

With a paid upgraded account, they get the ability to post messages and marketing materials like YouTube videos, link to Instagram accounts and remove banner ads. So far, more than 1,000 K-12 schools and districts and 330 colleges are paying customers of this service. Clients include Harvard Westlake School, Boston University and online schools operator K12 Inc.

The average contract value for Niches’ suite of subscription services is about $10,000 a year. Niche doesn’t charge per enrollment or guarantee enrollents, Skurman says.

However, schools cannot dictate changes to reviews, ratings and rankings, says Skurman, 39. “They have no bearing on our editorial coverage,” he says. “We have to maintain trust with users.”

The company also sells licenses for its data to third-party organizations starting at $5,000. Customers include real estate firms that want to provide insights on neighborhoods and businesses that want to learn more for market expansion and recruitment. The relationship between school ratings and rankings and real estate information have led to concerns that such metrics may perpetuate racial and economic disparities.

One way Niche has combat this issue is through a particular rankings list for “standout schools” that focuses on factors like diversity, graduation rates and state test scores for economically disadvantaged students. The list is limited to schools with an overall Niche grade of B or higher and with at least half of its student population identifying as economically disadvantaged.

Sally Rubenstone, a contributor to college admissions counseling website College Confidential and an admissions counselor for more than 15 years, said in an email that U.S News remains the top resource for college rankings, much to her chagrin.

While the rankings have helped her champion lesser-known universities and liberal arts colleges, she still feels that rankings add unnecessary stress to college applications and that families have come to rely on scores and prestige over other factors like programs that interest students.

With the COVID-19 outbreak, more schools have made the SAT and ACT standardized tests optional for the class of 2021. The test-optional movement already saw adoption from about 1,000 U.S. schools before the outbreak.

Rubenstone hopes less focus on standardized test requirements and more flexible transfer policies “will throw a monkey wrench into the ranking protocol and outcomes and may even spur some folks to more eagerly look beyond the rankings when making college decisions.”

 Wade Tyler Millward is a reporter at EdSurge covering edtech business. Reach him at wade [at] edsurge [dot] com.

Pittsburgh biotech firm ‘milestone’ will help it speed Covid-19 therapy to clinical trial 

 

By Paul J. Gough  – Reporter, Pittsburgh Business Times

Apr 28, 2020, 5:17pm EDT

A Pittsburgh biotech firm’s newly announced partnership with an England-based pharmaceutical manufacturer will allow the company to bring its drug candidate into clinical trials to see if it will be an effective therapy for Covid-19.

CytoAgents Inc., a two-year-old company based in Pittsburgh, is collaborating with Quotient Sciences of Nottingham, England, to allow for rapid development of CytoAgent’s drug candidate GP1681 for Phase I and II clinical trials in 2020. Quotient will help develop and supply the pills to be used in the trials from its Philadelphia-region facility in Garnet Valley, Pa.

The drug candidate developed by CytoAgents doesn’t treat Covid-19 per se but instead addresses an underlying illness caused by Covid-19, an excessive immune response that turns the body against not only the virus but also against healthy cells. This immune response, called a cytokine storm, is becoming a major complication of Covid-19 and other respiratory diseases like influenza, SARS and MERS.

“It triggers an inflammation that leads to respiratory distress,” said CytoAgent CEO Teresa Whalen. The drug candidate fine tunes the immune response, much like immunotherapy works to change the cellular response to cancer.

CytoAgents initially focused its efforts at startup on a drug candidate that would address influenza, which is another infectious respiratory disease that can trigger the potentially deadly cytokine storm. GP1681 was isolated as a new chemical entity from another drug, Beraprost, which was developed in Asia to treat pulmonary hypertension. The same drug candidate that was going to be used in clinical trials for influenza will be used for Covid-19; it’s in the regulatory process for the additional clinical trial.

Whalen said that GP1681 could be incredibly useful as a therapy beyond Covid-19 if it does well, because the symptoms are similar between respiratory diseases.

“Our mission to is to create a powerful, lasting solution not just for the current crisis but any respiratory epidemic,” Whalen said.

Even before the Covid-19 pandemic, CytoAgents has attracted the interest of the Pittsburgh investment community. It’s a portfolio company of Blue Tree Allied Angel, and has received support of the Pittsburgh Life Sciences Greenhouse, Innovation Works and others. It’s prerevenue and has a small staff but works with an advisory board and regulatory and drug development consulting firms.

The partnership with Quotient is an important step in the development of the Covid-19 drug candidate.

“This is definitely a big milestone for the company,” Whalen said. “The collaboration with Quotient will ensure that we continue to reach our target to go into clinical human trials in the summer. This is a key partnership for us.”

Another big factor: The drug candidate has been well studied in its previous form and found to be effective and well tolerated. It’s also stable on the shelf for years, so it could be stockpiled for the future if it is successful.

The next step is evaluating locations for trial as well as receiving FDA approval to expand the medication’s investigational new drug status beyond influenza to Covid-19.

“We are very fortunate in that we have more than one option ready and willing to run our trials for us,” Whalen said Tuesday. “We’re just evaluating what the best solution for us will be.”

https://www.bizjournals.com/pittsburgh/news/2020/04/28/pittsburgh-biotech-firm-milestone-will-help-it.html?ana=lnk

 

COVID-19:  FDA Issues Emergency Use Authorization for Hemolung RAS
ALung is committed to the safety and support of health care professionals, patients, and employees in the treatment of COVID-19.  The following represents ALung’s commitment to supporting FDA’s response to the COVID-19 pandemic in the United States.

FDA Issues Emergency Use Authorization for Hemolung RAS to treat COVID-19

On April 22, 2020, ALung was issued Emergency Use Authorization (EUA) for the use of the Hemolung Respiratory Assist System (RAS) to treat lung failure due to COVID-19.

A public health emergency has been declared by the Secretary of Health and Human Services (HHS) on February 4, 2020. The FDA has issued an Emergency Use Authorization for the Hemolung RAS to treat lung failure caused by Coronavirus Disease 2019 (COVID-19).

Per the EUA, the FDA believes that the Hemolung RAS has the potential to treat lung failure as an adjunct to noninvasive or invasive mechanical ventilation, to reduce hypercapnia and hypercapnic acidosis due to COVID-19 and/or to maintain normalized levels of partial pressure of carbon dioxide (PCO2) and pH in patients suffering from acute, reversible respiratory failure due to COVID-19 for whom ventilation of CO2 cannot be adequately, safely, or tolerably achieved and, in turn, may provide clinical benefit.

For more information for the use of the Hemolung RAS and ECCO2R at your site to treat COVID-19, please contact Tracey Dill at Hemolung_EUA@alung.com.

*The Hemolung RAS has not been FDA cleared or approved;

 *The Hemolung RAS has been authorized for the above emergency use by FDA under an EUA;

 *This device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Hemolung RAS under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.

FDA greenlights two blood-filtering systems for COVID-19

red blood cells
ALung’s Hemolung removes carbon dioxide from the bloodstream, while Baxter’s Oxiris device filters out cytokines and kidney toxins. (Pixabay)

A Pittsburgh company focused on providing solutions for drug-resistant bacterial infections is eligible to receive as much as $12.17 million to advance its lead program through Phase 1 clinical studies for its first indication of prosthetic joint infections.

By Patty Tascarella  – Senior Reporter, Pittsburgh Business Times

Feb 25, 2020, 7:08am EST Updated 9 hours ago

A young Pittsburgh-based biotech company on Tuesday announced an agreement with CARB-X, a global nonprofit partnership, through which it is eligible to receive as much as $12.17 million.

Peptilogics Inc. is focused on providing solutions for drug-resistant bacterial infections.

CARB-X, short for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, is based at Boston University School of Law.

As part of the agreement, Peptilogics is eligible to receive up to $12.17 million in non-dilutive capital to advance its lead program through Phase 1 clinical studies for its first indication of prosthetic joint infections. Funding from CARB-X also enables Peptilogics to accelerate expansion of its peptide discovery platform for the development of other novel compounds.

“The antimicrobial crisis is here and the world is paying closer attention to the threats posed by infectious diseases, as evidenced by recent news headlines,” Jonathan Steckbeck, Peptilogics founder and CEO, said in a release. “We are excited by our partnership with CARB-X because they recognize and fund only the most robust science and are aligned with our goal of bringing best-in-class medicines to patients suffering from a lack of effective alternatives.”

Antibiotic resistant bacteria are one of the largest global public health challenges today and current treatments often fail to treat new and emerging resistant strains, resulting in exponentially increasing patient deaths. Peptilogics discovered a new class of anti-infectives using its proprietary algorithmic design process, which have applications across multiple industries and a broad spectrum of resistant bacteria. Its lead candidate, PLG0206, works by targeting and disrupting bacterial membranes leading to the death of bacterial cells. PLG0206 has been granted Qualified Infectious Disease Product status by the U.S. Food and Drug Administration, which provides incentives for the development of new antibiotics, including an additional five years of market exclusivity, as well as eligibility for Priority Review and Fast Track designation.

CAREER & WORKPLACE

Jason Camm, managing director and chief medical officer of Thiel Capital, an investor since summer 2017, said in a prepared statement that Peptilogics “continues to demonstrate a differentiated approach to building their business – with a unique indication strategy and a computational discovery platform that targets among the most prevalent infectious disease indications worldwide.“

Camm, who serves on Peptilogics’ board, said the young company looks forward to working together with CARB-X.

Peptilogics, which spun out of the University of Pittsburgh, was formed in 2013. It has also had strong local support as both the BlueTree Allied Angels and BlueTree Venture Fund gave the company capital to get started and continued to invest.

http://www.bizreport.com/2019/08/study-finds-larger-creative-more-likely-to-engage.html

According to new data, size does matter where advertising is concerned. but, is simply having oversized ads enough? We asked a digital expert to weigh in on how size matters – but so do other aspects of a campaign.

by Kristina Knight

The size of businesses advertising does matter, especially in the busy digital space. That is a key takeaway from data hub Adelaide, whose new report finds 300×600 creatives capture about 4x more attention than 320×50 ads. Their data also shows that mobile ad placements capture well over 50% more attention that desktop placements.

“[We] have found that coverage – the percent of the screen covered by the ad, largely driven by ad size – was the strongest indicator of attention, even more so than viewability. The reason for this, as you might expect, is that larger ads are more likely to be looked at,” said Marc Guldimann, CEO, Adelaide. “Our research, and that of Lumen which used eye-tracking, found adjacent advertising – typical in desktop environments – to be less effective at capturing consumer attention. On the flip side, the most effective mobile ads appear directly in a user’s feed. While the amount of time those ads are in-view tends to be lower in mobile than on desktop, that time is far more valuable on mobile. Coupled with the fact that mobile is an inherently smaller screen size, it means that most ads on mobile have a higher screen coverage too and this makes mobile a more attentive medium.”

That attentiveness, says Guldimann, is key to audience engagement, to that point that Adelaide has created an attention metric, called Cost Per Attention, which looks at the size of the ad, length of viewability, ad location, and what is in full view, giving advertisers a better idea of how to optimize ad placement along with campaign creative. According to company information clients using the attention metrics have seen up to a 30% increase in their Cost Per Attention.

“Attention is to brands what clicks or conversions are to performance advertisers. Understanding the quality of media through the lens of attention metrics helps brand advertisers leverage the same strategies and tactics that direct response advertisers have used since the dawn of digital advertising. Now a brand can compare the cost of consumer attention across formats, publishers and mediums and optimize their advertising to the most efficient brand impact. This is revolutionary for brand marketers who have traditionally relied on feedback loops that took months and were driven by data that is devoid of incrementality,” said Guldimann.

But, of course, simply having a consumer’s attention isn’t enough. Ads need relevance and interest to engage the shopper. To go along with a larger size ad, he suggests adding animation and including a visual hierarchy.

“The best advice for digital creatives is to use simple animation with large brand assets and a clear visual hierarchy. While Adelaide is focused on the quality of media, we’re impressed by the research from System 1 on fluent devices and Jenni Romaniak at the Ehrenberg Bass Institute on distinctive brand assets. As attention data becomes more integrated in to marketing decision systems, innovative marketers will use media quality as a guide for what type of creative they should use. For example, in low attention environments a simple logo might be best,” said Guldimann.

Study focuses on noninvasive alternative to a ventilator in severe COPD

Michael Benninghoff, D.O.

Christiana Care Health System is participating in national research that may provide a non-invasive alternative to a ventilator for patients with severe chronic obstructive pulmonary disease (COPD).

COPD is the third leading cause of death in the U.S., according to a report from the Global Initiative for Chronic Obstructive Lung Disease. Patients with COPD are prone to flare-ups, or exacerbations, where their symptoms suddenly become worse. These exacerbations can lead to high levels of carbon dioxide (CO2) in the patient, which can result in respiratory failure and the need for life-saving intubation and mechanical ventilation.

The trial, called Vent-Avoid, is studying the safety and efficacy of Hemolung RAS, an investigational medical device that provides low-flow extracorporeal CO2 removal, or ECCO2R, for adults with severe acute exacerbations of COPD. The research is sponsored by ALung Technologies, Inc., with FDA permission.

To be eligible for the Vent-Avoid trial, patients must be failing support with noninvasive ventilation or have been intubated and failed at least one spontaneous breathing trial.

Eligible patients will be assigned randomly into an investigational group or a control group. Patients in the investigational group will receive ECCO2R with the Hemolung RAS plus standard-of-care mechanical ventilation. Patients in the control group will receive standard-of-care mechanical ventilation alone.

The primary outcome measure for the trial is the number of ventilator-free days in a 60-day period.

For more information on the trial, contact Michael G. Benninghoff, D.O., section chief of Medical Critical Care, and medical director of Respiratory Care at 302-623-7600.

PITTSBURGH–(BUSINESS WIRE)–ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced today the achievement of a major milestone with the enrollment of the 50th patient in its U.S. based VENT-AVOID clinical trial.

COPD affects 30 million Americans1 and is the third leading cause of death in the United States behind cancer and heart disease.2Acute exacerbations, defined as a sudden worsening of COPD symptoms, are a major cause of morbidity and mortality in COPD patients.

The VENT-AVOID pivotal trial is the world’s first and largest prospective Randomized Controlled Trial (RCT) ever conducted on the utilization of ECCO2R in AE-COPD, studying the avoidance or minimization of the need for mechanical ventilation. The results of the study are expected to validate the safety and efficacy of the Hemolung Respiratory Assist System (RAS) for COPD patients experiencing acute exacerbations requiring ventilatory support.

“The attainment of this significant enrollment milestone in the VENT-AVOID trial illustrates the significant interest by clinicians of having the Hemolung RAS and ECCO2R therapy available in their clinical arsenal for the treatment of AE-COPD. We believe our continued focus and progress in this trial, coupled with our ongoing collaboration with the FDA, will assist in further accelerating enrollment and reducing the time to complete the trial,” stated Peter DeComo, Chairman and CEO of ALung.

The Hemolung RAS is also the sole technology being used in the UK REST Trial, a landmark prospective pivotal study of the use of the Hemolung RAS in patients with acute respiratory distress syndrome (ARDS). The UK REST Trial continues to make significant progress with 378 patients enrolled and is currently the largest clinical study of extracorporeal lung support ever conducted. The research is jointly led by Queen’s University and Belfast Health and Social Services Trust under the direction of investigators Professor Danny McAuley and Dr. James McNamee of the Centre for Experimental Medicine at Queen’s University Belfast.

The Hemolung RAS has European marketing clearance (CE Mark) and is the world’s only fully integrated Respiratory Dialysis® system providing low-flow ECCO2R. ALung is the only company pursuing two major pivotal trials to validate the safety and efficacy of extracorporeal carbon dioxide removal therapy.

About ALung Technologies

ALung Technologies, Inc. is a privately held Pittsburgh-based developer and manufacturer of innovative lung assist devices. Founded in 1997 as a spin-out of the University of Pittsburgh, ALung has developed the Hemolung RAS as a dialysis-like alternative or supplement to mechanical ventilation. ALung is backed by Philips, UPMC Enterprises, Abiomed, The Accelerator Fund, Allos Ventures, Birchmere Ventures, Blue Tree Ventures, Eagle Ventures, Riverfront Ventures, West Capital Advisors, and other individual investors.

For more information about ALung and the Hemolung RAS, visit www.alung.com.

For more information on the VENT-AVOID trial, and a list of enrolling sites, please visit clinicaltrials.gov.

For more information about the REST Trial, please visit UK National Institute for Health Research (NIHR) – REST Trial Project Website.

CAUTION: The Hemolung RAS is an Investigational Device and limited by United States law to investigational use.

This press release may contain forward-looking statements, which, if not based on historical facts, involve current assumptions and forecasts as well as risks and uncertainties. Our actual results may differ materially from the results or events stated in the forward-looking statements, including, but not limited to, certain events not within the Company’s control. Events that could cause results to differ include failure to meet ongoing developmental and manufacturing timelines, changing GMP requirements, the need for additional capital requirements, risks associated with regulatory approval processes, adverse changes to reimbursement for the Company’s products/services, and delays with respect to market acceptance of new products/services and technologies. Other risks may be detailed from time to time, but the Company does not attempt to revise or update its forward-looking statements even if future experience or changes make it evident that any projected events or results expressed or implied therein will not be realized.

References

1. https://www.copdfoundation.org/What-is-COPD/COPD-Facts/Statistics.aspx

2. http://www.lung.org/assets/documents/research/copd-trend-report.pdf

Contacts

ALung Technologies, Inc.
Peter M. DeComo
Chairman and CEO
+1-412-697-3370 ext. 207
pdecomo@alung.com

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P.O. Box 1323
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