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Local Biotech Firm Develops Drug For Respiratory Distress In COVID-19 Patients

  10 HOURS AGO

Pittsburgh-based biotech company CytoAgents is launching into phase one of clinical trials this month on a drug designed to treat people with COVID-19 who develop serious respiratory distress when their immune system overreacts to the virus.

According to CytoAgents CEO Teresa Whalen, severe illness in some patients is triggered by a cytokine storm which is an excessive immune response that attacks the body. She said the drug could be particularly helpful for someone hospitalized with COVID-19.

“Our drug will be used as soon as the patient enters the hospital to keep the patient from progressing to the ICU and avoiding the need for ventilators,” Whalen said.

The drug, GP 1681, is given orally and Whalen said that makes it more affordable than traditional immunotherapy treatments known as biologics which are often administered intravenously.

“Biologics are more than $10,000 for one course of therapy and we would likely be in the hundreds, possibly low one thousands, so there is a significant difference,” Whalen said.

In addition to COVID-19, Whalen said the drug is designed to combat cytokine storm in other infectious diseases like influenza.

“We are really excited by the potential of the science and the fact that we could be therapeutically helpful for not only this pandemic but many future pandemics,” Whalen said. She also noted her company is working with partners to conduct drug trials to treat people who have suffered intense respiratory failure and lung damage caused by vaping.

In July, CytoAgents announced it received an investment of $250,000 from the Richard King Mellon Foundation to support its first phase of clinical trials. The funding is part of the foundation’s $25 million Pandemic Solutions package to help local organizations respond to the coronavirus crisis.

CREDIT CYTOAGENTS

Other pandemic assistance from RK Mellon includes $2.5 million to help colleges and universities in western Pennsylvania cover additional expenses they will incur as they reopen for the fall semester.

Debut on NFL Kickoff Game – Thurs., Sept. 10, 8:20 p.m. ET on NBC – Marks First NFL Broadcast with Immersive Replays from Overhead

STAMFORD, Conn. – August 27, 2020 – NBC’s Sunday Night Football, primetime television’s #1 show for an unprecedented nine consecutive years, will present viewers with a unique overhead replay perspective this season with the innovative C360 camera, which is expected to yield looks at everything from the techniques of linemen along the line of scrimmage to plays along the sidelines.

Beginning with the NFL Kickoff Game on Thurs., Sept. 10 at 8:20 p.m. ET on NBC, and continuing throughout the NBC SNF season, the camera will provide for the first time on an NFL broadcast an immersive overhead replay experience.

The C360 camera will fly attached to the bottom of SkyCam to provide up-close and intimate replays of the game inside the tackle box, illuminating the talents of stars like Los Angeles Rams defensive tackle Aaron Donald and Dallas Cowboys guard Zach Martin in a way not previously seen on NFL telecasts. In addition, because the camera shoots in 8K and records in a 180-degree immersive field of view, production can go back in time to reframe a play to better provide definitive views from C360.

If there’s a question about a receiver catching a pass on the sideline, the technology can freeze the entire image, zoom in and focus on the player’s hands to confirm possession, before panning down to the player’s feet and zooming in to confirm both touched the ground before going out of bounds.

“We are excited to provide some of the most compelling overhead replays that football fans have ever seen, and look forward to working with C360 Technologies on this presentation,” said Fred Gaudelli, executive producer of NBC Sunday Night Football.

“We’re thrilled to be working with NBC Sports and to provide this novel immersive capability.  As a secondary camera on SkyCam, we anticipate capturing a fresh perspective of the game over the trenches,” said Evan Wimer, co-founder of C360 Technologies.

The C360 camera technology has previously been used in car on NASCAR on NBC broadcasts, and was nominated for a 2019 Sports Emmy for its use while embedded within line-to-gain pylons and first-down markers last season.

ABOUT C360 TECHNOLOGIES, INC.

C360® is personalizing the sports viewing experience. We’ve entertained millions of viewers worldwide while working with the largest sports broadcasters and Fortune 500 companies across the globe. Our platform integrates the smallest, most innovative cameras and patented software with v-commerce, sports betting and player/object tracking.  C360 is leading the personalized viewing revolution across every streaming channel, device and social media service allowing unlimited viewers to control their own fully immersive viewing experience.

– NBC SPORTS –

3 months in a coma, local man beats COVID

Vlad Laroche is going home on Friday

The steps were slow and shuffling, but they were steps.

And for Vlad Laroche, that means recovery.

“I’m thankful to God,” he said. “He made it happen. He brought me back.”

Laroche is a physician in West Palm Beach.

In April, he was admitted to Palm Beach Gardens Medical Center with COVID-19.

He spent months in a coma on life support.

Now, he’s awake and on Friday, he’s going home.

“God touched him, picked him up with his own hands and got him home,” said Paul Laroche, Vlad’s brother.

Doctors at the hospital said they had to be creative as they worked for months to keep Laroche alive.

“We just kept faith,” said Dr. Ribal Darwish. “We just kept facing challenges, and every time we had a new challenge, we had to come up with a new solution.”

Darwish said one of those solutions was is something called a Hemolung, a machine that removes carbon dioxide from the blood and replaces it with oxygen.

It allows the lungs to rest and heal.

Doctors also used a medication called Dornase Alpha, normally only prescribed for patients with cystic fibrosis.

Darwish said Palm Beach Gardens Medical Center is the only place using it to fight COVID-19, and he hopes other hospitals are paying attention.

“I think many lives can be saved if they are going to utilize some of the treatments that we are utilizing here at Palm Beach Gardens,” he said.

Vlad Laroche said there’s no question it definitely saved his life.

“They were guided, you know?” he said about his doctors. “I would not have made it if I was in any other setting.”

Paul Laroche compared his brother’s recovery to the feeling he got holding his newborn children.

“I don’t know if there’s anywhere beyond that in terms of happiness,” he said. “But whatever that is, utopia, I’m there.”

Laroche has no plans to go back to work any time soon.

He said he will just spend the next few months regaining his strength and reminding people that COVID-19 is not something to take lightly.

“People have to wear masks, socially isolate, maintain your distance,” he said. “If you don’t have to go out, stay in your place.”

Richard King Mellon Foundation boosts funding for COVID-19 aid to $25 million

Among recipients: colleges adapting for fall; Wilkinsburg small business incubator; and public art for riverfront trails

JOYCE GANNON
Pittsburgh Post-Gazette
jgannon@post-gazette.com

JUL 2, 2020

The Richard King Mellon Foundation is adding $10 million to its commitment to help the Pittsburgh region deal with the fallout from the COVID-19 pandemic.

The new funding — which includes money for economic and health initiatives and support for the arts — follows a $15 million commitment that the city’s largest philanthropy made in April for COVID-19 relief.

The April pledge came “with the real clear understanding this crisis wasn’t going to subside in the short term,” said Sam Reiman, foundation director.

As the unemployment rate skyrocketed and disproportionate effects of the pandemic on the Black community and other groups became more pronounced, “We realized this is something you couldn’t just finish with one level of investment,” he said.

The foundation, created from the fortunes of Pittsburgh’s Mellon banking family, had an endowment of $2.7 billion in 2019.

Its new package for COVID-19 aid includes $2.5 million to help colleges and universities in Western Pennsylvania cover additional expenses they will incur to reopen for the fall semester such as virus testing.

The money, to be distributed to about a dozen schools through grants that will average $200,000 to $250,000, could also help students fill financial gaps and be used for faculty needs such as transitioning to remote learning, said Mr. Reiman.

Providing funds to higher education institutions was a priority for the foundation, he said, because especially in smaller, rural communities, colleges “play an outsized role in the local economy.”

Also included in the new round is $3.3 million to continue an economic impact and recovery initiative the foundation launched as part of its April commitment to COVID-19 relief.

It recently awarded 37 grants totaling more than $5 million from its first round of funds.

The board approved another 24 grants because “there were so many worthy ideas” among the submissions it received from the community, said Mr. Reiman.

Among the new allocations is $175,000 to Locally Grown, a nonprofit trying to jump-start small businesses in Wilkinsburg through an incubator program based at the former Johnston Elementary School.

Others include $175,000 to Community Human Services Corp., a Strip District nonprofit, to expand telehealth access for behavioral health services for vulnerable people such as the homeless; $100,000 to the Westmoreland County Community College Education Foundation for job training and job placement programs; $150,000 to the Center that Cares in the Hill District for digital literacy programs; and $100,000 to the Mediation Council of Western Pennsylvania to reduce an expected surge in evictions linked to job losses among renters.

Some of the economic recovery grants will boost arts and recreation organizations that have seen revenues practically dry up since shelter-in-place orders were issued in March.

A grant of $100,000 to the Pittsburgh Symphony, for instance, will fund a new marketing initiative to attract people back to Downtown, said Mr. Reiman.

“If you’re in the business of generating revenues through large gatherings, there’s been virtually no improvement in your business since the economy shut down,” he said.

Riverlife, a nonprofit that promotes reuse of the city’s riverfronts, received $200,000 for a program to install public art along riverfront trails.

Some of the $10 million will go to health-related initiatives.

In its earlier round, the foundation supported vaccine research at the University of Pittsburgh and local production of protective face shields.

The new funding includes $250,000 in North Side biotech firm CytoAgents to fund clinical trials of a drug that could reduce the severity of human response to the coronavirus.

Some of the new funding has yet to be committed to specific initiatives, said Mr. Reiman, because, “We don’t really know when this will end.”

Another surge of cases could result in shortages of personal protective equipment and more funds may be needed for vaccine development.

“We’re really trying to keep our powder dry,” he said.

https://www.post-gazette.com/business/career-workplace/2020/07/02/Richard-King-Mellon-Foundation-COVID-19-relief-recovery-Pittsburgh/stories/202007010154

ALung Announces Commercial Development of its Breakthrough Next Generation Artificial Lung
The next generation Hemolung RAS was developed by Bioengineering Professor William Federspiel and was partially funded by the Coulter Program

PITTSBURGH–(BUSINESS WIRE)– April 4, 2020 ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced the recent initiation of commercial development of its next generation artificial lung, which expands the Company’s focus on highly efficient gas exchange devices and also broadens its applicable market.

The Company’s current product, the Hemolung® Respiratory Assist System (RAS), is the only fully comprehensive extracorporeal carbon dioxide removal (ECCO2R) system specifically designed and manufactured for this therapy, as compared to complex competitive products that are modifications of existing technologies designed for other purposes. The Hemolung continues to be the most highly efficient and simple to use ECCO2R system on the market today.

The next generation Hemolung RAS is based upon intellectual property recently licensed to ALung from the University of Pittsburgh. Developed by Professor William Federspiel, PhD and colleagues at the Swanson School of Engineering and the McGowan Institute for Regenerative Medicine, this new technology platform significantly enhances gas exchange efficiency while reducing the deleterious hematologic effects from extracorporeal blood circulation. The licensed research was supported in part by the National Institutes of Health and the Coulter Translational Research Partners II Program at the University of Pittsburgh. Dr. Federspiel has an equity holding in the company and is compensated as an advisory board member.

“The next generation Hemolung RAS is a direct result of the continued collaboration between the University of Pittsburgh and ALung Technologies. This collaboration, spanning 20+ years, has resulted in a rich pipeline of innovation for ALung that will accelerate the development of highly efficient, simple to use artificial lung devices for the treatment of acute respiratory failure. The foundation of our next generation system is an integrated artificial lung cartridge/blood pump that will be unparalleled in the industry as the most efficient carbon dioxide removal and oxygen delivery system, which will address the needs of acute respiratory failure patients that require ECCO2R and/or ECMO (extracorporeal membrane oxygenation). All of this will again be consolidated in a comprehensive, easy to use system without all of the complexities represented in competitive systems,” stated Peter M. DeComo, Chairman and CEO of ALung Technologies.

Jeremy Kimmel, PhD, Vice President of New Technology at ALung Technologies stated, “Professor Federspiel and colleagues at the University of Pittsburgh have rapidly advanced this technology toward commercial readiness through state of the art computational, in vitro and in vivo testing, including successful 7-day and 30-day large animal studies. ALung has initiated commercial development of the next generation Hemolung RAS to provide clinicians with the flexibility to support patients across the full spectrum of acute and acute-on-chronic respiratory failure using a single integrated device. The system design will accommodate bedside therapy as well as portability and wearability, further enhancing device usability and expanding potential clinical indications.”

Key features and benefits of the next generation Hemolung RAS will include:

  • Patent-pending technology that generates superior blood flow uniformity to maximize gas exchange efficiency.
  • A custom designed centrifugal pump integrated with a low surface area (0.65 m2) gas exchange membrane without the need for additional components (e.g. heat exchanger, pressure ports) that will reduce operational complexity of the system.
  • Low flow ECCO2R (250 – 700 mL/min) as well as full ECMO (2 – 4 L/min) using a single integrated pump and gas exchange membrane.
  • The highest efficiency oxygenation of any ECMO device on the market providing full oxygen saturation at ≤4 L/min blood flow with membrane surface area of 0.65 m2.

COPD affects 30 million Americans1 and is the third leading cause of death in the United States behind cancer and heart disease.2 Acute exacerbations, defined as a sudden worsening of COPD symptoms, are a major cause of morbidity and mortality in COPD patients. ARDS is estimated to affect more than 10% of intensive care unit patients globally, has a mortality rate as high as 45% and requires invasive mechanical ventilation in the majority of cases.3,4 Combined, these disorders represent a significant need and a global market for innovative respiratory assist devices. The COVID-19 pandemic is a recent example of such a dramatic need.

Currently, the Hemolung RAS has European marketing clearance (CE Mark). In addition, it is the only system that has been studied for safety and efficacy in two large landmark pivotal trials; the FDA approved VENT-AVOID trial and the U.K. REST trial. The Hemolung RAS was recently granted Emergency Use Authorization (EUA) by FDA for the treatment of acute respiratory failure caused by COVID-19.

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.

For more information on the use of the Hemolung RAS for COVID-19 patients, please visit https://www.alung.com/covid-19/covid-19-us/

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

3. Bellani. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016;315(8):788-800.

4. Walkey A. Acute respiratory distress syndrome: epidemiology and management approaches. Clinical Epidemiology 2012:4 159–169.

5/14/2020

Contact: Peter M. DeComo

Pittsburgh biotech company receives $1.6 million grant to develop drug to treat COVID-19

The Pittsburgh company, CytoAgents, received a $1.6 million grant to develop a drug that could help treat COVID-19

https://www.wtae.com/article/coronavirus-what-we-know-and-what-we-don-t-explained/32493740

The Pittsburgh company, CytoAgents, received a $1.6 million grant to develop a drug that could help treat COVID-19.

The biotech company is located on Pittsburgh’s North Side.

The CEO of CytoAgents, Teresa Whalen, said: “It’s certainly a validation of our science and the potential of our drug.”

CytoAgents was awarded a National Institutes of Health grant for the drug called GP1618.

“This is so exciting. This is a critical milestone for CytoAgents and an excellent example between a collaboration between the National Institute of Health and the private sector to accelerate innovation,” said Whalen.

Scientists said when a person gets sick from viruses, their symptoms are triggered by a cytokine storm.

Whalen said, “The cytokine storm is an overreaction of our immune system, driving severe illness. Our drug calms that cytokine storm, reducing inflammation and restoring balance and allowing our patients to recover.”

Whalen said the drug would help with COVID-19, influenza and other respiratory illnesses.

“We have incredible trust in the promise of our drug. Pittsburgh has such a long history of excellence with health care system and world renown academic institutions and it’s really a privilege to be part of that ecosystem,” said Whalen.

She said the drug could also stop overcrowding at hospitals by getting patients off ventilators and out of the ICU.

Whalen said clinical trials could start in August and the drug could be available by the beginning of next year.

ALung Announces Commercial Development of its Breakthrough Next Generation Artificial Lung

https://www.businesswire.com/news/home/20200505005548/en/ALung-Announces-Commercial-Development-Breakthrough-Generation-Artificial

(Photo: Business Wire)

(Photo: Business Wire)

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 the recent initiation of commercial development of its next generation artificial lung, which expands the Company’s focus on highly efficient gas exchange devices and also broadens its applicable market.

The Company’s current product, the Hemolung® Respiratory Assist System (RAS), is the only fully comprehensive extracorporeal carbon dioxide removal (ECCO2R) system specifically designed and manufactured for this therapy, as compared to complex competitive products that are modifications of existing technologies designed for other purposes. The Hemolung continues to be the most highly efficient and simple to use ECCO2R system on the market today.

The next generation Hemolung RAS is based upon intellectual property recently licensed to ALung from the University of Pittsburgh. Developed by Professor William Federspiel, PhD and colleagues at the Swanson School of Engineering and the McGowan Institute for Regenerative Medicine, this new technology platform significantly enhances gas exchange efficiency while reducing the deleterious hematologic effects from extracorporeal blood circulation. The licensed research was supported in part by the National Institutes of Health and the Coulter Translational Research Partners II Program at the University of Pittsburgh. Dr. Federspiel has an equity holding in the company and is compensated as an advisory board member.

“The next generation Hemolung RAS is a direct result of the continued collaboration between the University of Pittsburgh and ALung Technologies. This collaboration, spanning 20+ years, has resulted in a rich pipeline of innovation for ALung that will accelerate the development of highly efficient, simple to use artificial lung devices for the treatment of acute respiratory failure. The foundation of our next generation system is an integrated artificial lung cartridge/blood pump that will be unparalleled in the industry as the most efficient carbon dioxide removal and oxygen delivery system, which will address the needs of acute respiratory failure patients that require ECCO2R and/or ECMO (extracorporeal membrane oxygenation). All of this will again be consolidated in a comprehensive, easy to use system without all of the complexities represented in competitive systems,” stated Peter M. DeComo, Chairman and CEO of ALung Technologies.

Jeremy Kimmel, PhD, Vice President of New Technology at ALung Technologies stated, “Professor Federspiel and colleagues at the University of Pittsburgh have rapidly advanced this technology toward commercial readiness through state of the art computational, in vitro and in vivo testing, including successful 7-day and 30-day large animal studies. ALung has initiated commercial development of the next generation Hemolung RAS to provide clinicians with the flexibility to support patients across the full spectrum of acute and acute-on-chronic respiratory failure using a single integrated device. The system design will accommodate bedside therapy as well as portability and wearability, further enhancing device usability and expanding potential clinical indications.”

Key features and benefits of the next generation Hemolung RAS will include:

  • Patent-pending technology that generates superior blood flow uniformity to maximize gas exchange efficiency.
  • A custom designed centrifugal pump integrated with a low surface area (0.65 m2) gas exchange membrane without the need for additional components (e.g. heat exchanger, pressure ports) that will reduce operational complexity of the system.
  • Low flow ECCO2R (250 – 700 mL/min) as well as full ECMO (2 – 4 L/min) using a single integrated pump and gas exchange membrane.
  • The highest efficiency oxygenation of any ECMO device on the market providing full oxygen saturation at ≤4 L/min blood flow with membrane surface area of 0.65 m2.

COPD affects 30 million Americans1 and is the third leading cause of death in the United States behind cancer and heart disease.2 Acute exacerbations, defined as a sudden worsening of COPD symptoms, are a major cause of morbidity and mortality in COPD patients. ARDS is estimated to affect more than 10% of intensive care unit patients globally, has a mortality rate as high as 45% and requires invasive mechanical ventilation in the majority of cases.3,4 Combined, these disorders represent a significant need and a global market for innovative respiratory assist devices. The COVID-19 pandemic is a recent example of such a dramatic need.

Currently, the Hemolung RAS has European marketing clearance (CE Mark). In addition, it is the only system that has been studied for safety and efficacy in two large landmark pivotal trials; the FDA approved VENT-AVOID trial and the U.K. REST trial. The Hemolung RAS was recently granted Emergency Use Authorization (EUA) by FDA for the treatment of acute respiratory failure caused by COVID-19.

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.

For more information on the use of the Hemolung RAS for COVID-19 patients, please visit https://www.alung.com/covid-19/covid-19-us/

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

3. Bellani. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016;315(8):788-800.

4. Walkey A. Acute respiratory distress syndrome: epidemiology and management approaches. Clinical Epidemiology 2012:4 159–169.

Contacts

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

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

 

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