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

April 29, 2020 | In: Uncategorized

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

 

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

April 28, 2020 | In: Uncategorized

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

April 28, 2020 | In: Uncategorized

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)

Pittsburgh biotech firm could receive more than $12M through new agreement

March 2, 2020 | In: Uncategorized

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.

Study finds larger creative more likely to engage

August 20, 2019 | In: Uncategorized

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.

Our Region’s Business:

July 11, 2019 | In: Uncategorized

Research: COPD Trial at Christiana Care

July 11, 2019 | In: Uncategorized

Study focuses on noninvasive alternative to a ventilator in severe COPD

March 5, 2019

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.

ALung Announces the Achievement of a Key Milestone in the U.S. Based VENT-AVOID Trial and Continued Progress Towards Completion of the Trial

July 11, 2019 | In: Uncategorized

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

ALung Announces that the Independent Data and Safety Monitoring Board (DSMB) Recommends Continuation of VENT-AVOID Trial and Reports that Significant Progress Continues with their Clinical Trial Programs

July 2, 2019 | In: Uncategorized

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 in its U.S. based VENT-AVOID clinical trial and reports continued progress in its clinical trial programs. The independent Data and Safety Monitoring Board (DSMB) of the VENT-AVOID trial recommended continuation of the trial without modification following its first scheduled review of safety data from the initial 31 subjects enrolled.

“The attainment of this significant VENT-AVOID milestone is gratifying, and we look forward to the continuation of these pivotal trials, both of which hold the promise that the Hemolung RAS and ECCO2R therapy will provide a new tool in the treatment of acute respiratory failure”

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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. The VENT-AVOID Trial is the world’s first pivotal study of ECCO2R in the AE-COPD population. The study aims to validate the safety and efficacy of the Hemolung Respiratory Assist System (RAS) for COPD patients experiencing acute exacerbations requiring ventilatory support. Nearly thirty hospitals have been brought online and are screening patients for ALung’s VENT-AVOID Trial of the Hemolung RAS.

In the United Kingdom, the REST Trial, a landmark pivotal study of the Hemolung RAS in patients with acute respiratory distress syndrome (ARDS), has enrolled greater than 360 patients. Significant progress continues to be made enrolling patients in this landmark pivotal study of the Hemolung RAS in patients with acute respiratory distress syndrome, and it is now the largest prospective clinical study of extracorporeal lung support ever conducted. ALung’s Hemolung RAS is the exclusive ECCO2R technology being used in the trial. 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 attainment of this significant VENT-AVOID milestone is gratifying, and we look forward to the continuation of these pivotal trials, both of which hold the promise that the Hemolung RAS and ECCO2R therapy will provide a new tool in the treatment of acute respiratory failure,” stated Peter DeComo, Chairman and CEO of ALung.

The Hemolung RAS has European marketing clearance (CE Mark) and is the world’s only fully integrated Respiratory Dialysis® system. 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

Pittsburgh startup makes polo play, partners with Ralph Lauren

April 30, 2019 | In: Uncategorized

https://www.bizjournals.com/pittsburgh/news/2019/04/29/pittsburgh-startup-partners-with-ralph-lauren.html

That famous logo of a mallet-wielding rider at full gallop now bears a bag for recycling, so to speak.

A Pittsburgh company that converts discarded plastic bottles into fabric has a new customer — the Ralph Lauren Corp. (NYSE:RL).

Thread International PBC Inc. is no stranger to working with major brands, supplying Timberland, Reebock and Aerie. Now its fabric is being used by Ralph Lauren for the retailer’s latest twist on its iconic polo shirt.

Last week, the Earth Polo, made from fabric created from recycled plastic bottles, debuted at $89.50 per shirt, according to www.RalphLauren.com. Each shirt is made from 12 plastic bottles and Ralph Lauren has pledged to recycle170 million plastic bottles by 2025.

Ian Rosenberger, Thread founder and CEO, declined to disclose financial terms.

“They’re kind of America’s brand,” Rosenberger said of Ralph Lauren. “We’ve been chatting for a year or so. We have a well-established pipeline of companies we want to work with.”

Rosenberger launched Thread in the wake of the 2010 earthquake that devastated Haiti, creating an initiative to pay people for retrieving plastic bottles which are in turn converted to fabric for clothing, footwear and accessories. Sourcing was subsequently expanded to Honduras and Taiwan.

Thread isn’t limited to fabric. Since 2016, Hewlett-Packard Co. has used its recycled plastic to manufacture inkjet cartridges.

Last year, Thread debuted its own first product, a bag it dubbed “the Better Backpack.” Rosenberger plans to extend Thread’s line while continuing to supply materials to other companies.

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