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Exicure adds new sites

Exicure has added four new clinical trial sites for its Phase Ib/II trial of AST-008 for the treatment of various cancer types.   The sites are based in the US, including Dana Farber Cancer Institute in Massachusetts, Holden Comprehensive Cancer Center at the University of Iowa, John Wayne Cancer Institute at Providence St John’s Health Center in California, and Sylvester Comprehensive Cancer Center at the University of Miami in Florida.

Exicure CEO Dr David Giljohann said: “We are encouraged by the results of our Phase I clinical trial, which demonstrated that our drug is well-tolerated and activates key immune cells and signals.”

The initial stage of the open-label Phase Ib/II trial includes a dose-finding Phase Ib stage, where AST-008 is expected to be evaluated in combination with an anti-PD-1 therapy pembrolizumab (Keytruda). The Phase Ib stage is set to be followed by a Phase II expansion stage.

Exicure aims to enroll patients with superficial injectable tumours as part of the Phase Ib portion of the trial.  For more on this update, click here. 

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North American Genotoxicity Workshop

Join Charles River on April 2-3.  Genetic toxicology testing is required for all classes of chemicals and drugs, but its conduct can differ from compound to compound. A poor strategy can result in repeated studies, failure to meet timelines, or worse – abandonment of a once promising program.

At the North American Genotoxicity Workshop, you’ll learn how to successfully execute this unique aspect of your compound’s safety assessment, satisfying regulatory criteria and smoothing your path to market. Over two days, you’ll tackle program guidelines, regulations, and best practices, gain an in-depth understanding of the in vitro and in vivo assays that comprise a solid testing program, and gain insight into accurate evaluations of the results.

You’ll network with peers who face similar challenges and meet scientists who perform the assays and can offer strategic advice. Don’t miss this opportunity to arm yourself with the knowledge that can help your compound move forward through development.

The workshop will take place over the course of two days (Tuesday and Wednesday, April 2-3). Tuesday’s program includes the seminar and meals, including breakfast, lunch, snacks, and a dinner reception.

Day two includes breakfast, a half-day of presentations, and lunch followed by a tour of our laboratory facilities with assay demonstrations. The speakers and other Charles River scientists will join you for all meals, allowing for one on one conversations.

For more program information, click here

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Vetter – Current Market Developments

Increasingly, contract development and manufacturing organizations (CDMOs) like Vetter are acting as the interface between small biotech firms and large drug manufacturers

Flexibility, responsiveness and operational excellence are being demanded by drug developers. The challenge faced by companies like Vetter Pharma International is to deliver these to customers. Oskar Gold, notes that Vetter believes that partnership is always the key to success, with operational excellence being decisive in both the development and commercial phases.

“Particularly in the early drug development phases, a number of issues that can affect the entire development project scope can arise and thus flexibility is critical,” Gold says. “Also, it is important that a sponsor and service provider with a common target in mind act as one to successfully perform a drug development project that can get the drug on the market as fast as possible, where it can improve or even save patient lives.”

Listen to the video interview with Oskar Gold of Vetter discussing current market developments and their multifaceted impacts.

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Chicago Life Science Opportunities

Long a hotbed of life sciences titans like Abbott Laboratories, Baxter International and Takeda Pharmaceuticals that have established the northern suburbs as a biotechnology hub, the Chicago area has recently seen a rush of startups as schools including Northwestern and U of C have pushed to commercialize faculty research in ways championed by universities like Stanford and MIT.
The biomedical and biotech sectors accounted for 44 percent of the $877 million in funding raised by all 942 startups spun out from Illinois universities between 2013 and 2017, according to data from the Illinois Science & Technology Coalition, a nonprofit advocacy group.
But the number of local facilities available for clinical tests and that also offer the equipment startups need hasn’t grown as quickly. One reason lab space isn’t pervasive is that it is expensive and risky to build. Structures like these need special ventilation, electrical and safety systems to accommodate chemical reactions, and extra security to protect highly valuable intellectual property.
The fully occupied ISTP in Skokie, on the site of the former research complex for pharmaceutical giant G.D. Searle, today houses several life sciences companies that originated at Northwestern. Read more in this article from Crain’s

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Exicure Breakthrough

The ‘Koosh ball’ that can cure.
David Giljohann has developed a breakthrough that has the ability to infiltrate a sick cell to correct the genes inside and make it healthy—or kill it.

DNA-altering drugs have been a fascination in medicine since the human genome was decoded, but until now these medications have been hitting an impenetrable wall. “The challenge was no one could figure out how to effectively deliver DNA into the cell,” explains David Giljohann. His company, Skokie-based Exicure, has over 150 patents on a technology that is solving the cellular-level delivery challenge.

His product is a “spherical nucleic acid,” or “SNA construct” for short. It’s a configuration of DNA arranged around a nanoparticle, which the 37-year-old CEO says “looks like a Koosh ball.” This unique 3D design has the ability to infiltrate a sick cell to correct the genes inside and make it healthy—or kill it. Giljohann discovered the phenomenon in 2006 with his Northwestern University graduate school classmates in the lab of Chad Mirkin, an industry leader in science and entrepreneurship who is also a co-founder of Exicure. “It’s a major, major discovery,” says Mirkin. “One that will really change the course of pharmaceutical development.”

Four drugs are being tested in patients in the U.S., the U.K. and Germany, including a clinical trial at Northwestern for brain cancer. Other trials focus on general oncology and the topical treatment of psoriasis and atopic dermatitis. Giljohann hopes the technology will revolutionize the standard of care for any genetically based disease, including cancer. “If you look at chemotherapeutics, your goal is to kill the cancer cells faster than you kill every other cell in the body. The idea behind Exicure technologies for the SNA, as well as the DNA space in general, is let’s just kill the bad cells.”

When his medicines start coming to market in the mid-2020s, Giljohann anticipates he’ll be pioneering treatments for illnesses that currently have none and introducing drugs that are more targeted, easier to administer, safer and less expensive. “From a business standpoint, that’s nirvana,” Mirkin says.

Exicure has only 30 team members but operates at the pace of a company of 300. Thanks to the human genome codes, the team is able to digitally design, test and prototype a medicine before building it. Instead of making a thousand designs for testing, they make only one, shortening the development cycle and driving down costs.

An adjunct professor in chemical and biological engineering at Northwestern, Giljohann lives in Evanston, “although our running joke at the company is that I live on seat 7A on American Airlines.” He racked up 128 flights to and from O’Hare International Airport last year visiting clinical trial sites, giving scientific talks and visiting his impressive list of investors, including Bill Gates, Eric Lefkofsky, Pat Ryan and David Walt. Exicure has raised over $100 million and became a publicly traded company in May.  Click here for a link to the original article in Crain’s Chicago Business

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Top Companies Choose Chicago

U.S. News recently reported on why Chicago has become a top city for startups and entrepreneurs. Community supporters who help to drive entrepreneurial activity are a unique collaboration between startup accelerators and incubators that work in concert to nurture and showcase the region’s best and brightest emerging companies.

These accelerators drive innovation across the spectrum of sectors, such as mHUB, which is an innovation center for advanced manufacturing. Serving entrepreneurs in the healthcare sector is MATTER, where innovators are working together to drive major developments in the healthcare industry. Chicago also boasts the world’s #1 business incubator, 1871, and TechNexus, which both support technology startups of different stages. To read more, click here. 

The City of Broad Shoulders is becoming a City of Innovation as it attracts or creates more tech companies and jobs. Chicago had 14,014 tech businesses in 2017, 46 more than in 2016. The city also had 341,600 tech workers across all industries in 2017.  To read more about job creation, click here.  

Founders who start companies in Chicago can enjoy both the benefits of a big city and the warmth of a Midwestern town. The Windy City’s startup scene is boosted by a strong talent pipeline from local MBA and engineering programs. Female founders are drawn to Chicago: a solid third of the city’s startups are run by women. To read more on this topic, click here. 

“There’s a strong work ethic in the Midwest that you will not find anywhere else,” Chicago Mayor Rahm Emanuel noted. “It cannot be replicated or bottled, and it’s a dedication that they don’t have on either coast.”

Google opened a small sales office 18 years ago and has since expanded to 1,000 workers, says Karen Sauder, vice president of sales and site lead for Google Chicago. “The city’s culture, diversity and strong emphasis on community made it a perfect fit for Google and we look forward to our continued growth for years to come,”

“I saw this explosion at the intersection of technology, innovation, and established companies in Chicago,” says Penny Pritzker, billionaire entrepreneur.

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Benefits of a CDMO

Dr. David Brett of Vetter Pharma International noted in a recent article in Contract Pharma.

Today, many pharma and biotech companies frequently look to contract development manufacturing organizations (CDMOs) that have the high-level of expertise needed to help them achieve their goals and successfully cover all aspects of the processes involved. From early development support to commercial filling and secondary packaging, the accomplished CDMO can offer everything at a single source.

Full-service CDMOs offer customers a great deal of secondary packaging services. Typical services include labeling, packaging of user sets, packaging into blister packs and cartons as well as serialization services. Customer redesign for any commercial changes driven by situations such as patient friendliness, product safety, cost efficiency and country specific requirements is also offered. For syringes and cartridges including pens and auto-injectors, a customized assembly service for e.g. safety devices is available. Click for the article.

An experienced CDMO can help by:

  • Selecting the most appropriate packaging material;
  • Developing and implementing flexible, extendable, reproducible and efficient processes;
  • Producing clinical test samples;
  • Providing analytical and regulatory support;
  • Scaling-up processes and technology transfers; and
  • Aseptic filling of liquid or lyophilized drug substances in vials, syringes or cartridges.

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NuMat Building the Future

NuMat Technologies was recently featured as a company that is redefining our future. The writer noted that during his discussion with Ben Hernandez and Omar Farha, he found that within 30 seconds , he was being pushed to reconfigure his imagination toward a world where we can create a chunk of rare metal from seawater, extract rare gases from air or the ocean, or turn toxic waste into drinking water.

Hernandez and Farha co-founded NuMat from a desire to rethink the scale of manufacturing. Rather than going for a big, expensive engineering solution, they believe the most civilization-threatening challenges we face are actually going to be solved at the smallest possible level.

By using their state of the art, rapid prototyping software, NuMat has been working to create millions upon millions of hypothetical building blocks — that is, chemical structures and molecules and the things that house them — which would otherwise take scientists centuries to discover using old-school techniques.

To access the entire article, that provides more on Numat and use cases, click here.

“The future of manufacturing is building materials with utility at the molecular level,” Hernandez says. He added, “Our accelerated approach to application commercialization significantly reduces the time and costs of solving extremely complex moon-shot challenges, or alternatively, helps us get to ‘no’ faster, which is equally valuable,”

Farha added, “I believe that these materials will revolutionize the world in a good way. Helping us to live in a world which is cleaner and where growth is truly sustainable.”

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Chicago Poised for Growth

Chicago is one of the nation’s leaders for employment in the life sciences industry according to a recent report from CBRE. While many U.S. industries are navigating fundamental disruption, the life-sciences industry – which includes pharmaceuticals, biotechnology and medical-device manufacturing – is on a long-term expansion track. Chicago is primed to benefit from this industry’s growth, as the market has seen strong gains in employment and National Institutes of Health (NIH) funding in recent years.

Noted Scott Brandwein, executive vice president with CBRE in Chicago; “Chicago is well-positioned for future growth in life sciences thanks to its large cluster of pharmaceutical and biotech companies and world-renowned research institutions such as Northwestern, Chicago, Rosalind Franklin, the University of Illinois at Chicago, Fermi and Argonne Labs.”

Chicago has received an employment boost in recent years, especially in its traditional industries of pharmaceuticals and medical manufacturing, which have experienced a sharp uptick since 2013. Jobs in this sector total increased nearly 18,000, exceeding the previous high of approximately 17,500 in 2006. In total, Chicago is the fifth largest market in the nation for employment in this sector. To read the entire CBRE report, click here.


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