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PreCAAP Company: Tracery Opthalmics Wins $50K First Prize at JLABS AI for Drug Discovery QuickFire Challenge

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CATCHING “GENETIC TYPOS” WITH TORONTO-BASED DNASTACK

“In the nucleus of trillions of cells in your body, there are 23 pairs of chromosomes that comprise a genome. There are about 6 billion letters in a human genome, that collectively spell out a sort of molecular blueprint. A mutation of just a single letter in that genetic blueprint can literally change your life.”

This is the succinct raison d'être outlined on the website of Toronto-based DNAstack, a company that develops cutting-edge technologies to help scientists discover and treat the causes of genetic diseases. Amazing, isn’t it? If the human genome is a story, a minor “typo” can result in a life-threatening disease.

It was one of these genetic mistakes that presented DNAstack Chief Executive Officer and Co-Founder Marc Fiume’s best friend with a devastating diagnosis – cystic fibrosis, an inherited, incurable, and life-threatening disorder. Fiume took this personal tragedy in stride, honoring his friend by using his story as the inspiration for a new company that would give doctors and patients a leg up on such illnesses.

Thus, DNAstack, a cloud-based platform for genomics data storage, bioinformatics, and sharing was born with the goal of helping researchers find the cause of genetic disease, clinicians diagnose those diseases, and pharmaceutical companies design treatments faster and with more precision than ever before.

And since launching its cloud platform in October 2016, DNAstack is barreling full speed ahead on the road to doing just that – strategically partnering with tech and life science giants along the way. Google, which has embraced DNAstack as an extension of its cloud platform, and Johnson & Johnson Innovation, which last June welcomed DNAstack to its JLABS @ Toronto facility, are just two such examples.

For Fiume, these relationships are “very intentional” and give his company the freedom to “focus on product not sales.” “With JLABS, we have the nimbleness of a startup but the resources of a big company, which allows us to make a big impact quickly,” said Fiume. Among these resources is Rebecca Yu, former Head of JLABS Canada, whom Fiume describes as one of his “biggest champions.” 

With its fresh ideas and knack for grabbing hold of opportunities, DNAstack has expanded quickly – doubling its size, launching two new products, and obtaining non-dilutive financing in its short time at JLABS @ Toronto. The company has also successfully established itself at the forefront of one the hottest (and most important) trends in bioinformatics: democratization of access to genomic data.

While DNAstack has always been free for researchers, earlier this year, the company launched “Workflows,” an application for scalable, reproducible bioinformatics workflows based on open standards. Per DNAstack, Workflows enables anyone with an internet connection to run any genomics data analysis pipeline at any scale – a game changer that is already accelerating research in cancer, autism, and rare disease. 

Fiume is quick to point out, however, that despite its early success, his company (like any other) has faced challenges. 

“The most difficult thing for DNAstack is breaking down traditional mindsets in government and healthcare to make way for the adoption of new, vastly superior technologies that will drastically improve and save lives,” said Fiume. “The reasons why traditional music, video, and bookstores no longer exist are the same reasons that we will see a revolution of health through digitalization.”

In the face of such obstacles, Fiume leans on his team, whom he says are his “most valuable resources.” When asked for his top piece of advice for budding life science entrepreneurs, he says simply “focus, and regularly refocus, [your team] on what matters.”

As a relatively new venture ourselves, in the trenches with our residents to address the world’s most pressing healthcare challenges, we at JLABS couldn’t agree more. We can’t wait to see the additional success the next year brings for DNAstack, and look forward to supporting Fiume and his team every step of the way!

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Houston Healthcare Start-ups: Starting to achieve escape velocity from the gravitational pull of oil & gas

On March 2, 2018, JLABS @ TMC celebrated its second anniversary. The pace of our evolution over the past 24 months continues to be rapid. We started with 22 companies, and have grown to just under 50, we have quadrupled the size of our device prototyping labs in order to meet the ongoing demands of our medical device resident companies, and our internal team continues to grow in order to support the needs of the many companies on our site.  While these are meaningful growth metrics for us, we find that we are just a part of an emerging healthcare start-up dynamic here in Houston

The growth we are witnessing here has surpassed the expectations that I had when I moved here a year ago from Boston. Our neighbors are the strong team within the TMC Innovation Institute who run the TMCx accelerator program sponsored by the Texas Medical Center.  They opened their doors a year before us and welcomed their first cohort of 21 companies. In three short years, they have had 6 cohorts and hosted 108 companies from around the globe. The current cohort of 22 health tech companies is drawn internationally, only 3 are from Houston, with 20% coming to Texas from Silicon Valley.  Here at JLABS we have welcomed 7 of their graduating companies to stay in Houston and become JLABS residents.

In addition to the accelerator program, the TMC Innovation Institute at 2450 Holcombe also holds X+, a co-working space for healthcare companies that now houses 70 life science companies.  J&J’s Center for Device Innovation is also located here, run by Billy Cohn, and now staffed with over 10 J&J machinists and engineers.  So, in just three short years, this place has gone from being a former cookie factory, to a vibrant life sciences community housing over 175 different healthcare startups, employing hundreds of people, that you could meet here on any given day. I walk down the halls, and I am consistently challenged to remember names of people, companies, and technologies.  This close proximity creates crucial connection points for entrepreneurs, scientists, and venture capitalists that previously did not exist in H-town. And if you ask them, they will all tell you that this is absolutely critical to their success.

With the commitment of time and capital from Bill McKeon and his team at the Texas Medical Center, in addition to our neighbors the institute including BioHouston, TMC BioDesign and angelMD, we have helped establish a strong foundation in Houston for the growing life science community. Houston has begun to creep up on the short list for the hot spots for innovation, and when you come here you can see why. We have all helped to build it, and start-ups have responded by coming. It is our goal to recruit and foster these companies to find continued success, whether that’s in the clinic or through financial partnering. Johnson & Johnson Innovation helps to provide the connective tissue to the east and west, while the Texas Medical Center provides access to one of the largest concentrations of patient populations in the world.

We will continue to look ahead, as more growth at this site is planned. It is an absolute kick to be here every day and be a part of it.  So, if you’re into solving some of the challenges we all face in healthcare, or curious to see for yourself, head down to the former cookie factory. We’ll be happy to show you why the Innovation Institute at 2450 Holcombe is adding rocket fuel to Houston’s growing healthcare footprint (pardon the pun, but it is Houston…).

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JLABS COMPANY STORIES | VIRACYTE: A COMPANY DEDICATED TO FIGHTING TRANSPLANT RELATED INFECTIONS

Imagine being a transplant patient, and you’ve just received the bone marrow transplant you desperately need to survive.  Unfortunately, a full recovery is not a given. Immediately after a transplant, before the immune system reconstitutes, the patients are very vulnerable to infection. In fact, research shows that more than 27,000 patients are projected to receive allogeneic hematopoietic stem cell transplant (allo-HSCT) in 2017 (US and EU), and up to 70 percent of those patients may suffer from a severe viral infection1.  Unfortunately, today there are no FDA approved drugs or effective experimental therapies to treat most of these infections, but ViraCyte is on a mission to change that.                            

ViraCyte, a resident company at JLABS @ TMC in Houston, Texas, focuses on combating these infections. Spun out of Baylor College of Medicine in 2013, the company’s mission is simple: to safely and effectively treat viral infections that attack people with weakened immune systems. ViraCyte’s therapies infuse patients with activated T cells that are highly specific for attacking viruses; these T cells are obtained from normal donors and following activation and expansion, can be kept cryopreserved for years until patients need them.

“I was a pediatric critical care physician prior to joining ViraCyte, and some of the most challenging cases I faced were severe viral infections after stem cell transplant,” said Brett Giroir, M.D., President and CEO of ViraCyte. “Typically when patients contract a virus like this, there’s nothing we can do except to provide supportive care and wait for the immune system to reconstitute.” When I saw the work that ViraCyte was doing, I knew I had to be a part of it.”

The results are positive and encouraging. In the past 8 months, ViraCyte has released its phase 1 and phase 2 clinical results. In phase 1, which focused on the safety and efficacy of Viralym-C, the therapy controlled infections within six weeks of infusion for all ten patients with drug-refractory CMV infection. In the phase 2 results, Viralym-M, ViraCyte’s flagship therapy, achieved a 92% overall clinical response after a single infusion and demonstrated efficacy against all five targeted viruses.

Based on the results of phase 1, ViraCyte was granted a Fast Track designation by the U.S. Food and Drug Administration in early January of 2017.

“Fast Track designation emphasizes the importance of new cell therapies, like Viralym-C, which holds unique promise in treating severe infections in patients with weakened immune systems such as adults and children following stem cell transplants,” said Dr. Giroir. “This was a huge step forward for us as a company.”

The success didn’t stop there.  ViraCyte continued to get positive results and shortly thereafter, Viralym-C was granted an Orphan Drug designation by the FDA. Orphan Drug designation qualifies sponsors who are developing therapies for rare diseases that affect fewer than 200,000 people in the United States for certain development incentives, including tax credits for clinical research costs, frequent FDA interactions, and protocol assistance. 

Although ViraCyte focused on the stem cell transplant population first, their roadmap includes all patients suffering from viruses due to weakened immune systems. Other organizations are starting to take notice, and in early July ViraCyte announced that the NIH National Heart, Lung and Blood Institute (NHLBI) awarded the company a $3 million Phase IIB Small Market Award under the NIH Small Business Innovation Research (SBIR) program. The Program supports the development of innovative technologies addressing rare diseases and/or young pediatric populations to advance the commercialization of promising new products. With this new capital, ViraCyte will perform advanced clinical development of a T cell immunotherapy for BK virus in stem cell transplant recipients. BK virus causes severe disease including hemorrhagic cystitis and nephritis and can lead to renal failure, hemorrhage, and death in transplant recipients.

Additionally, ViraCyte was recently awarded a $750,000 Orphan Products Clinical Trials Grant by the FDA Office of Orphan Product Development (OOPD) for a Phase I clinical trial of Viralym-A in stem cell transplant recipients with Adenovirus.  The OOPD funds the clinical development of products for use in rare diseases for which there are limited or no current therapeutic options. There are currently no FDA-approved treatment options for BK virus or Adenovirus.

With all ViraCyte’s success in the clinic, the most impactful is that on the patient population. Because of the clinical results, and market need for these therapies, the Cancer Prevention and Research Institute of Texas (CPRIT) Oversight Committee recommended funding for a product development research grant totaling $8.99M to support the clinical development of Viralym-M.

So, it begs the question, why would a company with solid funding, strong ties to academia, and nationally recognized leadership come to JLABS? According to Chief Scientific Officer, Dr. Ann M. Leen, it’s all about the infrastructure. “ViraCyte could not have happened without financial backers, professional advisers and JLABS. Here, we have everything we need to be successful. The labs are state of the art, we have access to expertise inside Johnson & Johnson, and the infrastructure allows us to focus solely on the science.”

Congratulations ViraCyte!

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