Nabriva signs licensing deal worth up to $95 million with Chinese drug company


Nabriva Therapeutics has entered into a licensing agreement valued at up to $95 million that covers the development and commercialization of its experimental antibiotic product in China.

Under the terms of the agreement, Roivant Sciences of Hong Kong will make an upfront payment of $5 million to Nabriva, which is based in Dublin, Ireland, and has its U.S. headquarters in King of Prussia. Narbiva (NASDAQ: NBRV) would be eligible for additional payments, described as “about $90 million,” tied to achieving milestones related to the development of its new drug candidate Lefamulin. If the product is approved in China, Nabriva would also receive royalty payments.

Lefamulin has completed an international phase-III clinical trial testing its effectiveness as a treatment for adults with moderate to severe community-acquired bacterial pneumonia (CABP). Results from a second international phase-III clinical trial are expected later this spring.

Under the terms of the license agreement, Nabriva has granted a Roivant subsidiary an exclusive license to develop and commercialize Lefamulin in the greater China region consisting of the People’s Republic of China, Hong Kong, Macau and Taiwan. The companies will establish a joint development committee to review and oversee all development and commercialization plans.

“Our partnership with Roivant underscores our commitment to ensuring rapid access to Lefamulin for adults with CABP around the globe,” said Dr. Colin Broom, CEO of Nabriva Therapeutics. “Roivant has a broad therapeutic portfolio and deep development and commercialization expertise, making the company an excellent partner as we pursue bringing an important and much-needed new treatment option for CABP — and potentially other serious bacterial infections — to China and surrounding territories.

Broom said the funding from this agreement will contribute to his company’s efforts to prepare for launching Lefamulin in the United States, should the drug receive regulatory approval.

Nabriva expects to file a new drug application for Lefamulin with the Food and Drug Administration during the second half of 2018.

Vivek Ramaswamy, founder and CEO of Roivant, said in a statement the deal with Nabriva “demonstrates our commitment to build out a robust pipeline of products in China.… It is also indicative of our desire to develop treatments for infectious diseases beyond the hepatitis B virus.”

Pneumonia is a leading cause of infectious disease mortality worldwide. In China, pneumonia is the fourth leading cause of death in urban areas and the leading cause of death in rural areas.


Novocure brings Optune tech to drug trial for glioblastoma


Novocure (NSDQ:NVCR) said today that it joined a Phase Ib study to evaluate the safety of Celgene‘s (NSDQ:CELG) marizomib and temozolomide in combination with Optune for patients with newly-diagnosed glioblastoma.

The trial is the first to assess Optune, the company’s “Tumor Treating Fields” delivery device, in combination with an investigational drug.

Celgene and Triphase changed their ongoing Phase Ib study of marizomib in combination with temozolomide and radiotherapy to include Optune. A group of 12 gliobastoma patients will be treated with the combination therapy following initial treatment with radiation and temozolomide, according to St. Helier, N.J.-based Novocure.

The primary endpoint for the study’s Optune branch is to evaluate the safety of the combination treatment with the addition of Optune. Secondary endpoints include preliminary clinical activity of the combo, Novocure said, including progression-free survival and overall survival.

The Optune arm is slated to open in the third quarter of this year.

The FDA-approved Optune device delivers low-intensity, intermediate frequency, alternating electric fields to inhibit cancer cell replication.

“This collaboration marks an important first step toward testing Optune with a promising new investigational compound for the treatment of GBM,” principal investigator Dr. Roger Stupp, associate director for strategic initiatives at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, said in prepared remarks. “Optune is the first treatment in over a decade to improve survival in GBM. I believe that combining Optune with new pharmacologic treatments in clinical trials, like this Phase Ib study, will help advance our understanding of how to treat this devastating disease.”

“We believe TTFields has the potential to be an excellent development candidate in combination with other solid tumor cancer treatments,” chief science officer & head of R&D, Eilon Kirson, added. “As innovators in cancer treatment, we know collaboration is essential to improve patient outcomes. We hope this is the first collaboration of many.”

Healthcare payment analysts Cotiviti Holdings acquires RowdMap in $70M deal

Give and take concept on black background

Doug Williams, Cotiviti CEO, noted in a news release that the need for its services has increased in line with the shift toward value-based care and the more complex payment system that accompanies it. RowdMap will help the companies expand and deepen their product offerings to their customer base.

“With the addition of RowdMap, we will be able to offer adjacent solutions to payment accuracy that together target over $600 billion of the estimated $900+ billion in waste and abuse in healthcare expenditures,” Williams said.

RowdMap uses publicly available healthcare data to create risk benchmarks for physicians, health plans, and hospital systems to help them identify and quantify no-value and low-value care. As a result, payers can reduce their medical costs by 30 percent and hospitals. The startup has expanded rapidly in the past couple of years from having a presence in 10 states two years ago to 49 states in 2017. It also added Geisinger Health System as a customer earlier this year.

In an interview earlier this year, RowdMap Cofounder and Chief Science Joshua Rosenthal highlighted the benefit of its approach.

“You can have a great clinical outcome on surgery you don’t need. You can even have a low cost and a great patient experience on that surgery,” he said. “But we take a broader view of quality. Whether you need something or not actually trumps whether you have a good outcome.”

Both companies are all about providing analytics software support to make risk bearing, value-based care workable because it relies so much on data analytics.

Cotiviti is a public company based in Atlanta that provides its services to 20 of the largest payers in the U.S. and eight of the top ten retailers, according to a news release. Earlier this year Rosenthal said RowdMap planned to focus more on helping payers compensate providers on the basis of high-value care metrics.

“We believe we are well positioned to help RowdMap achieve its full potential by leveraging our broad data set and established client relationships,” Williams said. “In addition, the RowdMap technology platform and analytics are highly complementary with Cotiviti’s, creating an opportunity for our teams to collaborate and share mutual insights to enhance existing solutions and develop a new set of innovative solutions.”

Photo: crazydiva, Getty Images


Forget antimicrobials, Evelo just raised $50M for its pro-microbial approach


The latest installment, announced Tuesday, came as a $50 million Series B courtesy of its founding and principal investor, Flagship Pioneering. GV (formerly Google Ventures), Celgene, Mayo Clinic, and Alexandria Venture Investments also chipped in.

Evelo’s platform is based on what it calls monoclonal microbials. These are single strains of naturally occurring microbes that selectively target human gut cells. That supposedly initiates specific immunological pathways, which can modulate aspects of inflammation, neurodegeneration, and even cancer.

“Humans have evolved over millennia with the microbes in and on our bodies and these microbes play a vital role in developing and directing immune and biological responses,” Evelo CEO Simba Gill explained via email.

Using microbials as a drug is an interesting deviation from the standard small molecule or antibody-based approach. By isolating naturally-occurring strains, Gill said the company is looking to improve the speed, cost, and success of drug discovery and development. They can be taken orally and he’s also anticipating fewer off-target effects.

“One of the key advantages of monoclonal microbials is that we are not seeing systemic exposure of the microbe, and therefore do not expect to see side effects driven by off target systemic exposure,” Gill noted.

With the new funding in hand, Evelo hopes to advance multiple product candidates into human trials in 2018. In the crosshairs right now are cancers and so-called immuno-inflammatory diseases — a category that includes psoriasis, rheumatoid arthritis, and food allergies.

“Based on the data we have generated, our monoclonal microbials have the potential to really move the needle for all of the disease areas listed,” he said.

Resources will also be committed to improving the foundational platform.

While it’s all new terrain, Flagship does have some related experience. Its VentureLabs incubator gave birth to what is arguably the most advanced microbiome-based drug company, Seres Therapeutics. It underwent a successful IPO and recently initiated the field’s first pivotal trial.

VentureLabs also seeded Epiva Biosciences, which joined forces with Evelo in 2016. It had become apparent that both companies were working on the same problem from different angles. Evelo was working to create cancer therapies and studied immune responses to tumors, while Epiva explored treatments for allergy, inflammatory and autoimmune diseases.

The two firms consolidated into one location in Cambridge, Massachusetts location, with Evelo’s Gill taking the helm.

“The rationale for combining the two companies was positive growth,” Gill told MedCity News at the time. “It was driven by the recognition that fundamentally the biological platform for both companies was a mirror image. We both independently uncovered the biology of the immune-microbiome.”

Let’s see how much of a punch the two-for-one pro-microbial company can now deliver.


Picture: Andrew Brookes, Getty Images

Baidu’s Apollo platform becomes the ‘Android of the autonomous driving industry’

Baidu now claims one of the largest partner ecosystems for an autonomous driving platform in the world: Its Apollo autonomous driving program now counts over 50 partners, including FAW Group, one of the major Chinese carmakers that will work with Baidu on commercialization of the tech. Other partners include Chinese auto companies Chery, Changan and Great Wall Motors, as well as Bosch, Continental, Nvidia, Microsoft Cloud, Velodyne, TomTom, UCAR and Grab Taxi.

The Apollo program (if that name seems familiar, it’s because it’s actually named after the U.S. mission to the moon) also includes five of China’s top universities, and local government tie-ups as well. Baidu’s COO Qi Lu called the platform the “Android of the autonomous driving industry, but more open and powerful,” and it aims to provide developers with tools including data, APIs, open source code for some portions and even reference hardware to help them bring autonomous driving products to market.

To demonstrate what the platform can do, U.S. autonomous system supplier startup AutonomouStuff showed off two cars they turned into self-driving models using Apollo’s 1.0 software release in just three days. These cars ran circuits at a track near Baidu’s AI developer conference, which is where the Apollo program news was announced.

The goal is to open up Apollo’s abilities to developers gradually over time, and this month, developers will get access to driving technologies for specific, restricted areas. By the end of 2020, Baidu hopes to offer a platform that can handle full autonomous driving on both urban roads and highways.

In the autonomous driving industry there have been a lot of partnership announcements, amounting to a sort of ‘musical chairs’ with many players seeking to team up on various aspects of the challenge. In that context, Baidu may have just sat down in all the chairs at once. These partnerships tend to be open, as players hedge their bets and prepare for multiple leaders to emerge in the space, but Baidu’s open approach with the resulting product is interesting and different.

Baidu, as an Internet company with business similar to Google’s, seems to believe that the data and services business resulting from use of its platform will be worth making it more broadly available (the Android model). It’s an interesting approach, and one that could prove a winning strategy, especially in the potentially massive Chinese market.

New York Approves Guardant Health’s Liquid Biopsy Test

Guardant Health.  (PRNewsFoto/Guardant Health)

NEW YORK (GenomeWeb) – Guardant Health today announced the Guardant360 assay has been approved by New York State’s Clinical Laboratory Evaluation Program.

The assay is the first liquid biopsy permitted by the program, which Guardant said is one of the most demanding lab certification programs in the country, and the approval means Guardant360 can be offered in all 50 states.

The blood-based 73-gene test investigates actionable somatic alteration across all solid tumor sites to provide clinicians information to better manage their patients’ disease, according to Guardant. Last week, Medicare contractor Palmetto GBA released a draft local coverage determination for the test, proposing limited coverage for it in patients with advanced non-small cell lung cancer.

The test was launched in 2014 and has been ordered more than 40,000 times by more than 3,500 oncologists since, Guardant said.


Deep Genomics Shifts Focus to Genetic Medicines


By Allison Proffitt 

May 12, 2017 | In August 2015 when Deep Genomics first launched, co-founder Brendan Frey made a prediction. “There’s a sea change coming,” he told Bio-IT World. “People are going to be focusing now on the machine learning component and trying to understand what the genome means, not just sequence a bunch of genomes.” It’s been nearly two years, and he’s been proven right as more and more efforts arise to apply deep learning, machine learning, and artificial intelligence to medicine.

But maybe Frey isn’t wholly prescient. Earlier this month Deep Genomics announced a shift in company focus. Genetic testing was the Deep Genomics business plan in August of 2015; today the company is working to develop genetic medicines.

The company’s technology and foundation haven’t changed. Frey’s vision is to use computer science to accurately model what’s going on in cells and how disease arises from mutations. “Closing the genotype-phenotype gap means understanding how mutations impact what’s going on in cells and how that impacts diseases, whether that’s cancer or Alzheimer’s Disease,” Frey told Bio-IT World earlier this week. Detecting mutations is the first step; figuring out what to do about the mutations is the second part.

But genetic testing as an industry is bound in regulatory constraints. “What we found is that the genetic testing community is very conservative and a lot of issues need to be sorted out. They’re political issues; they’re insurance issues; they’re FDA issues. Sorting that out is not something that we want to focus on in the short term. As the community moves forward and those issues get resolved, then we’ll re-engage with the genetic testing community. But right now we’re focused on genetic medicine,” Frey said.

Deep Genomics intends to understand disease starting with its genetics, and then rationally develop drugs to target the genetic underpinnings of disease. Frey believes the regulatory landscape for that type of genetic medicine is much more fertile, citing the 21st Century Cures Act.

“If you look at pharmaceuticals and therapeutics… everybody realizes that this $2.8b per drug [cost] to produce a drug doesn’t work and an 85% failure rate is just not acceptable. Many people are suffering because of this. So the regulatory constraints are dropping; it’s becoming easier and easier to develop drugs.”

Into The Wet Lab

You might expect that Deep Genomics would simply offer its deep learning platform to companies and groups as software-as-a-service or platform-as-a-service. Frey laughs when I ask him about it; he understands the assumption. But from the beginning, Deep Genomics has employed both computer scientists and cell biologists. The Deep Genomics platform has already identified genetic medicine candidates and the company is pursuing options for central nervous system, eye, and liver disorders, validating them now in tissue culture.

Deep Genomics has lab space at JLABS @ Toronto, a 40,000-square-foot life sciences incubator sponsored by Johnson & Johnson Innovation that just celebrated its first year. Frey is also making good use of the science-on-demand capabilities now available. “Nowadays, over the internet you can order compounds… companies will synthesize the compounds and do the chemistry for you. Companies like Transcriptic enable cloud labs, that allow you to do experiments by uploading basically a computer script.”

The company has previously been funded by angel investors and had revenue from clients and partners. But now Frey is securing additional funding for a Series A round to “massively scale up” the company’s experimental unit. He hopes to announce his own compounds in the next 18 months.

In addition, Deep Genomics is seeking pharma partners. “The path for us is to focus on the early-stage development right now, and collaborate with other pharmaceutical companies and help them get their products out as fast as they can, reduce risk for other pharmaceutical companies,” he said.

Platform Progress

Deep Genomics’ vision, Frey stressed, hasn’t changed. “The core idea of Deep Genomics is that the pharmaceutical company of the future is going to look like a computer science company with an amazing team of biologists and chemists and experts in clinical trials rather than a traditional pharmaceutical company with biologists and chemists who are using computational tools. It’s a question of culture; it’ll be a culture of computer science.”

The platform has matured over the past two years. The company has diversified the types of molecular phenotypes it looks at, considering transcription initiation, polyadenylation, and mRNA stability, in addition to splicing errors, and has added protein-related molecular phenotypes.

For the past few months, Frey said, the company has been focusing on how to introduce genetic modifications or therapies to fix various mutations.

“Say there’s a mutation that causes a problem with splicing or a transcriptionally-related problem,” he proposes. “Now what kind of a genetic modification or genetic medication would be needed to fix that problem?”


For some, access to healthcare could start with at-home lab testing

Scientist holding DNA gel in front of samples for testing in laboratory

Most at-home lab testing devices like Scanadu and Cor are still waiting for FDA approval, but simple lab testing can still be done in the confines of your own home and then shipped to a lab and that’s led to a handful of new startups offering services like STD or food allergy tests.

Everlywell, an Austin-based at-home lab testing startup (and a Disrupt Battlefield company), aims to make the testing it offers affordable and easily accessible to the masses. The company debuted two years ago and has grown quite a bit in a short amount of time. Founder Julia Cheek tells me Everlywell is now generating millions in sales and ships to 46 states in the U.S. The company recently announced it had pulled in another $2 million in seed funding, bringing the total to $5 million to help it grow its service offerings.

Everlywell so far offers eight different tests including food sensitivity, thyroid and metabolism testing or fertility testing to get a clear picture of how you are doing in those areas.

MyLabBox is another startup offering a detailed list of STD tests available for use in the home and at your convenience. The costs might seem high if not covered by insurance (and most at-home lab testing doesn’t seem to be) but you could still see about FSA/HSA reimbursements.

Though the debate wages on for how to cover America, these types of startups present a new range of abilities for the healthcare industry and could help lower the cost and ease of access for service workers and others who don’t work regular hours or don’t typically have insurance coverage.

The process is pretty simple for each startup — you order online and a kit arrives in the mail. Each test is different but some require a sample of blood or saliva. Just follow the instructions and then pop it back in the mail for analysis by a third-party lab.

The idea for these types of startups might be similar to something the embattled blood testing company Theranos once hoped to accomplish. Theranos held a lot of promise when it first launched, claiming it could test for hundreds of diseases on one drop of blood. However, you had to go into a Walgreen’s partner lab if you wanted to get results.

These newer lab startups offer the ability to test in privacy and instead use certified third-party facilities for accurate measurements. They may also be the preferred method for those who just want to see their results before determining whether they need to see a doctor as sitting face-to-face with someone who might tell them they have an STD can be a very real fear.

Both startups stand by the accuracy of their results and I’ve personally tried a food sensitivity test from Everlywell that I can say helped me determine certain foods that were causing stomach issues — including green peas, which is one I never would have thought of otherwise.

It’s not exactly full access to healthcare (that’s another debate I could get into but not today), but this new crop of health startups do offer a regulated option for those who can scrape up the money without paying insurance premiums to find out what might be going on inside their body — and with an easy and convenient solution to some of the fear they might have about going to the doctor’s office to get results.


Tencent increases its focus on artificial intelligence

Tencent Holdings Ltd.'s new headquarters stand under construction in Shenzhen, China, on Monday, Aug. 22, 2016. The new headquarters for Tencent is a $599 million project aimed at creating a campus-like atmosphere for the urban setting. Scheduled for completion next year, the Shenzhen skyscraper could become one of the largest labs for new internet services and connected devices. Photographer: Qilai Shen/Bloomberg via Getty Images

When it comes to artificial intelligence (AI) and Chinese tech companies, thoughts often begin and end with Baidu. But Tencent, Asia’s second highest-valued tech company behind Alibaba, has reminded the world that it too is investing in the field.

Search giant Baidu was one of the first to make a major commitment to deep learning. It spent over $2.9 billion on R&D over a 2.5 year period, according to Bloomberg, and currently has more than 1,300 specialists working on a variety of technologies that include AI and augmented reality. Baidu, however, suffered a blow when its chief scientist Andrew Ng, who heads up its U.S.-based research team, announced his departure last week.

There’s one more exit to add to that list after Tencent announced today that it poached machine learning researcher Tong Zhang, who heads up Baidu’s Big Data Lab, to lead its own AI Lab. The Shenzhen-based lab is focused on computer vision, speech recognition, and natural language processing.

Tencent, best known for WeChat, China’s top messaging app, announced the lab last April. It said today that it has 50 AI specialists housed there. Aside from that development facility, Zhang — who received a PhD in Computer Science from Stanford and has worked at IBM and Yahoo — will lead a team of 200 product engineers that’s tasked with converting AI advances into tangible features and updates for Tencent’s apps and services.

“Tencent is looking at four areas for AI application: content, social, online games and cloud services. At present, over a hundred Tencent products, including Weixin/WeChat, QQ and Tian Tian Kuai Bao, a Tencent news app, use AI technology,” the company added.

That’s a similar goal to Baidu, which got serious on deep learning when it hired Ng, a co-founder of online learning startup Coursera, in 2014.

A world-renowned AI expert, Ng previously made his name when it helped found Google’s deep learning team, Google Brain. Ng said in his departure note that Baidu’s AI efforts had been felt across its “existing businesses in search, advertising, maps, take-out delivery, voice search, security, consumer finance and many more” areas.

“The team is stacked up and down with talent; I am confident AI at Baidu will continue to flourish,” he added.

For now, Tencent is talking up its AI prowess in the field of Go, the strategic game that Google made its mark on when its AI (AlphaGo) triumphed over world champion Lee Seedol last year.

Tencent said its ‘Fine Art’ AI, which was developed by 13 Tencent engineers, defeated high-ranking Japanese Go player Ryo Ichiriki last week. All in all, the firm said the AI has taken on 100 “renowned human players,” winning 406 of over 500 rounds that it has competed in.


Uber’s autonomous test cars return to the road in San Francisco today


Uber has confirmed that its small fleet of autonomous vehicles in San Francisco will be back on the road today. The company grounded its entire self-driving test fleet in the U.S. on Saturday, following an accident involving one of its vehicles in Arizona earlier in the day.

“We are resuming our development operations in San Francisco this morning,” an Uber spokeswoman told us this morning.

The spokeswoman also confirmed Uber’s autonomous cars in Arizona and Pittsburgh remain grounded, but said the expectation is for them to shortly be back on the roads too.

Uber grounded all its self-driving test cars following the accident, initially suspending the operation in Arizona but also in the two other cities where it is currently testing the vehicles: San Francisco and Pittsburgh, pending the outcome of an investigation.

While Uber’s self-driving cars are able to drive autonomously, the test vehicles include a human driver sitting in the passenger seat so they are in a position to take over should it become necessary.

The two vehicles it’s testing in SF are apparently at a different stage of development vs the 12 test cars apiece it’s been piloting in the other locations — explaining why it’s feeling confident enough to return to the road in SF but not yet elsewhere.

Early reports of the Arizona incident appear to have cleared Uber’s technology of blame, with local police saying the accident occurred because a normal (i.e. human-driven) vehicle failed to yield to the Uber, which was in self-driving mode at the time.

The company’s self-driving test program has, however, previously faced safety-related criticism — including when one of the vehicles ran apparently ran a red light. In that instance Uber claimed the car had not been in self-driving mode at the time — though a New York Times report, citing two Uber sources, has suggested the opposite.

Beyond questions over the safety of its self-driving tech, Uber continues to face wider criticisms relating to its company culture — with accusations of sexism by a former employee continuing to pile pressure on the leadership (and apparently contributing to the decision of president Jeff Jones to leave the company earlier this month, amid the turmoil).