Autolus Therapeutics Sets U.S. HQ, R&D in Maryland

Autolus Therapeutics, based in London, UK, announced plans to locate its U.S. headquarters in Rockville, Maryland. In addition to the headquarters, it will have all U.S.-based research and development, commercial and corporate functions and a first full commercial-scale manufacturing center at the location.

The company inked a lease with Alexandria Real Estate Equities for construction and development of an 85,000 square foot build-to-suit facility in the Shady Grove Life Sciences Center in Rockville. The company has set up a temporary U.S. headquarters in Rockville until the new facility is ready, which is expected in 2021.

The company is also building out a manufacturing plant in Enfield, UK, expected to open in 2020. It will global commercial viral vector in addition to commercial T-cell therapy products.

“This facility in the United States will be purpose-built to deliver on our commitment to provide advanced T-cell therapies to patients based on a manufacturing process designed to be scalable and economical,” stated Christian Itin, Autolus’ chairman and chief executive officer.

Autolus spun out of the University College of London in 2014, built on the advanced cell programming technology developed by Martin Pule. The company’s focus is on T-cell programming and manufacturing for cancer treatment. The company just listed on the NASDAQ Biotechnology Index as of December 24, 2018.

On December 2, 2018, the company released updated data from its ongoing Phase I/II AMELIA clinical trial of AUTO3 in patients with relapsed/refractory pediatric acute lymphoblastic leukemia (pALL) and its ongoing Phase I/II ALEXANDER clinical trial in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL). The company presented the data at the 60th American Society of Hematology (ASH) Annual Meeting held in San Diego.

AUTO3 is a dual-targeted therapy that incorporates two distinct chimeric antigen receptors (CARs).

To incentivize Autolus to set its U.S. operations in Maryland, the Maryland Department of Commerce approved a $525,000 conditional loan through the Advantage Maryland Fund. Montgomery County also provided a $200,000 conditional loan to start the construction project.

Autolus is also eligible for various state and local tax credits, including the Job Creation Tax Credit and the More Jobs for Marylanders Tax Credit.

“Autolus’ decision to locate its new U.S. headquarters and create more than 170 jobs in our state underscores our administration’s promise to continue creating job opportunities for Marylanders, particularly in a field as close to my heart as cancer research,” stated Maryland Governor Larry Hogan. “Our highly educated workforce and proximity to leading federal research labs and world-class universities makes Maryland an outstanding location for global companies looking to establish or grow their U.S. presence in the life sciences and technology sectors.”

Matthias Alder, Autolus senior vice president and chief business officer, told the Washington Business Journal that the new facility is part of the company’s plan to double its workforce from about 200 employees currently to almost 400 in the next 12 to 18 months.

“It’s all driven by the growth of our business operations in terms of our development programs,” Alder told the Journal. “We have seven clinical studies going on parallel and so that requires a lot of development staff but also manufacturing staff to make the product.”

Hiring for the positions has already started, with about 20 people having been hired.

https://www.biospace.com/article/autolus-therapeutics-sets-u-s-hq-in-maryland-will-create-170-jobs/

Medical Nanorobotics–The Next Generation of Development

From the dawn of time, humans sought to cure rampant disease and devastating illnesses. One can find that from the first appearance of the written word, soon thereafter, texts were penned regarding medicine and different treatments of illness known at the time. Even contemporary sounding ideas like diagnosing the patient, treating accordingly and updating our collective knowledge in accordance with the results had been prevalent in India two and half thousand years ago!

The research in medicine is quite astounding today as there are more questions than answers and new diseases emerge on a regular basis. There are people in the academic community who will argue that cancer, for example, was a disease that people suffer from much earlier than previously acknowledged and were just diagnosed incorrectly.

Others may claim that the increased use of radio technology and electro-signals that surround us in our modern daily lives is the key to the development of cancer. But, nevertheless, all agree that cancer is one of the major problems in medicine in the 21th century.

The current research in medicine involves two major aspects: diagnostics and treatment. There are another two main groups: operations and drugs. A promising solution for both diagnostics and drugs treatment are nanorobots.

Nanorobots (NR) are a nano-sized (10^-9 meters) particles. In a few possible stages they react with the environment. Thus, NR are injected into the bloodstream and flow there until they hit a place that triggers them. Such a process is called “targeted drug delivery” and reduces side effects we experience in drugs such as capsules.

NR even uses a less active drug as they deliver it to the right location on the body where the illness is and therefore more healthful than the drugs we have consume today.

This promising technology which should make you live longer and happier is still young and not ready for massive production. But do not give up yet as there are many good search groups facing the challenges of replacing the capsule drugs we know today with nanorobotics.

A leading place in the global NR research in Israel at Bar-Ilan University, Tel-Aviv University and Technion University. Bar-Ilan has one of the widest nano-centers in the world in which they conduct research on many uses of nanotechnology. One of the most exciting discoveries is the use of gold base medical nanoparticles to find cancerous tumors [1].

The Technion opened the gate on its own nano-center in the early days of the nanotechnology research back in 2005 and has presented promising first results in self-healing sensors for diagnostic micro medical devices [2].

Israel is known as the startup nation in general and a leader in computer sciences (cs) in the global academic world. So, it is only natural that search groups in Israel would combine efforts from the bioengineering world of NR and cs.

One such example of compelling research published only in 2016 in a search group called “Mavrix” at Bar Ilan university is a software program which allows physicians to describe in a code-like language to the computer the treatment needed for the patient. The program provides a mix of nanorobotics in order to provide a personal cure for the patient [3].

Israel’s hospitals hold enormous amounts of medical data and are considered leaders in IT institutes, considering the size of Israel. The hospitals, according to the law, are willing to share anonymous big-data to help Israeli researchers study large scale problems.

If you wish to help the medical nanorobotics research and have an academic search engine (like Google but for articles) you can gain enormous insight into this fascinating and burgeoning field of medicine.

Rivendellscholar.info is an academic search engine developed in Bar-Ilan University to allow search groups to easily find and manage relevant data for their research work. If you search for nanotechnology related subjects it will assist the site in improving their algorithm to find new nanorobots based cures. Sounds exciting, doesn’t it?

In summary, Israel is successfully establishing its place as a global leader in nanotechnology (one of the most promising technologies of the future) research and development. It is a nation that has committed itself to a strong academic effort, industry funds and government support. This is only the beginning. If research and advancements continue to progress at the expedited rate that they currently are, Israel is poised to be a dominant force in the scientific and environmental world.

[1] https://pubs.acs.org/doi/abs/10.1021/acsnano.5b07114

[2] https://lnbd.technion.ac.il/research/application-of-the-na-nose-diffrential-diagnosis-of-cancer/

[3] http://u.cs.biu.ac.il/~galk/Publications/Papers/fnano16.pdf

http://thejewishvoice.com/2019/01/16/medical-nanorobotics-the-next-generation-of-development-in-israel-2/

FDA calls in inspectors as shutdown drags on

With the government shutdown now in its fourth week—the longest ever—FDA Commissioner Scott Gottlieb, M.D., says about 400 staff have been recalled to restart inspections, with most of those targeted at drug, biologics and device inspections.

Gottlieb said in a series of Tweets on Tuesday that because of the holidays very few, if any, inspections have been missed and that scheduling picked up on Tuesday. Gottlieb, who has taken on the role of media director since other staff is furloughed, said user fee-supported programs are using carryover fees to keep operating but some, including the PDUFA program, are nearing the end of the till.

“Behind the collective dedication of our professional staff in our inspectorate and our programs, we’re focused on the core aspects of our consumer protection role,” Gottlieb said. “This is requiring hard operational decisions. We’re focused on preserving the function of our programs for as long as we can. We’re closely monitoring the burn rates of all of our user programs, but we’re the most concerned about the PDUFA balances, which have the lowest runway.”

---

Scott Gottlieb, M.D.

@SGottliebFDA

PDUFA is our most vulnerable program and will run out of money first. We’ll get into February but how far into Feb is still very fluid. We’re trying to free resources to extend its runway. We said 4/5 weeks counting this week. That could change but is our rough estimate right now

Derrick@dgingery

Better than PDUFA @MedtechDavid … https://twitter.com/MedtechDavid/status/1085244537386295301 …

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6:26 PM – Jan 15, 2019

He said about 260 of the 400 recalled employees are handling medical product inspections, 90 for biologics, 70 for drugs and 100 for medical devices. The other 140 are food inspectors and support staff.

The government shutdown began Dec. 22, when new funding was not approved because of a fight between President Trump and congressional Democrats who took control of the House in the midterm elections. Trump is insisting that funding bills include $5.7 billion for a wall along the border with Mexico. Democrats have refused to approve that, saying the president is just trying to force through an unrealistic campaign pledge and that border security money would be better spent on technology.

An indication of the impact of the shutdown can been seen on the FDA Warning Letters site. While postings are always affected by the end-of-the-year holidays, the last warning letter posted was in early December.

Other agencies like the aviation administration and the IRS were also calling in unpaid workers to handle critical functions and get ready for the 2019 tax season, Politico reported, saying it was hard to get exact numbers because most federal media personnel have been furloughed during the shutdown.

Gottlieb gave credit to field staff for the efforts to keep the agency operating during the shutdown.

“This was a major functional accomplishment amidst one of the biggest operational challenges in FDA’s modern history and it was fully enabled by the leadership of FDA’s field force and the colleagues who serve the country on the front lines of that mission,” he said.

https://www.fiercepharma.com/manufacturing/fda-recalls-inspectors-as-shutdown-drags-gottlieb-calls-pdufa-most-vulnerable

Allergan, Mohawk tribe ask SCOTUS to review Restasis patent licensing deal

When Allergan transferred six Restasis patents to the Saint Regis Mohawk tribe in 2017 in a bid to shield the dry-eye treatment from generic competition, it was widely maligned by everyone from industry insiders to tech giants like Microsoft. And in July, the U.S. Court of Appeals for the Federal Circuit ruled that Allergan’s effort to shield its patents by declaring tribal immunity is a no-go tactic.

Now, Allergan and the tribe want the U.S. Supreme Court to weigh in.

On its website, SCOTUS posted (PDF) a writ of certiorari that Allergan and the Mohawk filed in late December. The court will decide by Feb. 11 whether to hear the case.

The dispute over Allergan’s partnership with the Mohawk tribe dates back to early last year, when would-be Restasis generics maker Mylan challenged the six patents. The tribe tried to get Mylan’s bid thrown out on the grounds that sovereign immunity should shield it from patent challenges. But the Patent Trial and Appeal Board struck down the tribe’s motion.

The U.S. appeals court upheld that decision on the grounds that inter partes reviews by the U.S. Patent and Trademark office constitute an agency enforcement action, not a civil suit where tribal immunity might be relevant. Allergan and the Mohawk tribe disagree with that assessment and are asking SCOTUS to decide whether inter partes reviews that are presented to the Patent Trial and Appeal Board should be protected by tribal sovereign immunity.

Allergan has good reason to pursue out-of-the-box ideas for protecting Restasis. The drug, which brought in $1.4 billion in sales in 2017, continued to drive much of the company’s sales growth last year. But concerns that the product could be facing generic competition soon have driven some disgruntled shareholders to press CEO Brent Saunders to come up with a new strategy for the company. Those calls may get louder as Allergan’s top-selling Botox faces pressure in the migraine market from a new class of CGRP inhibitors.

Even though Allergan appealed to SCOTUS for a review of the Mohawk tribe partnership, the company doesn’t seem all that optimistic about keeping Restasis generics off the market. In November, Allergan nixed a planned $200 million expansion of its manufacturing site in Waco, Texas, deciding instead to spread $180 million in investments across all of its manufacturing sites.

The expected loss of Restasis exclusivity, a spokeswoman told FiercePharma at the time, “has shifted our priority from expanding the Waco site to investing significantly in our existing operations.”

Mylan is not the only generics maker looking to steal Restasis market share from Allergan. InnoPharma, Akorn and Teva have also filed generics applications for the drug, and Teva is already marketing its version in Canada.

https://www.fiercepharma.com/pharma/allergan-and-mohawk-tribe-ask-scotus-to-review-controversial-restasis-patent-licensing-deal

Magnetic therapy developer Brainsway files for $30M Nasdaq IPO

Brainsway, developer of magnetic device treatments for depression and obsessive-compulsive disorder, plans to raise $30 million through an initial public offering on the Nasdaq under the symbol “BWAY.”

Currently listed on the Tel Aviv Stock Exchange under the symbol “BRIN,” the Jerusalem-based company confidentially filed in November 2018, according to Renaissance Capital. Pricing terms were not disclosed.

The company obtained a de novo clearance from the FDA last August for the use of its noninvasive, deep transcranial stimulation system in treating OCD through about 20-minute-long sessions. That authorization was the second for Brainsway in the U.S., following a 2013 clearance for treatment-resistant major depressive disorder.

Brainsway’s device has received CE marks for stimulating nerve cells in different regions of the brain to treat multiple disorders, including chronic pain, autism, bipolar disorder, schizophrenia and others, as well as for Alzheimer’s and Parkinson’s diseases.

According to its prospectus, the company is currently conducting clinical trials to support FDA clearance of its technology for smoking cessation and post-traumatic stress disorder. Future studies could explore opioid addiction, fatigue in multiple sclerosis and post-stroke rehabilitation.

The U.S. represents Brainsway’s primary market, providing about 89% of its revenues in 2017. Currently, the company is ramping up its commercialization efforts in OCD, although it has yet to secure reimbursement coverage in the indication. Still, it aims to generate review from flexible pricing models and the out-of-pocket market.

The company brought in $11.6 million in revenues over the first nine months of 2018, a 54% increase compared to the same nine months the year before, and more than the $11.1 million it raised through all of 2017.

https://www.fiercebiotech.com/medtech/magnetic-therapy-developer-brainsway-files-for-30m-nasdaq-ipo

Roche launches uPath multislide digital pathology software

Roche has launched its uPath enterprise software for digital pathology, billing it as an improvement in speed and performance compared to its previous version known as Ventana Virtuoso.

According to the big biotech, the workflow software offers automated image analysis and makes it easier to share cases between pathologists and request second opinions. Its development was supported by Leeds Virtual Microscope technology, which Roche acquired from the University of Leeds in the U.K. and the Leeds Teaching Hospitals NHS Trust.

uPath allows pathologists to inspect all slides in a case in a single view, alongside all available patient information. Unlike a typical microscope and glass slides, multiple digital slides appear on a canvas-like display—allowing pathologists to move between hematoxylin and eosin, immunohistochemistry, special stains and others—to help them diagnose a patient faster, Roche said.

In addition, pathologists can aggregate notes, measurements and slide scoring into sharable images or PDFs, alongside automated and manual slide analyses markups. The virtual microscope system can also scale to display sizes ranging from laptops to high-definition wall screens.

“With this launch, we are able to deliver an improved digital pathology experience consisting of the Ventana DP 200 slide scanner and uPath software, which are the foundation to further enrich our portfolio of automated clinical algorithms for pathologists,” Jill German, head of Roche Tissue Diagnostics, said in a statement.

Last year, Roche and GE Healthcare teamed up to develop clinical decision support software, including joint-branded dashboards that collate data from in vitro diagnostics and medical scanners, starting in oncology and critical care.

That software aims to pull in equipment-generated information—including diagnostic images, pathology and genomic information, alongside patient records and research outcomes—for use in machine learning analyses.

https://www.fiercebiotech.com/medtech/roche-launches-upath-multi-slide-digital-pathology-software

Fitbit launches bring-your-own-device program for the NIH All of Us megastudy

Fitbit and the National Institutes of Health (NIH) have launched a bring-your-own-device project for participants in the All of Us research program, with its first foray into wearables and digital health technology being led by Scripps Research.

Fitbit users that are currently enrolled in the Precision Medicine Initiative program can now sync their accounts and share their data with NIH researchers, including readouts of physical activity, heart rate, sleep quality and health outcomes. The device will not be required to participate.

The All of Us program launched nationwide in May 2018 with the goal of enrolling at least one million people. It aims to support a wide range of studies by building one of the largest and most diverse datasets based on individual lifestyles, environmental factors and genetics. Participants will share different types of health information through surveys, electronic medical records, biological samples and digital health tracking.

“Collecting real-world, real-time data through digital technologies will become a fundamental part of the program,” Eric Dishman, director of the All of Us program, said in a statement.

“This information in combination with many other data types will give us an unprecedented ability to better understand the impact of lifestyle and environment on health outcomes and, ultimately, develop better strategies for keeping people healthy in a very precise, individualized way,” Dishman said.

A second All of Us research initiative using Fitbit devices is planned for later this year, and involves providing up to 10,000 devices to randomly invited participants. That study, conducted by the Scripps Research Translational Institute, will explore relationships between indicators such as physical activity, heart rate and sleep with other critical health outcomes.

Scripps is spearheading the program’s digital health effort, and previously selected Fitbit as All of Us’ first wearable in 2017. According to Fitbit, its devices are the most commonly used tracker in biomedical research, based on more than 675 published studies and additional registrations on Clinicaltrials.gov.

https://www.fiercebiotech.com/medtech/fitbit-launches-bring-your-own-device-program-for-nih-s-all-us-megastudy