Qiagen to Acquire FORMULATRIX® Digital PCR Technology

FORMULATRIX has announced that their digital PCR assets, including the CONSTELLATION^® series of instruments, is being acquired by QIAGEN N.V. for up to $260 million ($125 millionupfront payment and $135 million of milestones). QIAGEN has announced plans for a global launch in 2020 of a new series of digital PCR platforms that utilize the advanced dPCR technology developed by FORMULATRIX combined with QIAGEN’s expertise in assay development and automation.

Digital PCR is one of the fastest-growing molecular testing techniques in the life science industry with a wide range of applications. It has proven specificity and precision advantages over quantitative PCR (qPCR). The increased specificity allows for the detection of rare mutations that were not possible to detect with existing qPCR methods. QIAGEN intends to develop this technology for future applications in clinical healthcare beyond the initial focus on life science applications.

FORMULATRIX has developed a novel plate-based dPCR technology that has many advantages over existing dPCR technologies. The fully automated workflow has a fast time-to-answer and low hands-on time. The sample throughput is much higher than existing instruments, with up to 200 samples per hour. The available 6-channel detection also allows for high multiplexing.

“The dPCR technology that we’ve developed is unlike anything on the market today, and we are excited that QIAGEN will be bringing the technology to researchers around the world. We believe the combination of QIAGEN’s strong expertise in PCR and broad global presence will advance digital PCR to a new level,” said Jeremy Stevenson, president and CEO of FORMULATRIX.

“The addition of a digital PCR platform, which builds on the highly differentiated assets we are acquiring from FORMULATRIX, is a logical evolution for our PCR portfolio and presents a very exciting opportunity for QIAGEN,” said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. “As the use of digital PCR continues to emerge and gains utility across a wide range of applications in Life Sciences, we plan for expansion into applications for Molecular Diagnostics. We expect to launch the first of these new digital PCR solutions in 2020 and create seamless integration with our workflows, assay menus and service offerings to help customers unlock valuable molecular insights.”

FORMULATRIX was established in 2002 to provide protein crystallization automation solutions. Since then, we’ve been developing the next generation of liquid handlers (the MANTIS^® and TEMPEST^®) using our patented microfluidic technology. From there we have expanded our technology portfolio to include the digital PCR solution that is being acquired. Headquartered in Bedford, Massachusetts, we supply software and robotic automation solutions to leading pharmaceutical companies and academic research institutions around the world.

https://www.marketscreener.com/QIAGEN-40135659/news/Qiagen-FORMULATRIX-Digital-PCR-Technology-to-Be-Acquired-by-QIAGEN-27861154/

FDA Action Alert: Exelixis and Immunomedics

Because of the government shutdown, which as of Monday, January 14 is into its fourth week, 40 percent of the U.S. Food and Drug Administration (FDA) employees were furloughed. There’s been a fair amount of media attention paid to how this affects routine food inspections—they weren’t being performed—but less attention was paid to how it affected drug approvals.

The agency is continuing to carry out reviews funded by fiscal year (FY) 2018 Prescription Drug User Fee Act user fees, so the two approvals described here should still be on track. However, the FDA is not currently accepting FY 2019 user fees until the government gets back to work.

Forbes noted on Thursday, January 10, “Consequently, the FDA has suspended reviews of existing Investigational New Drug (IND) and Biologics License Applications (BLA) applications not covered by user fees and is not reviewing applications for new drugs and biologics submitted during the shutdown period, except for emergency INDs and BLAs. The FDA is also not reviewing medical device applications submitted during the lapse period. And, the FDA is curtailing work on regulatory guidance documents pertaining to medical devices, drugs, and biologics.”

Exelixis’ Cabometyx for Previously Treated Advanced Hepatocellular Carcinoma

The FDA has a target action date of Monday, January 14, 2019 for Exelixis’ supplementary New Drug Application (sNDA) for Cabometyx (cabozantinib) for patients with previously treated advanced hepatocellular carcinoma (HCC). The company also announced that on March 28, 2018, with its partner Ipsen, the application for this to the European Medicines Agency (EMA)had been validated. On November 15, 2018, the EMA approved Cabometyx as a monotherapy for HCC in adults who have previously been treated with sorafenib.

“This approval of Cabometyx in the European Union is a very important milestone for our partner Ipsen and marks significant progress for people living with liver cancer, which is the second-leading cause of cancer death worldwide,” stated Michael M. Morrissey, Exelixis’ president and chief executive officer. “This patient community is in dire need of new options to treat this aggressive disease, and we are excited to work with Ipsen to make this treatment available to patients in the European Union and other countries worldwide.”

Under the terms of Exelixis’ and Ipsen’s deal, Exelixis will pay Ipsen a milestone payment of $40 million for the approval of the second-line treatment of HCC. The European approval was based on data from the CELESTIAL trial of patients with advanced HCC who received prior treatment with sorafenib. Cabometyx demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo. The drug has also been approved in Europe for advanced renal cell carcinoma (RCC) in adults who were previously treated by VEGF-targeted therapy and for previously untreated intermediate- or poor-risk advanced RCC.

Liver cancer causes more than 700,000 deaths a year, with more than 800,000 cases diagnosed each year. Liver cancer incidence has more than tripled in the U.S. since 1980. HCC is the most common type of liver cancer and makes up about 75 percent of the estimated 42,000 new cases in the U.S. last year.

Immunomedics and Bavituxumab Govitecan for Triple-Negative Breast Cancer

The FDA has a target action date of Friday, January 18 for Immunomedics’ sacituzumab govitecan for patients with metastatic triple-negative breast cancer (mTNBC) who had at least two previous treatments. The company’s Biologics License Application (BLA) was filed and granted with Priority Review status. If approved, it will be the first and only antibody-drug conjugate (ADC) approved for mTNBC.

On December 6, 2018, Immunomedics updated results from its Phase II trial of sacitizumab govitecan as a monotherapy in mTNBC. The drug showed an objective response rate (ORR) of more than 30 percent among heavily pre-treated patients and a manageable safety profile. Response rates to chemotherapy in pre-treated mTNBC patients are generally low.

“We believe these results show that sacituzumab govitecan can be a viable treatment option and help alleviate the unmet need in mTNBC,” stated Robert Iannone, head of R&D and Immunomedics’ chief medical officer, at the time. “We have shared these updates with the FDA during its ongoing priority review of our Biologics License Application for accelerated approval of sacituzumab govitecan in metastatic TNBC.”

https://www.biospace.com/article/fda-action-alert-exelixis-and-immunomedics/

Ascletis, Alphamab to Collaborate to Treat Hepatitis B and Other Viruses

Ascletis Pharma Inc. (Ascletis, 1672.HK) and Suzhou Alphamab Co., Ltd. (Alphamab) jointly announce today that Ascletis’ subsidiary and Alphamab have entered into a strategic collaboration and exclusive licensing agreement for anti-PD-L1 KN035 to treat hepatitis B and other viral diseases in Greater China (Ascletis code: ASC22). KN035 is an investigational programmed cell death ligand-1 (PD-L1) monoclonal antibody which has been exposed to more than 500 patients in multiple clinical trials in US, China and Japan.

Under the terms of the agreement, Ascletis has an exclusive license from Alphamab to develop and commercialize ASC22 (KN035) for viral diseases including hepatitis B in Greater China. Ascletis will pay Alphamab a cash upfront payment and Alphamab will be eligible to receive payments in development and commercial milestones as well as tiered royalties from the mid-teens to around twenty percent on future sales of ASC22 (KN035). Alphamab will manufacture ASC22 (KN035) for clinical trials and commercialization of viral indications in Greater China for Ascletis. For ASC22 (KN035) in viral indications worldwide outside Greater China, Ascletis will be eligible to share certain economics such as upfront, milestone payments and royalties, depending on the development and regulatory status of ASC22 (KN035) inside Greater China.

Professor Guiqiang Wang, MD, President of Infectious Diseases Society of China, Vice-President of Chinese Society of Physicians for Infectious Diseases and Director of Centre for Liver Diseases at Peking University First Hospital, commented, “There is a lack of new innovative drugs that can lead to effective clinical cures for chronic Hepatitis B. As T cell exhaustion in HBV infections is an important factor in immune tolerance, blocking the PD-1/PD-L1 pathway could be an effective immunotherapy approach to improve specific T cell function and lead to a clinical cure for chronic Hepatitis B. PD-L1 antibody KN035 has been investigated in several global clinical trials in cancer patients, including pivotal cancer trials in China. These clinical trials provided invaluable human safety data for KN035. The subcutaneous route of administration for PD-L1 antibody ASC22 (KN035) provides a differentiated approach, which can increase patient compliance in clinical practice. I am very pleased that innovative Chinese biotechs are taking the lead in clinical studies of PD-L1 antibody for chronic Hepatitis B. Immunotherapy with PD-L1 antibody approach may lead to a significant breakthrough towards a clinical cure for chronic Hepatitis B.”

Jinzi J. Wu, PhD, Founder, Chairman and CEO at Ascletis said, “Alphamab is a leading biopharmaceutical company and we’re excited to partner with them. Hepatitis B remains a highly unmet medical need in China and globally. Through the strategic collaboration with Alphamab, we have the opportunity to develop ASC22 (KN035) as a potential first-in-class HBV immunotherapy and offer a clinical cure for Hepatitis B patients. Following the recent collaboration with Roche on Pegasys, this collaboration marks another major step forward for Ascletis to expand its pipeline and platform with biological drugs and to fulfill its commitment to developing innovative Hepatitis B therapies.”

“We are pleased to enter this strategic collaboration with Ascletis, a pioneer in innovative antiviral drug development,” said Dr. Ting Xu, Chairman of Alphamab. “Alphamab has been working on HBV for several years, we are excited to see KN035 to move into clinical development for Hepatitis B. With Ascletis’ demonstrated clinical development expertise in liver infectious diseases, we are confident that KN035 immunotherapy may lead to an effective clinical cure for Hepatitis B. With KN035 collaboration as a good starting point, Alphamab is looking forward to a much broader and long-term partnership with Ascletis in viral and liver diseases.

https://www.marketscreener.com/ASCLETIS-PHARMA-INC-46512723/news/Ascletis-Pharma-and-Alphamab-Announce-Strategic-Collaboration-and-Licensing-Agreement-for-Anti-PD-27861035/

PG&E CEO Steps Down Amid California Wildfire Crisis

PG&E Corp. said Sunday that Chief Executive Geisha Williams was stepping down as the company grapples with the growing political and financial fallout of its role in helping spark California wildfires.

California’s largest utility said John Simon, the company’s general counsel since 2017, will serve as interim CEO as PG&E’s board of directors conducts a search for a new chief.

PG&E faces billions of dollars in potential liability costs stemming from wildfires, many started by the company’s equipment, that have led state regulators, lawmakers and others to question the safety of the company’s electric distribution system.

Investigators have already found PG&E’s equipment responsible in at least 17 major wildfires in 2017. State investigators haven’t determined whether the company played a role in November’s Camp Fire, the deadliest in California history, but the company disclosed that some of its equipment malfunctioned in the area shortly before the fire started.

The California Public Utilities Commission has stepped up a continuing probe into the company’s safety practices and is considering whether the company should be broken up, among other things.

“While we are making progress as a company in safety and other areas, the board recognizes the tremendous challenges PG&E continues to face,” PG&E Chairman Richard Kelly said in a statement announcing Ms. Williams’ departure Sunday evening. “Our search is focused on extensive operational and safety expertise, and the Board is committed to further change at PG&E.”

Ms. Williams couldn’t immediately be reached for comment Sunday evening. Her 2017 total compensation was $8.6 million.

The company said earlier this month that it plans to shake up its board of directors and institute other changes, though it didn’t specify what those might be.

Ms. Williams joined PG&E in 2007 and rose through the ranks as the company was put on the defensive from criticism by federal pipeline-safety officials. The officials said PG&E’s gas pipeline system was a public threat after a 2010 pipeline explosion in San Bruno incinerated a neighborhood and killed eight people.

Ms. Williams, who once worked on hurricane response at Florida Power & Light, now owned by NextEra Energy Inc., represented PG&E at a town hall as officials were still finding bodies in San Bruno, answering questions from angry residents. PG&E later promoted her to senior vice president of electric operations. She became CEO in 2017.

Mr. Simon, PG&E’s interim CEO, became the executive vice president and general counsel in March 2017. He joined the utility a decade earlier and had previously been the head of human resources. He earned total compensation of $3.76 million in 2017.

Numerous top executives have left the company in recent days. Patrick Hogan, senior vice president of the electric operations unit for Pacific Gas and Electric Co., was last week replaced by Michael Lewis, another executive within the electric division. Two other executives in the electric division, Kevin Dasso and Gregg Lemler, will retire by the end of the month.

Michael Wara, head of the climate and energy policy program at Stanford University’s Woods Institute, said the decision to appoint a new chief executive is a step PG&E needed to take to begin re-establishing trust with its regulators and the state.

“That is not to say that Geisha Williams is to blame, but the reality is she has been the person in charge during this time and made executive decisions regarding how to manage this risk,” he said. “She is accountable.”

Paul Patterson, an analyst who follows PG&E at Glenrock Associates LLC, said Ms. Williams’ exit appears designed to appease California political leaders more than Wall Street.

“Making management changes is something the state is looking for, and handing the head of the CEO might placate the state,” he said.

The long-term health of the company depends on what actions the state takes to help it pay for fire-related liabilities. Credit agencies recently downgraded PG&E and raised the possibility of bankruptcy, given the enormous liability costs it could face.

California law makes utilities responsible for any fire started by their equipment, even if they weren’t negligent. PG&E faces dozens of lawsuits from residents and insurers seeking compensation for fire damages. Analysts have estimated that PG&E could face as much as $30 billion in wildfire liability costs.

State lawmakers are considering whether to let PG&E turn much of its liabilities into securitized debt, which customers would pay off through their electricity prices. But public criticism of PG&E is mounting, complicating the prospect of a move that could be viewed as a bailout for the company.

State Sen. Jerry Hill, a longtime critic of the company, called the move to replace Ms. Williams long overdue. But he added that the management shake-up won’t affect the key question facing the utility and its ratepayers: whether California would provide PG&E with the financial aid it needs to survive.

“I don’t believe the state is willing to make that decision, nor should it,” he said.

The company said the board will look for a new CEO with operational and safety experience.

https://www.marketscreener.com/PG-E-CORPORATION-13946/news/PG-E-CEO-Steps-Down-Amid-California-Wildfire-Crisis-Update-27861147/

The threat inside ‘internet of things’ devices

As Americans increasingly buy and install smart devices in their homes, all those cheap interconnected devices create new security problems for individuals and society as a whole. The problem is compounded by businesses radically expanding the number of sensors and remote monitors it uses to manage overhead lights in corporate offices and detailed manufacturing processes in factories. Governments, too, are getting into the act – cities, especially, want to use new technologies to improve energy efficiency, reduce traffic congestion and improve water quality.

The number of these “internet of things” devices is climbing into the tens of billions. They’re creating an interconnected world with the potential to make people’s lives more enjoyable, productive, secure and efficient. But those very same devices, many of which have no real security protections, are also becoming part of what are called “botnets,” vast networks of tiny computers vulnerable to hijacking by hackers.

Botnets have caused problems on the internet, from sending vast amounts of spam mail to disrupting websites around the world. While traditionally most botnets are comprised of laptop and desktop computers, the growth of unsecured devices such as industrial sensors, webcams, televisions and other smart home devices is leading to a growing disruptive capability.

Tiny computers everywhere

The “internet of things” includes countless types of devices – webcams, pressure sensors, thermometers, microphones, speakers, stuffed animals and many more – made by a vast array of companies. Many of these manufacturers are small and unknown, and don’t have popular brands or public reputations to protect. Their goals are to produce lots of devices to sell as cheaply as possible. Customers’ cybersecurity isn’t a real concern for them.

Credit: Chart: The Conversation, CC-BY-ND Source: IoT Analytics

These devices’ variety means they’re useful for lots of things, but also means they have a wide range of vulnerabilities. They include weak passwords, unencrypted communications and insecure web interfaces. With thousands, or hundreds of thousands, of identically insecure devices scattered all over the world, they’re a wealth of targets ripe for the hacking.

If, for instance, a manufacturer has set an unchangeable administrative password on a particular type of device – it happens more often than you might think – a hacker can run a program searching the internet for those devices, and then logging in, taking control and installing their own malicious software, recruiting the device into a botnet army. The devices run normally until the hackers issue instructions, after which they can do more or less anything a computer might do – such as sending meaningless internet traffic to clog up data connections.

Blocking internet access

That type of attack when emanating from thousands of devices at once, called a “distributed denial of service,” can shut down companies’ servers or even block wide swaths of the internet from being publicly accessible. A major DDoS attack in 2016 interrupted connections to Amazon, Netflix and Paypal from customers on the east coast of the U.S.

That attack was linked to a botnet-control software program created by three teenagers seeking to use more than 100,000 hijacked webcams and other internet-connected devices from around the world to gain an advantage over other players of the “Minecraft” online video game.

A botnet took down connections through a major internet company in October 2016. Credit: DownDetector/Wikimedia Commons, CC BY-SA

The size and scale of these attacks – and the broad range of devices that can contribute to them – make this both a private problem and a public one. People want to secure the devices in their homes and pockets, of course. Yet the same networks that stream television shows and music also link burglar alarms to police, manage traffic lights in congested areas and let self-driving cars talk to each other.

All that activity can be drowned out if hackers flood the internet, or sections of it, with meaningless messages. Traffic would stall across towns, even counties, and police officers would have a hard time communicating with each other to try to straighten everything out. Even small devices, in their hundreds of thousands, all around the world, can work together to have huge repercussions both online and in the physical world.

 Explore further: Tips on protecting devices from hackers

https://phys.org/news/2019-01-quiet-threat-internet-devices.html#jCp

A nod to seniors at CES

With artificial intelligence to detect falls, virtual reality to combat isolation and “powered” clothing to assist the incapacitated, the tech world is stepping up its effort to “disrupt” aging.

At the Consumer Electronics Show this week in Las Vegas, exhibitors were showcasing new ways to help the elderly remain independent, mentally fit and connected.

Some systems took a page from the gaming world of youngsters to help seniors “travel” to new places and connect with loved ones.

“Everyone knows seniors get lonely but that isolation can also lead to a lot of medical problems, including the acceleration of dementia,” said Kyle Rand, founder and chief executive of Rendever, a startup which works with assisted living homes to give seniors a way to virtually visit remote locations.

“They can stand atop the Eiffel Tower, they can go on an African safari, or revisit their childhood home.”

Rendever was launched in the Washington DC tech incubator created by the American Association of Retired Persons (AARP), which in recent years has been funding efforts to develop new technologies for seniors.

In the consumer space from the AARP incubator, Alcove VR enables seniors to be part of a virtual world with loved ones who may be far away.

Jerry Wilmink of CarePredict holds a wearable tech band that can help monitor seniors in assisted living and help predict falls or other health issues at the 2019 Consumer Electronics Show

“You can step into a virtual living room (with a friend or family member and just hang out,” said Cezara Windrem, the AARP product manager for Alcove.

Alcove was launched this week as a free application on Oculus, the Facebook-owned virtual reality unit.

The AARP exhibit also included VRHealth, which offers cognitive behavioral therapy using virtual reality, and Pillo, a device which serves as a personal assistant and medication dispenser focused on health for seniors.

Virtual caregivers

Other exhibitors showcased technology that could help seniors remain in their homes, and give family members peace of mind by monitoring their condition, in some cases using predictive analytics to determine if they are at risk.

Walabot, a wall-mounted monitoring system developed by the Israeli startup Vayyar, uses radio waves and three-dimensional imaging to keep tabs on seniors living alone.

David Keeley of SameDay Security debuts the Addison Virtual Caregiver system at the Consumer Electronics Show in Las Vegas, a digital assistant designed to monitor seniors living alone

“You don’t need to wear anything, there are no cameras,” said Ofer Familier, head of business development for Vayyar.

The company, which makes a range of sensor equipment, says Walabot can detect subtle changes in gait, movement or breathing which could signal a risk of a fall or other problem.

“We can detect falls, but the predictive aspect of it is to monitor changes in behavior so we can alert family members,” Familier said.

Also launched at CES was the Addison Virtual Caregiver, a video-based assistant with a female avatar which can converse, offer reminders on medication and detect potential health issues.

With the data gathered from the device, “we can classify people as high-risk or low-risk fallers,” said David Keeley, research director for Addison parent firm SameDay Security.

“We can predict the rate of functional decline.”

The Walabot fall detection device for seniors from Israeli startup Vayyar is displayed at the 2019 Consumer Electronics Show

Alicia Mangram, a Phoenix-based trauma surgeon who is an advisor to Addison, said the system can be useful in helping seniors remain independent.

“Right now when we send people home (from a hospital) we don’t know what happens to them,” Mangram said. “This allows us to check on them.”

Florida-based startup CarePredict exhibited its system based on a wearable band that helps monitor seniors in assisted living facilities.

“We can passively and unobtrusively monitor the daily activities of seniors, and our predictive tools can help identify if they are at risk of falls, depression, malnutrition or urinary tract infections,” said CarePredict’s Jerry Wilmink.

Tech firms see a promising market in these kinds of devices, with public attention focused by the Apple Watch’s feature of fall detection.

According to research firm eMarketer, Americans of age 55 and older are the fastest-growing group of electronic wearable users in the US, largely due to the devices’ enhanced health features.

Sarah Thomas (R) of California startup Seismic talks to the 2019 Consumer Electronics Show about “powered clothing” using robotic muscles to help people with fatigue and disabilities, as customer Bob Copani of San Francisco models the garment

Artificial muscles

For those with mobility issues, the California startup Seismic unveiled its wearable tech body suit which can augment a user’s muscles and help them maintain posture.

The “core wellness suit,” which weighs under five pounds and can be worn under street clothes, has robotic components that provide up to 30 watts of power to each hip and the lower back to support sitting, standing, lifting, or carrying—similar to an exoskeleton but without the bulk.

Sarah Thomas, a Seismic vice president and advisor to tech startups, said the new product is designed not only for the elderly but for factory workers to ease fatigue and anyone with mobility issues.

Thomas said tech products for seniors should not be “stigmatized” with unsightly products.

“We should be designing with age in mind but without the ageist perspective,” Thomas told a CES panel.

 Explore further: Sensors help smartphones keep eye on solo seniors

https://phys.org/news/2019-01-kids-seniors-vegas-tech.html#jCp

Ansell upgraded to Outperform from Neutral at Macquarie

Macquarie analyst David Bailey upgraded Ansell to Outperform while lowering his price target for the shares to A$26.50 from A$27.20. The analyst sees easing butadiene prices and moderating natural rubber latex prices aiding the company’s growth.
https://thefly.com/landingPageNews.php?id=2847825