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Monday, March 4, 2019

Gamida, Editas to Evaluate CRISPR Editing Tech in Natural Killer Cells

Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, announced an agreement with Editas Medicine, Inc., a leading genome editing company, to evaluate the potential use of Editas Medicine’s CRISPR technology to edit NAM-NK cells, which are natural killer cells that have been expanded using Gamida Cell’s proprietary nicotinamide-based, or NAM, technology. Through this agreement, the companies aim to discover optimized NAM-NK cells that could be used to improve the treatment of hematologic malignancies (blood cancers) and solid tumors.
“We are encouraged by the early data generated in the Phase 1 study of NAM-NK as an investigational therapy for patients with non-Hodgkin lymphoma and multiple myeloma, and we are pleased to have the opportunity to accelerate and broaden our NAM-NK research efforts through this agreement,” stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. “By leveraging the collective expertise of the Gamida Cell and Editas Medicine teams, we hope to enhance the efficacy of NAM-NK cells through CRISPR editing and potentially bring life-changing immunotherapy treatments to patients.”
“Natural killer cells are increasingly recognized as a potential breakthrough approach to treating various cancers. This agreement with Gamida Cell enables us to combine our industry-leading genome editing platform with Gamida Cell’s proprietary NAM-NK cells in an effort to develop best-in-class cellular medicines,” said Charles Albright, Ph.D., chief scientific officer of Editas Medicine.

Diplomat Pharmacy to delay filing 10-K, cites need to record impairment charge

The company stated: “Diplomat Pharmacy is unable to file, without unreasonable effort or expense, its Annual Report on Form 10-K for the year ended December 31, 2018 within the prescribed time period because the company has recently determined the need to record a significant non-cash impairment charge related to the company’s Goodwill and Definite-lived intangible assets, as a result of reduced financial forecasts for the business, which will materially impact results for the fourth quarter and full year ended December 31, 2018. As a result, the company needs additional time to finalize the level of impairment for Goodwill and the Definite-lived intangible assets, the tax implications and the total impact on the company’s 2018 fourth quarter and full year financial results. The issues identified require the company to perform additional procedures and analyses, and other third-party review of the foregoing, that affect the timeliness of the company’s annual financial statement and preparation of the Annual Report. Management is in the process of completing these additional procedures and the Annual Report. The company expects to file the Annual Report as soon as reasonably practicable after completion of the foregoing.”
https://thefly.com/landingPageNews.php?id=2874055

Device Monitors, Gauges Agitation in Dementia

A device that emits low-frequency radio waves and collects detailed data on movements can help inform treatment decisions for dementia patients with agitation, new research suggests.
Known as Emerald, the novel sensing device uses radio wave sensing and signal processing “to map human behavior in a contact-free, completely remote and relatively private way. We are really excited about the potential of this technology and how it might guide real time medication changes,” study investigator, Ipsit V. Vahia, MD, from McLean Hospital, Belmont, Massachusetts, and Harvard Medical School, Boston, told Medscape Medical News.
The findings were presented here at the American Association for Geriatric Psychiatry (AAGP) 2019.

Discreet Device

Vahia’s team is collaborating with Massachusetts Institute of Technology (MIT) researchers who developed the device.
The wall-mounted device is plugged into a power source “so no one needs to remember to charge it,” said Vahia.
Dr Ipsit Vahia
Patients aren’t constantly reminded that their movements are being tracked. They don’t need to wear anything or carry a mobile device and the technology doesn’t involve intrusive cameras taking pictures of them, said Vahia.
The device emits wireless radio signals similar to WiFi signals but 100 times less powerful. It can relay information on a person’s exact location in a room at any given time, and extracted information may shed light on respiration and other vital signs.
“It can detect gait, so based on gait and gait speed, we can map out pacing, agitation, and restlessness,” said Vahia.
The device can also measure length of sleep and other parameters. “We can detect periodic limb movements in sleep, which has important implications,” said Vahia.
The data the device collects is compressed and displayed in patterns that illustrate changes over time. To Vahia, the ability to collect data longitudinally is the most exciting element of the technology.
“We can see changes in behavior over time, which we believe may allow us to study the impact of treatments and interventions.”

Advancing Quickly

The researchers presented data collected for individual dementia patients in assisted-living facilities that illustrate potential applications of the device.
One example was an 85-year-old white woman diagnosed with a major neurocognitive disorder, major depression and anxiety, with a history of restlessness and agitation.
Sensor data collected over time showed “fairly classic pacing behavior in the context of Alzheimer’s disease,” said Vahia.
His team used the wave patterns to suggest medication changes — decisions that were “100% verified” by conferring with onsite attending staff, he said.
The investigators were keen to learn more about the cause of the spikes in this patient’s behavior. After combing through staff logs, they found that the patient paced more on the days following visits from her husband or son. This knowledge also informed important treatment alterations.
Current investigation of the device is restricted to patients with dementia, which Vahia called “the most expensive clinical problem facing us across all of medicine.”
It’s a condition where early intervention may reduce hospitalization, and impact negative outcomes such as falls, he said.
“This work is early stage but rapidly moving,” said Vahia. “The goal of our team is to expedite the implementation of this technology in real-world care, to the greatest extent possible, but in a manner that is evidence-based.”
The availability of “easy, efficient technology and rapid analytics” represents a “tipping point” in this research area, said Vahia.
“It has turned this work from being cumbersome and not translatable into something that you can immediately translate into care.”

“Groundbreaking” Research

Commenting on the study for Medscape Medical News, Prasad Padala, MD, professor of Psychiatry and Geriatrics, University of Arkansas for Medical Sciences in Little Rock, called it “groundbreaking.”
Sensor-based measurements can be superior to clinician-driven data collection, said Pradala, who was not involved with the current research.
He used the example of in-office assessment of gait speed, which is a marker for longevity.
“The moment I tell patients that I’m measuring their gait speed, they want to put their best foot forward, and that defeats the purpose.”
Vahia’s team is collecting data “without the explicit awareness of the patient” so in a more objective manner than is possible with a clinician, said Padala. “The data will be more reflective of what’s in reality.”
He doesn’t believe this noncontact data collection process will eliminate the role of the physician. “Once we get the data, what we do with it is where the doctor comes into the picture.”
The research was supported in part by the National Institute of Mental Health, Once Upon a Time Foundation, Massachusetts Institute of Technology, Stein Institute for Research on Aging, UCSD RPC iPad Project, and the John A. Hartford Foundation. Vahia and Padala have disclosed no relevant financial relationships.
American Association for Geriatric Psychiatry (AAGP) 2019: Abstract LB6. Presented March 3, 2019.

Stroke-prevention devicemaker Silk Road Medical files $86M IPO

Silk Road Medical, manufacturers of a stent and neuroprotection system designed to restore blood flow in the carotid arteries and prevent strokes, announced plans for an $86.25 million IPO on the Nasdaq, under the ticker symbol SILK.
The Sunnyvale, California-based company plans to use the proceeds to expand its sales force and commercial operations in the U.S. and internationally, as well as increase its R&D activities and conduct new clinical studies, according to its prospectus filed with the SEC. The financial terms of the offering were not disclosed.
Silk Road first began selling its products in the U.S. in 2015. Designed for transcarotid artery revascularization, or TCAR procedures, the minimally invasive system redirects carotid blood flow away from the brain to protect it from stray pieces of plaque that may break loose during the placement of a stent or balloon angioplasty. The blood is instead shunted through a filtration system before being returned to the body through the femoral vein in the patient’s thigh.
By completely reversing the blood flow in the artery and filtering it outside the body, compared to strainers placed entirely within the artery, Silk Road says it’s able to stop smaller pieces of debris from reaching the brain and causing damage.
The company brought in $34.6 million in 2018, a 142% increase compared to its $14.3 million in revenue the year before. Its stent and neuroprotection system have also received a CE mark, and Silk Road said it plans to pursue additional regulatory clearances in China, Japan and other markets in the future.
Silk Road raised $47 million in July 2017 to help boost commercialization of its devices—with funds from Norwest Venture Partners and Janus Capital Management, as well as Warburg Pincus, The Vertical Group and CRG—less than two years after netting $57 million in venture capital financing.

LivaNova delays filing of Form 10-K

In a regulatory filing, LivaNova said that its Annual Report on Form 10-K for the year ended December 31, 2018 cannot be filed within the prescribed time period without unreasonable effort or expense because the company needs additional time to complete certain reviews and analyses necessary for the assessment of the company’s internal control over financial reporting and to complete its financial reporting process, and for its independent registered public accounting firm to complete its audit. The company expects to report two material weaknesses in the Form 10-K due to certain deficiencies in the design of its internal control over financial reporting. Although the company’s analysis is still ongoing, these deficiencies relate to information technology and end-user access of the financial reporting system and the review of price and quantity in the revenue process. The company expects to file the Form 10-K within the fifteen-calendar day extension provided under Rule 12b-25 under the Securities Exchange Act of 1934, as amended.
https://thefly.com/landingPageNews.php?id=2874039

Odonate Therapeutics initiates phase 2 study of Tesetaxel in breast cancer

Odonate Therapeutics announced that it has initiated CONTESSA 2, a multinational, multicenter, Phase 2 study of tesetaxel, Odonate’s investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer who have not previously received a taxane. CONTESSA 2 will investigate the combination of tesetaxel plus a reduced dose of capecitabine in approximately 125 patients with human epidermal growth factor receptor 2 negative, hormone receptor positive disease. The primary endpoint is objective response rate as assessed by an Independent Radiologic Review Committee.
https://thefly.com/landingPageNews.php?id=2874023

Addus HomeCare says ‘well positioned to achieve further profitable growth’

CEO Allison concluded, “Looking ahead to 2019, we believe we are well positioned to achieve further profitable growth both from our current operations and acquisitions. Our objectives for organic growth for the year are consistent with our targeted range of 3% to 5% for same-store revenue growth. In addition, we previously announced a definitive agreement to purchase VIP Health Care Services, with annual revenues of approximately $50 million, and we expect to close this transaction during the second quarter of 2019. We continue to pursue other potential acquisitions in 2019 that fit with our strategic plan, and we have the financial strength to pursue additional growth opportunities that we believe will enhance our market presence and add shareholder value.”
https://thefly.com/landingPageNews.php?id=2873989