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Monday, April 12, 2021

Microsoft ramps up focus on healthcare AI with $19.7B Nuance acquisition

 Microsoft has its head in the clouds—the Microsoft Cloud for Healthcare, that is, which will soon get a major boost from the tech giant’s acquisition of Nuance Communications.

Microsoft will shell out $19.7 billion cash for Nuance, its largest acquisition by far since it scooped up LinkedIn for $26.2 billion in 2016.

That headline price represents $56 per share, approximately 23% above Nuance’s closing price on April 9, the last full trading day before the acquisition plans were made public. The deal is expected to close by year-end.

With Nuance’s speech recognition and conversational AI software under its umbrella, Microsoft will expand its push to bring cloud-based AI tools to the healthcare industry on a broader scale.The tech giant figures the new products expand its target market in the clinical field to $500 billion.


The two companies already have experience combining their technologies: They formed a partnership in October 2019 that began by adding Nuance’s note-taking ambient AI to Microsoft’s Azure cloud computing service so it could be more easily integrated into healthcare providers’ electronic health record platforms.

“Nuance provides the AI layer at the healthcare point of delivery and is a pioneer in the real-world application of enterprise AI,” Microsoft CEO Satya Nadella said. “AI is technology’s most important priority, and healthcare is its most urgent application.”

Nuance CEO Mark Benjamin will stay in that job and report to the head of Microsoft’s cloud and AI business after the deal closes. Nuance’s financial results will fold into its new parent company’s Intelligent Cloud segment.


In 2020, that segment alone posted an annual revenue increase of 24%, totaling more than $48 billion, driven largely by its server products and Azure cloud services. Nuance, meanwhile, also saw double-digit growth, with a 37% year-over-year increase in healthcare cloud revenue over the 2020 fiscal year.

That growth came as a product of Nuance's recent prioritization of healthcare and enterprise AI, with a focus on building "more personal, affordable and effective connections" through its conversational AI technology, Benjamin said in a statement.

“The path forward is clearly with Microsoft—who brings intelligent cloud-based services at scale and who shares our passion for the ways technology can make a difference," he said.

https://www.fiercebiotech.com/medtech/microsoft-ramps-up-focus-healthcare-ai-19-7b-acquisition-nuance

Sage’s technical tremor win fails to move

 When a disease has no available treatments for its underlying cause any clinical success is welcome. This holds true for essential tremor and for Sage/Biogen’s Sage-324, whose phase 2 Kinetic study just about cleared the efficacy bar in this disease.

However, investors wondering whether Sage-324 is now derisked are not celebrating just yet, and the stock crept down 2% this morning. Among the concerns are the win’s narrow margin, a high rate of adverse events, and Sage’s admission that, rather than going into phase 3, a new mid-stage study was now needed.

The purpose of such a trial, which on an investor call today Sage termed phase 2b, would be to explore new formulations and different dose frequencies for Sage-324, presumably to counteract side effects. This study is expected to begin later this year.

The biggest worries to emerge from Kinetic are that 68% and 38% of patients on Sage-324 experienced somnolence and dizziness respectively, and though there were no falls 15% had balance disorder. 38% of subjects on active treatment discontinued, while dosing had to be reduced in 62%.

Stifel analysts wrote that such levels of somnolence and dizziness were “simply too high” to differentiate Sage-324, a Gaba A modulator. In other diseases even a high rate of adverse events might not be disastrous, but essential tremor patients tend to be old and afflicted by comorbidities.

Paper thin

There is a silver lining: given the remarkably high dropout rate, for Sage-324 to show significance seems unexpectedly positive. 

Still, Sage's analysis does not appear to comprise the all-comers population of 69, but rather 67 patients in Kinetic. And the success Sage is claiming is paper thin: the p value for Sage-324 versus placebo for Kinetic’s primary efficacy metric, change from baseline in an essential tremor scale at day 29, was 0.049.

Sage had been hoping to see a 30-50% absolute reduction versus placebo, and in the event saw 36%.

The group added a further positive, saying this metric also met the standard for statistical significance at all time points up to day 29. And the effect was apparently most pronounced in 47 patients with the most severe tremor at baseline, though this hints at the possibility of Sage-324 being limited to this population.

Such issues might seem trivial, but for a company valued at $4.5bn they cannot be ignored. Sage does have the endorsement of Biogen, which last November gave it $1.5bn for rights to Sage-324 as well as the more advanced antidepressant asset, zuranolone (Biogen’s Sage advice amounts to $1.5bn, November 30, 2020).

But zuranolone has already failed one depression trial, Mountain. Waterfall, a separate study with a different design and testing a higher zuranolone dose, is due to yield results in the current quarter and represents Sage’s most important catalyst.

The positive topline hit in Kinetic notwithstanding, Sage-324 falls into the same category as zuranolone did after the Mountain readout: needs more work.

Sage's clinical-stage pipeline
ProjectDescriptionLead indication & trial details2026e sales ($m)
Marketed
ZulressoIV Gaba A modulatorPostpartum depression67
Phase 3
Zuranolone (Sage-217)*Oral Gaba A modulatorMajor depressive disorder, Waterfall data due Q2 20212,231
Phase 2
Sage-324*Oral Gaba A modulatorEssential tremor, ph2 Kinetic study met primary endpoint132
Sage-718Oral NMDA modulatorCognitive impairment linked with Alzheimer's (NCT04602624) & Parkinson's (NCT04476017), completion Jun 202138
Phase 1
Sage-904Oral NMDA modulatorNMDA hypofunction-
Sage-689Intramuscular Gaba A modulatorAcute Gaba hypofunction-
*Partnered with Biogen. Source: Evaluate Pharma & company presentations.

https://www.evaluate.com/vantage/articles/news/trial-results/sages-technical-tremor-win-fails-move

Evelo upped to Buy from Hold by Jefferies

 Target to $18 from $11

https://finviz.com/quote.ashx?t=EVLO

Bose Sleepbuds II Put You to Sleep Faster and Keep You Asleep Longer

 For many, sleep has been elusive this past year. Between the pressure of lockdowns, pandemic planning and home offices bursting with school and work, getting a good night’s rest has become something of a hardship. For us, insomnia has always been right around the bend, so we were intrigued by the Bose Sleepbuds II.

These comfortable, simple to insert earbuds were created specifically to help people sleep, by a company known for its audio prowess. Nope, you can’t stream music or podcasts. Only soothing sounds to help you relax and an alarm to get you up in the morning. Think of them as a personal, wearable sound machine you control with your phone. But do they really work? Here’s what you need to know.

Price and Availability: The Bose Sleepbuds II are available now for $249 at BoseAmazonBest Buy, and HSN.

Why We Chose It: Sleep is not our friend. In fact, we frequently use those hours lying awake to get some reading done or sometimes even work. So, when Bose announced a product which it claimed could clinically help you fall asleep faster, we were psyched to give it a try.

As the name suggests, the Bose Sleepbuds II are the second iteration of the product, the first being plagued with battery and Bluetooth issues. The newest Sleepbuds seem to have gotten past these problems, at least as far as we tested them.

Bose is known for its noise-canceling technology, which it uses so well in its QuietComfort line of headphones. So it makes sense that they would use this expertise to create a product that masks noise rather than just cancels it.

The SleepBuds come in a sleek, slide open battery case and pair with an app on your smartphone via Bluetooth. Once you set it up, you simply take the earbuds out of the case to connect them, then use the app to decide which type of sleep noise you want to listen to—if any—and at what volume. You can also choose to add an alarm as a wake-up call since you’ll be hard-pressed to hear anything externally.

The design makes for comfortable sleeping and comes with little wings to secure them, though you will have to get used to getting your Z’s with something jammed in your ears. They also come with several different sized silicone tips to make sure they won’t fall out during the night.

Why You Need It: Whether you’re like us, and have always had trouble sleeping, or the anxiety of a global pandemic has been keeping you awake, these Bose Sleepbuds II are quite the revelation.

Once we got the right fit for the tips and set the battery case up next to our bed, we were impressed with the comfort and how they truly masked the noise of snoring, sirens from the streets outside our Downtown Brooklyn apartment, and even video game noise from our teenagers who definitely stay up later than us most of the time.

The first few nights we actually didn’t bother with the different sounds and used them strictly as noise masking earplugs. But we soon felt the need to check out some of the nifty sounds on the app, which come in three categories: Noise Masking, Naturescapes and Tranquilities. It may be boring, but we really enjoyed listening to the rolling waves in Swell which was in the Noise Masking sounds, though if you’re a white noise fan, we thought Warm Static, Rinse and Rustle all fit the bill. The Tranquilities noises like Gilded Dream and Fabled reminded us too much of getting a massage, and the more consistent noise of the Naturescapes, like the pounding rain in Window Seat, were just a tad too aggressive for us. But to each their own.

The one thing we had to reconcile with was the idea that the Sleepbuds are easier to control if you have your phone next to your bed. That way, you can easily change the volume or even switch to a different sound at any time in the night. We have a strict rule of leaving our phone out of the bedroom, so instead we used the phone-free mode in the app and set-up a timer once we figured out how long we wanted to listen to our crashing waves (not all night it turns out).

Were we completely cured of insomnia? Not so much. But we definitely fell asleep quicker after waking up in the night.

What Others Are Saying: The folks at TechRadar share our view on comfort, and think Bose Sleepbuds II are designed for sleeping in. “Just when we thought they couldn’t get any better than the originals, the Sleepbuds 2 design offers even better ergonomics. They’re super lightweight and delicate and so go completely unnoticed in your ears. The new soft and springy silicon tips help here, adding an extra feeling of comfort in the ears. This is all packed up superbly in a sleek and minimal-looking anodized aluminum charging case.”

Cnet was also impressed with the sound masking and the alarm function. “You can program the Sleepbuds to play a soothing sound for a relatively short duration (30 or 60 minutes) or have it play for the whole night. It’s worth noting, too, that you can use the app to set an alarm that wakes only you and not your partner. That’s a thoughtful feature.”

 Final Conclusion: The Bose Sleepbuds II do exactly what they claim: help you fall asleep faster and stay asleep longer. There is a nice selection of different noises to choose from—though they also work sans audio if that floats your boat. The one caveat is the steep price of $249, but if you’re ready to change your sleeping patterns, the Bose Sleepbuds II are most definitely worth it.

https://decider.com/2021/04/10/bose-sleepbuds-ii-review/

AACR: 'Tissue agnostic' indication for Retevmo? Lilly says possible with RET cancer win

 Eli Lilly’s Retevmo is already approved to treat lung and thyroid cancers driven by alterations in the RET gene. Now, the Indianapolis pharma believes it has data to support an expansion into all cancers bearing that biomarker.

In a phase 1/2 study, Retevmo shrunk tumors in 47% of patients with RET fusion-positive cancers originating from different sites in the body other than the lung and the thyroid, Lilly reported at the American Association for Cancer Research annual meeting. After a median follow-up of 13 months, the drug was still spurring benefits in more than half of patients.

The company now plans to discuss the data with the FDA to see if they can potentially support a “tumor agnostic” nod that would allow Retevmo to treat all RET fusion-positive cancers regardless of their location, David Hyman, M.D., Lilly’s chief medical officer of oncology, said in an interview. But uncertainties remain as to whether the agency will buy into that notion.

The new data come from the phase 1/2 Libretto-001 trial, the same one that earned Retevmo its original go-ahead last May in non-small cell lung cancer and thyroid cancer with RET abnormalities. At that time, the data package included tumor shrinkage information for the drug in 144 NSCLC and 27 thyroid cancer patients with RET fusion-positive disease.

This time, the 47% tumor response rate was generated from just 32 patients spanning 12 unique cancer types with RET fusion, many of whom had exhausted treatment options. Over 60% of patients had treatment-resistant gastrointestinal cancers that typically don’t respond well to targeted therapy, Hyman pointed out. Of the 12 cancer subtypes, nine recorded confirmed responses. Question is, will the FDA allow a broad tumor-agnostic label based on such a small patient population?


RET cancers are rare, though occurring predominantly in NSCLC and thyroid cancers, according to a presentation of the study by Vivek Subbiah, M.D., from MD Anderson Cancer Center. The fact that the study only recruited such a small group of patients outside of NSCLC and thyroid cancer in about three years speaks to the scarcity of the genetic problem and the challenge of identifying patients, Hyman said.

The diversity of cancer types among people who are responding is encouraging, Hyman said. The “overall consistency of response,” in the context of Retevmo’s performance in RET fusion-positive lung and thyroid cancers, is “something we’re very pleased with in the regulatory context,” he said. As Hyman sees it, though three cancer subtypes didn’t record responders, the overall data showed that RET-driven cancers are “actionable” with Retevmo.

The study is still enrolling patients to better understand the efficacy profile for Retevmo in the broader range of RET cancers, Hyman added.

Retevmo was brought to Lilly through its acquisition of Loxo Oncology in early 2019. Loxo is plenty familiar with tissue-agnostic indications: It was the developer of Bayer’s Vitrakvi, the first targeted cancer therapy to get an FDA nod in a tissue-agnostic indication.


Lilly’s running the Libretto-431 and Libretto-531 trials to confirm Retevmo’s use in NSCLC and thyroid cancer. The NSCLC study pits Retevmo against chemotherapy with or without Merck’s PD-1 immunotherapy Keytruda. The thyroid study compares Retevmo with the combination of Exelixis’ Cabometyx and Sanofi’s Caprelsa.

Retevmo’s in-class rival, Roche and Blueprint Medicines’ Gavreto, is also undergoing phase 3 trials in thyroid and NSCLC.

In what Hyman described as an “aspirational” clinical trial, the company just launched the phase 3 Libretto-432 trial, testing whether the use of Retevmo after surgery or radiation could prevent early-stage RET fusion-positive NSCLC from returning.

https://www.fiercepharma.com/pharma/aacr-a-tissue-agnostic-indication-for-retevmo-lilly-says-it-s-possible-ret-cancer-win

Akari Therapeutics Announces Initiation of Pivotal Phase III Trial

 FDA investigational new drug application (IND) now open

Clinical sites expected to open for recruitment mid-2021

https://finance.yahoo.com/news/akari-therapeutics-announces-initiation-pivotal-141600807.html

VBI Vaccines: Phase 1b/2a Data, Progress of Hepatitis B Immunotherapeutic

 

  • Data from Phase 1b/2a study in chronic HBV patients show robust HBV specific T cell responses in ≥ 50% of evaluable patients across all study arms of VBI-2601 (BRII-179)

  • VBI-2601 (BRII-179) was well-tolerated with no safety signals observed at both low- and high-dose levels

  • Patient screening for the Phase 2 combination study of high-dose VBI-2601 (BRII-179) and BRII-835 (VIR-2218) initiated March 2021 – first patient first dose anticipated early Q2 2021