Device to Prevent Athletes' Brain Injury Wins FDA Nod

 

A simple-seeming neck collar can be marketed to prevent brain injury resulting from subconcussive head impacts in athletes, the FDA said Friday.

The Q-Collar is designed and sold by Q30 Innovations of Westport, Connecticut. It's a compressive device that fits around the sides and back of the neck. The idea behind it, according to Q30, is to squeeze the jugular veins in such a way as to produce "a temporary increase in intracranial blood volume." This, in turn, "results in an expansion of the venous structures within the skull," holding the brain "in a more stable state" that is less vulnerable to "sloshing" inside the skull as a result of impacts.

Repeated head blows that don't necessarily cause overt concussion have nevertheless been tied to long-term adverse neurological effects, including chronic traumatic encephalopathy or CTE.

The FDA based the authorization on multiple studies, including one conducted with a high school team that included 284 participants age 13 and older. About half the young athletes wore the collar in the open-label trial: MRI scans conducted at baseline and after a season of play showed that fewer of those who wore the collar developed significant white-matter changes, the FDA said in a news release.

Specifically, 73% of the no-collar control group showed white-matter alterations versus 23% of the players who wore the collar.

Q30 also worked with researchers at Cincinnati Children's Hospital, Walter Reed, and West Virginia University on published studies regarding the Q-Collar, according to the company's website -- studying populations of football, soccer, and hockey players. The evidence base in sum includes 15 peer-reviewed published studies.

The FDA is not authorizing the Q-Collar to prevent concussion or other serious brain injury, the agency noted, nor for those who have not been medically cleared to play contact sports.

The FDA encourages consumers to contact a medical professional to consult on whether wearing the Q-Collar could help "if a user is unsure."

"Today's action provides an additional piece of protective equipment athletes can wear when playing sports to help protect their brains from the effects of repetitive head impacts while still wearing the personal protective equipment associated with the sport," said Christopher M. Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health, in the agency's announcement.

The FDA reviewed the device through de novo premarket review, a regulatory pathway for new types of low- to moderate-risk devices.

Q30's chief medical advisor is Julian Bailes, MD, a neurosurgeon with NorthShore Medical Group (near Chicago), according to the Q30 site. Bailes is a long-time sports concussion researcher and team doctor with pro football's Pittsburgh Steelers, who was spotlighted in the 2015 movie "Concussion" (played by Alec Baldwin). Other Q30 advisors include Vernon Davis, a retired standout NFL tight end; Allison Kumar, a former FDA senior program manager; and Phil Phillips, a former FDA deputy director for medical devices.

The Q-Collar was previously OK'd for use in Canada and is now on sale there.

https://www.medpagetoday.com/sportsmedicine/generalsportsmedicine/91384

Novocure finds timing inopportune for Optune

 With its electrical field-emitting Optune device, Novocure has achieved something biotech has repeatedly failed to do: improve the survival of glioblastoma patients. A different version of the device, Optune Lua, is also approved for mesothelioma. Efforts to extend into other cancers, however, have hit a snag, with the company yesterday admitting that several clinical trial readouts would be delayed by Covid-19. Most important of these is Panova-3, the pivotal trial of Optune in pancreatic cancer, whose readout has been pushed back a year. The 14% fall in Novocure’s share price yesterday, though, was also to do with the glioblastoma indication. Medicare coverage for the use of Optune to treat the brain cancer had initially been denied; a reversal of this decision in 2019 has allowed Novocure to appeal previously denied claims, creating a backlog of payments and swelling the group’s top and bottom lines. This backlog has now been pretty much exhausted, so many analysts expect Novocure’s sales to grow much more slowly in the coming years. R&D expenses are also taking their toll, with the company sponsoring an astonishing 34 active clinical trials, 26 of which are in brain tumours. 

Selected upcoming Optune trial readouts
Trial	Details	N	Readout
Hepanova	Pilot ph2 in advanced liver cancer	25	Final data Q2 2021 (delayed from Q1)
Innovate-3	Pivotal ph3 in recurrent ovarian cancer	540	Interim data Q3 2021; final data 2023
Lunar	Pivotal ph3 in NSCLC	534	Interim data Q4 2021; final data 2023
EF-31	Pilot ph2 in gastric cancer	28	Final data 2022 (delayed from 2021)
Metis	Pivotal ph3 in brain mets from lung cancer	270	Final data 2022
EF-33	Pilot ph2 of high-intensity arrays in recurrent glioblastoma	25	Final data 2022
Panova-3	Pivotal ph3 in pancreatic cancer	556	Interim data 2022 (delayed from 2021); final data 2023
Source: EvaluateMedTech & company release. https://www.evaluate.com/vantage/articles/news/snippets/novocure-finds-timing-inopportune-optune

Dynavax's Q4 Results Show It's Not Just About Heplisav-B Anymore

 Dynavax Technologies (NASDAQ:DVAX) has been chock-full of good news so far this year. Earlier this month, the company announced plans to initiate a phase 2/3 clinical study of Clover Biopharmaceuticals' COVID-19 vaccine candidate with Dynavax's CpG 1018 adjuvant. The U.K. ordered an extra 40 million doses of another COVID vaccine that uses the company's adjuvant. And Dynavax won a $99 million deal with the Coalition for Epidemic Preparedness Innovations (CEPI) to supply CpG 1018.

You can now add even more good news to the list. Dynavax announced its fourth-quarter results after the market closed on Thursday. Here are the highlights from the company's Q4 update.

By the numbers

Dynavax reported revenue in the fourth quarter of $19.6 million. This reflected an 85% rise from the prior-year period revenue total of $10.6 million. It also trounced the Wall Street consensus estimate of $13.1 million.

The company announced a Q4 net loss of $15.5 million, or $0.14 per share, based on generally accepted accounting principles (GAAP). In the prior-year period, Dynavax posted a net loss of $36.8 million, or $0.44 per share. Analysts were expecting a Q4 net loss of $0.24 per share.

Dynavax ended the fourth quarter with cash, cash equivalents, and marketable securities of $165 million. The company's cash position stood at $151 million as of Dec. 31, 2019.

Behind the numbers

Hepatitis B virus (HBV) vaccine Heplisav-B continued to pick up momentum in the fourth quarter. Dynavax reported sales for the vaccine of $11.5 million, an 8.5% year-over-year increase. The company said that its market share in targeted accounts jumped to 26% in Q4 from 20% in the prior-year period.

Dynavax's vaccine adjuvant CpG 1018 also contributed to its revenue growth. The biotech recorded net revenue of $1.6 million in the fourth quarter from the adjuvant, compared to no revenue for CpG 1018 in the Q4 of 2019.

However, the company's biggest growth driver in the fourth quarter came from its collaborations. Other revenue totaled $6.4 million in Q4. In the prior-year period, Dynavax's other revenue was only $12,000.

Dynavax's bottom line improved in part because of its solid revenue growth. The company also spent significantly less in the fourth quarter, compared to the same period in 2019. Research and development expenses fell 23% to $9.5 million. Selling, general, and administrative expenses decreased 12% to $17.8 million.  

Looking ahead

The biotech stock should have several potential catalysts ahead. A final report from the post-market study of Heplisav-B should be on the way in Q2. Dynavax's collaboration partners using CpG 1018 should announce data readouts throughout the year. The company expects to report results from its phase 1 study of an experimental Tdap (tetanus, diphtheria, and pertussis) vaccine with CpG 1018 as an adjuvant in Q4. 

CpG 1018 seems likely to play an increasingly important role in Dynavax's future. CEO Ryan Spencer stated that the adjuvant "could be utilized in up to 500 million to 1.5 billion doses of vaccine annually starting in 2022, with additional capacity expansion available depending on global demand."

Heplisav-B will remain key to the company's fortunes, as well. Dynavax recently received approval from the European Commission for the HBV vaccine and plans to launch it in Europe beginning in the fourth quarter of 2021.

https://www.fool.com/investing/2021/02/26/dynavaxs-q4-results-show-its-not-just-about-heplis/

FDA panel unanimously recommends third Covid vaccine as J&J wins key vote

 A key Food and Drug Administration advisory panel on Friday unanimously backed Johnson & Johnson’s single-shot coronavirus vaccine for emergency use, a critical step paving the way to distribute a third preventative treatment in the U.S. next week.

The nonbinding decision, which was adopted 22-0, by the FDA’s Vaccines and Related Biological Products Advisory Committee comes as the Biden administration works to ramp up the supply of vaccine doses and get Americans vaccinated as quickly as possible. U.S. health officials are growing concerned about new, emerging variants of the virus, particularly the B.1.351 strain from South Africa, which has been shown to reduce the effectiveness of the vaccines that are both on the market and under development. 

The head of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, warned earlier Friday that the declines in Covid-19 cases reported in the U.S. since early January may now be flattening as variants continue to spread.

“Over the last few weeks, cases and hospital admissions in the United States have been coming down since early January and deaths have been declining in the past week,” Walensky said during a White House news briefing. “But the latest data suggest that these declines may be stalling, potentially levelling off at still a very high number.”

Scaling-up vaccinations could help blunt the impact of the highly contagious variants, Adam MacNeil, an epidemiologist at the CDC, said during a presentation Friday before the vote. He added that the U.S. “nowhere close” to herd immunity, but vaccinations could help in “moving us closer to filling the herd immunity gap.”

The FDA advisory committee plays a key role in approving flu and other vaccines in the U.S., verifying the shots are safe for public use. While the FDA doesn’t have to follow the advisory committee’s recommendation, it often does. During similar requests by Pfizer and Moderna, the FDA authorized those companies’ vaccinations a day after the committee backed emergency use authorization. If J&J’s follows the pattern, a third vaccine could be authorized on Saturday.

Initially, doses would be limited. The U.S. plans to ship 3 million to 4 million doses of J&J’s vaccine to states, pharmacies and community health centers next week, pending FDA authorization, Jeff Zients, President Joe Biden’s Covid czar, told reporters on Wednesday. The company expects to deliver 20 million doses by the end of March, J&J’s vice president of U.S. medical affairs, Dr. Richard Nettles, told House lawmakers on Tuesday. J&J has a deal with the U.S. government to supply 100 million doses of its vaccine by the end of June.

Federal and state health officials have been eagerly awaiting the authorization of J&J’s vaccine. Unlike Pfizer’s and Moderna’s vaccines, which require two doses given three to four weeks apart, J&J’s requires only one dose, easing logistics for health-care providers. J&J’s vaccine can also be stored at refrigerator temperatures for months, unlike the two other vaccines that have to be stored at sub-zero temperatures.

J&J’s one-dose vaccine “makes it operationally easier in lots of contexts,” Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, told the Journal of the American Medical Association during a Q&A event on Friday. “I expect lots of considerations state health departments are having around these vaccines is more about the ease of use of the J&J vaccine and how it might be better suited for some populations.”

An EUA means the FDA will allow some people to receive the vaccine as the agency continues to evaluate data. It isn’t the same as full approval, which requires more data and can typically take several months longer. J&J, like Pfizer and Moderna, has submitted only two months of safety data, but the agency usually requires six months for full approval. The company is asking the FDA to approve the use of the vaccine in people age 18 and older.

J&J submitted its Covid vaccine data to the FDA on Feb. 4. The vaccine’s level of protection varied by region, J&J said, with the shot demonstrating 66% effectiveness overall, 72% in the United States, 66% in Latin America and 57% in South Africa, where the B.1.351 variant is rapidly spreading. However, FDA staff documents show the vaccine was 64% effective in South Africa after about a month. The company said the vaccine prevented 100% of hospitalizations and deaths.

The FDA has indicated it would authorize a Covid-19 vaccine that’s safe and at least 50% effective. The flu vaccine, by comparison, generally reduces people’s risk of getting influenza by 40% to 60% compared with people who aren’t inoculated, according to the CDC.

FDA staff endorsed J&J’s vaccine on Wednesday, saying in documents that the clinical trial results and safety data were “consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19.”

No specific safety concerns of the vaccine were identified when analyzed by age, race and comorbidities, according to the FDA report. Headaches, fatigue and muscle pain were some of the most common side effects among people who received the inoculation, the report said. There were also reports of nausea, fever and pain at the injection site. 

Macaya Douoguih, head of clinical development and medical affairs for J&J’s vaccines division Janssen, told the FDA panel on Friday that two people suffered severe allergic reactions shortly after getting the vaccine. One of the people was participating in an ongoing trial in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction.

The FDA report said there were some Bell’s palsy cases, a condition that causes half of your face to droop, but they were “balanced” with the number generally found in the overall population. The FDA had previously said the condition would be monitored among recipients of vaccines after it was flagged as a potential concern with Pfizer’s shots, noting that it’s not necessarily a side effect but is worth watching out for.

https://www.cnbc.com/2021/02/26/johnson-and-johnson-covid-vaccine-fda-panel-recommends-emergency-use.html

Harbert Discovery Fund Letter to the Independent Directors of Enzo Biochem

 BIRMINGHAM, Ala., Feb. 26, 2021 

Enzo Biochem, Inc.

Dr. Mary Tagliaferri, Director
Dr. Ian Walters, Director
Rebecca Fischer, Director
Dov Perlysky, Director
60 Executive Boulevard
Farmingdale, NY 11735
  
Independent Directors of the Board,

It has been over 50 days since a majority of the shareholders of Enzo Biochem Inc. (“Enzo” or the “Company”) voted against Dr. Rabbani’s re-election to the Board of Directors (the “Board”) causing him to tender his resignation as Chairman of the Board. Since the annual meeting, additional evidence against Dr. Rabbani has emerged. Even before this evidence, the case to accept his resignation was incontrovertible. We urge you to immediately accept his resignation from the Board, replace him as CEO, and turn to your duty of creating value for all shareholders.

On February 3, 2021, Enzo announced the issuance of a new patent. The Company did not disclose that one of the Inventors listed on the patent was Joshua Rabbani. According to a New York Times obituary for Benjamin Greenberg from December 9, 1997, Joshua Rabbani is Elazar Rabbani’s son. Joshua Rabbani is listed as an inventor on 18 Enzo patents going back to a first filing date of August 24, 2010. Despite SEC disclosure requirements and what appear to be years of related party transactions, there is no mention of any related party transaction with Joshua Rabbani in any of Enzo’s public filings. We sent four separate emails to the Independent Directors on this topic over the last several weeks and have not received a response. As we stated via email, these transactions should have been reviewed by the Governance Committee, the Audit Committee, and the external Auditors. So, it should be fairly easy to provide an explanation. Perhaps there is a simple one?

Alternatively, perhaps this apparent undisclosed related party transaction has been in place for many years, and is consistent with Dr. Rabbani’s long history of seeming complete disregard for the interests of shareholders, the owners of the business. Perhaps Dr. Rabbani is so intent on maintaining control of Enzo because there are benefits he and his family members receive that go well beyond what has been disclosed to shareholders.

We continue to believe that Enzo would be worth significantly more in a sale than where it is currently valued. We fear that Dr. Rabbani is currently or will attempt to thwart any attempts at a genuine strategic alternatives process. Shareholders have clearly and overwhelmingly stated they do not trust Dr. Rabbani’s judgement or leadership. He is conflicted and should recuse himself from any discussions with respect to strategic alternatives. If the Board has not already done so, the Board should immediately form a special committee and enter into discussions with potential acquirers.

As we stated previously, we are happy to consider a longer-term value creation plan under a new leadership team with a proven history of success. Dr. Rabbani, however, has proven incapable of creating shareholder value throughout his excessively long tenure. Even ignoring the potential undisclosed related party transactions there is no reasonable justification for refusing to accept his resignation.

The appropriate path forward is clear. Immediately accept Dr. Rabbani’s resignation and engage with the interested acquirer(s) in order to determine whether the price they are willing to pay today is greater than the risk adjusted present value that can be realized over time under a new leadership team.

Sincerely,

Harbert Discovery Fund, LP
Harbert Discovery Co-Investment Fund I, LP

Kenan Lucas, Managing Director and Portfolio Manager of Harbert Discovery Fund GP, LLC and Harbert Discovery Co-Investment Fund I GP, LLC

https://www.globenewswire.com/news-release/2021/02/26/2183639/0/en/Harbert-Discovery-Fund-Issues-Letter-to-the-Independent-Directors-of-Enzo-Biochem-Inc-February-26-2021.html

Sensus Health upped to Outperform by Northland

From Market Perform.

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

Bots hyped up GameStop on major social media platforms: cybersecurity firm

 Bots on major social media platforms have been hyping up GameStop Corp and other “meme” stocks, according to an analysis by Massachusetts-based cyber security company PiiQ Media, suggesting organized economic or foreign actors may have played a role in the Reddit-driven trading frenzy.

Shares of GameStop soared last month after Reddit users banded together to squeeze hedge funds that had bet against the video game retailer and other companies. Reddit Chief Executive Steve Huffman told Congress this month that bots, artificial or fake accounts with automated content, had not played a “significant role” in GameStop Reddit message traffic.

PiiQ Media’s analysis of Twitter Inc, Facebook Inc, Instagram and YouTube posts, however, found that bots used the platforms to push GameStop and other “meme” stocks, although it is unclear how influential they were in the overall saga.

A startup that focuses on social media risks, PiiQ said it examined patterns of keywords such as “Hold the Line” and GameStop’s stock symbol, “GME,” across conversations and profiles prior to the Jan. 28 frenzy, through Feb. 18. For comparison, it also assessed posts on an unrelated set of stocks.

PiiQ said it identified very similar daily “start and stop patterns” in the GameStop-related posts, with activity starting at the beginning of the trading day, followed by a large spike at the end of the trading day. Such patterns are indicative of bots, said Aaron Barr, co-founder and chief technology officer of PiiQ.

“We saw clear patterns of artificial behavior across the other four social media platforms. When you think of organic content, it’s variable in the day, variable day-to-day. It doesn’t have the exact same pattern every day for a month,” he said.

Based on its authenticity scoring system, PiiQ estimates there are tens of thousands of bot accounts hyping GameStop, the meme stocks, and Dogecoin, a cryptocurrency swept up in the frenzy. Thousands of fake accounts can be purchased for as little as $200, it said.

The company did not analyze Reddit data, but Barr said he would expect to see a similar pattern of activity on Reddit, indicating bot-like or coordinated management of conversations.

A representative for Reddit did not comment beyond Huffman’s testimony. Representatives for YouTube, Facebook and its Instagram subsidiary did not respond to requests for comment. The social media platforms generally try to weed out harmful bots, said Barr.

A representative of Twitter said “bots” had become a catch-all term that can often mischaracterize the nature of the account. The company notes bots can be used on its platform for creative or innovative purposes.

The U.S. Securities and Exchange Commission (SEC) is probing the GameStop saga and on Friday suspended trading in 15 companies due to unusual trading activity and apparent attempts on social media to artificially inflate their stock prices. That is in addition to six stocks it recently suspended due to suspicious social media activity.

“We proactively monitor for suspicious trading activity tied to stock promotions on social media, and act quickly to stop that trading,” the SEC’s acting enforcement director, Melissa Hodgman, said in a statement on Friday.

In addition to traders, organized criminals may use social media to stoke asset prices, and undermining the integrity of U.S. markets is a known goal of hostile state actors, said Barr. But it is unclear how successful, if at all, these types of influence efforts are, he said.

“Measuring the effect of those campaigns is often illusive.”

https://www.reuters.com/article/retail-trading-gamestop-robots/update-1-bots-hyped-up-gamestop-on-major-social-media-platforms-analysis-finds-idUSL1N2KW2TW