Brooklyn ImmunoTherapeutics To Acquire License for mRNA Technology Platform

 Brooklyn ImmunoTherapeutics, Inc. (NYSE American: BTX) ("Brooklyn"), a biopharmaceutical company focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, today announced it has paid $1 million towards the acquisition of a license for Factor Bioscience’s and Novellus’ mRNA Gene Editing and Cell Therapies technology and has extended through May 21, 2021 its option exercise period for entering into a related license agreement with Factor Bioscience and Novellus.

If a license agreement is completed, it would allow Brooklyn to utilize an extensively patented process to seek to develop gene edited compounds using mRNA, which preclinical data suggest to be more efficient, non-immunogenic and non-mutagenic, for treatment of several solid tumor and liquid indications, sickle cell anemia, as well as a number of additional inherited disorders. Gene editing is an investigational technique that is used to add, delete, or correct a patient’s genetic material in an effort to treat a disease. Research suggests that editing genes in patients could potentially result in cures for a number of genetic diseases. The licensed platform would include mRNA cell reprogramming, mRNA-based gene editing, a proprietary gene editing protein, and the proprietary ToRNAdo lipid delivery system that provides efficient delivery of mRNA ex vivo and in vivo to skin, brain, eye and lung tissue.

If Brooklyn does not enter into the license agreement by May 21, 2021, it will be entitled to be reimbursed for the $1 million payment.

https://www.businesswire.com/news/home/20210415005935/en/Brooklyn-ImmunoTherapeutics-Pays-1-Million-Towards-Acquisition-of-License-for-mRNA-Technology-Platform-to-Develop-Genetically-Edited-Cells-for-Multiple-Cancers-and-Blood-Disorders

Biogen Grows Presence in China with Approval of TECFIDERA for MS

 

• TECFIDERA was approved under the National Medical Products Administration priority review process evaluating therapies with urgent clinical needs

• More than 500,000 individuals worldwide living with multiple sclerosis (MS) have been treated with TECFIDERA, which has a well-established safety and efficacy profile

• Biogen’s expansion in China now includes treatment options approved for relapsing MS and spinal muscular atrophy

https://finance.yahoo.com/news/biogen-grows-presence-china-approval-203000380.html

2 Best Reddit Healthcare Stocks

 Over the past quarter, traders of the legendary r/WallStreetBets have propelled shares of GameStop, AMC Entertainment Holdings, and BlackBerry to some mouth-watering (albeit roller-coaster-like) returns. The same group of investors is now eyeing two medical stocks, Trevena (NASDAQ:TRVN) and Tonix Pharmaceuticals (NASDAQ:TNXP).

The two firms are identical in that they rely almost entirely on the success of one drug in their respective pipelines. Betting on the future of one product is always risky, but it has its upside as well. Trevena and Tonix stocks are up almost 250% and 55%, respectively, over the past 12 months. Let's look at how they can further enrich investors. 

1. Trevena

Right now, Trevena has no product revenue and a quarterly net loss of $11.9 million per quarter, but a market cap of $283 million. What gives? 

As investors know, a company's valuation isn't only about how much cash flow it generates, but also about future earnings potential based on its assets -- and Trevena is eyeing up a $1.5 billion market opportunity. Last year, the company secured regulatory approval of its drug, Olinvyk, for the treatment of acute pain in hospital and controlled clinical setting. It launched the opioid for use in the first quarter of 2021 for $17.50 per milligram (mg).

The company plans to target 9 million surgical procedures with its medication out of 45 million operations each year in the U.S. Compared to traditional opioids, like intravenous (IV) morphine, Olinvyk offers slightly less analgesia but a much better safety profile. Patients are far less likely to suffer from nausea, vomiting, dizziness, and critical respiratory events after receiving Olinvyk instead of IV morphine. 

Based on its list price and safety benefits, Trevena thinks it can help hospitals achieve 10 times in medical savings by switching from IV morphine to its new branded opioid. In a recent survey (conducted by Trevena), 75% of pharmacists and physicians found Olinvyk's study results meaningful. In other words, they saw clinical and safety benefits in the drug's respiratory and gastrointestinal profiles. While it scales up, the company has more than $100 million in cash and equivalents on its balance sheet and is well funded through the end of 2022. Trevena is a great under-the-radar stock by the merit of this new drug. 

2. Tonix Pharmaceuticals 

Tonix Pharmaceuticals is a $382 million market cap company with a $17 million quarterly net loss and no revenue. Its intangible asset, TNX-102 SL (sublingual cyclobenzaprine), which is being studied for the management of fibromyalgia, is what's backing up the current share price. Tonix is well positioned to capitalize off the $764.1 million market to treat the condition.

Fibromyalgia is a chronic condition that affects 2% to 4% of the U.S. population. It causes recurring pain, sleep disturbances, fatigue, and cognitive symptoms. There is currently no cure for the disease. 

In phase 3 clinical trials, patients who took TNX-102 SL saw their pain symptoms decrease by 1.9 from baseline on the Daily Numeric Pain Rating Scale (NPRS). Patients who received a placebo had a 1.5-point baseline decrease in their pain symptoms. The difference of 0.4 was small, but highly statistically significant. However, an endpoint measuring patients' overall impression of change compared to the placebo cohort was not met, albeit by a slim margin.

Although the results might not seem very all that impressive at first glance, keep in mind that fibromyalgia has always been a challenging condition to treat. Patients with fibromyalgia frequently take two or three medications simultaneously to manage their pain, with 50% discontinuing one course of therapy in 12 months. The last medication approved to treat fibromyalgia, AbbVie's (NYSE:ABBV) Savella, still managed to hit $130 million in peak sales despite only marginally improving patients' condition. 

That's not all: Tonix is also exploring TNX-102 SL for treating post-traumatic stress disorder, agitation in Alzheimer's disease, and alcohol use disorder. Aside from that, the company also has TNX-1300 in phase 2 for treating cocaine intoxication. Tonix also has a variety of preclinical programs in the works targeting COVID-19. I'd highly recommend healthcare investors with a healthy appetite for risk add this one to their watch lists.

https://www.fool.com/investing/2021/04/15/2-best-reddit-healthcare-stocks-to-buy-now/

Stanford enrolls children as young as 2 in Pfizer vaccine trials

 Stanford Medicine on Wednesday began administering shots to children ages 2 to 5 in a trial for the Pfizer coronavirus vaccine, marking another step forward in getting younger children vaccinated.

Stanford’s trial is part of a larger, nationwide Pfizer study that is testing the vaccine in children as young as 6 months old. The advancement of pediatric vaccine trials is important because even though children are at lower risk than adults of developing severe disease and dying from COVID-19, many have nonetheless fallen ill and died. It will also be critical to inoculate children in order to reach higher immunity levels in the overall population, since they can spread the virus to others even if they themselves do not become ill.

“We need to make sure that children are protected,” said Dr. Yvonne Maldonado, a pediatric infectious diseases expert who is leading the trial at Stanford. “There’s been over 3 million children infected, thousands hospitalized and almost 300 deaths. Even though it’s not the half a million-plus adult deaths we’ve seen, we’ve seen an impact in children and we want to make sure they’re protected. And they can transmit to others so we want to make sure they can protect the community as well.”

About 3.5 million children in the United States have been infected with COVID-19, representing about 13.5% of overall U.S. cases, according to the American Academy of Pediatrics. And 347 children have died, representing less than 1% of overall U.S. COVID-19 deaths.

Coronavirus vaccines are slated to be tested, authorized and rolled out in descending order by age. Currently, the Pfizer vaccine can be given to people as young as 16, and the Moderna and Johnson & Johnson vaccines can be given to people as young as 18. Younger groups are expected to come next, starting with adolescents and younger teens, followed by children, toddlers and babies as young as 6 months old.

Pfizer last week applied for Food and Drug Administration authorization for its vaccine to be used in youths ages 12 to 15, after clinical trial data showed it is 100% effective at preventing COVID-19 symptoms in that age group. The FDA could authorize that soon, and vaccines could start being administered to that age group by summer. Locally, Kaiser Permanente was part of that trial, enrolling teens in Santa Clara as well as in Sacramento.

Results for Pfizer’s trial for people under 12 are expected the second half of this year.

Stanford is one of five U.S. sites enrolling children in Pfizer pediatric trials for children younger than 5, and the only one on the West Coast. On Wednesday, Stanford researchers gave one of their first shots to children in this age group to Eloise LaCour of Alameda, who is 3.

Eloise’s parents, Angelica and Chris LaCour, said they enrolled their daughter in the trial to help protect her, as well as to advance scientific understanding of the vaccine in kids so other kids can get vaccinated soon. Angelica LaCour has gotten the Pfizer vaccination herself and felt comfortable with her daughter getting it as well.

https://www.sfchronicle.com/health/article/Stanford-enrolls-children-as-young-as-two-in-16101721.php

If you got the J&J vaccine, here's what you should do now

 About 6.8 million Americans have received the Johnson & Johnson COVID-19 vaccine, which federal health officials on Tuesday asked states to pause after six women in the U.S. developed serious blood clots within about two weeks of their vaccinations.

“It’s an exceedingly rare side effect. But a very concerning one,” said Dr. Warner Greene, a senior investigator with the Gladstone Institutes in San Francisco. Greene and other vaccine experts added that the benefits of the Johnson & Johnson shot almost certainly still outweigh the rare risk of a blood clot or stroke.

Gov. Gavin Newsom said that “out of an abundance of caution” California would follow the recommendation by CDC and FDA officials. The single-dose Johnson & Johnson vaccine has been accounting for a steadily greater share of California’s fully completed coronavirus vaccinations — about 10% of a total of 8.5 million so far, up from 2% on March 15, according to the Los Angeles Times coronavirus tracker. Pfizer accounts for 48% and Moderna for 41%.

Federal health officials said in a briefing Tuesday that for those who received the Johnson & Johnson vaccine more than a month ago, the risk of severe complications is very low. However, they said those vaccinated within the last three weeks should be aware to look for the following symptoms:

• Severe headaches

• Abdominal pain

• Leg pain

• Shortness of breath

If any of those symptoms occur, they should contact a health provider and seek assistance.

https://www.sfchronicle.com/local/article/If-you-got-the-J-J-vaccine-here-s-what-experts-16097628.php

Sununu to Lift All New Hampshire COVID Restrictions

 New Hampshire could be the first state in New England to lift all of its coronavirus restrictions, with the mask mandate the first to go.  

Gov. Chris Sununu indicated that most of the state’s restrictions would be lifted "wicked soon," long before Memorial Day, during a virtual business meeting Wednesday. 

Sununu predicted a very low case count by June, citing a lower death rate due to vaccinations protecting the most vulnerable.

He said his first repeal would be the mask mandate. New Hampshire would be the first state in New England to do so.

“[That] will be ending very, very, very, very soon. We’re there, we’re really there." Sununu said. "I can’t tell you exactly what date it’s going to be, but I think the term we use in New Hampshire is wicked soon. Wicked soon.”

Sununu is scheduled to provide his weekly coronavirus update at 3 p.m. Thursday.

Meanwhile, New Hampshire will begin vaccinating people from out of state Monday.

Sununu had faced some criticism from Democrats and officials in college communities over the state’s initial decision to prohibit college students from other states other non-residents from being vaccinated in New Hampshire. But that restriction is being lifted because the state anticipates having plenty of doses to go around.

Nearly 90,000 people have tested positive for the virus in New Hampshire, including 412 cases announced Wednesday. Four new deaths were announced, bringing the total to 1,261 in the state.

The seven-day rolling average of daily new cases in New Hampshire has risen over the past two weeks from 369 new cases per day on March 29 to 441 new cases per day on Monday.

https://www.nbcboston.com/news/local/new-hampshire-to-lift-covid-restrictions/2355521/

Pfizer CEO says third Covid vaccine dose likely needed within 12 months

 Pfizer CEO Albert Bourla said people will “likely” need a booster dose of a Covid-19 vaccine within 12 months of getting fully vaccinated. His comments were made public Thursday but were taped April 1.

He also said it’s possible people will need to get vaccinated against the virus annually.

“It is extremely important to suppress the pool of people that can be susceptible to the virus,” he told CNBC’s Bertha Coombs during an event with CVS Health. He added the vaccines will be an important tool in the fight against highly contagious variants.

The comment comes after Johnson & Johnson CEO Alex Gorsky told CNBC in February that people may need to get vaccinated against Covid-19 annually, just like seasonal flu shots.

Researchers still don’t know how long protection against the virus lasts once someone has been fully vaccinated.

Pfizer said earlier this month its Covid-19 vaccine was more than 91% effective at protecting against Covid and more than 95% effective against severe disease up to six months after the second dose. Moderna’s vaccine, which uses technology similar to Pfizer’s, was also shown to be highly effective at six months.

Pfizer’s data was based on more than 12,000 vaccinated participants. However, researchers say more data is still needed to determine whether protection lasts after six months.

Earlier Thursday, the Biden administration’s Covid response chief science officer David Kessler said Americans should expect to receive booster shots to protect against coronavirus variants.

Kessler told U.S. lawmakers that currently authorized vaccines are highly protective but noted new variants could “challenge” the effectiveness of the shots.

“We don’t know everything at this moment,” he told the House Select Subcommittee on the Coronavirus Crisis.

“We are studying the durability of the antibody response,” he said. “It seems strong but there is some waning of that and no doubt the variants challenge ... they make these vaccines work harder. So I think for planning purposes, planning purposes only, I think we should expect that we may have to boost.”

In February, Pfizer and BioNTech said they were testing a third dose of their Covid-19 vaccine to better understand the immune response against new variants of the virus.

Late last month, the National Institutes of Health started testing a new vaccine from Moderna designed to protect against a problematic variant first found in South Africa.

Moderna CEO Stephane Bancel told CNBC on Wednesday that the company hopes to have a booster shot for its two-dose vaccine available in the fall.

https://www.cnbc.com/2021/04/15/pfizer-ceo-says-third-covid-vaccine-dose-likely-needed-within-12-months.html