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>>> BioNTech alone could lift German economy by 0.5% this year
Reuters
August 10, 2021
https://finance.yahoo.com/news/1-biontech-alone-could-lift-124733103.html
BERLIN, Aug 10 (Reuters) - The development and domestic production of a groundbreaking COVID-19 vaccine by German start-up BioNTech could boost economic growth in Europe's largest economy by up to 0.5 percentage points this year, an economist said on Tuesday.
The German economy is seen growing by roughly 4% this year following a pandemic-related plunge by 4.6% last year. This means that BionTech and its breakthrough development of a coronavirus vaccine based on mRNA technology could account for roughly an eighth of overall GDP growth in 2021, based on estimates by Sebastian Dullien, head of think tank the Macroeconomic Policy Institute (IMK).
"I can't think of another example in which a single company had such an impact on German GDP," Dullien told Reuters.
A government official said it was absolutely plausible to assume that the BioNTech effect on overall economic growth would easily reach up to 0.5 percentage points this year.
Dullien said that as a macro economist, he normally does not look at individual companies. "Sometimes, however, there are rare cases in which individual companies have macroeconomic relevance. BioNTech is such a rare example," Dullien said.
His calculations are based on BioNTech's latest earnings released on Monday which showed the start-up now expects to accrue 15.9 billion euros ($18.63 billion) in revenue from the vaccine this year, up from an earlier estimate of 12.4 billion euros.
That is roughly 0.5% of German GDP, Dullien said. In 2020, Germany's gross domestic product stood at about 3.3 trillion euros.
"Since BioNTech procures relatively few preliminary products from abroad, this is almost entirely domestic added value," Dullien said. "So this has a direct impact on economic growth."
In contrast to Germany's big car companies that produce many vehicles outside the country, BioNTech is producing its vaccine in a factory in Marburg, in western Germany. In addition, it receives licensing fees from its U.S. partner Pfizer.
BioNTech and Pfizer got the world's first approval for a COVID-19 vaccine at the end of 2020. "The success of BioNTech is impressive," Dullien said. "There is an excellent research landscape in Germany that has potential for the future."
ING Bank economist Carsten Brzeski also said Dullien's calculation was plausible, adding that BioNTech's success story was simply extraordinary.
"There aren't many companies that can go from zero to a hundred in just a year," Brzeski said.
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>> who can you trust <<
Yes, the mainstream media is clearly untrustworthy, as are most government related institutions, private corporations, NGO related entities, etc. Many of the larger 'alt' media sources are also not trustworthy, and most smaller players/bloggers are just as 'in the dark' as everyone else.
So we bumble along with limited real info, while being bombarded with endless streams of mis-info and dis-info. After a while you just say screw it, life is too short. But now events are too big to ignore. In addition to this 'forever virus', how long before the economy and financial system finally come unglued for good? It's only being kept alive by continuous $ trillion infusions of new debt. The dollar reserve system is nearing the end of its useful life, to be replaced by a new paradigm.
>> You roll the dice either way <<
That sums it up pretty well. Personally, I don't believe the official side effect or efficacy statistics because, face it, these institutions routinely lie. Luckily I can stay away from indoor crowds, and use a KN-95 mask when going into a store, which is rare. But working people with families, they're stuck between a rock/hard place. I try to stay healthy, good diet, vitamins, etc. A strong immune system is still the best defense against illness.
Covid is almost certainly a souped up lab creation, made more virulent and contagious, which changes the equation. But vaccines, forget it. I remember the Swine Flu fiasco in the mid-1970's, the contaminated polio vaccines of the 1950s (contaminated with SV-40, a cancer virus), the first Hep-B vaccine (pre-Recombivax), contaminated with HIV, and the dubious Anthrax vaccines given to the US military. So excuse me for being a skeptic.
SV-40 - https://en.wikipedia.org/wiki/SV40
HIV in first Hep-B vaccine - https://pubmed.ncbi.nlm.nih.gov/3016352/
Polio, hepatitis B and AIDS: an integrative theory on a possible vaccine induced pandemic - https://pubmed.ncbi.nlm.nih.gov/11388787/
There have been less than .1% near term serious side effects reported for the mRNA vaccines and those effects are transient...not permanent.
Based on the MOA of mRNA the chances of long term side effects are next to zero IMO. The mRNA does it's job in a few days then disappears. That's a fact. There have been no blood clotting issues reported with the mRNA vaccines. The blood clotting problems are associated with the J&J and AstraZeneca vaccines which are not mRNA.
You are deathly afraid of some unknown or some side effect with very low odds of happening when the odds of contracting COVID or dying of COVID are exponentially higher. You worry about long term side effects of the vaccine with zero supporting evidence when you should be worried about long term COVID complications of which there is a mountain of evidence.
The vaccine may not protect you 100% from the Delta variant but data so far shows that if you are vaccinated and contract the Delta the infection will be much milder and your chances of hospitalization or death are minimal compared to contracting Delta while unvaccinated.
You roll the dice either way. Getting vaccinated is a no-brainer to me. Your odds of dying or serious illness are exponentially higher if you remain unvaccinated.
Biocqr, Yes, but to find out if a specific drug or vaccine works as designed, and determine its safety/side effects, requires the full animal and human testing process, and this wasn't done with these vaccines. They rushed them out without full testing.
Then in May, the CDC stopped even looking for side effects or efficacy among the vaccinated (article below), just as they (CDC) were removing the mask and distancing recommendations. Now it turns out vaccinated people can harbor just as much virus and be just as contagious as the non-vaxed. We already knew about the blood clots associated with the vaccines, and there are credible reports that the spike protein cleaves off and bioaccumulates in the brain and organs, and is itself cytotoxic.
With all the confusion and conflicting narratives, the public is faced with - 1) an engineered virus, or 2) an engineered virus plus an engineered vaccine. It's a dilemma, the vaccine may no longer work that well on the variants, and may have serious near term side effects along with unknown longer term effects.
Fwiw, I'll always remain a skeptic when it comes to Big Pharma, FDA, CDC, NIH since there are many sound reasons to distrust these institutions.
>>> CDC Scaled Back Hunt for Breakthrough Cases Just as the Delta Variant Grew
Bloomberg identified more than 100,000 vaccine breakthroughs
Bloomberg
By Drew Armstrong, Rebecca Torrence, and Fiona Rutherford
July 30, 2021
https://www.bloomberg.com/news/articles/2021-07-30/cdc-scaled-back-hunt-for-breakthrough-cases-just-as-the-delta-variant-grew
The U.S. agency leading the fight against Covid-19 gave up a crucial surveillance tool tracking the effectiveness of vaccines just as a troublesome new variant of the virus was emerging.
While the Centers for Disease Control and Prevention stopped comprehensively tracking what are known as vaccine breakthrough cases in May, the consequences of that choice are only now beginning to show.
At the time, the agency had identified only 10,262 cases across the U.S. where a fully vaccinated person had tested positive for Covid. Most people who got infected after vaccination showed few symptoms, and appeared to be at low risk of infecting others.
But in the months since, the number of vaccine breakthrough cases has grown, as has the risk that they present. And while the CDC has stopped tracking such cases, many states have not. Bloomberg gathered data from 35 states and identified 111,748 vaccine breakthrough cases through the end of July, more than 10 times the CDC’s end-of-April tally...
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Full article -
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165209093
Event 201 - US Coronavirus exercise Oct 18, 2019 -
https://en.wikipedia.org/wiki/Johns_Hopkins_Center_for_Health_Security#Event_201
Event 201
On October 18, 2019, the CHS partnered with the World Economic Forum and the Bill and Melinda Gates Foundation to host the tabletop exercise Event 201 in New York City.[29] According to the CHS, "[t]he exercise illustrated areas where public/private partnerships will be necessary during the response to a severe pandemic in order to diminish large-scale economic and societal consequences".[29]
Event 201 simulated the effects of a fictional coronavirus originating in bats but passing to humans via pigs.[30] Claims that Event 201 was a rehearsal for the world's response to COVID-19 have been declared invalid by fact-checking outlets such as USA Today and FullFact. [30][31]
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>>> Congress is investigating whether the 2019 Military World Games in Wuhan was a covid-19 super-spreader event
The Washington Post
by Josh Rogin
June 23, 2021
https://www.washingtonpost.com/opinions/2021/06/23/congress-wuhan-military-games-2019-covid/
In October 2019, more than 9,000 international athletes from more than 100 countries traveled to Wuhan, China — and many of them later got sick with covid-19-like symptoms. But there has never been a real investigation into whether the virus that causes covid-19 was already spreading at the Wuhan Military World Games. Now, multiple U.S. lawmakers are demanding the U.S. government begin one.
... The State Department’s only consideration of the Wuhan Military World Games came when the Chinese foreign ministry began citing the event in its own propaganda in March 2020. The Chinese asserted that U.S. Army personnel might have brought the virus to Wuhan from Fort Detrick in Frederick, Md., where the U.S. Army bioresearch program is based. That didn’t make sense because the first outbreak was in Wuhan, not Maryland. But the Trump team never took it any further than that.
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Full article -
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164870279
Biocqr, Normally these new mRNA vaccines would have to go through many years of clinical trials and safety studies. The headlong drive to vaccinate the earth's population seems very risky considering -
1) The vaccines are experimental and have not been fully tested
2) They have a brand new mechanism that has never been used before in a vaccine, ie gene therapy/modification
3) No long term safety studies have been done
4) We're talking about almost everyone on the planet getting this experimental treatment
As bad as Covid is, let's hope the long term effects of the treatment don't turn out to be worse than the pandemic itself.
One discussion the country/world should have is how to close these BSL-4 labs and end bioweapons testing and development. Countries get around the existing bio weapons ban by calling it 'research to develop countermeasures'. But something needs to be done or more lab leaks are inevitable, and future pathogens could be much worse than Covid. Biological agents are much easier for smaller countries / groups to obtain, compared to say nuclear weapons, so a dangerous future for the world.
Blade, Sorry to hear about your friend. I think there have been lies and misinformation coming from both sides of the Covid/vaccine arena.
But there is some credible evidence that the mRNA vaccines may have major problems - 1) the spike protein cleaves off and bioaccumulates in the organs and brain, and 2) the spike protein itself exhibits cytotoxicity -
Right-wing radio host who attacked Dr. Fauci changed his tune on his deathbed.
https://www.huffpost.com/entry/dick-farrel-newsmax-right-wing-scamdemic-dies-of-covid_n_610f50d3e4b041dfbaaabac6?utm_source=spotim&utm_medium=spotim_recirculation
Bladerunner
P.S. One of my closest friends died of COVID last week. Two weeks previously he had lost both parents to COVID. All of them had refused to be vaccinated. My friend was young and completely healthy and though he was invulnerable. He dies three days after entering the hospital. This virus is deadly and very contagious. To my mind, all those who are spreading lies and misinformation about COVID and the vaccinations, including the moderator of this board, have the blood of my friend and many others on their hands.
Rickards - >>> Stop the Lies
BY JAMES RICKARDS
AUGUST 3, 2021
https://dailyreckoning.com/stop-the-lies/
Stop the Lies
Health officials continue to lose credibility over COVID-19. They seem to change their minds daily based on whim rather than science. But that’s been the case since the pandemic started.
Going back to last January, official comments on COVID have been mostly wrong. The comments were either outright lies or were prescriptions based on politics, not medicine.
In January 2020, the World Health Organization said there was no human-to-human transmission of COVID. They knew better because of data from China, so that was a lie. Dr. Anthony Fauci said there was little risk of COVID coming from China to the U.S. Another lie.
Then, over the course of 15 months, Fauci said not to wear masks, then he said to wear them, then he said you could take them off. Now, he says it’s time to put them on again.
Fauci is an over-the-hill bureaucrat, not a true scientist. His greatest skill has been successfully navigating the Washington swamp for the past four decades. He’s heavily conflicted because he owns patents on inputs to the vaccines.
He also has a lot to hide, because he funded the Wuhan laboratory coronavirus research in the first place. The science is clear that masks don’t work (because the virus is far smaller than the mask weave), and lockdowns don’t work (because people indoors in confined spaces spread the virus faster than people outside who are in motion).
Masks are positively dangerous for children because they force you to breathe your own CO2, which causes dizziness, lethargy, inability to focus and can cause people to pass out. The latest lie is Biden’s call for vaccine mandates for federal workers or weekly testing, masking and distancing.
What Vaccine Mandate?
The White House had repeatedly said there would be no federal vaccine mandates. It’s true that there is no single mandate that applies to all Americans. But there are now hundreds of mini-mandates that add up to the same thing.
Biden’s federal worker mandate covers 4 million federal employees and as many as 4 million federal contractors.
Meanwhile, universities are imposing vaccine mandates on returning students. Large companies like Facebook and Google are imposing vaccine mandates on their workers. New York State has imposed a vaccine mandate on state workers. Sports and entertainment venues are barring anyone who cannot prove they have been vaccinated.
When you add it all up, we’re turning into a society of vaxxed and unvaxxed where the latter are denied the opportunity to work, attend school, go out for a show or sporting event and so on.
“There is no vaccine mandate,” they’ll say. But in reality, the unvaccinated will be treated as second-class citizens who can’t live regular lives or participate fully in society.
Why Are So Many Vaccinated People Getting Sick?
This is all over so-called vaccines that are really experimental gene modification treatments with dangerous side effects and limited efficacy since many vaccinated individuals are now being infected again. The vaccines won’t stop you from getting the virus or from spreading it.
In one Massachusetts town, for example, 74% of new cases have already been vaccinated. Data from overseas is even more revealing since many countries report new cases daily, which doesn’t allow for the type of data manipulation U.S. health agencies often engage in.
In Israel, about 85% of adults over 30 are fully vaccinated. Over 90% of those above 60 are fully vaccinated. But Israel is experiencing a dramatic rise in new cases. The number of serious cases has increased about 10 times since the beginning of July. Importantly, the vast majority are vaccinated.
The data reveal that rates of severe cases among the vaccinated are currently as high as the unvaccinated’s rate just two weeks ago.
The Israeli Prime Minister, Naftali Bennett, warns that cases may quadruple within three weeks and that authorities are preparing for new lockdowns (even though lockdowns have proven to be ineffective against stopping the virus).
Most Israelis have taken the Pfizer vaccine, incidentally.
Gene Therapy
But why should these vaccines stop you from getting the virus or from spreading it? Again, these aren’t vaccines in the traditional sense, which introduce weakened or inactive parts of a virus, against which your body produces antibodies.
Instead, these COVID vaccines introduce mRNA (messenger RNA) into your muscle cells. The cells then reproduce the spike protein. These vaccines are, therefore, a form of gene therapy.
Fauci has said that the recent surge in infections is a “pandemic of the unvaccinated,” that 99% of deaths were unvaccinated. But that’s another lie. The CDC’s own data indicated that 15% of fatalities occurred among the unvaccinated during the period in question. There’s reason to believe the actual figures are higher.
But the demands for universal vaccination continue. The American Medical Association (AMA) has reported that 96% of practicing physicians are fully vaccinated, based on a poll of 300 respondents.
The point is to try to convince those who aren’t vaccinated that if almost all doctors are vaccinated, you should be too. But a separate survey of 700 participants conducted by the Association of American Physicians and Surgeons (AAPS) revealed that nearly 60% of respondents said they were not “fully vaccinated.”
Which numbers do you believe are more likely?
Cheap, Effective Therapeutics Are Suppressed
At the same time, health authorities have suppressed cheap, effective therapeutics like Ivermectin and hydroxychloroquine that can significantly reduce COVID hospitalizations and deaths. These drugs have been around for decades and are extremely safe.
But the alphabet soup of health agencies says they need more testing before they can be approved. Yet these are the same people who are shoving experimental gene therapy down people’s throats, which were rushed through on an emergency basis without the usual testing that takes years.
Any health professional who cites the benefits of these therapeutics can be banned from social media, despite numerous clinical studies that demonstrate their effectiveness, especially if used in the early stages of illness. They aren’t magic bullets, but the data indicate they provide substantial benefit.
Why are public health authorities so determined to suppress these cheap but effective therapeutics? Well, you might want to follow the money.
The FDA granted emergency use approval for the vaccines. But for the FDA to grant that emergency approval, “no formally approved alternatives” can be available at the time.
If these other therapeutics were deemed effective, the vaccines couldn’t be rushed through on an emergency basis. And a lot of powerful interests stood to profit from the vaccines. They wouldn’t profit from off-patent therapeutic drugs that might cost pennies per pill.
Meanwhile, the push for new lockdowns, universal vaccination and vaccine passports continues.
It’s a Brave New World, and it’s not going away soon.
Regards,
Jim Rickards
for The Daily Reckoning
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Axsome Therapeutics - >>> 3 “Strong Buy” Stocks Trading at Steep Discounts
TipRanks
August 2, 2021
https://finance.yahoo.com/news/3-strong-buy-stocks-trading-142616588.html
How do you define a stock market opportunity? Is it a windfall, a piece of luck, or the result of careful planning, a strategy to make the most of any opening? The savvy investor seeks out the latter, looking for stocks that offer inducements to entry, be it a high upside or a depressed share price or a recent positive analyst review – or better yet, a combination of all three.
So there’s a profile. We’ve used the TipRanks database to look up three stocks that fit it – stocks with Strong Buy consensus ratings, plenty of upside potential, and recent thumbs up from the analyst corps. And, while these stocks have plenty of positives in the profile, each one has also seen steep share price losses in recent weeks. Let's take a closer look.
Axsome Therapeutics (AXSM)
We’ll start with Axsome, a biopharma research company working on new medication therapies for diseases of the central nervous system (CNS). Axsome’s target conditions currently have limited treatment options – and also have a deep potential patient base. The company is researching medications with ‘novel mechanisms of action’ as a way to transform the approach to CNS treatment. The company is investigating treatments for a varied range of conditions, from Alzheimer’s, to fibromyalgia, to severe migraines, to depression.
Axsome currently has four drug candidates in the development pipeline. The leading candidate, AXS-05, is a multimodal treatment, developed to treat major depressive disorder, Alzheimer’s-related agitation, and smoking cessation. The depressive disorder track, for which AXS-05 has a breakthrough therapy designation, is farthest along – the New Drug Application has been submitted, and the FDA has given a PDUFA target date of August 22 this year. If approved, the company plans to launch commercially in 4Q21. On the Alzheimer’s track, AXS-05 is currently undergoing the Phase 3, double-blind ACCORD study. Enrollment is currently ongoing.
The next big update for the company is planned NDA submission for AXS-14, a new treatment for fibromyalgia. This drug candidate has competed two trials, a Phase 2 with 267 patients and a Phase 3 with 1,122 patients, both with positive results. Data from the trials will be included in the NDA submission, which is planned for Q4 of 2022.
Finally, Axsome has AXS-7 as a migraine treatment. This candidate has demonstrated effective pain relief in patients within two hours of dosing, and has a potential patient base of 37 million. The company has an NDA in preparation for this drug candidate, and hopes for approval next year.
The pipeline is the key point here, and Berenberg’s Esther Hong bases her Buy rating on the potential of AXS-05 as a treatment for major depressive disorder.
“We are bullish on the prospects and see a potential commercial launch in Q4 2021. Second, the company expects to submit a new drug application (NDA) with the FDA this quarter for a second product (AXS-07 for the treatment of migraine). Approval could come in 2022. We see opportunity for significant price appreciation over the remainder of the year driven by these key upcoming catalysts with longer-term upside from a robust pipeline,” Hong opined.
The analyst added, "We are bullish on the prospects for AXS-05 in MDD due to 1) its robust efficacy in treating depression as a result of its novel mechanism of action [MOA]; 2) the speed of efficacy compared to traditional antidepressants; and 3) a superior safety profile compared to other NMDA antagonist antidepressants..."
Hong puts a $112 price target on the stock, suggesting an upside of 123% for the year ahead. (To watch Hong’s track record, click here)
With a unanimous Strong Buy consensus rating, based on 8 recent reviews, it’s clear that Wall Street agrees with Hong on the potential of this stock. The shares fell in the past year, mainly due to regulator hurdles, but in the Street’s estimation, that has opened up an opportunity. The stock is selling for $50.27 and has an average target of $135.33, indicating room for ~170% upside potential this year. (See AXSM stock analysis on TipRanks)
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Humanigen - >>> Lenzilumab Treatment May Provide Enhanced Likelihood of Survival Without Ventilation in Hospitalized Black and African-American COVID-19 Patients
Yahoo Finance
August 4, 2021
https://finance.yahoo.com/news/lenzilumab-treatment-may-enhanced-likelihood-100000585.html
Lenzilumab treatment in Black and African-American patients in the positive LIVE-AIR Phase 3 trial, having a CRP<150 mg/L, resulted in a nearly 9-fold increase in survival without ventilation
CDC data shows Black and African-American persons are at an almost 3-fold greater risk of hospitalization and 2-fold greater risk of death from COVID-19 infection1
Black American vaccination rates are lowest nationally, resulting in higher risk of infection, hospitalization, and death2
BURLINGAME, Calif., August 04, 2021--(BUSINESS WIRE)--Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’, announced analysis of results from its Phase 3 LIVE-AIR study of lenzilumab in hospitalized patients with COVID-19 suggesting Black and African-American patients having a CRP<150 mg/L may be the highest responders to treatment, with a nearly 9-fold increase in likelihood of survival without ventilation (SWOV) [n=51, p-value=0.0412]. In the overall population with CRP<150 mg/L, LIVE-AIR Phase 3 results show patients treated with lenzilumab demonstrated a 2.5-fold increased likelihood of SWOV [mITT, n=351, p-value=0.0009].
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210804005396/en/
"Humanigen believes this analysis is an important finding because Black and African-American patients are hyper-vulnerable to COVID-19," said Cameron Durrant, MD, Chief Executive Officer, Humanigen. "In light of the rapid ongoing spread of the Delta variant, data suggesting that Black and African-American patients, who are hyper-vulnerable to COVID-19, and may be hyper-responsive to lenzilumab is important in the broader context of the potential benefits that may result if the FDA were to grant emergency use authorization."
The Centers for Disease Control and Prevention (CDC) has found that race and ethnicity are risk markers for other conditions that affect health, including socioeconomic status, access to health care, and exposure to SARS-CoV-2 related to occupation, such as frontline, essential, and critical infrastructure workers.1 The American Heart Association’s COVID-19 Cardiovascular Disease Registry found that Black patients had the highest prevalence of obesity, hypertension, and diabetes, all of which are medical conditions the CDC identifies as making adults of any age more likely to get severely ill from COVID-19.3,4
"In the interest of public health and safety, it is our priority to share data with stakeholders to improve our understanding of the disease and potential treatments," said Adrian Kilcoyne, MD, Chief Medical Officer, Humanigen. "While there may be some limitations to subset analyses, we believe the ongoing public health crisis caused by SARS-CoV-2 warrants consideration of these important data by regulatory authorities."
Humanigen intends to submit data from this analysis for publication in a peer-reviewed journal and present the findings at a medical meeting. These new data from the LIVE-AIR study will also be shared with regulatory authorities in the US, UK, European Union, and other geographies.
About the LIVE-AIR, Phase 3 Study of Lenzilumab
LIVE-AIR Phase 3 study met its primary endpoint of survival without ventilation demonstrating a 1.54-fold improvement overall and trended to a 2.68-fold improvement in Black and African-American patients. This study was a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial for the treatment and prevention of serious and potentially fatal outcomes in patients hospitalized with COVID-19 pneumonia. The primary objective was to assess whether lenzilumab, in addition to other treatments, which included dexamethasone (or other steroids) and/or remdesivir, could alleviate the immune-mediated ‘cytokine storm’ and improve survival without ventilation, or ‘SWOV’ (sometimes referred to as ‘ventilator-free survival’). SWOV is a composite endpoint of time to death and time to invasive mechanical ventilation (IMV), which is a robust measure that is less prone to favor a treatment with discordant effects on survival or days free of ventilation.5
The LIVE-AIR study enrolled 520 patients in 29 sites in the US and Brazil who were at least 18 years of age; experienced blood oxygen saturation (SpO2) of less than or equal to 94%; or required low-flow supplemental oxygen, or high-flow oxygen support, or non-invasive positive pressure ventilation; and were hospitalized but did not require IMV. Following enrollment, subjects were randomized to receive three infusions of either lenzilumab or placebo, each infusion separated by eight hours over a 24-hour period. The primary endpoint was the difference between lenzilumab treatment and placebo treatment in SWOV through day 28 following treatment. Key secondary endpoints, also measured through day 28, included ventilator-free days, duration of ICU stay, incidence of IMV, extracorporeal membrane oxygenation (ECMO), and/or death, time to death, all-cause mortality, and time to recovery. Results of the trial have been submitted for publication in a peer-reviewed journal.
About Humanigen, Inc.
Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’. Lenzilumab is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Early in the COVID-19 pandemic, investigation showed high levels of GM-CSF secreting T cells were associated with disease severity and intensive care unit admission. Humanigen’s Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19. Humanigen is developing lenzilumab as a treatment for cytokine storm associated with CD19-targeted CAR-T cell therapies and exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease (aGvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT), eosinophilic asthma, and rheumatoid arthritis. Humanigen is also developing a portfolio of clinical and pre-clinical therapies for the treatment of inflammation and immuno-oncology. For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and Facebook.
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>>> David E. Martin - Covid-19, Vaccinations, and Other Mass Casualty Events <<<
https://kunstler.com/podcast/kunstlercast-347-chatting-with-david-e-martin-about-covid-19-vaccinations-and-other-mass-casualty-events/
Blade, That info sounded credible enough to at least justify further research.
What definitely sounds like crapola is the lockstep mainstream narrative surrounding these vaccines, complete with censorship of all who question it, including prominent scientists. 200,000 posters were reportedly booted off of Facebook, so what's that all about? Something's not right here.
What do you make of this? (link below) Sounds credible to me -
gfp,
Why are you posting this horseshit here? I remember you as a fairly reasonable guy, and now you're spouting Tucker Carlson-type crapola. What's happened to you? Why are you drinking the FOX Kool-Aid? You should stop posting this junk science horse manure.
Blade
$IBIO Covid19 1.27 +0.0299 (2.41%)
$CEMI $28.3 million purchase order from Bio-Manguinhos for the purchase of Chembio's COVID-19 antigen tests. https://markets.businessinsider.com/news/stocks/chembio-diagnostics-stock-price-cemi-covid-test-order-investing-retail-2021-7
Dr. Peter McCullough on the suppression of Covid therapeutics -
>>> "Spike protein is very dangerous, it's cytotoxic (Robert Malone, Steve Kirsch, Bret Weinstein)" <<< -
LYRA, ready to move into Phase III with Significant Efficacy (p=0.03) in a $50 B market, 80 million patients in China alone
https://investors.lyratherapeutics.com/news-releases/news-release-details/lyra-therapeutics-announces-positive-outcome-end-phase-2-meeting
Analyst: William Blair Focus Conference
https://wsw.com/webcast/blair59/lyra/1950784
$IBIO Ibio Inc., formerly known as iBioPharma Inc., is a biopharmaceutical company that primarily focuses on developing vaccines and therapeutic proteins based upon its plant-based iBioLaunch platform technology. The Company's hydroponically grown green plants can be used for the development and manufacture of proteins applicable to a range of disease agents, such as influenza, sleeping sickness, anthrax, plague, human papillomavirus and veterinary influenza applications. IBio, Inc. is headquartered in Newark, Delaware. https://www.barchart.com/stocks/quotes/IBIO/profile
#Covid19 Vaccine Maker $IBIO Top Mutual Fund Holders
Holder Shares Date Reported % Out Value
Vanguard Total Stock Market Index Fund 6,182,400 Mar 30, 2021 2.84% 9,520,896
iShares Russell 2000 ETF 4,868,109 May 30, 2021 2.23% 7,058,758
Vanguard Extended Market Index Fund 2,725,700 Mar 30, 2021 1.25% 4,197,578
Fidelity Small Cap Index Fund 1,655,392 Apr 29, 2021 0.76% 2,267,887
iShares Russell 2000 Growth ETF 1,586,587 May 30, 2021 0.73% 2,300,551
Fidelity Extended Market Index Fund 1,144,666 May 30, 2021 0.53% 1,659,765
iShares Micro Cap ETF 574,587 May 30, 2021 0.26% 833,151
Schwab Capital Trust-Small Cap Index Fund 456,189 Apr 29, 2021 0.21% 624,978
iShares Core S&P Total U.S. Stock Market ETF 429,442 May 30, 2021 0.20% 622,690
TIAA-CREF Funds-Small-Cap Blend Index Fund 370,538 Apr 29, 2021 0.17% 507,637
https://finance.yahoo.com/quote/IBIO/holders?p=IBIO
Blade, Just curious if you are adding to CRIS after the selloff? Looks like it has stabilized and found support at the 200 MA.
Also, any thoughts on CCXI's chances? I got in briefly to get the recent bounce (small position), but am leery of being long going into the PDUFA date.
Thanks for any insights :o)
MGTA upgraded
Magenta upgraded to buy on stem cell transplant potential
BTIG has upgraded Magenta Therapeutics (NASDAQ:MGTA) from under review to buy and a price target of $20 (~43% upside).
Analyst Yun Zhong says that hematopoietic stem cell transplant ("HCST") market is growing with a strong unmet medical need.
Zhong notes that the number of HCST procedures doubled in the past 10 years, and more than 50,000 people per year have the procedure. However, many more could benefit but are not eligible.
Bladerunner
KZIA in new clinical collaboration with Cornell Universaity for glioblastoma
Kazia Enters Clinical Collaboration With Cornell University for Phase II Clinical Study Using Paxalisib in Combination With Ketogenic Diet for Glioblastoma
BY PR Newswire
— 10:00 AM ET 06/15/2021
SYDNEY, June 15, 2021 /PRNewswire/ -- Kazia Therapeutics Limited ( KZIA
) , an oncology-focused drug development company, is pleased to announce that it has entered a collaboration with the Joan & Sanford I Weill Medical College of Cornell University in the United States, to launch a phase II clinical study investigating the use of Kazia's investigational new drug, paxalisib, in combination with ketogenesis, for glioblastoma.
Key Points
• Research by Professor Lew Cantley, who discovered the PI3K pathway, suggests that ketogenesis may enhance the activity of PI3K inhibitors in glioblastoma, with impressive preclinical data previously published in Nature
•
• Ketogenesis represents an alternative biochemical mechanism in which the body is fueled by fats and proteins rather than by glucose; it occurs in states such as starvation, and also in response to a 'ketogenic diet'
• Data from this study has the potential to significantly enhance the activity of paxalisib in glioblastoma, and to minimize certain side effects, including hyperglycemia (high blood sugar)
•
• Dr Howard Fine, founding Director of the Brain Tumor Center at New York-Presbyterian Weill Cornell Medical Center, will serve as Principal Investigator; Professor Cantley will be a scientific advisor to the study
• Kazia will provide support including study drug and a financial grant
•
Dr Fine, Principal Investigator to the study, commented, "glioblastoma remains an immensely challenging disease, and we need the most potent array of tools at our disposal in order to treat it. My lab has extensive experience of translational research in this area, and I am excited to explore the potential for a brain-penetrant PI3K inhibitor in combination with ketogenesis."
Professor Cantley, who is a scientific advisor to the study, added, "the interplay between the PI3K pathway, insulin signaling, and tumor growth has been a focus of scientific interest for some time now. Our research clearly shows the synergistic benefits of PI3K inhibition and ketosis in animal models of glioblastoma. This is an important project, designed to verify these laboratory findings in the human setting."
Ketogenesis and Glioblastoma
Cells in the human body generally rely on glucose as 'fuel' for their energy requirements. However, when glucose is not readily available, cells can metabolise fats and proteins to provide energy. The fats and proteins are broken down to an intermediate form known as ketones, and so this biochemical pathway is referred to as 'ketogenesis'.
Unlike healthy cells, most tumour cells are poorly able to metabolise ketones, and so depend on glucose for their energy needs. Consequently, many researchers have experimented with 'ketogenic diets' as a potential treatment for cancer.[1]
In addition, scientists in Professor Cantley's lab have shown that insulin has the potential to counteract the anti-tumor effects of PI3K inhibitors.[2] Insulin is a hormone produced by the body in response to high levels of glucose. When the body is in a state of ketosis, glucose is absent, and so insulin falls to very low levels.
For these reasons, there is a sound rationale to explore a combination of ketogenic diet and paxalisib in glioblastoma. In this study, patients will also receive metformin, a common anti-diabetic drug, which will help to further lower insulin levels.
[1] A Kapelner & M Vorsanger (2015). Medical Hypotheses. 84(3):162-168
[2] B Hopkins et al. (2018). Nature. 560:499-503
Clinical Trial Design
This study will comprise two arms. The first will contain patients with newly diagnosed glioblastoma who have unmethylated MGMT promotor status. These patients are essentially resistant to temozolomide, the existing standard-of-care therapy. The second arm will contain patients with recurrent disease, who have progressed after taking standard-of-care therapy.
In each arm, paxalisib will be combined with metformin and with a ketogenic diet. The diet will be overseen by expert clinical dieticians to ensure that it is scientifically appropriate and that patients are compliant.
An initial cohort of approximately sixteen patients will be recruited to each arm. If there are signals of activity in a given arm, that arm will be expanded to approximately thirty patients. The primary endpoint will be progression-free survival at six months (PFS6). In addition to efficacy and safety, the study will examine a range of metabolic and pharmacodynamic biomarkers to help inform future research and clinical practice. The study is expected to take approximately two years to complete.
Dr Howard Fine will serve as Principal Investigator to the study. Dr Fine is the founding Director of the Brain Tumor Center at New York-Presbyterian Weill Cornell Medical Center, and Associate Director for Translational Research at the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine. He is an internationally recognized leader in the field of neuro-oncology, with more than 30 years of experience in both laboratory and clinical research as well as in the care of patients with brain tumors. Dr Fine has built large multidisciplinary brain tumor programs at top academic institutions such as the Dana Farber Cancer Institute / Harvard Medical School and the National Institutes of Health, has cared for nearly 20,000 patients with brain and spinal cord tumors in his career, has conducted over 100 clinical trials, published over 250 papers and book chapters on brain tumors, and for over two decades has run a continuously operating translational genetic / molecular laboratory devoted to a better understanding of, and better therapies for, brain tumors.
Weill Cornell Medical Center
The Joan & Sanford I. Weill Medical College of Cornell University, known generally as Weill Cornell Medicine, and based in New York, NY, is the medical school of Cornell University, and is one of the leading medical research centers in the United States. Its notable alumni include Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Disease.
Paxalisib Clinical Program
The initiation of this trial in glioblastoma brings the number of ongoing clinical studies of paxalisib in brain cancer to nine.
Sponsor Phase Indication Registration
Kazia Therapeutics ( KZIA
) II Glioblastoma NCT03522298
Global Coalition for
Adaptive Research II / III Glioblastoma NCT03970447
Weill Cornell Cancer
Center II Glioblastoma
(with ketogenic diet + metformin) TBD
Alliance for Clinical Trials
in Oncology II Brain metastases NCT03994796
Dana-Farber Cancer
Institute II Breast cancer brain metastases
(with Herceptin) NCT03765983
Dana-Farber Cancer
Institute II Primary CNS lymphoma NCT04906096
Pacific Pediatric Neuro-
Oncology Consortium N/A DIPG & DMGs TBD
St Jude Children's
Research Hospital I DIPG (childhood brain cancer) NCT03696355
Memorial Sloan
Kettering Cancer Center I Brain metastases
(with radiotherapy) NCT04192981
Next Steps
Recruitment to this study is expected to commence by the end of CY2021, subject to approval by Institutional Review Boards, FDA, and other authorities.
About Kazia Therapeutics Limited ( KZIA
) is an oncology-focused drug development company, based in Sydney, Australia.
Our lead program is paxalisib, a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults. Licensed from Genentech in late 2016, paxalisib commenced recruitment to GBM AGILE, a pivotal study in glioblastoma, in January 2021. Eight additional studies are active in various forms of brain cancer. Paxalisib was granted Orphan Drug Designation for glioblastoma by the US FDA in February 2018, and Fast Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the US FDA for DIPG in August 2020.
Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided compelling evidence of synergy with immuno-oncology agents. A phase I study is expected to begin in CY2021.
For more information, please visit www.kaziatherapeutics.com or follow us on Twitter @KaziaTx.
This document was authorized for release to the ASX by James Garner, Chief Executive Officer, Managing Director.
View original content to download multimedia:http://www.prnewswire.com/news-releases/kazia-enters-clinical-collaboration-with-cornell-university-for-phase-ii-clinical-study-using-paxalisib-in-combination-with-ketogenic-diet-for-glioblastoma-301312028.html
SOURCE Kazia Therapeutics Limited ( KZIA )
Bladerunner
$MJNA The First to Deliver Cannabis Brands Across U.S. State Lines and International Borders, Making Cannabidiol Available Across 50 States, and in Dozens of Countries
CV Sciences, Inc. $CVSI http://www.cvsciences.com
$MJNA First with a License to Commercialize the U.S. National Institutes of Health Patent “Cannabinoids as Antioxidants and Neuroprotectants.”
Medical Marijuana, Inc. subsidiary Kannalife™ Sciences holds the first two licenses awarded to develop and commercialize drug treatments under the U.S. government’s only cannabinoid patent. Kannalife™ Sciences is a phyto-medical company specializing in the research and development of cannabinoid based pharmaceuticals
https://www.medicalmarijuanainc.com/company-of-firsts/the-first-to-license-to-commercialize-the-us-national-institues-of-health-patent/
MGTA reports positive results in multiple myeloma at ASCO. Stock down. I don't know why. Results look good to me. Comments?
Magenta Therapeutics Announces Additional Preliminary Positive Results from Ongoing Phase 2 Clinical Trial of MGTA-145 and Plerixafor in Patients with Multiple Myeloma at the American Society of Clinical Oncology (ASCO) Annual Meeting
Fri, June 4, 2021, 6:00 AM
MGTA
-2.83%
– Preliminary results from the initial cohort of 10 patients were previously reported on May 12 in a published abstract at the European Hematology Association (EHA) Congress –
– The cumulative data as of the data cut-off date show that all patients (15/15) treated with MGTA-145 and plerixafor met the primary endpoint of sufficient stem cell mobilization and collection for transplant –
– All patients (12/12) transplanted with MGTA-145 and plerixafor to date have successfully engrafted; six patients have completed day-100 follow up with demonstrated durable engraftment –
– These results will also be presented at the EHA Congress, June 9-17, 2021 –
Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, today announced additional positive results from a Phase 2 clinical trial of MGTA-145 and plerixafor in patients with multiple myeloma at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held virtually June 4-8, 2021.
"We are very pleased to see continued favorable results for MGTA-145 and plerixafor for stem cell mobilization and collection in patients with multiple myeloma," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. "These results build on those previously disclosed from this study and the Phase 1 trials to further demonstrate MGTA-145 and plerixafor’s potential as a rapid, reliable, well-tolerated approach to stem cell mobilization and collection, which has positive implications for patients and donors."
Additional Results – MGTA-145 Multiple Myeloma Phase 2 Clinical Trial
The investigator-initiated, 25-patient Phase 2 clinical trial is designed to evaluate the ability of MGTA-145, in combination with plerixafor, to mobilize and collect hematopoietic stem cells for autologous stem cell transplant in patients with multiple myeloma. This study is led by Surbhi Sidana, M.D., Assistant Professor of Medicine in the Division of Blood and Marrow Transplantation and Cellular Therapy at Stanford University School of Medicine.
Previously reported results from this trial were announced on May 12, 2021, in a published abstract for the European Hematology Association (EHA) Congress and provided preliminary data from the initial cohort of 10 patients.
Summary of cumulative results through data cut-off date:
All patients (15/15) have met the primary endpoint of mobilization and collection of 2 million CD34+ stem cells per kg in up to two days. Twelve of 15 patients achieved the primary endpoint in a single day of dosing and collection.
The median number of total CD34+ stem cells collected on day 1 and 2 (if needed) was 6.3 million per kg. Current standard of care with G-CSF-based regimens require a minimum of five days of dosing to initiate stem cell collection.
All transplanted patients to date (12/12) successfully engrafted, with median recovery of neutrophils after 12.5 days and platelets after 18 days, which are within transplant expectations in multiple myeloma.
Six patients have completed day-100 follow up, with demonstrated durable engraftment indicative of a successful transplant.
The collected CD34+ stem cells contain a high percentage (40%) of CD34+CD90+, a stem cell population associated with multi-lineage, long-term engraftment, an amount substantially greater than historically observed with G-CSF-mobilized cells.
The regimen of MGTA-145 and plerixafor was well tolerated. Acute, transient, MGTA-145-related grade 1 bone or musculoskeletal pain was observed in 40% of patients shortly after MGTA-145 infusion, resolving within 10 minutes for all patients, and none required pain medication or other intervention.
As indicated previously, this trial has broad and clinically representative inclusion criteria and includes patients that represent the general transplant-eligible population of patients with multiple myeloma. Patients enrolled in this trial included those patients with risk factors that could impact stem cell mobilization and collection, such as myeloma-directed therapies that are known to impact stem cell collection, previous malignancy treated with chemotherapy and/or radiation, and other co-morbid conditions. Mobilization agents may be less effective in patients with multiple risk factors. Final clinical data from this trial are anticipated by the end of 2021. MGTA-145 is also being evaluated for its ability to mobilize and collect stem cells from donors for allogenic transplant in patients with acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in a Phase 2 trial, and an additional Phase 2 study is planned to initiate in patients with sickle cell disease in the second half of 2021.
ASCO Poster Presentation
Title: Phase 2 Study of MGTA-145 + Plerixafor for Rapid and Reliable Hematopoietic Stem Cell (HSC) Mobilization for Autologous Stem Cell Transplant in Multiple Myeloma (Abstract #8023)
Author: Surbhi Sidana, M.D., Assistant Professor of Medicine in the Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University School of Medicine
Poster Session: Hematologic Malignancies – Plasma Cell Dyscrasia
Date/Time: All e-posters are now available in the ASCO Annual Meeting virtual platform
These results will also be presented as an encore at the EHA Virtual Congress, available via the conference’s virtual platform on Friday, June 11 at 3:00am EDT / 9:00am CEST.
About Magenta Therapeutics
Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of stem cell transplant to more patients with blood cancers, genetic diseases and autoimmune diseases. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant community to revolutionize immune reset for more patients.
Magenta is based in Cambridge, Mass. For more information, please visit www.magentatx.com.
Follow Magenta on Twitter: @magentatx.
Bladerunner
>>> Humanigen Submits Application to FDA for Emergency Use Authorization for Lenzilumab in COVID-19
Yahoo Finance
May 28, 2021
https://finance.yahoo.com/news/humanigen-submits-application-fda-emergency-130000674.html
Humanigen, Inc. (Nasdaq:HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, today announced that the company submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for lenzilumab for the treatment of patients hospitalized with COVID-19. This EUA application follows positive results from the LIVE-AIR Phase 3 clinical trial evaluating the ability of lenzilumab to improve the likelihood of survival without ventilation (SWOV) in newly hospitalized COVID-19 patients.
"Filing for EUA in the U.S. is a critical step to making a therapeutic option available for COVID-19," said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. "There is a need for therapies for hospitalized patients who require supplementary oxygen. Treatments can be lifesaving; despite vaccinations, infections and significant breakthrough disease will continue. Lenzilumab, should the FDA grant authorization, can address a critical unmet need for an effective treatment. We are extremely grateful to the investigative team and volunteers in the clinical trial program, as their involvement was vital in delivering this positive Phase 3 study."
Lenzilumab achieved the primary endpoint with a 54% relative improvement in the likelihood of SWOV compared to placebo. Lenzilumab also improved the relative likelihood of SWOV by 92% in subjects who received both corticosteroids and remdesivir and resulted in a 3-fold improvement in the likelihood of SWOV in patients with a CRP<150 mg/L and less than 85 years of age. In these patients, a 2.2-fold improvement in the likelihood of survival was observed with lenzilumab. No serious adverse events were attributed to lenzilumab and the overall safety profile was comparable to placebo.
"We are excited and encouraged by these clinical results and are preparing to distribute lenzilumab if granted Emergency Use Authorization," said Edward P. Jordan, MBA, Chief Commercial Officer, Humanigen. "We are committed to getting lenzilumab into the hands of medical professionals for the treatment of COVID-19. It is anticipated that thousands of patients will continue to be hospitalized daily, some of whom may benefit from lenzilumab."
About Humanigen, Inc.
Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. Humanigen’s immediate focus is on the development of lenzilumab as a therapy for hospitalized, hypoxic COVID-19 patients. Humanigen recently announced plans to initiate a randomized, multicenter, potentially registrational, Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in diffuse large B-cell lymphoma.
Humanigen is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, Humanigen is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. Humanigen is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter and Facebook.
<<<
>>> Why Provention Bio Stock Is Soaring Today
The FDA posted briefing documents that appear to bode well for approval of the company's lead candidate.
Motley Fool
by Keith Speights
May 25, 2021
https://www.fool.com/investing/2021/05/25/why-provention-bio-stock-is-soaring-today/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
What happened
Shares of Provention Bio (NASDAQ:PRVB) were soaring 21.6% as of 10:56 a.m. EDT on Tuesday. The big jump came after the U.S. Food and Drug Administration (FDA) released briefing documents in advance of an advisory committee meeting scheduled for May 27. This advisory committee will review Provention's Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
So what
Provention couldn't have asked for better news in the FDA's briefing documents. The agency stated that the company's TN-10 pivotal study "successfully demonstrated the treatment effect of teplizumab in delaying T1D diagnosis in at-risk relatives of T1D patients for a median time of approximately 2 years."
The FDA briefing documents also noted that there aren't any approved therapies currently for delaying the onset of T1D. Because of the medical need and "the impracticality of conducting a second long-term clinical trial," the agency appeared to encourage the advisory committee to accept Provention's TN-10 study as meeting the threshold for showing effectiveness.
Now what
The next key catalyst for the biotech stock will come in just a couple of days when the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meets to review the regulatory filing for teplizumab. Although the advisory committee could take a less favorable stance than the FDA briefing documents do, investors are betting that won't be the case.
<<<
re: MYOV
Myovant Sciences Receives Positive CHMP Opinion for RYEQO® (Relugolix Combination Tablet) for the Treatment of Women With Uterine Fibroids
Myovant Sciences, Inc.
Fri, May 21, 2021, 5:30 AM
MYOV
+5.89%
CHMP opinion recommending approval based on data from the Phase 3 LIBERTY program in women with uterine fibroids
Gedeon Richter will commercialize RYEQO for uterine fibroids, if approved, in Europe
Relugolix combination tablet for uterine fibroids is also under U.S. FDA review with a target action date of June 1, 2021
BASEL, Switzerland, May 21, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the approval of RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The European Commission will review the CHMP recommendation, and a final decision on the Marketing Authorization Application is expected to be available in approximately two months. The decision will be applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.
“Over 25% of women of reproductive age develop uterine fibroids. This chronic disease can cause debilitating symptoms that have a significant impact on quality of life and require long-term treatment, yet there are currently limited treatment options in Europe and many women are faced with the decision to undergo surgery to alleviate symptoms,” said Roberta Venturella, M.D., Ph.D., Associate Professor, Magna Græcia University of Catanzaro and investigator in the LIBERTY program. “The CHMP’s positive opinion further validates RYEQO’s potential to effectively address heavy menstrual bleeding and pain associated with uterine fibroids and serve as an important new treatment option for patients and physicians.”
“This positive CHMP opinion represents an important step in advancing our mission to redefine care for women living with uterine fibroids,” said David Marek, Chief Executive Officer of Myovant Sciences, Inc. “We look forward to Gedeon Richter’s launch of RYEQO, if approved, as a new treatment option for uterine fibroids.”
The positive opinion recommending approval is based on safety and efficacy data from the Phase 3 LIBERTY program, which consisted of two replicate, 24-week, multinational clinical studies (LIBERTY 1 and LIBERTY 2), a one-year extension study, and a randomized withdrawal study assessing the safety and efficacy for up to two years of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg). Results from the LIBERTY 1 and LIBERTY 2 studies were published in the New England Journal of Medicine in February 2021.
In March 2020, Myovant and Gedeon Richter entered into an exclusive license agreement for Gedeon Richter to commercialize relugolix combination tablet for uterine fibroids and endometriosis in Europe, the Commonwealth of Independent States including Russia, Latin America, Australia, and New Zealand. Under the terms of the agreement, Myovant continues to lead the global development of relugolix combination tablet while Gedeon Richter is responsible for local clinical development, manufacturing, and all commercialization for its territories.
Relugolix combination tablet for the treatment of uterine fibroids is also under review by the U.S. Food and Drug Administration, with a target action date of June 1, 2021.
About Uterine Fibroids
Uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus and are among the most common reproductive tract tumors in women. In addition to an individual's genetic predisposition, estrogens are well known to play an important role in the regulation of fibroid growth.
Although uterine fibroids are benign tumors, they can cause debilitating symptoms such as heavy menstrual bleeding (frequently resulting in anemia and fatigue), pain (including painful periods, abdominal pain, painful intercourse, backache), increased abdominal girth and bloating, urinary frequency or retention, constipation, pregnancy loss, and, in some cases, infertility. These symptoms can also lead to loss of productivity at work, limitations in normal activities of daily living, and social embarrassment.
About RYEQO®
RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is being evaluated for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. RYEQO contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen), which may reduce the risk of bone loss, and norethindrone acetate (a progestin), which is necessary when women with a uterus (womb) take estrogen.
RYEQO is not approved for any indication in any geography.
About Myovant Sciences
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. ORGOVYX™ (relugolix) was approved by the U.S. Food and Drug Administration in 2020 as the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer, and relugolix is also under regulatory review in Europe for men with advanced prostate cancer. Our lead product candidate, relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg), is under regulatory review in the U.S. and Europe for women with uterine fibroids, has completed Phase 3 registration-enabling studies for women with endometriosis, and is being assessed for contraceptive efficacy in healthy women ages 18-35 years who are at risk for pregnancy. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is our majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.
Bladerunner
gfp,
re: CCXI
I looked at the briefing docs and I'm no expert in these things, but I don't see how the drug can be approved, regardless of panel decision. Maybe this is another Dendreon-type situation, but I wouldn't bet on it.
CCXI was once my largest position. I sold my last tranche at $64.50, so this was my largest gain on any stock ever. This stock secured my retirement. It was dumb luck.
Bladerunner
Blade, Any thoughts on CCXI's chances for approval? I see the FDA panel actually did recommend approval, but by a slim margin. But it sounds like an additional Phase 3 might be needed. I've never seen so many class action lawsuits filed so quickly.
Wasn't CCXI the stock that you cleaned up on in 2019-2020? A while back I remember you saying that you had sold the last of your shares, so excellent timing :o)
Looking at what happened shows how treacherous this sector can be. I'm reminded of the famous Andy Grove saying - 'Only the paranoid survive'.
Years ago Dendreon had a similar flattening, only to rise again, but then ultimately was flattened for good. The crazy world of bio..
Blade, Yes, nice move for FSTX. Those Q-1 results came out on Monday, so I guess today's move was a delayed reaction. It was a strong day for the markets and biotech in general, which helps.
It takes a lot of patience with these bio stocks. I've been trying to get into a longer term mindset. With the overall stock market so high, the tendency is to take profits quickly when they appear.
Fwiw I currently have small positions in HGEN and IPIX. The last time IPIX was this cheap I managed to get a quick double, and HGEN looks poised for a move. Keeping fingers crossed :o) Just small positions, so mainly for the fun aspect.
Any new stocks you are looking at?
FSTX reports 1st quarter results. Stock up 13%.
GlobeNewswire
F-star Therapeutics Reports First Quarter 2021 Financial Results and Provides Corporate Update
F-star Therapeutics, Inc.
Mon, May 17, 2021, 5:00 AM
FSTX
+12.48%
Company to Host Conference Call Today at 9 a.m. EDT
CAMBRIDGE, United Kingdom and CAMBRIDGE, Mass., May 17, 2021 (GLOBE NEWSWIRE) -- F-star Therapeutics, Inc. (NASDAQ: FSTX), a clinical-stage biopharmaceutical company dedicated to developing next generation bispecific immunotherapies to transform the lives of patients with cancer, today announces first quarter 2021 financial results and provides a corporate update.
Strengthens balance sheet with successful closing of $65 million public offering of common stock and;
Received $9.2 million in net proceeds under its "at-the-market" equity offering program
LAG-3 and PD-(L)1 co-targeting validation with LAG-3 validated in late-stage clinical trial as third checkpoint inhibitor pathway
FS118 patent protection granted in Europe expanding F-star’s extensive IP portfolio
FS222 presentation at AACR on the importance of tuning both affinity and avidity for differentiation
Nature publication on STING agonist demonstrating that SB 11285 enhances preclinical efficacy of radiation therapy
Merck KGaA, Darmstadt, Germany exercises option to bring third target into pipeline
Eliot Forster, CEO of F-star Therapeutics, Inc., said, “I’m very proud of what F-star accomplished in our first full quarter as a publicly traded company. The successful close of our public offering means we have now strengthened our financial position to ensure delivery on our future milestones. We have made excellent progress across all four clinical stage programs. We have also delivered with our partners, as noted in the recent update on our collaboration with Merck KGaA. We have added new insights into the unique properties of our platform technology, including presenting new data on FS222, our potentially best-in-class bispecific antibody targeting CD137 and PD-L1. This year will be another exciting one for F-star with clinical data expected and huge potential to provide transformational treatment options for patients with cancer.”
“We have had a great start to 2021 and are very pleased to complete our $65 million underwritten public offering,” said Darlene Deptula-Hicks, Chief Financial Officer of F-star Therapeutics. “Based on our current operating plans we believe our current cash and cash equivalents will be sufficient to meet our capital requirements into the second half of 2023.”
FIRST QUARTER 2021 AND RECENT HIGHLIGHTS
Clinical validation of LAG-3: Aligning with F-star’s promising internal data, new headline phase 3 data reported during the quarter by a global pharmaceutical company has potentially validated LAG-3 as an immuno-oncology target. Importantly for FS118, these data also confirm the necessity of co-targeting the LAG-3 and PD-1/PD-L1 pathways to achieve efficacy in patients.
FS118 European patent protection granted: The European Patent Office (EPO) granted a patent in January 2021 with claims protecting the composition of matter of F-star’s FS118 molecule giving protection until June 2037. The phase 2 proof-of-concept trial of FS118 is proceeding on plan and the Company plans to provide an update on progress in the first half of 2022.
FS222 Poster presented at the American Association for Cancer Research (AACR) Annual Meeting in 2021: F-star presented a poster at AACR 2021 entitled ‘FS222, a Tetravalent Bispecific Antibody Targeting CD137 and PD-L1, is Designed for Optimal CD137 Interactions Resulting in Potent T cell Activation Without Toxicity’. This poster and the associated data showcased the differentiation of FS222 from competitor molecules and highlighted the importance of ‘tuning’ for both the affinity and avidity of bispecific antibodies. The ongoing phase 1 clinical trial is proceeding on plan and the Company plans to provide an update on progress before the end of 2021.
SB 11285 in Nature publication: F-star published on its second-generation STING agonist, SB 11285, in the April 2021 issue of Nature Communications. The study, entitled ‘STING enhances cell death through regulation of reactive oxygen species and DNA damage’ demonstrated that systemic administration of a STING agonist in combination with radiation in a preclinical model enhances local control in Head and Neck Squamous Cell Carcinoma (HNSCC) and suggests that STING expression in the tumor is required for maximal therapeutic benefit. The Company plans to provide an update on the progress of SB 11285 in the phase 1 clinical trial in mid-2021.
Merck, KGaA, Darmstadt, Germany exercised third target option: F-star continued to deliver on the collaboration with Merck, KGaA, Darmstadt, Germany. The third option to license an F-star preclinical immuno-oncology program was exercised in the ongoing collaboration in March 2021. The companies entered into the agreement in 2019 with the first option to license. In July 2020, Merck KGaA, Darmstadt, Germany brought the second program from the collaboration into its pipeline, and has recently exercised its third option, taking over future development and commercialization of the program.
Denali Therapeutics announcement: F-star is pleased by the announcement from Denali Therapeutics that following positive preliminary data in a Phase 1/2 study, the Food and Drug Administration (FDA) has granted Fast Track designation to DNL310, which is derived from F-star's unique Fcab technology, for the treatment of patients with Hunter syndrome.
Strengthened balance sheet in 2021: In April the Company completed the sale of $9.5 million in gross proceeds through its previously announced “at-the-market” (ATM) equity offering program. In addition, in April the Company entered into and drew down $5 million under its $10 million debt facility with Horizon Technology Finance Corporation and in May raised gross proceeds of $65 million, before deductions of underwriting discounts and commissions, in a public offering.
FIRST QUARTER 2021 FINANCIAL SUMMARY
Cash and cash equivalents as of March 31, 2021 were $3.7 million, compared to $18.5 million at December 31, 2020. Based on the Company’s current operating plan, the Company believes its cash and cash equivalents at March 31, 2021, together with the net proceeds from the recent sales of common stock in the underwritten public offering and under the ATM, and funds from its debt facility will be sufficient to fund its current operating plans into the second half of 2023.
Research & Development (R&D) expenses were $7.3 million for the quarter ended March 31, 2021, compared to $3.4 million for the same quarter in 2020. The increase of $3.9 million in R&D expense was primarily related to manufacturing costs and clinical costs with Q1 being the first full quarter with four programs in the clinic.
General & Administrative (G&A) expenses were $6.4 million for the quarter ended March 31, 2021, compared to $3.2 million for the first quarter of 2020. This $3.2 million increase in G&A expense was primarily due to increased non-cash stock-based compensation expense, professional fees and insurance associated with operating as a public company and rent expense associated with building leases assumed in the share exchange.
Net loss was $9.9 million or a loss per share of $1.08 (basic and diluted), for the quarter ended March 31, 2021, compared to a net loss of $7.2 million or a loss per share of $3.92 (basic and diluted) for the quarter ended March 31, 2020.
CONFERENCE CALL AND WEBCAST
F-star will host a conference call today, May 17, 2021 beginning at 9:00 AM EDT. To join the webcast, go to website. To join by phone, participants may dial 1-833-471-0868 in the US/Canada or 1-914-987-7751 for International calls or 0800 0288438 or 0203 1070289 for the United Kingdom, at least 10 minutes prior to the start of the call.
Bladerunner
ONCT up over 13% in AH after presenting data that will get an oral presentation at ASCO
Oncternal Therapeutics Presents Updated Interim Data for TK216 in Patients with Relapsed or Refractory Ewing Sarcoma in an Oral Session at ASCO 2021
Oncternal Therapeutics
Wed, May 19, 2021, 2:30 PM
ONCT
-4.14%
Latest data from study TK216-01 remain encouraging, are consistent with previous results, and are updated over data contained in ASCO Abstract #11500 released today
Two patients who achieved a complete response (CR) remain with no evidence of disease, one for over 24 months and the other for over 14 months on study
TK216 remained generally well tolerated with a manageable safety profile
SAN DIEGO, May 19, 2021 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced updated interim clinical data from the oral presentation on its ongoing Phase 1/2 clinical trial evaluating TK216, an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins, in patients with relapsed or refractory Ewing sarcoma, to be presented at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting.
Ravin Ratan, M.D., Assistant Professor, Department of Sarcoma Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, will present at the ASCO 2021 Annual Meeting Sarcoma oral session that two heavily pre-treated and metastatic Ewing sarcoma patients treated at the recommended Phase 2 dose (RP2D) of TK216 continue to demonstrate prolonged complete regression of Ewing sarcoma for greater than one and two-years on study and have tolerated ongoing treatments well with TK216 alone or in combination with vincristine.
The data will be presented at the ASCO 2021 Annual Meeting:
Abstract Title: TK216 for Relapsed/Refractory Ewing Sarcoma: Interim Phase 1/2 Results
Abstract number: 11500
Session Title: Sarcoma
Session Date and Time: June 4, 2021, from 1:30 – 4:30 p.m. (Eastern Time)
“I am optimistic about the durable disease control observed in the two heavily pre-treated metastatic patients with Ewing sarcoma, and that both tolerated their treatments with TK216 with or without vincristine well,” said Dr. Joseph Ludwig, M.D. Department of Sarcoma Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center. “Advanced, refractory Ewing sarcoma is a serious and devastating condition, and novel therapies are desperately needed. These encouraging interim results from study TK216-01, along with evolving preclinical data, suggest that this agent may warrant further clinical development.”
As of the April 16, 2021 data cut-off date, a total of 68 patients with relapsed/refractory Ewing sarcoma have been treated with TK216 in study TK216-01, 29 patients in the dose-finding cohorts, and 39 patients treated at the RP2D of TK216 (200 mg/m2/day for 14 days) with vincristine 0.75-1.5 mg/m2 administered on the first day of each cycle. All patients treated at the RP2D had metastases at study entry and were heavily pretreated, with a median number of three prior systemic therapies (range 1-8). Two patients treated at the RP2D have achieved marked and sustained regression in target lesions after as little as two cycles of therapy. The first patient experienced 100% regression of target lesions following two cycles of TK216 alone. After six cycles of treatment that included concomitant vincristine starting in the third cycle, a single 7 mm non-target lung lesion was resected, resulting in a surgical complete remission. The patient remained on study with no evidence of disease after more than 24 months. The second patient attained 90% resolution of target lung lesions following two cycles of TK216 plus vincristine, then achieved a CR after six cycles of therapy. This patient also remained on study disease-free after more than 14 months, treated with TK216 alone following cycle 5. At the RP2D, the objective response rate (ORR) was 9.7% (3 of 31 evaluable patients), including one patient with an unconfirmed partial response (PR). Eleven patients (35.5%) had stable disease (SD), for a disease control rate (CR, PR, SD) of 45.2% (14 of 31 evaluable patients). The median progression-free survival (PFS) for patients treated at the RP2D was 1.9 months (95% CI: 1.5, 3.0), with an encouraging tail of extended PFS for some patients. Updated safety data showed that TK216 at the RP2D has been generally well tolerated, with frequent side effects including myelosuppression, fatigue, and alopecia. No unexpected off-target toxicities or deaths related to TK216 toxicity have been observed.
“We are encouraged by the durable clinical responses in this updated clinical data set, and the sustained disease control observed in two heavily pre-treated patients with refractory metastatic Ewing sarcoma treated with TK216 with or without vincristine,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “This first-in-class investigational agent may also have potential in a variety of other malignancies driven by ETS alterations including acute myeloid leukemia, large B-cell lymphoma and prostate cancer.”
About TK216
TK216 is an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins including fusion proteins. Tumorigenic fusion proteins involving the EWS protein and an ETS protein can be found in most cases of Ewing sarcoma. ETS-related translocations or overexpression are also found in many other tumors such as prostate cancer, acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL). TK216 was developed based on discoveries in the laboratory of Jeffrey Toretsky, M.D., at Georgetown Lombardi Comprehensive Cancer Center, who discovered inhibitors of EWS-FLI1 using a novel chemical screening assay. In preclinical models, TK216 was observed to bind to EWS-FLI1, blocking the interaction between this fusion protein and other transcriptome proteins such as RNA helicase A, leading to tumor cell apoptosis and inhibiting tumor growth in animal models. The U.S. Food and Drug Administration (FDA) has granted Orphan Designation, Fast Track designation, and Pediatric Rare Disease Designation to TK216 for the treatment of Ewing sarcoma. TK216 is an investigational medication that has not been approved by the FDA for any indication.
About Study TK216-01
TK216 is being evaluated in an ongoing Phase 1/2 clinical study as a single agent and in combination with vincristine in patients with relapsed or refractory Ewing sarcoma, a rare pediatric cancer with no standard treatment available after first-line chemotherapy. The dose-finding portion of the study is complete. Oncternal is currently enrolling patients in a Phase 2 expansion cohort to evaluate the clinical response of treatment with TK216 in combination with vincristine using the recommended Phase 2 dosing regimen. This multi-center study is enrolling patients at nine clinical trial centers across the U.S. Additional information about the TK216 study may be accessed at ClinicalTrials.gov ( NCT02657005).
About Oncternal Therapeutics
Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of cancers with critical unmet medical need. Oncternal focuses drug development on promising yet untapped biological pathways implicated in cancer generation or progression. The clinical pipeline includes cirmtuzumab, an investigational monoclonal antibody designed to inhibit the ROR1 pathway, a type I tyrosine kinase-like orphan receptor, that is being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) and in an investigator-sponsored, Phase 1b clinical trial in combination with paclitaxel for the treatment of women with HER2-negative metastatic or locally advanced, unresectable breast cancer, as well as a Phase 2 clinical trial of cirmtuzumab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. Oncternal is also developing a chimeric antigen receptor T cell ( CAR-T) therapy that targets ROR1, which is currently in preclinical development as a potential treatment for hematologic cancers and solid tumors. The clinical pipeline also includes TK216, an investigational targeted small-molecule inhibitor of the ETS family of oncoproteins, that is being evaluated in a Phase 1/2 clinical trial for patients with Ewing sarcoma alone and in combination with vincristine chemotherapy. More information is available at globenewswire.com.
Bladerunner
P.S. To my untrained eye, this data looks quite strong to me. Comments?
More on B. Riley's initiation of coverage of MGTA
Magenta Therapeutics Shares Up 16%; B. Riley Initiates at Buy
BY Dow Jones & Company, Inc.
— 12:35 PM ET 05/18/2021
Magenta Therapeutics Inc. ( MGTA
) shares were up 16% to $12.04 in early afternoon trading.
B. Riley initiated coverage on the stock at Buy with a $21 price target.
"We are initiating coverage of Magenta Therapeutics Inc. ( MGTA
) with a Buy rating and a 12-month price target of $21 per share based on our conviction that the company's core pipeline programs could fundamentally revolutionize key prerequisite steps for conducting hematopoietic stem cell transplants," the firm said in an analyst note.
Magenta is a clinical-stage biotechnology company focusing on medicines for stem cell transplant in patients with blood cancers, genetic diseases and autoimmune diseases.
B. Riley said the company's core pipeline is addressing an area of high unmet need, which could enable broader market adoption. B. Riley said that based on its estimates, an additional 12,000 more bone marrow transplants are possible per year in the U.S. and EU if Magenta's lead products are successful. (This is the type of drug that could create its own market, as patients who were previously not eligible or who were very reluctant to seek bone marrow transplant may now do so--Blade)
"We project that the company's mobilization and conditioning programs could bring in a combined $1.5B in risk- unadjusted peak sales, respectively, across a range of indications," the analyst note said.
Bladerunner
MGTA: B. Riley initiates coverage of MGTA with $21 price target
Bladerunner
'Re-opening' looks premature - >>> UK readies for major reopening but new variant sparks worry
Washington Post
By Jill Lawless
May 16, 2021
https://www.washingtonpost.com/politics/uk-readies-for-major-reopening-but-new-variant-sparks-worry/2021/05/16/225910f0-b63a-11eb-bc4a-62849cf6cca9_story.html
LONDON — Travelers in England were packing their bags, bartenders were polishing their glasses and performers were warming up as Britain prepared Sunday for a major step out of lockdown — but with clouds of worry on the horizon.
Excitement at the reopening of travel and hospitality vied with anxiety that a more contagious virus variant first found in India is spreading fast and could delay further plans to reopen.
Cases of the variant have more than doubled in a week in the U.K., defying a sharp nationwide downward trend in infections and deaths won by hard-earned months of restrictions and a rapid vaccination campaign. A surge in testing and stepped-up vaccination effort was being conducted in the northern England areas hardest hit by that variant.
Health Secretary Matt Hancock said the variant, formally known as B.1.617.2, is more transmissible than the U.K.’s main strain and “it is likely it will become the dominant variant.”
“This isn’t over yet,” Hancock told the BBC on Sunday. “The virus has just gained a bit of pace and we’ve therefore all got to be that bit much more careful and cautious.”
On Monday, people in England will be able to eat a restaurant meal indoors, drink inside a pub, go to a museum, hug friends and visit one another’s homes for the first time in months. A ban on overseas holidays is also being lifted, with travel now possible to a short list of countries with low infection rates. Scotland, Wales and Northern Ireland are following similar but slightly different reopening paths.
Patrick Dardis, chief executive of brewery and pub chain Young’s, said the indoor opening — which follows the reopening of outdoor patios and beer gardens last month — is “a big step back on to the path to normality.”
“The weather has been pretty dire, and people are hardy, but we really needed this next step to come,” he said.
But hospitality and entertainment venues say they won’t be able to make money until they can open at full capacity. That’s due to happen June 21, the date set by the government for lifting its remaining COVID-19 restrictions, including social distancing and mask-wearing rules.
Prime Minister Boris Johnson has said if the new variant causes a big surge in cases, it could scupper that plan.
Britain has recorded almost 128,000 coronavirus deaths, the highest reported toll in Europe. But new infections have plummeted to an average of around 2,000 a day, compared with nearly 70,000 a day during the winter peak, and deaths have fallen to single figures a day.
Almost 70% of British adults have received a first dose of a coronavirus vaccine, and more than 37% have had both doses.
Health officials, backed by the army, are carrying out surge testing in Bolton and Blackburn in northwest England, where cases of the new variant are clustered, and pop-up vaccination sites have been set up to speed the inoculation drive. Across the country, the government is shortening the gap between doses for people over 50 from 12 to eight weeks in a bid to give them more protection.
Hancock said scientists had a “high degree of confidence” that current vaccines work against the Indian-identified variant.
Critics of Britain’s Conservative government say lax border rules allowed the new variant to enter the country. They accuse the government of delaying a ban on visitors from India, which is experiencing a devastating coronavirus outbreak, because it is seeking a trade deal with the vast country.
India was added to the U.K.’s high-risk “red list” on April 23, weeks after neighbors Pakistan and Bangladesh.
“We shouldn’t be in this situation,” said opposition Labour Party lawmaker Yvette Cooper. “This was not inevitable.”
The government denies that its health policies were influenced by political or trade considerations.
Mark Walport, a member of the government’s Scientific Advisory Group for Emergencies, said Britain was at a “perilous moment,” and people should be cautious with their new freedoms.
“My advice is that just because you can do something doesn’t necessarily mean you should,” he told Sky News. “As far as possible, socialize outside, maintain social distancing. If you’re going to hug, hug cautiously.”
<<<
>>> Oppenheimer Starts F-Star Therapeutics Inc. (FSTX) at Outperform
StreetInsider.com
April 15, 2021
https://www.streetinsider.com/Analyst+Comments/UPDATE%3A+Oppenheimer+Starts+F-Star+Therapeutics+Inc.+%28FSTX%29+at+Outperform/18268042.html?classic=1
Oppenheimer analyst Jartaj Singh initiates coverage on F-Star Therapeutics Inc. (NASDAQ: FSTX) with a Outperform rating and a price target of $30.00.
The analyst comments "We are initiating coverage on F-star Therapeutics (FSTX) with an Outperform rating and a $30 PT. We believe FSTX screens well among various bispecific antibody (BsAbs) platforms evolving rapidly in the past two years, given the company platform's ability to leverage the three key features of BsAbs: conditionality / crosslinking / clustering through its molecules' Fc-gamma receptor (Fc?R) independent tetravalent binding and generate uncorrelated high-value oncology assets. In our opinion, FSTX's story has checked the boxes for:
(1) a biomarker-driven targeted oncology approach identifying a patient population subset that allows accelerated approval;
(2) enhanced risk/benefit profile with low immunogenicity/high-affinity target engagement/no hook effect/etc.;
(3) unveiling novel target synergy unattainable by mAbs combination; and
(4) experienced/execution-focused management. We are bullish on the story."
For an analyst ratings summary and ratings history on F-Star Therapeutics Inc. click here. For more ratings news on F-Star Therapeutics Inc. click here.
Shares of F-Star Therapeutics Inc. closed at $9.85 yesterday.
<<<
BPTH reports 1st quarter results.
Company is being valued at cash; EV of ZERO. It would seem to be worth more than that. Unknown on The Street. A lottery ticket.
GlobeNewswire
Bio-Path Holdings Reports First Quarter 2021 Financial Results
Bio-Path Holdings, Inc.
Fri, May 14, 2021, 4:00 AM
BPTH
+0.78%
Conference Call to be Held Today at 8:30 A.M. ET
HOUSTON, May 14, 2021 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced its financial results for the first quarter ended March 31, 2021 and provided an update on recent corporate developments.
“The start of 2021 has been marked by substantial progress across our portfolio of targeted nucleic cancer drugs which included both presented and published data in support of our DNAbilize platform,” stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. “We recently announced the successful completion of the safety run-in of Stage 2 of the Phase 2 clinical study of prexigebersen for the treatment of acute myeloid leukemia (AML) in combination with frontline therapies, decitabine and venetoclax. This was particularly important as the efficacy portion of this study will include de novo fragile AML patients for whom a clean safety profile will be critical.”
“Last month, we were particularly pleased to have supportive preclinical data from our BP1002 program presented before an audience of world-leading cancer specialists at the AACR Annual Meeting and to have published an analysis highlighting the potential of prexigebersen within the oligonucleotide drug delivery landscape in the peer-reviewed journal, Biomedicines. This presentation and publication significantly enhanced the oncology community’s awareness of the potential for our DNAbilize platform in a variety of hard to treat cancers and we look forward to building on this momentum throughout the remainder of this year,” continued Mr. Nielsen.
Recent Corporate Highlights
Announced Publication in Biomedicines. In April, Bio-Path announced the publication of an analysis highlighting the potential of prexigebersen (BP1001) within the antisense oligonucleotide drug delivery landscape in the peer-reviewed journal, Biomedicines.
Presented BP1002 Data at 2021 AACR Annual Meeting. In April, Bio-Path presented a poster highlighting preclinical BP1002 data at the 2021 American Association for Cancer Research (AACR) Annual Meeting. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with poor prognosis for patients diagnosed with AML. The data presented in the AACR poster show that venetoclax-resistant cells are sensitive to the inhibitory effects of BP1002 combined with decitabine, suggesting that this combination is a potential treatment for patients who have relapsed from frontline venetoclax-based therapies.
Successfully Completed Safety Cohort of Triple Combination in Stage 2 of Phase 2 Clinical Trial in AML. In April, Bio-Path announced the successful completion of the safety run-in of Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of acute myeloid leukemia (AML), in combination with frontline therapies, decitabine and venetoclax, in acute myeloid leukemia (AML) patients. The safety run-in of Stage 2 of the Phase 2 clinical trial was comprised of six evaluable patients who were treated with the triple combination of prexigebersen, decitabine and venetoclax.
Raised $13.0 Million in Public Offering. In February, Bio-Path announced the closing of a public offering for 1,710,600 shares of common stock at a price of $7.60 per share, for aggregate gross proceeds to the Company of approximately $13.0 million, before deducting the fees and estimated offering expenses payable by the Company.
Received Third U.S. Patent Grant Related to Manufacture of Platform Technology. In February, Bio-Path announced that the United States Patent and Trademark Office granted U.S. Patent No. 10,898,506 titled, "P-ethoxy nucleic acids for liposomal formulation." The new patent builds on earlier patents granted that protect the platform technology for DNAbilize®, the Company’s novel RNAi nanoparticle drug.
Financial Results for the First Quarter Ended March 31, 2021
The Company reported a net loss of $2.4 million, or $0.43 per share, for the three months ended March 31, 2021, compared to a net loss of $3.3 million, or $0.90 per share, for the three months ended March 31, 2020.
Research and development expense for the three months ended March 31, 2021 decreased to $1.3 million, compared to $2.0 million for the three months ended March 31, 2020 primarily due to decreased preclinical expense related to timing of activities for BP1003 as well as decreased clinical trial expense due to timing of activities for our Phase 2 clinical trial of prexigebersen in AML and our Phase 1 clinical trial of BP1002 in lymphoma.
General and administrative expense for the three months ended March 31, 2021 decreased to $1.2 million, compared to $1.3 million for the three months ended March 31, 2020 primarily due to decreased franchise tax expense.
As of March 31, 2021, the Company had cash of $30.8 million, compared to $13.8 million as of December 31, 2020. Net cash used in operating activities for the three months ended March 31, 2021 was $1.6 million compared to $2.5 million for the comparable period in 2020. Net cash provided by financing activities for the three months ended March 31, 2021 was $18.6 million.
Conference Call and Webcast Information
Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these first quarter 2021 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 5064037. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.
About Bio-Path Holdings, Inc.
Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous infusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers, and prexigebersen-A, a drug product modification of prexigebersen, is under consideration by the FDA to commence a Phase 1 study in solid tumors. This is followed by BP1002, targeting the Bcl-2 protein, where it is being evaluated in a Phase 1 study in advanced lymphoma and CLL patients.
For more information, please visit the Company's website at http://www.biopathholdings.com.
Bladerunner
$IBIO IBIO-201, the Company’s vaccine candidate combining antigens derived from the spike protein (“S protein”) fused with iBio’s patented LicKM™ booster molecule, recently completed IND-enabling toxicology studies. The studies identified no adverse effects at low or high doses.
“Combined with data from previous immune-response studies, these pathology results help demonstrate the potential value of LicKM as a useful tool in our vaccine development toolbox,” said Tom Isett, Chairman and CEO of iBio.
https://ir.ibioinc.com/news-events/press-releases/detail/157/ibio-reports-successful-covid-19-vaccine-toxicology-study
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