With the spotlight firmly on Covid variants, it’s easy to lose sight of what will probably be the most important segment of the biopharma space over the next ten years: oncology. This is where the biggest success stories will be found. It’s where the largest revolutions will happen. It’s the epicenter of the most important advances we will make in healthcare over coming years.
However, because so much attention is currently being paid to Covid plays, interesting developments in the oncology space are happening with relatively little fanfare, presenting some interesting opportunities for investors.
At the same time, the pick-up in volatility across the market stands to drive capital away from cyclical names and companies highly correlated with the major indices, including big-cap tech names. Cancer drugs represent a long-term growth theme with no cyclical correlation, no ties to supply chain issues, no risk associated with Covid variants, and a ton of potential value in play that has been out of favor over recent months.
With that in mind, we take a look below at some of the most interesting stories among oncology biopharma stocks.
Regeneron Pharmaceuticals Inc. (Nasdaq:REGN) is a biotechnology company, which engages in the discovery, invention, development, manufacture, and commercialization of medicines. The company’s product portfolio includes the following brands: EYLEA, Dupixent, Praluent, Kevzara, Libtayo, ARCALYST, and ZALTRAP.
The firm accelerates the traditional drug development process through its proprietary VelociSuite technologies such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully-human antibodies and bispecific antibodies.
Regeneron Pharmaceuticals Inc. (Nasdaq:REGN) recently announced that new and updated data from its diverse hematology program in blood cancers and disorders will be presented at the 2021 American Society of Hematology (ASH) Annual Meeting from December 11-14 in Atlanta, GA.
“Our hematology portfolio continues to expand with multiple trials now underway to investigate our bispecific antibodies, RNA-based therapies and gene editing, among other approaches,” said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Hematology at Regeneron. “Our diverse pipeline includes investigational medicines across several blood cancers including multiple myeloma and lymphoma, in addition to blood disorders such as paroxysmal nocturnal hemoglobinuria, aplastic anemia, amyloidosis and thrombosis. We continue to make progress across our hematology portfolio with eight assets currently in the clinic.”
Even with that news, the action hasn’t really heated up in the stock, with shares moving net sideways over the past week. REGN shares have been relatively flat over the past month of action, with very little net movement during that period.
Regeneron Pharmaceuticals Inc. (Nasdaq:REGN) pulled in $3.5B during the company’s most recently reported quarterly financial data, powering dramatic growth topping 50%. In addition, the company has a strong balance sheet, with cash levels exceeding current liabilities ($5.8B against $3.7B).
Oncotelic Therapeutics Inc (OTC US:OTLC) is a small-cap player that looks like it’s starting to really break onto the scene in both the oncology and virology markets. The company has developed a first-in-class anti-TGF-β RNA therapeutic, OT-101, that has exhibited single agent activity in relapsed/refractory cancer patients. OT-101 also has shown activity against SARS-CoV-2 and has completed a phase 2 trial against COVID-19, with data analysis in progress. As a Covid asset, it should function agnostic of variants, which is obviously becoming an increasingly important factor.
However, as an oncology treatment, OT-101 is advancing along several paths right now. And the latest one pits it alongside KEYTRUDA, which is one of the most important cancer drugs to emerge over the past two decades.
Oncotelic Therapeutics Inc (OTC US:OTLC) announced this week that it has submitted clinical study protocol information to the US FDA for the initiation of a Phase 2 Trial (designated “M201”) for OT-101 in combination with Keytruda, a leading anti-PD-1 drug, as a treatment for patients with Malignant Pleural Mesothelioma (MPM).
This is part of a larger OT-101 oncology program designed to assess the impact of the treatment across multiple cancer indications where local tumoral secretion of TGF-β suppressed the clinical activity of checkpoint inhibitors, CAR-T, and vaccine. The OT-101-ONC program has been moving forward steadily through strategic alliance with top pharmaceutical companies. Of note is the biomarker program spanning mesothelioma, glioblastoma, lung and colorectal cancers, where AI driven transcriptome analyses will be used to derive the predictive biomarker for TGF-β therapeutics such as OT-101.
“This is the first of a series of planned clinical trials in patients with various solid tumors evaluating clinical benefit while also assessing a host of parameters associated with changes in the tumor microenvironment, including but not limited to T-cell infiltration, expression of various cytokines, and phenotypic and functionality changes pre-therapy versus post-therapy.” noted Dr. Anthony Maida, Chief Clinical Office – Translational Medicine.
Oncotelic Therapeutics Inc (OTC US:OTLC) CEO Dr. Vuong Trieu stated, “The groundwork laid down by OT-101/IL-2 and OT-101/PD-1 will serve as the foundation for future strategic alliances for OT-101/CAR-T and OT-101/Vaccines. CAR T-cell therapy, in which a patient’s immune T cells are modified so they will bind to cancer cells and kill them, has been shown to benefitted greatly from TGF-β inhibition in early clinical testing.”
Amgen Inc. (Nasdaq:AMGN) engages in the discovery, development, manufacture and marketing of human therapeutics.
The company’s products include the following brands: Aranesp, Aimovig, KANJINTI, EVENITY, AMGEVITA, AVSOLA, BLINCYTO, MVASI, Corlanor, Enbrel, EPOGEN, IMLYGIC, Kyprolis, Neulasta, NEUPOGEN, Nplate, Parsabiv, Prolia, Repatha, Sensipar, Vectibix, Otezla, RIABNI, and XGEVA.
Amgen Inc. (Nasdaq:AMGN) recently announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending conditional marketing authorization of LUMYKRAS® (sotorasib), known as LUMAKRAS® in the U.S., for the treatment of adults with advanced non-small-cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy. If the European Commission follows the recommendation for approval, LUMYKRAS will be the first targeted therapy available in the European Union (EU) for the KRAS G12C mutation, one of the most prevalent biomarkers in NSCLC.
“After 40 years of cancer research to target the KRAS mutation, many in the scientific community believed that KRAS was ‘undruggable’ leaving patients with this mutation with limited treatment options,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “The LUMYKRAS development program was designed to bring this targeted therapy to patients with KRAS G12C-mutated non-small cell lung cancer as quickly as possible. The EMA CHMP positive opinion brings patients in the EU closer to this transformative therapy and highlights our commitment to improving patient outcomes in difficult-to-treat cancers.”
Even in light of this news, AMGN hasn’t really done much of anything over the past week, with shares logging no net movement over that period. Over the past month, shares of the stock have suffered from clear selling pressure, dropping by roughly -5%.
Amgen Inc. (Nasdaq:AMGN) managed to rope in revenues totaling $6.7B in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 5.2%, as compared to year-ago data in comparable terms. In addition, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($12.9B against $14.8B, respectively).
Other key stocks in the oncology biopharma space include Illumina Inc. (Nasdaq:ILMN), Eli Lilly & Co. (NYSE:LLY), Gilead Sciences Inc. (Nasdaq:GILD), and Merck & Co. Inc. (NYSE:MRK).
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The post Biotech Growth Stocks Set to Benefit from Rising Volatility (REGN, OTLC, AMGN, ILMN, LLY, GILD, MRK) appeared first on Wall Street PR.nasdaq stocks covid-19 small-cap otc vaccine treatment testing fda clinical trials antibodies therapy rna epicenter european eu
New Zealand Ousts Leftist Lockdown Loons After Conservative Wins Election
New Zealand Ousts Leftist Lockdown Loons After Conservative Wins Election
Voters in New Zealand on Saturday ousted the party once led by Jacinda…
Voters in New Zealand on Saturday ousted the party once led by Jacinda Ardern, and have instead elected the country's most conservative government in decades.
On Saturday, conservative Christopher Luxon was elected New Zealand's next prime minister. While the exact makeup of Luxon's government has yet to be determined, his center-right National party looks set to form a coalition government with one or two minor parties.
The National Party will likely combine its indicated 50 seats with the ACT party (11 seats), to give them 61 seats, providing a slim majority in the 121-seat New Zealand parliament. As Goldman notes, the results are largely in line with pre-election polling, with the incumbent Labour party on track to lose their outright majority in parliament for the first time since 2017.
"You have reached for hope and you have voted for change," Luxon told supporters to rapturous applause at an event in Auckland, alongside his wife Amanda and their children.
Outgoing Prime Mininster Chris Hipkins, who's held the job for nine months following the abrupt resignation of Jacinda Ardern, told supporters late Saturday that he'd called Luxon to concede.
Hipkins said that while the result wasn't his desired outcome, "I want you to be proud of what we achieved over the last six years," he told supporters in Wellington.
On the economic front, Goldman notes that Luxon's party has vowed to reduce effective tax rates on incomes and investment parties. And while National has pledged to offset the fiscal impact of tax cuts with savings elsewhere, Goldman sees the risks as "skewed to more stimulatory fiscal policy in 2024" vs New Zealand's current fiscal projections.
The proposed tax cuts and new spending amounts to around 0.8% of annual GDP, which would boost household disposable income by around 1.5% and also provide a tailwind to house prices in 2024. While National has pledged to offset the new spending and lower taxes with a reduction in spending and new taxes, overall we view the risks as skewed to more fiscal stimulus (compared to the current fiscal projections) and additional rate hikes from the RBNZ (GSe: base case on hold at 5.5%).
Luxon has also addressed crime in New Zealand, telling supporters that it's "out of control," adding "And we are going to restore law and order, and we are going to restore personal responsibility."
He's also vowed to fix the capital's traffic woes with a new tunnel project.
“We Can’t Force The Human Body To Accept Foreign Genetic Code” Dr. McCullough On mRNA Technology
"We Can’t Force The Human Body To Accept Foreign Genetic Code” Dr. McCullough On mRNA Technology
Authored by Naveen Athrappully via The Epoch…
Authored by Naveen Athrappully via The Epoch Times (emphasis ours),
Cardiologist Dr. Peter McCullough warned that messenger RNA (mRNA) vaccines inject “foreign genetic code” into human beings, which the body fails to break down or expel for a prolonged period of time.
Research on mRNA “has been going on for decades,” Dr. McCullough said during an Oct. 5 interview. The 2023 Nobel Prize for medicine was awarded to two scientists for making “messenger RNA long-lasting in the human body,” he said. “I mean, it has been tested in multiple applications … It's an absolute bust. It was just the worst idea ever to install the genetic code for a lethal protein without being able to shut it off. It wasn't the fact that it was rushed; it's just ill-conceived from the very beginning.”
“We can't force the human body to accept foreign genetic code and produce a foreign protein … Messenger RNA for vaccines is a completely failed concept. It’s a dangerous concept, and the U.S. government wasn't honest. They should have been honest. Trump should have come out and said, ‘Listen, it's on our website; our military's been working on this since 2012.’”
During a testimony at the European Parliament last month, Dr. McCullough said, “There's not a single study showing that the messenger RNA is broken down” in the human body once it is injected.
“There's not a study showing it leaves the body.” Since the vaccines are “made synthetically, they cannot be broken down.”
He added that the lethal protein from the [COVID-19] vaccines found in the human body after vaccination was found to be circulating “at least for six months, if not longer.”
In the case of seasonal jabs, that is, taking an injection or booster at the end of six months as recommended by the authorities, “there's another installation in more circulating potentially lethal protein.”
Scientist Drew Weissman, who won the 2023 Nobel Prize in Medicine for his role in developing mRNA technology, warned in a 2018 paper that not only did clinical trials of mRNA vaccines produce “more modest [results] in humans than was expected based on animal models,” but that the “side effects were not trivial.”
Dr. Mccullough’s comments come as the Gates Foundation is spending $40 million on countries in Africa and other economically backward nations to produce new mRNA vaccines in efforts to prevent diseases like tuberculosis and malaria.
Concealing a ‘Global Security Threat’
In the Steve Deace interview, Dr. McCullough said that the ineffectiveness of the technology was not unknown to the government since they’ve been testing it for nearly 40 years.
He referred to a February 2023 paper published in the British Medical Journal (BMJ), which cited that the U.S. government has been investing billions of dollars in developing messenger RNA technology since 1985.
The Defense Advanced Research Projects Agency (DARPA) began investing in mRNA tech in 2011. DARPA then launched the Pandemic Prevention Platform (P3) program in 2016 that sought to produce “relevant numbers of doses” against infections within 60 days of identifying them.
The ADEPT P3 was a program by the U.S. military “to end pandemics in 60 days.” There is no other technology “that our government has invested more in,” Dr. McCullough said.
Dr. McCullough cited another paper that stated there were “over 9,000 patents on messenger RNA. And all the patent assignees are big entities. At the top is Sanofi, then Cervavac, BioNTech, Moderna, and the U.S. government. No single person invented messenger RNA. Someone who comes up in 2021 and says, ‘You know I invented it’. That's impossible. This has been going on for decades.”
Dr. McCullough pointed out that the United States and China have been in “collaboration for years” in their research on infectious and lethal coronavirus.
However, officials like Anthony Fauci, the former head of the National Institutes of Allergy and Infectious Diseases (NIAID), Francis Collins, the former head of the National Institutes of Health (NIH), and “a whole cadre of scientists, they collaborated to conceal this global security threat.”
“They actually intentionally lied to the world and said the virus came out of nature. They knew it came out of the Wuhan lab,” he said, citing a research paper by Ralph Baric and Dr. Zhengli-Li Shi that was published in the Nature journal in 2015.
Dr. Zhengli-Li Shi is affiliated with the Wuhan Institute of Virology, while Mr. Baric is from the Department of Epidemiology, University of North Carolina at Chapel Hill.
“They said they created SARS-CoV-2 virus. They called it the Wuhan Institute of Virology 1 virus. That was the prototype SARS-CoV-2. So, that's in 2015. Instead of bringing Ralph Baric out [and asking] ‘Dr. Baric, how do we get ourselves out of this disaster,’ you masterminded this virus funded by the US.”
‘Pull All COVID-19 Vaccines Off the Market’
In his interview, Dr. McCullough made three recommendations. “I say number one, I've called in the US Senate [and] now the European Parliament [to] pull all COVID-19 vaccines off the market before anyone else is harmed.”
“Number two, US, EU and all westernized Nations [should] pull out of the WHO. They're not trustable. And number three, I'm following the World Council for Health. I am recommending a halt on all childhood vaccines, the entire vaccine schedule until this is clarified since messenger RNA is now on the schedule without any concerns for safety.
While some studies related to the safety of COVID-19 vaccines have shown the jabs to be safe, others have raised concerns about the safety of the shots.
A December 2022 study analyzed trials comparing vaccine recipients with individuals who did not receive a vaccine or were given a placebo.
It concluded that “compared to placebo, most vaccines reduce, or likely reduce, the proportion of participants with confirmed symptomatic COVID-19, and for some, there is high-certainty evidence that they reduce severe or critical disease.”
However, a June 2022 study that looked at mRNA vaccinations found that “Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest (AESI).”
“The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials.”
‘Shedding’ the Infection
During the interview, Mr. Deace asked about hearing issues that he and his colleague suffered and whether they had any ties with the vaccines. While he did not take a COVID-19 shot, the colleague was vaccinated. Mr. Deace asked if this was “further proof that basically the last few years Peter everybody was a lab rat whether you took the vaccine or not.”
“It's true, nearly all of us have been exposed to the Wuhan spike protein,” Dr. McCullough replied. “When I see patients in the office, we check antibodies against the spike protein. Invariably, they're elevated. Rarely, I'll find somebody who hasn't been exposed.”
Dr. McCullough pointed out that there are “clear-cut papers” showing individuals suffering hearing loss after taking COVID-19 jabs. “It's all related to the spike protein,” he said. mRNA vaccines work by instructing cells in the body to produce the spike protein found on the surface of the COVID-19 virus.
Once vaccinated, an individual’s muscle cells begin producing spike protein pieces, displaying them on cell surfaces, which end up triggering the immune system to create antibodies. When such an individual gets infected with the COVID-19 virus, these antibodies will then fight the virus.
Dr. McCullough warned that even people who have not received mRNA COVID-19 vaccines can eventually get affected by messenger RNA through a vaccinated individual via “shedding.”
“Shedding means that one has been exposed to the spike protein or to the messenger RNA from close contact with another individual. We know both of them can travel via exosomes which are small phospholipid packets that can be exhaled [via] breath, through sweat, [and] various forms of body fluid, typically you know very close contact.”
“There was a big project called the Eva project in the UK showing 78 percent of women who take a vaccine—they actually have menstrual abnormalities. And those who even didn't take a vaccine, they end up having menstrual abnormalities. There's been plenty of these reports that have occurred.”
Dr. McCullough cited an interview he did with scientist Helene Banoun, an expert on shedding, who believes such things “clearly happens, for sure, in people who've taken the vaccine within 30 days, close contact.”
“Now, two studies—one in the United States, one in Japan—[show] the messenger RNA comes through breast milk. The spike protein may be shedded potentially for a much longer duration of time. It's been shown in the human body now for months, maybe even years afterward. And that's the rationale for what our recent proposal to actually undergo spike protein detoxification.”
The cardiologist pointed out that “every signal” related to cardiovascular disease, neurologic disease, blood clots, immune disease, and cancer “is up.”
“There can be debates on why all these chronic diseases are up, all-cause mortality up in every single area of the world,” he said. “The two big exposures we've had are COVID-19 infection and now COVID-19 vaccines, and I think both mechanisms have led to this wave of disease.”
“I think more powerfully with the vaccines since the vaccines are largely genetic, they're given every six months, and they install the genetic code for the disease-promoting and lethal Wuhan spike protein.”
Rent Control Is A Disaster – Don’t Let It Spread Across The Nation
Rent Control Is A Disaster – Don’t Let It Spread Across The Nation
Authored by Betsy McCaughey via The Epoch Times,
America’s renters -…
America’s renters - more than one-third of the nation’s households - are in for trouble.
Left-wing politicians are demanding rent regulation from coast to coast. Wherever it is adopted, the result will be a disastrous reduction in the rental housing supply, leaving renters desperate for places to live.
New York is the poster child for the failures of rent regulation. The U.S. Supreme Court is currently mulling a challenge to the constitutionality of the city’s rent regime.
Whatever the justices decide, the public needs to consider less destructive, more targeted ways to help low-income people pay for housing. The court of public opinion needs to consider these facts.
Fact No. 1: Rent regulation isn’t targeted to the poor.
In New York, there’s no means test. What you need is luck or connections. The mean income of a rent-stabilized apartment dweller is $47,000, but census data show that tens of thousands of them earn more than $150,000 per year. Some occupants use what they’re saving on rent to pay for a weekend place in the Hamptons or New England.
The pols don’t object—a sure sign they’re calling for rent regulation to help themselves politically, not the poor.
In New York, 44 percent of rental apartments are regulated by the Rent Guidelines Board (RGB), established in 1969, which sets the maximum amount by which landlords are allowed to raise the rent. Those limits apply to all buildings of six or more units built before 1974.
In 2022, the RGB set the maximum rent hike at 3.25 percent on one-year leases and this year at 3 percent. Never mind that last year, fuel costs to heat the buildings soared by 19 percent and overall inflation hit 8.3 percent.
The decisions are political, not economic. Many Democratic politicians vilify building owners as “greedy landlords” and depict themselves as the champions of the downtrodden. It’s a scam.
Fact No. 2: Winners and losers.
The winners are the lucky few with rent-regulated apartments and the pols who count on an army of tenant activists to turn out at the polls. The losers are the 56 percent of renters who don’t score a regulated apartment and have to scour neighborhoods for an unregulated place that they can afford. They’re paying more.
Why? Because regulation causes some landlords to walk away, reducing the overall supply of apartments. The laws of supply and demand mean rents go up. New Yorkers in unregulated apartments are paying the highest rents in the United States for a one-bedroom apartment. They're the real victims, and they should be furious.
Yet the left-wing press pretends that rent control offers only benefits. The New Republic warns that the Supreme Court challenge threatens “laws that have benefitted the city’s tenants for generations.” Sorry, untrue—only some tenants, and not always the neediest.
It’s economic madness. The saner way to help those who need assistance paying rent is with a voucher. We offer the needy SNAP debit cards to help them pay for groceries. No one slaps price controls on grocery stores or designates certain stores as “regulated,” forcing them to sell at below cost.
Yet New York forces certain landlords to pay what should be a public cost shared by all, an argument made to the court.
Fact No. 3: The Marxist fantasy that rent regulation will help the poor is spreading across the United States and Europe as well.
Maine and Minnesota have enacted laws allowing municipalities to impose rent regulations. In November 2024, California voters will be asked to approve a proposition allowing local governments to add additional restrictions to the state’s existing rent caps.
The laws of supply and demand are international. Berlin froze rents in 2019, and the rental supply plummeted, according to the Ifo Institute, a think tank.
Yet London Mayor Sadiq Khan is calling for freezing rents for two years. London provides housing vouchers to the poor—a smarter approach—but when the city froze the voucher amounts during the COVID-19 pandemic, fewer apartments were available in the price range. The answer is to raise the voucher amount. Freezing rents will only make the shortage worse.
Ignore the demagogues. The evidence is in: Rent regulation is a political scam. There are better ways to help Americans afford a place to live.
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