Connect with us

Science

Regeneron inks $1B+ deal for global rights to Sanofi-partnered PD-1 Libtayo

Sanofi CEO Paul Hudson made clear earlier this year that his mission to reshape the company would involve some pipeline pruning. For the right price that…

Published

on

Sanofi CEO Paul Hudson made clear earlier this year that his mission to reshape the company would involve some pipeline pruning. For the right price that apparently includes Libtayo, mere months ahead of an expected FDA decision on lung cancer.

Paul Hudson

Regeneron is putting down a whopping $900 million upfront for the full rights to Libtayo, their partnered PD-1 treatment that earned Regeneron $306 million last year, up 13% from the year before.

The Tarrytown, NY-based company is sweetening the deal with an 11% royalty on worldwide net sales. Plus, there’s another $100 million on the line if the drug wins approval in the US or EU in combination with chemotherapy for non-small cell lung cancer patients, and $100 million in potential sales-related milestones over the next two years.

The move is in line with Hudson’s warning earlier this year that some serious program cuts are on the way, this latest one signaling a shift to next-gen cancer meds.

Bill Sibold

“Our early steps with Libtayo in immuno-oncology provided a strong foundation for our revitalized oncology efforts. Now, we are focused on leveraging our internal capabilities and advancing a new generation of oncology medicines,” Sanofi’s EVP of specialty care and North America president Bill Sibold said in a news release.

“We continue to maintain a strong partnership with Regeneron in immunology, and will work closely with them on the seamless transition of Libtayo to ensure there is no impact for patients,” Sibold added.

Prior to the deal, Sanofi and Regeneron co-commercialized Libtayo in the US, while Sanofi held the rights everywhere else. Regeneron CEO Leonard Schleifer spelled out “several compelling reasons” for pursuing the global rights, perhaps most importantly the freedom to explore combination opportunities.

“You can look at what Merck and others are doing, and it sort of gives you a window to where the world is going,” he said on a call with investors. “They are well aware of the loss of exclusivity that might confront them, and they are looking to combine the drug, Keytruda for example, or others, with other agents that will improve the benefit to patients while simultaneously extending the exclusivity.”

Regeneron highlighted a series of potential Libtayo combinations, including with CD3 bispecifics, CD28 bispecifics, and other immune-modulating agents like fianlimab, its anti-LAG-3 candidate. LAG-3 is an immune checkpoint receptor associated with therapeutic resistance to anti-PD-1 therapy. Therefore, scientists believe it could enhance the anti-tumor effect in melanoma patients when combined with Libtayo.

George Yancopoulos

“We believe fianlimab is the first in a series of Libtayo combinations that we can develop to improve treatment for patients with cancer,” CSO George Yancopoulos said on the call while noting that new data from that combination won’t be available until at least 2024.

Libtayo was first approved in 2018 for a type of skin cancer called metastatic cutaneous squamous cell carcinoma, and last year won its second and third approvals in advanced basal cell carcinoma and as a monotherapy for certain advanced NSCLC patients. It has a Sept. 19 PDUFA date in combination with chemo as a first-line treatment for advanced NSCLC, and the EC is expected to decide in the second half of this year.

Earlier this year, Sanofi and Regeneron pulled an application for Libtayo in second-line cervical cancer after the companies and the FDA were not able to align on certain post-marketing studies.

Robert Landry

Sanofi and Regeneron’s partnership dates back to 2003. Over the last 19 years, the duo brought a handful of drugs to market in a collaboration that Hudson once called “one of the most productive in the industry.”

With the global rights to Libtayo, CFO Robert Landry said Regeneron isn’t afraid to explore opportunities outside of its own pipeline.

“We will continue to explore ways to bolster and complement our own research capabilities with externally sourced innovation,” he said, pointing to the company’s recent $250 million all-cash Checkmate Pharmaceuticals buyout as an example.

And it certainly has the cash to work with. Sales last year increased 89% to $16.07 billion, $6.19 billion of which was attributable to the company’s Covid-19 monoclonal antibody REGEN-COV.

“We are not only doing this internally,” Schleifer said. “We’re open for business.”

Read More

Continue Reading

Spread & Containment

Fatigue, headache among top lingering symptoms months after COVID

AUGUSTA, Ga. (Aug. 8, 2022) – Fatigue and headache were the most common symptoms reported by individuals an average of more than four months out from…

Published

on

AUGUSTA, Ga. (Aug. 8, 2022) – Fatigue and headache were the most common symptoms reported by individuals an average of more than four months out from having COVID-19, investigators report.

Credit: Augusta University

AUGUSTA, Ga. (Aug. 8, 2022) – Fatigue and headache were the most common symptoms reported by individuals an average of more than four months out from having COVID-19, investigators report.

Muscle aches, cough, changes in smell and taste, fever, chills and nasal congestion were next in the long line of lingering symptoms.

“Our results support the growing evidence that there are chronic neuropsychiatric symptoms following COVID-19 infections,” Medical College of Georgia investigators write in the journal ScienceDirect

“There are a lot of symptoms that we did not know early on in the pandemic what to make of them, but now it’s clear there is a long COVID syndrome and that a lot of people are affected,” says Dr. Elizabeth Rutkowski, MCG neurologist and the study’s corresponding author.

The published study reports on preliminary findings from the first visit of the first 200 patients enrolled in the COVID-19 Neurological and Molecular Prospective Cohort Study in Georgia, or CONGA, who were recruited on average about 125 days after testing positive for the COVID-19 virus.

CONGA was established at MCG early in the pandemic in 2020 to examine the severity and longevity of neurological problems and began enrolling participants in March 2020 with the ultimate goal of recruiting 500 over five years.

Eighty percent of the first 200 participants reported neurological symptoms with fatigue, the most common symptom, reported by 68.5%, and headache close behind at 66.5%. Just over half reported changes in smell (54.5%) and taste (54%) and nearly half the participants (47%) met the criteria for mild cognitive impairment, with 30% demonstrating impaired vocabulary and 32% having impaired working memory.

Twenty-one percent reported confusion, and hypertension was the most common medical condition reported by participants in addition to their bout with COVID-19.

No participants reported having a stroke, weakness or inability to control muscles involved with speaking, and coordination problems were some of the less frequently reported symptoms.

Twenty-five percent met the criteria for depression, and diabetes, obesity, sleep apnea and a history of depression were associated with those who met the criteria. Anemia and a history of depression were associated with the 18% who met the objective criteria for anxiety.

While the findings to date are not surprising and are consistent with what other investigators are finding, Rutkowski says the fact that symptoms reported by participants often didn’t match what objective testing indicated, was surprising. And, it was bidirectional.

For example, the majority of participants reported taste and smell changes, but objective testing of both these senses did not always line up with what they reported. In fact, a higher percentage of those who did not report the changes actually had evidence of impaired function based on objective measures, the investigators write. While the reasons are not certain, part of the discrepancy may be a change in the quality of their taste and smell rather than pure impaired ability, Rutkowski says.

“They eat a chicken sandwich and it tastes like smoke or candles or some weird other thing but our taste strips are trying to depict specific tastes like salty and sweet,” Rutkowski says. Others, for example, may rely on these senses more, even when they are preparing the food, and may be apt to notice even a slight change, she says.

Either way, their data and others suggest a persistent loss of taste and smell following COVID-19, Rutkowski and her colleagues write.

Many earlier reports have been based on these kinds of self-reports, and the discrepancies they are finding indicate that approach may not reflect objective dysfunction, the investigators write.

On the other hand, cognitive testing may overestimate impairment in disadvantaged populations, they report.

The first enrollees were largely female, 35.5% were male. They were an average of 44.6 years old, nearly 40% were Black and 7% had been hospitalized because of COVID-19. Black participants were generally disproportionately affected, the investigators say.

Seventy-five percent of Black participants and 23.4% of white participants met criteria for mild cognitive impairment. The findings likely indicate that cognitive tests assess different ethnic groups differently. And, socioeconomic, psychosocial (issues like family problems, depression and sexual abuse) and physical health factors generally may disproportionately affect Black individuals, the investigators write. It also could mean that cognitive testing may overestimate clinical impairment in disadvantaged populations, they write.

Black and Hispanic individuals are considered twice as likely to be hospitalized by COVID-19 and ethnic and racial minorities are more likely to live in areas with higher rates of infection. Genetics also is a likely factor for their increased risk for increased impact from COVID, much like being at higher risk for hypertension and heart disease early and more severely in life.

A focus of CONGA is to try to better understand how increased risk and effects from COVID-19 impact Blacks, who comprise about 33% of the state’s population.

A reason fatigue appears to be such a major factor among those who had COVID-19 is potentially because of levels of inflammation, the body’s natural response to an infection, remain elevated in some individuals. For example, blood samples taken at the initial visit and again on follow up showed some inflammatory markers were up and stayed up in some individuals.

These findings and others indicate that even though the antibodies to the virus itself may wain, persistent inflammation is contributing to some of the symptoms like fatigue, she says. She notes patients with conditions like multiple sclerosis and rheumatoid arthritis, both considered autoimmune conditions that consequently also have high levels of inflammation, also include fatigue as a top symptom.

“They have body fatigue where they feel short of breath, they go to get the dishes done and they are feeling palpitations, they immediately have to sit down and they feel muscle soreness like they just ran a mile or more,” Rutkowski says.

“There is probably some degree of neurologic fatigue as well because patients also have brain fog, they say it hurts to think, to read even a single email and that their brain is just wiped out,” she says. Some studies have even shown shrinkage of brain volume as a result of even mild to moderate disease. 

These multisystem, ongoing concerns are why some health care facilities have established long COVID clinics where physicians with expertise in the myriad of problems they are experiencing gather to see each patient.

CONGA participants who reported more symptoms and problems tended to have depression and anxiety.

Problems like these as well as mild cognitive impairment and even impaired vocabulary may also reflect the long-term isolation COVID-19 produced for many individuals, Rutkowski says.

“You are not doing what you would normally do, like hanging out with your friends, the things that bring most people joy,” Rutkowski says. “On top of that, you may be dealing with physical ailments, lost friends and family members and loss of your job.”

For CONGA, participants self-report symptoms and answer questions about their general state of health like whether they smoked, drank alcohol, exercised, and any known preexisting medical conditions. But they also receive an extensive neurological exam that looks at fundamentals like mental status, reflexes and motor function. They also take established tests to assess cognitive function with results being age adjusted. They also do at-home extensive testing where they are asked to identify odors and the ability to taste sweet, sour, bitter, salty, brothy or no taste. They also have blood analysis done to look for indicators of lingering infection like those inflammatory markers and oxidative stress.

Neuropsychiatric symptoms are observed in the acute phase of infection, but there is a need for accurate characterization of how symptoms evolve over time, the investigators write.

And particularly for some individuals, symptoms definitely linger. Even some previously high-functioning individuals, who normally worked 80 hours a week and exercised daily, may find themselves only able to function about an hour a day and be in the bed the remainder, Rutkowski says.

The investigators are searching for answers to why and how, and while Rutkowski says she cannot yet answer all their questions, she can tell them with certainty that they are not alone or “crazy.”  

One of the best things everyone can do moving forward is to remain diligent about avoiding infection, including getting vaccinated or boosted to help protect your brain and body from long COVID symptoms and help protect others from infection, Rutkowski says. There is evidence that the more times you are infected, the higher the risk of ongoing problems.

Rutkowski notes that their study findings may be somewhat biased toward high percentages of ongoing symptoms because the study likely is attracting a high percentage of individuals with concerns about ongoing problems.

SARS-CoV-2 is thought to have first infected people in late 2019 and is a member of the larger group of coronaviruses, which have been a source of upper respiratory tract infections, like the common cold, in people for years.

At least part of the reason SARS-CoV-2 is believed to have such a wide-ranging impact is that the virus is known to attach to angiotensin-converting enzyme-2, or ACE2, which is pervasive in the body. ACE2 has a key role in functions like regulating blood pressure and inflammation. It’s found on neurons, cells lining the nose, mouth, lungs and blood vessels, as well as the heart, kidneys and gastrointestinal tract. The virus attaches directly to the ACE2 receptor on the surface of cells, which functions much like a door to let the virus inside.

Experience and study since COVID-19 started both indicate immediate neurological impact can include loss of taste and smell, brain infection, headaches and, less commonly, seizures, stroke and damage or death of nerves. As time has passed, there is increasing evidence that problems like loss of taste and smell, can become chronic, as well as problems like brain fog, extreme fatigue, depression, anxiety and insomnia, the investigators write. Persistent conditions including these and others are now referenced as “long Covid.”

The research was supported by funding from the National Institute of Neurological Disorders and Stroke and philanthropic support from the TR Reddy Family Fund.

Read the full study.


Read More

Continue Reading

Government

TDR’s U.S. Stock Market Preview For The Week Of August 8, 2022

A weekly stock market preview and the data that will impact the tape. Sunday Evening Futures Open – Stock Market Preview Weekend News And Developments…

Published

on

A weekly stock market preview and the data that will impact the tape.

Sunday Evening Futures Open – Stock Market Preview

Weekend News And Developments

Berkshire Hathaway dramatically slowed new investment in the second quarter after setting a blistering pace at the start of the year, as the US stock market sell-off pushed the insurance-to-railroad conglomerate to a $43.8bn loss.

China’s southern island province of Hainan started mass Covid-19 testing on Sunday, locking down more parts of the province of over 10 million residents, as authorities scramble to contain multiple Omicron-driven outbreaks, including the worst in capital Sanya, often called “China’s Hawaii”.

Cuba: 17 missing, 121 injured as fire rages in oil tank farm in Matanzas City

Equity positioning for both discretionary and systematic investors remains in the 12th percentile of its range since January 2010, according to Deutsche Bank published last week.

Fisker Inc. (NYSE:FSR) unveils a process for qualifying US-based reservation holders of the Fisker Ocean all-electric SUV to retain access to the existing federal tax credit. The current $7,500 tax credit would be unavailable should Congress pass the Inflation Reduction Act of 2022 and President Biden signs the legislation into law.

Former Labour prime minister Gordon Brown has called for an emergency budget before the UK hits a “financial timebomb” this autumn. Mr. Brown said millions would be pushed “over the edge” if the government does not address the cost of living crisis.

Israel said Sunday it killed a senior Islamic Jihad commander in a crowded Gaza refugee camp, the second such targeted attack since launching its high-stakes military offensive against the militant group just before the weekend. The Iran-backed militant group has fired hundreds of rockets at Israel in response, raising the risk of the cross-border fighting turning into a full-fledged war.

NexJ Systems (TSX: NXJ) announced financial results for its second quarter ended June 30, 2022.

Rhine river hit by drought conditions, hampers German cargo shipping. According to reports, transport prices have shot up as drought and hot weather have affected water levels in the river Rhine in Germany leading cargo vessels to reduce loads during transportation.

Taiwan’s defense ministry said it had detected 66 Chinese air force planes and 14 Chinese warships conducting activities in and around the Taiwan Strait on Sunday, Reuters reports. Thursday’s drills involved the live firing of 11 missiles.

Unifor: 1,800 members from across the country arrive in Toronto this weekend before Monday’s start to the union’s 4th Constitutional Convention, where delegates will elect a new National President and vote on key priorities and initiatives. Unifor is Canada’s largest union in the private sector, representing 315,000 workers in every major area of the economy. 

U.S. rate futures have priced in a 69% chance of a 75 bps hike at its September meeting, up from about 41% before the payrolls data. Futures traders have also factored in a fed funds rate of 3.57% by the end of the year.

What The Analysts Are Saying…

Anybody that jumped on the ‘Fed is going to pivot next year and start cutting rates’ is going to have to get off at the next station, because that’s not in the cards. It is clearly a situation where the economy is not screeching or heading into a recession here and now.” — Art Hogan, chief market strategist at B. Riley Financial

“It is not a market bottom, things are not going to go up consistently from here because we are going to be buying low tech products for a while, so everyone has something to make up as COVID demand = pre-COVID​, there are fewer units for this. Reality check – unlike ‘Big Tech’, consumer discretionary related companies are offering more cautious guidance.”Morgan Stanley analyst commentary on a potential market bottom

The fact of the matter is this (Aug. 5 nonfarm payroll report) gives the Fed additional room to continue to tighten, even if it raises the probability of pushing the economy into recession. It’s not going to be an easy task to continue to tighten without negative repercussions for the consumer and the economy”. — Jim Baird, chief investment officer at Plante Moran Financial Advisors

“We are surprised to not see investors start to chase upside calls in fear of underperforming the market. People are just watching.” — Matthew Tym, head of equity derivatives trading at Cantor Fitzgerald

What We’re Watching

Psychedelic Sector Gaining Momentum: What started out as bottoming action after a protracted multi-quarter decline has now morphed into a tangible bullish impulse. We believe Netflix new docuseries How To Change Your Mind has played an important roll in the creation of critical mass awareness for the sector—and a rebound in broad market risk assets hasn’t hurt. At the tip of the spear for this sentiment shift is COMPASS Pathways plc (CMPS), which has risen 62.64% since  the docuseries debuted on July 12. Price on the benchmark Horizons Psychedelic Stock Index ETF has now breached the 20-day MA/EMA.

We are watching to see if investor sentiment shifts into laggard names such as Cybin Inc. and MindMed, which has continued to fall following a proposed 15-1 reverse stock split initiative announced this year. Many Tier-2/3 names still 90%+ off their highs…

Revive Therapeutics (RVV:CSE, RVVTF:OTC): This has been on our radar for the last couple of weeks, and remains on our watch list. The company has already confirmed that their statistician is in possession of 210 unblinded patient data for its Phase 3 clinical trial to evaluate Bucillamine to treat COVID-19. The company is currently attempting to revise endpoint data from a hospitalization/death focus to a symptoms focus. If they are to achieve this, it will mark a material event in the course of the trial.

YTD performance (+33.09%), Revive Therapeutics (RVVTF); Red line = 7day EMA

We believe an endpoint decision, either positive or negative, is imminent and will have cause a material price action event.

Consumer Price Index, August 10: Consumer inflation expectations for July are released by the New York Fed, while the University of Michigan’s preliminary survey of consumers for August is on tap. Taken together, these should give investors a better picture of how consumers are feeling about current economic conditions. 

As of June, it’s running at 9.1% on an annual basis. Investors, economists and consumers will be watching to see if price increases are easing as everything from gasoline to food is elevated.

Given the mixed signals on the overall state of the economy (i.e. indications of recession vs. this week’s strong nonfarm payrolls number), CPI will be in-focus by market participants. Scotiabank expects 8.9% y/y (9.1% prior) and 0.4% m/m for headline CPI; ex-food-and-energy: 6.1% y/y led by a 0.6% m/m gain.

Pot stocks earnings continue, with several Tier-1/Teri-2 names reporting including Curaleaf Holdings, Trulieve Cannabis, Marimed Inc., Cronos Group, TerrAscend Corp. and more. Last Wednesday, Green Thumb Industries allayed fears somewhat that this earnings season would be a write-off, producing solid numbers which beat expectations on several key metrics. An additional strong report or two will go a long way to help improve sentiment for a sector that’s been decimated over the past six quarters.

U.S. Economic Calendar

TIME (ET)REPORTPERIODMEDIAN FORECASTPREVIOUS
Monday, August 8
11:00 AMNY Fed 3-year inflation expectationsJuly3.60%
Tuesday, Aug. 9
6:00 AMNFIB small-business indexJuly89.589.5
8:30 AMProductivityQ2-4.30%-7.30%
8:30 AMUnit labor costsQ29.30%12.60%
Wednesday, August 10
8:30 AMConsumer price indexJuly0.30%1.30%
8:30 AMCore CPIJuly0.60%0.70%
8:30 AMCPI (year-over-year)July-8.70%9.10%
8:30 AMCore CPI (year-over-year)July6.10%5.90%
10:00 AMWholesale inventories (revision)June1.90%1.70%
2:00 PMFederal budget (compared with year earlier)July-$302 billion
Thursday, August 11
8:30 AMInitial jobless claimsAug. 6265,000260,000
8:30 AMContinuing jobless claimsJuly 301.42 million
8:30 AMProducer price indexJuly0.20%1.10%
Friday, Aug. 12
8:30 AMImport price indexJuly-0.80%0.20%
10:00 AMUMich consumer sentiment index (preliminary)Aug.5352
10:00 AMUMich 5-year inflation expectations (preliminary)Aug.2.90%

Meme Of The Week

Key Earnings (US Markets)

DateCompanySymbolEarnings estimate
Monday, August 83D SystemsDDD$0.00 per share
BarrickGOLD$0.22
BioNTechBNTX$7.08
EnergizerENR$0.76
News Corp.NWSA$0.08
NovavaxNVAX$5.18
Palantir TechnologiesPLTR$0.03
Take-Two Interactive SoftwareTTWO$0.86
Tyson FoodsTSN$1.97
UpstartUPST$0.08
Tuesday, Aug. 9Akamai TechnologiesAKAM$1.31
AramarkARMK$0.24
Bausch HealthBHC$0.91
Carlyle GroupCG$1.07
CoindeskCOIN-$2.68
Cronos GroupCRON-$0.07
EbixEBIX$0.58
EmersonEMR$1.29
GlobalFoundriesGFS$0.45
Grocery OutletGO$0.24
H & R BlockHRB$1.24
Hilton Grand VacationsHGV$0.88
Hyatt HotelsH$0.03
IAC/InterActiveCorpIAC-$2.35
iRobotIRBT-$1.55
Maxar TechnologiesMAXR$0.12
Norwegian Cruise LineNCLH-$0.83
Plug PowerPLUG-$0.20
Rackspace TechnologyRXT$0.16
Ralph LaurenRL$1.71
RobloxRBLX-$0.26
Spirit AirlinesSAVE-$0.46
Super Micro ComputerSMCI$2.35
SyscoSYY$1.11
The Trade DeskTTD$0.20
TTEC HoldingsTTEC$0.85
Unity SoftwareU-$0.21
Warner Music GroupWMG$0.20
World Wrestling EntertainmentWWE$0.55
Wynn ResortsWYNN-$0.97
Wednesday, August 10AppLovinAPP$0.50
CoherentCOHR$2.13
CoupangCPNG-$0.10
CyberArk SoftwareCYBR$0.01
Dutch BrosBROS$0.07
Fox Corp.FOXA$0.77
Franco-NevadaFNV$0.98
Jack in the BoxJACK$1.42
Manulife FinancialMFC$0.76
MatterportMTTR-$0.14
Pan Am SilverPAAS$0.14
Red Robin GourmetRRGB-$0.16
SonosSONO$0.21
TraegerCOOK$0.04
Wendy’sWEN$0.22
Wolverine World WideWWW$0.65
Thursday, August 11AerCapAER$1.42
BaiduBIDU$10.92
Brookfield Asset ManagementBAM$0.69
Canada GooseGOOS$2.98
Cardinal HealthCAH$1.18
Dillard’sDDS$2.88
Flower FoodsFLO$0.27
IlluminaILMN$0.64
LegalZoomLZ$0.02
Melco Resorts & EntertainmentMLCO-$0.44
NioNIO-$1.36
PoshmarkPOSH-$0.25
Rivian AutomotiveRIVN-$1.63
Ryan Specialty GroupRYAN$0.35
Six FlagsSIX$1.04
Solo BrandsSOLO$0.28
ToastTOST-$0.12
Utz BrandsUTZ$0.12
Warby ParkerWRBY-$0.02
W&T OffshoreWTI$0.37
Wheaton Precious MetalsWPM$0.32
Friday, Aug. 12Broadridge FinancialBR$2.65
Honest CompanyHNST$-$0.09
Spectrum BrandsSPB$1.42

FDA Calendar

None

Source: CNN Business – TDR’s stock market preview sentiment indicator

Past Week What’s Hot… and What’s Not

Source: TradingView – TDR’ stock market preview what’s hot this past week

Top 12 High Short Interest Stocks

TickerCompanyExchangeShortIntFloatShares O/SIndustry
BBBYBed Bath & Beyond Inc.Nasdaq46.38%61.57M79.96MRetail (Specialty Non-Apparel)
ICPTIntercept Pharmaceuticals IncNasdaq43.76%23.62M29.71MBiotechnology & Medical Research
MSTRMicroStrategy IncNasdaq39.29%9.32M9.33MSoftware & Programming
BYNDBeyond Meat IncNasdaq37.91%56.79M63.54MFood Processing
SWTXSpringWorks Therapeutics IncNasdaq37.51%31.64M49.41MBiotechnology & Medical Research
BIGBig Lots, Inc.NYSE37.37%26.49M28.92MRetailers – Discount Stores
EVGOEvgo IncNasdaq35.65%67.76M69.00MUtilities – Electric
UPSTUpstart Holdings IncNasdaq35.60%72.32M84.77MConsumer Lending
BGFVBig 5 Sporting Goods CorpNasdaq34.65%20.85M22.33MRetailers – Miscellaneous Specialty
SRGSeritage Growth PropertiesNYSE34.38%23.58M43.68MReal Estate Operations
NKLANikola CorporationNasdaq32.77%265.95M421.14MAuto & Truck Manufacturers
BLNKBlink Charging CoNasdaq32.54%33.98M50.20MUtilities – Electric

Tags: stock market preview, stock market preview August 8, 2022.

The post TDR’s U.S. Stock Market Preview For The Week Of August 8, 2022 appeared first on The Dales Report.

Read More

Continue Reading

Science

Regen BioPharma Inc (OTCMKTS: RGBP) Breaking Out as Biotech Files Patent on Dendritic Cell Technologies to Augment Efficacy of Survivin mRNA Cancer Immunotherapeutic Vaccine

Regen BioPharma Inc (OTCMKTS: RGBP) is making a powerful reversal rocketing back into penny land on Friday up 46% on $1.6 million in dollar volume. RGBP…

Published

on

Regen BioPharma Inc (OTCMKTS: RGBP) is making a powerful reversal rocketing back into penny land on Friday up 46% on $1.6 million in dollar volume. RGBP has a massive following of shareholders, many of them international that are jumping on board and accumulating heavily now that RGBP has reversed. Several weeks ago, the Company announced the filing with the United States Patent and Trademark Office of a provisional patent application covering utilization of dendritic cell technologies to augment efficacy of its patented survivin mRNA cancer immunotherapeutic vaccine.  RGBP CEO Dr. David Koos stated: “We are proud of our collaborators and colleagues who have worked on our first issued survivin patent, which was filed in 2015, before the world realized the potency of modified-mRNA technology that was first successfully commercialized with the COVID-19 vaccines by Moderna and Pfizer. The currently filed application discloses means of significantly increasing efficacy by combining modified-mRNA with unique cellular immunotherapy as well as adjuvant approaches.  We chose this strategy to maximally protect our intellectual property around this potentially very valuable mRNA cancer immunotherapy vaccine.”  

Microcapdaily has been reporting on RGBP since early last year. The last time we covered the Company we stated among other things: “RGBP is one of the most followed stocks in small caps with a huge investors base and it has a long history of big moves skyrocketing to 8 cents plus twice over the past 12 months. There are also plenty of buyout rumors on RGBP; notably in the July PR Dr. koos stated: “We are proud of our collaborators and colleagues who have worked on our first issued survivin patent, which was filed in 2015, before the world realized the potency of modified-mRNA technology that was first successfully commercialized with the COVID-19 vaccines by Moderna and Pfizer. Rumors are circulating that Dr. Koos has offers for either a B/O or potential joint ventures, licensing, partnerships, or a merger. He wants to get the best offer out there. Regen owns a valuable intellectual property portfolio including 8 issued patents and 13 published patent applications, these patents address enormous billion-dollar markets. RGBP has not seen the kind of volume and interest it showed on Friday in a long time and looks to be preparing to embark on something substantial here.  

Regen BioPharma, Inc. - HomeRegen BioPharma Inc (OTCMKTS: RGBP) is focused on the immunology and immunotherapy space. The Company is focused on rapidly advancing novel technologies through pre-clinical and Phase I/ II clinical trials. Currently, the Company is focused on mRNA and small molecule therapies for treating cancer and autoimmune disorders.  

Regen owns a valuable intelectuable property portfolio including 8 issued patents and 13 published patent applications. Zander Therapeutics, Inc. (a company under common control) has been granted an exclusive license to develop and commercialize IP controlled by the Company for non-human veterinary therapeutic use. Regen has granted an exclusive license to Oncology Pharma, Inc. to develop and commercialize “Antigen specific mRNA cellular cancer vaccines” for the treatment of pancreatic cancer and KCL Therapeutics, Inc. has granted an exclusive license to Oncology Pharma, Inc. to develop and commercialize certain intellectual property for the treatment of colon cancer. 

The Company is led by CEO David Koos who has over 30 years of investment banking and venture capital experience.  He has a deep knowledge of startup businesses, public markers and SEC reporting companies.  Dr. Koos has extensive relationships with large and small financial institutions, hedge funds and entities that Regen BioPharma expects to leverage for company growth. Dr. Koos has a Ph.D. in Sociology and a Doctor of Business Administration with an emphasis in finance.  Additionally, he has authored / co-authored numerous peer reviewed journal articles. Dr. Koos worked hard to get the filings up to date and get the Company compliant which has recently been completed with RGBP now “pink current”  

Earlier this year RGBP announced a program to accelerate the clinical development of its NR2F6 therapies. The Company intends to combine modified mRNA technology with Regen’s existing siRNA (small interfering RNA) intellectual property targeting the NR2F6 nuclear receptor which has been identified as a potentially very important immune cell inhibitor (an immune checkpoint) and cancer stem cell differentiator. mRNA is a single-stranded molecule that carries genetic code from DNA in a cell’s nucleus to ribosomes (the cell’s protein-making machinery).    

Regen has filed an Investigational New Drug Application (IND#16928) for their drug termed tCellVax   with the U.S. FDA. tCellVax is intended to utilize siRNA to silence NR2F6 activity in human immune cells thereby activating these immune cells in such a way that they can attack cancer cells. The Company believes that adding new intellectual property utilizing modified mRNA will profoundly simplify the drug development process and thus speed development. Dyo Biotechnologies has been contracted to assist Regen with the development of the above-mentioned technology. 

To Find out the inside Scoop on RGBP Subscribe to Microcapdaily.com Right Now by entering your Email in the box below

On July 26 RGBP announced the filing with the United States Patent and Trademark Office of a provisional patent application covering utilization of dendritic cell technologies to augment efficacy of its patented survivin mRNA cancer immunotherapeutic vaccine.  

In 2021 the Company was granted US patent # 11,090,332 on composition of matter of survivin modified-mRNA useful for teaching the immune system to kill cancer. In the current patent, specific types of dendritic cells, means of generating specialized dendritic cells, and the planned formulation that will enter clinical trials have been granted patent protection. 

Immunotherapy of cancer represents a very large market which is currently being led by the class of drugs called “checkpoint inhibitors” and “CAR-T” cells.  To date there is no mRNA immunotherapy available for treating cancer. This patent application protects the use of our patented survivin mRNA both as a stand-alone vaccine and as an immunotherapy. 

RGBP CEO Dr. David Koos stated: “We are proud of our collaborators and colleagues who have worked on our first issued survivin patent, which was filed in 2015, before the world realized the potency of modified-mRNA technology that was first successfully commercialized with the COVID-19 vaccines by Moderna and Pfizer. The currently filed application discloses means of significantly increasing efficacy by combining modified-mRNA with unique cellular immunotherapy as well as adjuvant approaches.  We chose this strategy to maximally protect our intellectual property around this potentially very valuable mRNA cancer immunotherapy vaccine.” 

For more on RGBP Subscribe Right Now!

Currently trading at a $55 million market valuation RGBP has 5,024,517,324 shares outstanding and a debt load that has caused significant dilution in the past. But RGBP is an exciting story developing in small caps, at current levels the selling pressure that decimated the share price from over $0.08 to half a penny is gone and buyers have stepped in and are accumulating heavily at current levels. RGBP is no stranger to big moves and has runner in its blood skyrocketing to $0.0819 not once but twice in the past year alone. Several weeks ago, the Company announced the filing with the United States Patent and Trademark Office of a provisional patent application covering utilization of dendritic cell technologies to augment efficacy of its patented survivin mRNA cancer immunotherapeutic vaccine.  RGBP CEO Dr. David Koos stated: “We are proud of our collaborators and colleagues who have worked on our first issued survivin patent, which was filed in 2015, before the world realized the potency of modified-mRNA technology that was first successfully commercialized with the COVID-19 vaccines by Moderna and Pfizer. The currently filed application discloses means of significantly increasing efficacy by combining modified-mRNA with unique cellular immunotherapy as well as adjuvant approaches.  We chose this strategy to maximally protect our intellectual property around this potentially very valuable mRNA cancer immunotherapy vaccine.” Rumors are circulating that Dr. Koos has offers for either a B/O or potential joint ventures, licensing, partnerships, or a merger. He wants to get the best offer out there. Regen owns a valuable intellectual property portfolio including 8 issued patents and 13 published patent applications, these patents address enormous billion-dollar markets. RGBP has not seen the kind of volume and interest it showed on Friday in a long time and looks to be preparing to embark on something substantial here. We will be updating on RGBP when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with RGBP.

Subscribe to Our 100% Free Penny Stock Newsletter. We Have Something Big Coming!

Disclosure: we hold no position in RGBP either long or short and we have not been compensated for this article

The post Regen BioPharma Inc (OTCMKTS: RGBP) Breaking Out as Biotech Files Patent on Dendritic Cell Technologies to Augment Efficacy of Survivin mRNA Cancer Immunotherapeutic Vaccine first appeared on Micro Cap Daily.

Read More

Continue Reading

Trending