Connect with us

Government

Biotech Investors Eye the Explosive PD1 Oncology Opportunity (MRK, OTLC, BMY, RHHBY, BGNE, GMAB)

The PD-1 blocker market has exploded into place as one of the most important and promising major biopharma oncology markets yet to appear. Immuno-oncology drugs that block the checkpoint PD-1 have been some of the most successful stories in the industry..

Published

on

The PD-1 blocker market has exploded into place as one of the most important and promising major biopharma oncology markets yet to appear. Immuno-oncology drugs that block the checkpoint PD-1 have been some of the most successful stories in the industry over recent years, launching blockbuster drugs like Opdivo and Keytruda – central assets from Bristol Myers Squibb Co. (NYSE:BMY) and Merck & Co. Inc. (NYSE:MRK), respectively.

The blossoming of this category has been rapid and remarkable, and fueled by a real and tangible need, resulting in the emergence of what is now estimated to be a $23 billion market.

For investors interested in this explosive space, there are a few interesting angles evolving this year that could provide fresh fireworks. With that in mind, we take a closer look at a handful of related stories that may offer interesting opportunities related to the PD-1 blocker theme.

Merck & Co. Inc. (NYSE:MRK) has been in the driver’s seat in the PD-1 blocker marketplace since it introduced Keytruda.

The company engages in the provision of health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products. It operates through its Pharmaceutical, Animal Health, and Other segments. The Pharmaceutical segment includes human health pharmaceutical and vaccine products. The Animal Health segment discovers, develops, manufactures, and markets animal health products, such as pharmaceutical and vaccine products, for the prevention, treatment, and control of disease in livestock and companion animal species.

Merck & Co. Inc. (NYSE:MRK) recently announced new data from studies evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, at the Society for Melanoma Research (SMR) 2021 Congress. Presentations demonstrate the company’s scientific expertise and continuing commitment to delivering meaningful advances for patients with melanoma. Key data include exploratory 7-year follow-up from KEYNOTE-006, the pivotal trial that supported the indication for KEYTRUDA in advanced melanoma, and updated findings from the KEYNOTE-716 trial that is evaluating KEYTRUDA as an adjuvant treatment for patients with resected stage IIB or IIC melanoma. These data were both selected for inclusion in plenary sessions at the SMR 2021 Congress.

“The seven-year data for KEYTRUDA in advanced melanoma is a significant milestone for the field of melanoma research and for patients,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “Just ten years ago, the median survival for patients with metastatic melanoma was less than a year and only 10% of patients could expect to survive more than five years. We are incredibly honored to present these new long-term survival data in advanced disease at this year’s SMR 2021 Congress, as well as updated findings in stage IIB and stage IIC melanoma.”

Even in light of this news, MRK hasn’t really done much of anything over the past week, with shares logging no net movement over that period. Shares of the stock have powered higher over the past month, rallying roughly 8% in that time on strong overall action. 

Merck & Co. Inc. (NYSE:MRK) managed to rope in revenues totaling $13.1B in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 4.7%, 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 ($10B against $23.7B, respectively).

Oncotelic Therapeutics Inc (OTC US:OTLC) is an artificial intelligence driven immuno-oncology company with a robust pipeline of first in class TGF-β immunotherapies for late stage cancers such as gliomas, pancreatic cancer and melanoma. This is the most speculative play in the space, but wheels are clearly turning, and it could be a dark-horse PD-1 star in the making.

OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-β RNA therapeutic that 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 cleaning and evaluation and datalock ongoing. 

Oncotelic Therapeutics Inc (OTC US:OTLC) most recently announced an update of its ongoing OT-101/IL-2 combination Multi-center, Open label, Phase Ib clinical trial to evaluate the safety, tolerance, and efficacy of TASO-001 (“OT-101”), a TGF-β targeting anti-sense oligonucleotide, in combination with recombinant interleukin-2 (Aldesleukin, “IL-2”), in patients with advanced or metastatic solid tumor cancer (ClinicalTrials.gov Identifier: NCT04862767), which has now successfully completed the safety evaluation of its safety cohort, allowing for further expansion of its clinical program into phase 2 clinical trials and higher doses.

OT-101 is a first-in-class anti-TGF-β ribonucleic acid therapeutic that has exhibited single agent activity in relapsed/refractory cancer patients in multiple clinical trials. OT-101 has also demonstrated activity against the SARS-CoV-2 virus, the virus that causes COVID-19, and is currently being evaluated in the Company’s C001 clinical trial against hospitalized severe COVID-19.

In the safety cohort treated during the Trial, the standard dosage of 140mg/m2 of OT-101was well tolerated in combination with IL-2, which has allowed for ongoing dose escalation to 190 mg/m2. The 140 mg/m2 dose was shown to be the optimal dose for OT-101 in the prior trial targeting pancreatic cancer, melanoma, and colorectal cancer. In the P001 trial, the maximum tolerated dose was not reached even at 330 mg/m2. Therefore, the Company believes that increasing the dose above 140 mg/m2 should further enhance the clinical activity of OT-101.

Oncotelic Therapeutics Inc (OTC US:OTLC) CEO, Dr. Vuong Trieu, noted in the release, “We are excited to see this clear demonstration of safety for the OT-101/IL-2 combination. Unlike other common treatments, such as chemotherapy, IL-2 has the potential to bring about long-lasting responses and even cures in about one in 10 patients with metastatic kidney cancer and metastatic melanoma. Our analysis to date suggests that the OT-101/IL-2 combination could further improve the cure rate of these cancers. We look forward to updating shareholders as we gain further insights with additional data.”

Roche Holding AG ADR (OTC US:RHHBY) is one of the most interesting names in the space. The company operates as a research healthcare company. It operates through its Diagnostics and Pharmaceuticals segments.

The Pharmaceutical segment refers to development of medicines in the field of oncology, immunology, ophthalmology, infectious diseases, and neuroscience. The Diagnostic segment refers to diagnosis of diseases through an in vitro diagnostics process. The company is levered to the PD-1 blocker theme through Tecentriq, a blocker developed by Genentech in 2016 – Genentech was acquired by Roche in 2009.

Roche Holding AG ADR (OTC US:RHHBY) recently announced that the US Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥1%, as determined by an FDA-approved test.

“Tecentriq is now the first and only cancer immunotherapy available for adjuvant treatment of NSCLC, introducing a new era where people diagnosed with early lung cancer may have the opportunity to receive immunotherapy to increase their chances for cure,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s landmark approval gives physicians and patients a new way to treat early lung cancer that has the potential to significantly reduce risk of cancer recurrence, after more than a decade with limited treatment advances in this setting.”

It will be interesting to see if the stock can break out of its recent sideways action. Over the past week, the stock is net flat, and looking for something new to spark things. RHHBY shares have been relatively flat over the past month of action, with very little net movement during that period. 

Roche Holding AG ADR (OTC US:RHHBY) managed to rope in revenues totaling $30.7B in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 0.8%, 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 ($8B against $25.2B, respectively).

Other key stocks in the space include BeiGene Ltd. ADR (Nasdaq:BGNE) and Genmab A/S ADR (Nasdaq:GMAB).

Please make sure to read and completely understand our disclaimer at https://www.wallstreetpr.com/disclaimer. We may be compensated for posting this content on our website by EDM Media LLC. For questions, comments or suggestions please contact ir@edm.media.

The post Biotech Investors Eye the Explosive PD1 Oncology Opportunity (MRK, OTLC, BMY, RHHBY, BGNE, GMAB) appeared first on Wall Street PR.

Read More

Continue Reading

Economics

DB: Is The World Learning To Live With The Virus?

DB: Is The World Learning To Live With The Virus?

After a day of zigzags on the virus front, we end with some encouraging observations from Deutsche Bank’s Jim Reid who shows in his "chart of the day" that according to global mobility data,..

Published

on

DB: Is The World Learning To Live With The Virus?

After a day of zigzags on the virus front, we end with some encouraging observations from Deutsche Bank's Jim Reid who shows in his "chart of the day" that according to global mobility data, most of the world is back close to pre-pandemic levels of mobility (at least on a population-weighted basis) even if the GDP-weighted figure still lags, partly due to some of the larger DM economies still being down vs. February 2019.

Regardless, as Reid observes, the graph shows that "on both measures mobility is notably above last year’s levels. This helps show why reasonably strong YoY growth shouldn’t be too difficult to attain in H1 2022. In H1 2021, the world wasn’t that mobile."

This is good news because it means that - at least so far- as the winter covid wave and Omicron hit us, aggregate mobility hasn’t yet dipped. This, according to Reid, shows that either people are learning to live with the virus more or that it’s too early to tell as travel and domestic restrictions, only very recently imposed, have yet to fully take their toll, with more possibly to come.

To be sure, Austrian mobility has declined significantly with Germany also drifting lower. So where restrictions have been imposed there has been a consequence.

A more detailed heatmap of global mobility is shown below.

To be sure, the swing factor to winter mobility will be Omicron. For those readers looking for good news, the second chart from Reid shows that in South Africa covid fatalities from the Omicron wave have not responded to the rise in cases in the same manner as prior ones (with a 12-day lag).

While it is still very early days with the data subject to revisions, Reid notes that "we are getting more and more (albeit patchy) evidence that the new variant is less severe. So much now depends on how more transmissible it is, especially in heavily-vaccinated populations." Reid says that he leans on the optimistic side here "but it seems the number of Omicron cases are building fast enough that we should get some decent data very soon on how its impacting well-vaccinated countries."

Tyler Durden Tue, 12/07/2021 - 18:25

Read More

Continue Reading

Government

The Great Realignment: Countless More Americans Will Be Moving From Blue States To Red States In 2022

The Great Realignment: Countless More Americans Will Be Moving From Blue States To Red States In 2022

Authored by Michael Snyder via The Economic Collapse blog,

We are rapidly becoming two very different nations with two very different cultu

Published

on

The Great Realignment: Countless More Americans Will Be Moving From Blue States To Red States In 2022

Authored by Michael Snyder via The Economic Collapse blog,

We are rapidly becoming two very different nations with two very different cultures.  At one time we truly were the “United” States of America, but now we have been split into two opposing camps that deeply hate one another.  As a result, in recent years we have watched millions of Americans relocate for ideological reasons.  This has caused “red states” to become even redder and “blue states” to become even bluer.  At this point, there are just a handful of “purple states”, and it is in those states where our presidential elections are determined.  It is really not healthy for just a few states like Pennsylvania and Michigan to have such power, but that is a topic for another article.  In this article, I want to discuss why the mass exodus from blue states to red states is actually going to accelerate in 2022.

Right now, there is no issue in the United States that is more divisive than the COVID vaccine.

Most conservatives want to be able to have the freedom to choose whether to take the injections or not, while many on the left want to use the power of government to compel people to get injected.

It has truly been frightening to watch many on the left embrace authoritarianism so eagerly, and many leftist politicians just continue to tighten down the screws.

For example, New York City Mayor Bill de Blasio just decided to impose a very strict vaccine mandate on all private employers in his entire city

Mayor Bill de Blasio announced what he called a first-in-the-nation vaccine mandate for private companies Monday.

He said the combination of the Omicron variant and holiday gatherings forced him to take “bold” steps. He’s giving businesses just three weeks to make sure their workers are vaccinated.

If you don’t get the jab, you won’t be allowed to keep your job.

There will not be a “testing option” under this new mandate, and so anyone that refuses to comply will be kicked to the curb two days after Christmas

De Blasio said the city will release specific rules on Dec. 15, before the mandate takes effect Dec. 27. He said it will apply to in-person employees, but would not provide any details about enforcement. He also said there will not be a weekly testing option.

This is complete and utter lunacy, but of course we are witnessing lots of that in blue states these days.

We are being told that this new mandate will apply to approximately 184,000 businesses, and that means that vast numbers of New Yorkers will soon be forced to search for greener pastures.

One of them is a woman named Cynthia.  She told a reporter that this mandate gave her yet another reason “to get the hell out of New York”

Cynthia, an employee at a Midtown marketing firm who refused to share her last name due to fear of blowback, told the Post that the new requirement is ‘another reason’ to leave the city.

‘Just terrific. Bill de Blasio just gave me another reason I need to get the hell out of New York, or at least find a job that lets me work remotely,’ she said.

Where will thousands upon thousands of displaced New Yorkers like Cynthia go?

One conservative member of Congress that represents New York fears that many of them will head to “the free state of Florida”

‘Mayor de Blasio can’t leave fast enough. He has crushed small business, the economy and quality of life. How many more New Yorkers does he want to see move to the free state of Florida?’ said US Rep. Nicole Malliotakis, who represents Staten Island and Brooklyn.

So New York is going to get even bluer in 2022, and Florida will be getting even redder.

Down in Massachusetts, hundreds of hospital workers were just ruthlessly canned because they refused to comply with a vaccine mandate…

About 200 UMass Memorial Health employees are out of a job because they missed the health care system’s COVID vaccination deadline.

UMass Memorial announced the mandate over the summer with a deadline to get vaccinated or receive an exemption by November 1.

Employees were let go on December 1 if they did not get the vaccine.

Many of those displaced health workers aren’t going to be able to find similar work in Massachusetts, and so they will head to red states.

As for UMass Memorial Health, I am not sure exactly what they plan to do.  You can’t just pull people off the streets to be medical professionals.  They will probably be short-handed for a long time to come, and that is just going to hurt the people that they are supposed to be serving.

In Oregon, a different sort of mandate has people thinking that it may be time to relocate.

If you can believe it, officials in Oregon are actually thinking of making their indoor mask mandate permanent

The Oregon Health Authority (OHA) assembled a Rules Advisory Committee (RAC) earlier this week to address a permanent indoor mask mandate in the state. Oregon is one of a few states that still retain one nearly two years into the pandemic.

The committee included several community stakeholders, including representatives from the hospitality industry, the business sector, and faith communities, according to local ABC affiliate KATU.

I cannot understand why any rational decision maker would want to do such a thing, but apparently they are quite serious.

There are a whole lot of very conservative people that live in eastern Oregon, and I think that even more of them are going to be moving over the border into Idaho in 2022.

Before I end this article, I want to mention what Canada has just done.

Beginning November 30th, all unvaccinated individuals are now banned from using any form of public transportation

In Canada, any travelers older than 12 years old must show proof of full vaccination to take any form of public transportation including domestic and international flights as well as trains.

“Starting November 30 at 3:01 am EST, vaccination will be required for travel within and to depart Canada,” the Candian travel website states. “A valid COVID-19 molecular test will no longer be accepted as an alternative to vaccination unless you’re eligible for one of the limited exemptions.”

Trudeau and his minions have completely gone off the deep end, and I feel so sorry for freedom-loving Canadians that are deeply suffering under his regime.

Of course the Biden administration is considering something similar for domestic travel inside the United States.

Let us hope that they never pull the trigger on such a move.

All over the globe we are seeing governments become more authoritarian, and that certainly sets the stage for some of the things that I warned about in my latest book.

Here in the U.S., countless numbers of freedom-loving Americans are fleeing to red states as they seek to escape the oppression that they have been experiencing in blue states.

Unfortunately, blue state tyrants have no intention of backing down, and this is going to create a tremendous amount of tension in our nation as we head into 2022 and beyond.

*  *  *

It is finally here! Michael’s new book entitled “7 Year Apocalypse” is now available in paperback and for the Kindle on Amazon.

Tyler Durden Tue, 12/07/2021 - 18:05

Read More

Continue Reading

Government

China Says US Trying To “Disrupt” Beijing Winter Olympics, Vows Retaliation

China Says US Trying To "Disrupt" Beijing Winter Olympics, Vows Retaliation

China has followed Monday’s White House confirmation that US government officials will boycott the 2022 Winter Olympic games with a vow to retaliate with "resolute…

Published

on

China Says US Trying To "Disrupt" Beijing Winter Olympics, Vows Retaliation

China has followed Monday's White House confirmation that US government officials will boycott the 2022 Winter Olympic games with a vow to retaliate with "resolute countermeasures"

Describing that it's lodged a formal diplomatic protest, China's Foreign Ministry said at a Tuesday press conference that the United States is seeking to "disrupt" Beijing's hosting of the games. "Out of ideological bias and based on lies and rumors, the US is trying to disrupt the Beijing Winter Olympics. This will only expose its sinister intention and further erode its moral authority and credibility," ministry spokesperson Zhao Lijian said.

China News Service/Getty Imagest

"The wrong move of the US has undermined the foundation and atmosphere for China-US sports exchanges and Olympic cooperation. It has shot itself in the foot. The US should understand the grave consequences of its move," Zhao added.

While US athletes will be allowed to compete in the games, the Biden administration's largely symbolic slap in the face is geared toward sending a strong message against China's "ongoing genocide and crimes against humanity in Xinjiang," according to a Monday statement. 

Beijing officials have meanwhile suggested that the US government boycott is likely to negatively impact bilateral dialogue and cooperation in key areas.

It's as yet unclear whether other Western-allied governments of the US will follow suit, but it was separately reported early this week that New Zealand officials will also not attend the Beijing games. However, in this case New Zealand Deputy PM Robertson cited the Covid-19 pandemic as the reason, and confirmed his country's diplomats would not attend.

Interestingly, some notable Chinese officials and pundits expressed that if US officials don't come, nobody in China actually cares. For example, Liu Pengyu, spokesperson of the Chinese Embassy in the US, had this to say on Twitter:

"Politicians calling for boycott #2022BeijingOlympics are doing so for their own political interests and posturing. In fact, no one would care about whether these people come or not, and it has no impact whatsoever on the #Beijing2022 to be successfully held."

And Hu Xijin, editor-in-chief of state-run English language Global Times, questioned: "Why the fuss?" He answered, "If US officials don't come, let it be. China didn't invite them anyway."

"Only super narcissistic people will regard their absence as a powerful boycott. Most of those US govt officials are close contacts of the Covid-19 patients according to China's standard, moreover picky and pretentious. You are the people that Beijing residents least want to see," the GT editor quipped sarcastically.

Tyler Durden Tue, 12/07/2021 - 19:45

Read More

Continue Reading

Trending