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Rahway Poised To Compete With AZ/Sanofi’s Monoclonal Antibody Therapy For RSV Virus, By Year End — With MK-1654 | Clesrovimab

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At the moment, the AZ/Sanofi monoclonal antibody therapy sold under the Beyfortus trademark is far and away the market leader. Many may recall that Merck returned a different RSV therapeutic candidate to Moderna, which subsequently brought it to market — with mixed results. Merck chose wisely to focus on MK-1654, and now a Phase 2b/3 trial has validated that bet.

Rahway said this week it hopes to have fully-scaled stock available for the Spring 2025 RSV infections “season”. And we should note that both GSK and Pfizer now offer approved vaccines for RSV — so the uptake on the therapy may “only” reach around $700 million a year, at peak sales — in a few years’ time, for Merck. Still, it is very good news — per Fierce Biotech’s reporting:

. . .Three months after revealing that its respiratory syncytial virus (RSV) preventive antibody clesrovimab had passed muster in a phase 2b/3 trial, Merck is putting numbers to the claim.

Clesrovimab, also known as MK-1654, scored on multiple trial endpoints, demonstrating its ability to protect infants against the virus in their first RSV season.

With the results, which were presented Thursday in Los Angeles during IDWeek 2024, Merck said it hopes to bring clesrovimab to the market for the 2025-26 RSV season. . . .

Clesrovimab achieved its primary objective by reducing the incidence of RSV-associated medically attended lower respiratory infections requiring at least one indicator of lower respiratory infection by 60% versus placebo through the first five months after dosing, the company said.

The drug also reduced RSV-related hospitalizations (secondary endpoint) and RSV-related lower respiratory infection hospitalizations (tertiary endpoint) by 84% and 91%, respectively, versus placebo through five months….

Now you know — and onward, to a Buff win tomorrow afternoon, in the Arizona desert heat. Grin….

नमस्ते

Still Cause For Concern: Now Over 1,100 Mpox Deaths — In Africa — This Time ‘Round…

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Adolescents are now approved to be vaccinated, on an emergency basis — as more and more palletized shipments of the highly-effective vaccine arrive in airports, across the continent. But again, the challenge is getting them to where the afflicted patients’ contacts live — in often remote, mountainous, difficult terrain.

Still the rate of expansion is now moderating — and there is every reason to believe the ring vaccinations are working — just as they have in prior Ebola flare ups. Here’s the latest, from ABC.com:

…KAMPALA, Uganda — The number of mpox -related deaths in Africa has surpassed 1,000, the head of the continent’s top public health agency said Thursday, warning of the continuing threat of cross-border contamination and a lack of rapid test kits.

There were 50 mpox-related deaths in the past week, bringing the total to 1,100, indicating that authorities face a challenge in stemming outbreaks currently affecting 18 of the continent’s 55 nations, said Jean Kaseya, director general of the Africa Centers for Disease Control and Prevention.

“We are still fighting with this outbreak,” Kaseya said. “We don’t want to see all African countries affected….”

Now you know. Be excellent to one another — always. Onward.

नमस्ते

In Which Mirengoff Dons His KKK-Hood… Yet Again. YAWN.

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Here is some richly ironic racism — in which Paul Mirengoff admits (nay, celebrates!) that he regularly demonizes various Jewish groups for what he calls “slavish” support of Democratic candidates and policies.

But in an immediately prior paragraph (and the main point of his post, no less!) he calls Mr. Obama’s similar exhortations to Black men (not to allow sexism to dictate that they won’t vote for a woman!)… as “racist”. [All while he recites widely debunked falsehoods — about crime rates, and out of wedlock birth trends, in America.]

Wow. Just… wow.

Let’s just assume (though he doesn’t make this explicit in his burpings) that Paul thinks because he is Jewish, that he cannot be considered as racist, or bigoted against Jews who don’t think of only themselves first (supporters of GOP/MAGA).

While I may disagree with that premise — even that won’t support his attacking Mr. Obama for speaking to fellow Black men candidly, and perhaps even scolding them — not to let their own prior bad experiences with OTHER women (i.e., not Kamala) prevent them from voting in their own enlightened self interest.

This is a wholly tangled, incoherent, and largely indefensible ball of… mess, from Paul.

That’s the sum up.

Onward.

We May Be In Highly-Active Solar Flare Storms — Through Mid-2025: Experts From NCAR, NASA And NOAA Say…

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As we mentioned last week, NASA yesterday hosted a teleconference with the National Oceanic and Atmospheric Administration, and the international Solar Cycle Prediction Panel at which the various experts opined that our Sol has reached “solar maximum”. Even so, the experts’ consensus is that the strong geo-magnetic storms we see from it… could continue — into mid 2025.

The Sun goes through an approximately 11 year cycle, transitioning between low and high magnetic activity. Thus, about every 11 years, at the height of the solar cycle, the Sun’s magnetic poles flip — here on Earth, that would be like the North and South poles swapping places every decade — and the Sun transitions from being calm to a very active and explosive mode.

Here is the full NASA run-down — on the press conference — but we should expect a few more events like that of October 3-4 (which reached Earth around October 10-11), yet in this cycle:

“…This announcement doesn’t mean that this is the peak of solar activity we’ll see this solar cycle,” said Elsayed Talaat, director of space weather operations at NOAA. “While the Sun has reached the solar maximum period, the month that solar activity peaks on the Sun will not be identified for months or years.”

Scientists will not be able to determine the exact peak of this solar maximum period for many months because it’s only identifiable after they’ve tracked a consistent decline in solar activity after that peak. However, scientists have identified that the last two years on the Sun have been part of this active phase of the solar cycle, due to the consistently high number of sunspots during this period. Scientists anticipate that the maximum phase will last another year or so before the Sun enters the declining phase, which leads back to solar minimum. Since 1989, the Solar Cycle Prediction Panel — an international panel of experts sponsored by NASA and NOAA — has worked together to make their prediction for the next solar cycle….

“Solar Cycle 25 sunspot activity has slightly exceeded expectations,” said Lisa Upton, co-chair of the Solar Cycle Prediction Panel and lead scientist at Southwest Research Institute in San Antonio, Texas. “However, despite seeing a few large storms, they aren’t larger than what we might expect during the maximum phase of the cycle.”

The most powerful flare of the solar cycle so far was an X9.0 on Oct. 3 (X-class denotes the most intense flares, while the number provides more information about its strength).

NOAA anticipates additional solar and geomagnetic storms during the current solar maximum period, leading to opportunities to spot auroras over the next several months, as well as potential technology impacts. Additionally, though less frequent, scientists often see fairly significant storms during the declining phase of the solar cycle….

[And as we’ve mentioned before, essentially all Suns are born as pairs, with one either being flung off, or consumed in the first million or so years of their joint lives. That’s my second, slightly poetic-licensed… graphic’s teaching.]

Now you know — and… do go cheer for the Buffs Saturday, all you NOAA and NCAR Boulder based fans!

नमस्ते

A First Ever Clinical Trial — For A Therapeutic, For Marburg’s — In Rwanda, Using Gilead’s Remdesivir (The Covid Therapeutic)… Now Underway.

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As with Mpox, it is increasingly looking like the rate of new cases is… trending in the right direction — toward zero.

As ever though, with no approved anti-virals for the specific Marburg outbreak, we have lots of work to do, yet. To that end, Gilead is testing its highly effective COVID treatment (not a vaccine) called Remdesivir, in Rwanda now. There is significant reason to think that it will work — using much the same mechanisms of action — as the ones that largely successfully bested viral loads, in COVID-19. Here’s that latest news:

…Rwanda has begun the world’s first clinical trial for a treatment of the Ebola-like Marburg virus, which has killed more than a dozen people in the country, the World Health Organization said Tuesday….

“Encouraging news from Rwanda,” WHO chief Tedros Adhanom Ghebreyesus said on X.

He hailed that the country had launched the “world’s first clinical trial for Marburg virus disease”, in collaboration with his agency, involving the use of a drug used to treat COVID-19.

The Marburg outbreak was first announced in Rwanda in late September and a vaccination program using a trial vaccine was launched earlier this month….

Marburg is transmitted to humans from fruit bats, and is part of the so-called filovirus family that includes Ebola. With a fatality rate of up to 88 percent, Marburg’s highly infectious hemorrhagic fever is often accompanied by bleeding and organ failure.

There are currently no officially approved vaccines nor approved antiviral treatments, but potential treatments, including blood products, immune and drug therapies are being evaluated….

Now you know — and do let football gods find the Buffs be ready, when tested in Arizona — at 3 pm local, this Saturday. Smile….

नमस्ते

Good News! An Added €20 Million — For Mpox Relief, In Africa — From The European Commission For International Partnerships…

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The situation in the seven or so nations inside Africa affected by this 2024 Mpox outbreak is improving — now that vaccines are being administered in ring fashion, to be sure. And this outbreak is not nearly as lethal as the current Marburg’s virus outbreak is, nor as any ebola flare up. But still, it afflicts primarily the very young, and runs at an about 10% mortality rate, now. So it is an urgent concern.

The prevailing thought among health care practitioners is that older people (age 30 and above, in Africa) likely acquired some mpox immunity, by virtue of being vaccinated against small pox, decades ago. The youngest (under age 10) in Africa remain largely unvaccinated, and are thus more susceptible to Mpox. Or so the common wisdom holds. In any event, here’s the latest good news, from the EU Commissioner for International Partnerships:

. . .Jutta Urpilainen, European Commissioner for International Partnerships, has announced an additional €20 million funding towards the fight against Mpox outbreak in the Democratic Republic of the Congo (DRC). This additional funding contributes to the DRC’s Mpox response and supports preparedness against epidemics as part of the EU’s objective to support the strengthening of health systems in Africa. Commissioner Urpilainen discussed the new announcement and coordination needed to tackle Mpox outbreaks with Director-General of the Africa Centres for Disease Control and Prevention (Africa CDC), H.E. Dr. Jean Kaseya….

The additional funding for the DRC complements the 215,000 doses of mpox vaccines donated by HERA to the Africa Centres for Disease Control and Prevention (Africa CDC) to address the current crisis across the African continent as well as the 365,000 doses of mpox vaccine donated by Team Europe.

“We are committed to tackle health crises and increase resilience together with the African partners. This is a joint mission to improve global health security. The additional funding of €20 million comes on to previous support and vaccine donations by the EU and its Member States.” — Jutta Urpilainen, EU Commissioner for International Partnerships

The funding announced today is part of a coordinated response by the EU towards strengthening the preparedness and response capacities for both current and future health emergencies in affected countries. Team Europe is a lead investor in global health initiatives such as the Pandemic Fund which is fast-tracking funds for enhanced laboratory capacity, surveillance and detection of the virus, and the training of emergency workforce for vaccinations.

The new funds will contribute to tackling both the current and future health emergencies in a coordinated intervention with partners such as the WHO and affected countries….

This is clearly a welcome step — but in Africa, both on Marburg and Mpox — and public health generally but (with prophylactic vaccine programs running decades behind)… much more work is needed. And much more funding, obviously.

[And equally obviously, the Powerline boys have nothing useful, or even interesting to say any longer… with Tangerine spending about 40 minutes… staring vacantly into space at his “town hall”, and bobbing his head — while classical arias blare at high-volume. The ancient reprobate coot has… completely lost it.]

As has Elon Musk — despite his chopsticks success over the weekend past. Onward.

नमस्ते

Onward, To… Europa — And A 2030 Series Of Sails, Around Lord Jupiter.

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At right is the “writ in water” multi-languages sound of the word for water tile, affixed to the body of the Clipper. Smile.

What a long, and commanded journey this will be: out to Mars, for a slingshot gravity assist, then back in a very close pass — to whip around Earth — for another gravity assist… then on to Europa, circa 2030. Here’s the NASA update, on it all:

…The largest spacecraft NASA ever built for a mission headed to another planet, Europa Clipper also is the first NASA mission dedicated to studying an ocean world beyond Earth. The spacecraft will travel 1.8 billion miles (2.9 billion kilometers) on a trajectory that will leverage the power of gravity assists, first to Mars in four months and then back to Earth for another gravity assist flyby in 2026. After it begins orbiting Jupiter in April 2030, the spacecraft will fly past Europa 49 times.

“Congratulations to our Europa Clipper team for beginning the first journey to an ocean world beyond Earth,” said NASA Administrator Bill Nelson. “NASA leads the world in exploration and discovery, and the Europa Clipper mission is no different. By exploring the unknown, Europa Clipper will help us better understand whether there is the potential for life not just within our solar system, but among the billions of moons and planets beyond our Sun.”

Approximately five minutes after liftoff, the rocket’s second stage fired up and the payload fairing, or the rocket’s nose cone, opened to reveal Europa Clipper. About an hour after launch, the spacecraft separated from the rocket. Ground controllers received a signal soon after, and two-way communication was established at 1:13 p.m. with NASA’s Deep Space Network facility in Canberra, Australia. Mission teams celebrated as initial telemetry reports showed Europa Clipper is in good health and operating as expected….

Now you know — and onward, as we have dusty snowflakes here, and some small hailstones (wind-chills of 35 degrees, already!) as I head over to get some taco-truck deliciousness. Heh. Nuthin’ gets in the way of that gravity-assisted… slingshot!

नमस्ते

[U] Take A Look — After [More Than] Ten Years… Still A Train-Wreck; All The Same Tired Old Schemes.

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We will be are now back, to explain, but see this 2013 backgrounder.

We were put in mind of this, because a long time reader was checking up on our older (2012-2014) predictions, as to specific stock bets, long and short, in the life sciences vertical.

This one in particular was pretty obvious to anyone who is versed in… the math of finance. Add to it, that the successive crews of management, and board seats… were mostly known for over-levering assets, in order to pay out what amounted to wasting dividends to private equity investors, and then often filing a chapter if all the rosy predictions didn’t turn out as planned. [And that is almost exactly what happened to Valeant — as it became Bausch Health.]

Here in 2024, nearly a full decade later, a renewed team is going to split the biz into a revamped B+L brand, and leave the lower margin businesses (in a remain-co, called “Health”)… to likely whither and die. You could look at the symbol “BHC” and read all the 2024 coverage on it. Or… you could just re-read anything I ever wrote here, about Brent Saunders and / or Fast Fred Hassan.

Same old; same old. Here’s the chart, for the record — now, more than a decade’s worth of “paths, diverging in the wood“:

…[T]he [Bausch Health company has endured a] shocking decline over three years. Indeed, the share price is down a whopping 72% in the last three years. So we’re relieved for long term holders to see a bit of uplift. The thing to think about is whether the business has really turned around.

Since Bausch Health Companies has shed US $136 million from its value in the past 7 days, let’s see if the longer term decline has been driven by the business’ economics….

[Confidential Hint Dept.: it hasn’t (as to the first) and it has been, as to the second. Cheers!] Onward.

नमस्ते

It Remains Immaterial To Rahway, But A Nice Validation For Exelixis’s Zanzalintinib Candidate — In Head and Neck, and Renal Cell Carcinomas…

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We had previously-mentioned Merck’s December 2023 FDA approval for Welireg®, in renal cell carcinoma patients.

Now, Welireg will be tried in combination with Exelixis’s Zanzalintinib candidate (in what amounts to a “supply agreement on steroids“, for Merck). The same sort of enhanced supply arrangement will obtain with Merck’s Keytruda® — which will be studied by Exelixis, in head and neck cancers with Zanzalintinib — for added progression free survival / efficacy. Here’s all of that good news, this afternoon:

…Exelixis and Merck announced that the companies have entered into a clinical development collaboration to evaluate the combination of Exelixis’ investigational tyrosine kinase inhibitor, or TKI, zanzalintinib with Merck’s anti-PD-1 therapy Keytruda in a phase 3 pivotal trial for the treatment of patients with head and neck squamous cell carcinoma, or HNSCC, and zanzalintinib with Welireg, Merck’s oral hypoxia-inducible factor-2 alpha inhibitor, in a phase 1/2 trial and two phase 3 pivotal trials for the treatment of patients with renal cell carcinoma, or RCC.

Under the terms of the collaboration, Merck will supply Keytruda for the ongoing, Exelixis-sponsored phase 3 STELLAR-305 pivotal trial in previously untreated PD-L1 positive recurrent or metastatic HNSCC. In addition, Merck will sponsor a phase 1/2 trial and two phase 3 pivotal trials in RCC.

Merck will fund one of these phase 3 studies, and Exelixis will co-fund the phase 1/2 trial and the other phase 3 study, as well as supply zanzalintinib and cabozantinib. Exelixis maintains all global commercial and marketing rights to zanzalintinib….

Now you know — be excellent to one another. Onward. Ever, onward… toward Europa by the decade’s end. Smile.

नमस्ते