Tonix Pharma Partnering In Kenya, For A Third Vaccine Candidate To Arrest Mpox — Phase I Trial Beginning, Now…

This is moving the ball forward (we’d mentioned the research program, at the end of August) — and it is hoped that there will be a large enough ‘n’ to establish effectiveness.

We expect that the vaccine will be well-tolerated in humans since it closely tracks tech used in many prior successful vaccine programs. In any event, here’s the latest, from Tonix Pharmaceuticals:

…Tonix today announced that it has entered into a sponsored research agreement with the Kenya Medical Research Institute (KEMRI) to design, plan and seek regulatory approval for a Phase I clinical study in Kenya to test the safety, tolerability, and immunogenicity of TNX-801 (horsepox, live virus) as a vaccine to prevent mpox and smallpox. Tonix will be the sponsor and KEMRI will lead the execution of the proposed clinical trial.

“We are excited to advance development of TNX-801 under this research agreement with KEMRI,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There is an urgent need for the worldwide availability of a single dose mpox vaccine with durable protection….

TNX-801 has demonstrated encouraging preclinical data and was recently shown to align with the World Health Organization’s (WHO’s) newly issued preferred target product profile (TPP) for mpox vaccines. Further, TNX-801 can be scaled up for manufacturing, distribution and storage without a costly supply chain. We believe TNX-801 has the potential to address and help interrupt the spread of mpox worldwide….”

TNX-801 is a live minimally-replicating attenuated horsepox vaccine that is believed to provide immune protection against mpox in animals with better tolerability than 20th century vaccinia viruses. Vaccinia vaccines from the 20th century are descendants of Edward Jenner’s circa 1800 that have become more virulent in connection with losing regulatory elements in their genomes. Given the modern understanding that Jenner’s circa 1800 vaccine would be called “horsepox” today, TNX-801 was designed to be similar to Jenner’s vaccine. After a single dose vaccination, TNX-801 protected animals against lethal challenge with intratracheal Clade Ia monkeypox virus.

Onward now — to a win for ordered liberty, dignity and equality… and for… moving forward, not back. Grin.

नमस्ते

UPDATE: The Able US Magistrate Judge In Floating Razor Wire Case Re-Opened Discovery, And Postponed Next Week’s Trial Date…

Just a short note here, as it seems both sides need more discovery in order to be ready to try the barbarous floating razor wire case, on the Rio Grande, at Eagle Pass.

Here’s the full two pager, with scant detail — on what is now open, as a factual matter, that requires more evidence / document collections:

…At the hearing, the parties agreed that the Motion to Preclude had been mooted by a continuance of the trial date and reopening of discovery….

Now you know. And… more importantly, she’s gonna’ WIN!

नमस्ते

Civil War Is Loony Hinderaker’s “Last Best Hope”?!

Yep. Hinderaker has gone full-on…

Chance, the Gardener.

If you know, you know.

Hinderaker will hate hearing “Madame President” almost as much as he’ll hate being…

an irrelevant old coot.

Onward, resolutely… onward.

With warm, clear weather forecast over most of Pennsylvania, Michigan, and Wisconsin… Hinderaker likely has no path to any destination that doesn’t lead to orange jumpsuits, and jail — for his boy Tangerine.

And I for one am… perfectly okay with that.

As Midnight Arrives — Now Election Day — Paul Knows Trump Has Lost.

As Mr. Mirengoff admits, Tangerine could scarcely have been a worse candidate for the GOP in 2024.

Later today, America will tell the GOP that hate is a losing brand.

Paul fully accepts that, even though for almost 10 years… He and the Powerline boys helped create the monstrous mythology of… Trump — as anything other than the reprobate he actually is. And always has been — his whole adult life.

Only now does Mirengoff admit that the boys each, over the last decade, had a substantial hand in making America meaner, smaller and more backward than it has been in well-over 70 years (back to Barry Goldwater’s days on the national radar):

…In both cycles, Republicans will have come up short…

What a wasted decade they all set out to make, and in fact… made.

Game over.

The One Mpox Clade 1b Case In Britain… Has Become… Three Cases: Same Household.

Not terribly surprising, but the health authorities will work feverishly now to contain it to the one household, and contacts of the same.

This is tough news, from the Beeb, indeed — but there are vaccines to deploy, now (and they certainly are being so deployed — in “rings of contacts” fashion):

…Two more cases of a new strain of the mpox virus have been detected in London, in household contacts of the first patient, health officials say.

The two individuals are now under specialist care at Guy’s and St Thomas’ NHS Foundation Trust.

All three patients were infected with the Clade 1b variant of the virus, which was first detected in central Africa and appears to transmit more easily between people.

Prof Susan Hopkins, chief medical adviser at the UK Health Security Agency (UKHSA), said mpox – formally known as monkeypox – could spread quickly within households and further cases were “not unexpected”….

Now you know. Onward — to a very important day in the life of our fragile experiment in democracy, tomorrow — and the days and nights following. Onward!

नमस्ते

While Still Quite Rare Here In The US, Clade 1b Mpox Is A Looming Threat. Public Health Subsidized Vaccinations — For Those At Risk — Should Begin (Again).

The NY Times has a well-sourced story, on what the longer term outbreak of Clade 1b Mpox might mean for the gay and bi-sexual communities (and sex workers of all genders), here in the US.

At about $300 per shot for the retail, branded Mpox vaccines (two varieties are available, and two doses are needed for maximum protection) — a reasonably high proportion of people at high risk of Mpox (including those who are already HIV+), are less likely to have any form of insurance at all. . . and the ACA/HHS gatekeepers have yet to establish a designated level of coverage — for Mpox co-infections.

So we wait, in a rather precarious position here now:

…A particularly deadly form of mpox, formerly called monkeypox, has led to more than 48,000 cases and more than 1,100 deaths in Africa this year. The Biden administration has donated one million doses of the vaccine to affected countries.

But in the United States, mpox vaccines are out of reach for many people who need them.

In the 2022 outbreak that reached this country, doses of the Mpox vaccine, Jynneos, were made available for free from the federal stockpile. That arrangement ended in April, when the vaccine became available commercially.

But insurance companies do not yet cover the vaccine or, if they do, reimburse only a tiny fraction of the cost. Some young gay or bisexual men hesitate to use insurance, because they are not out to their families….

Do be excellent to one another. In truth — we are all our brothers’, and sisters’ — keepers.

नमस्ते

EmptyWheel Is Spot On: Tangerine Will Be Charged With… Insurrection, Eventually.

But that in no manner should be seen as a problem with Merrick Garland, or Jack Smith.

Tangerine himself has engineered all this delay, by aggressive campaigning as far back as later 2022, and by filing lots of criminal defense motions.

But his time in the barrel is coming. Democrats cannot decide to blame themselves for his using the rights afforded to criminal indictees, thus — even if they push the edge of the envelope, on good faith arguments for reversing existing procedural law:

…As I keep laying out, we know how long the investigation took. We know it took 14 months before the first crime scene defendants could be tried. We know it took over a year to exploit Tarrio’s phone. We know J6C caused at least three months of delay by withholding transcripts. We know it took ten months to get privilege-waived testimony from necessary witnesses.

And we know that John Roberts chose to delay the legal questions from December 2023 until August 2024, eight months.

Merrick Garland might yet charge Trump with insurrection. He might need to, to sustain the tie between Trump and his mob. But we have a pretty clear understanding of why that didn’t happen, couldn’t have happened, before tomorrow’s election….

So the hand-wringers ought to just shut it, and go vote. Period.

Of Queen — and King “Birthday” Celebrations, Then And Now…

Just to stay in a light and bouncy mood, going into what may be some chaos tomorrow evening… we offer a “birthday” greeting of sorts… either 102 years on, or perhaps 3,320 years on… to a very special youngster (likely afflicted with congenital malformations) — who passed at age 18 or 19.

That he slept in peace for nearly 3,220 of those years… is astonishing, in and of itself. Happy “B-Day”, then, to the mighty and forever young… Tut!

…Before the discovery of Tutankhamun’s tomb in the Valley of the Kings over a century ago, the New Kingdom pharaoh was virtually unknown, even to Egyptologists.

The name had been systematically erased from the annals of history — in ancient times in retaliation for his father, Akhenaten, the “heretic pharaoh,” having banished the gods of ancient Egypt in favor of his one god, Aten. Tutankhamun’s association with that heresy would doom him to oblivion — that was until November 1922, when Howard Carter revealed the momentous discovery of his tomb to the world. When asked what was inside, the British archaeologist proclaimed, “wonderful things.” Until Carter removed Tut’s mummy from its solid-gold coffin in 1925, however, no one could have known that he was a teenager when he died….

It is not surprising, then, that the public was fascinated by every detail surrounding the discovery of the “Boy King,” a veritable made-for-the-movies story. The plot goes as follows: Howard Carter, the impoverished archaeologist, teams up with Lord Carnarvon, his wealthy English patron, and the two search for years for Tutankhamun and, finally, come upon his tomb and all its treasures — so many treasures that it would take Carter ten years to carefully remove them. And then, of course, there is the tragic subplot. Early in the excavation, Lord Carnarvon died of an infected mosquito bite, and the “Curse of Tutankhamun” was born….

So now, let’s all do go celebrate — as we have no idea what tomorrow might bring — but we trust it will be at least… peaceful. And do so, grinning widely — it is a day to… smile! I wish you only joy, and light — always!

नमस्ते

Bill Otis Has Repeatedly Opined That Trump Committed Felonies In The Stolen Documents Case, At Least…

…so it is simply preposterous he would write this, overnight:

“…As I said in my talk to the Berkeley Federalist Society, it is, ironically but precisely, the peaceful transfer of power that Trump’s indictments now put at risk. The entire, irreplaceable predicate of the peaceful transfer of power is the losing side’s faith that the winning side won’t try to put them in jail….”

What put “the peaceful transfer of power” at risk… was Tangerine’s own crimes. NOT his being indicted by a grand jury — for THOSE CRIMES.

Oh. And he tried, on J6 ’21 — to have his own Veep assassinated by his mob of insurrectionists.

Bill Otis — as ever, would re-write history to say those holding criminals to account are responsible for the criminals’ lawlessness. [Here is just one of the prior opinions from these boys that felonies were committed.]

Damn son. You were once (for a time) a prosecutor.

Do sit this one out.

Cheers — and onward, to a high turnout Tuesday, over most of the middle of America!

Get used to saying (and seeing!) Madame President, Billy-boy.