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Monday, May 6, 2024

GlycoMimetics fails phase 3 blood cancer trial

 GlycoMimetics CEO Harout Semerjian told investors in March that phase 3 blood cancer results could “fundamentally impact our company's trajectory.” And the CEO was absolutely right, just not in the way he hoped. 

Monday, GlycoMimetics reported the failure of the trial—spurring a 72% stock drop that crushed the company's share price to 51 cents in premarket trading Monday morning, compared to $1.83 at the close on Friday. Investors drove the biotech’s valuation down into penny stock territory as they chewed over the implications of a phase 3 study that tested the E-selectin antagonist uproleselan in patients with acute myeloid leukemia (AML).

Here’s what went down. GlycoMimetics randomized 388 people with relapsed or refractory AML to take uproleselan or placebo on top of a chemotherapy regimen. Overall survival was 13 months in patients taking uproleselan, compared to 12.3 months in people on placebo.

The result caused the trial to miss its primary endpoint. That is a problem for GlycoMimetics. The biotech weathered setbacks such as the failure of its Pfizer-partnered sickle cell disease prospect and loss of the Big Pharma bedfellow to emerge with a pipeline focused on uproleselan. The next most advanced asset, a successor to the candidate Pfizer dropped, cleared phase 1a in January. 

GlycoMimetics originally expected to complete the phase 3 AML trial in 2020 and pushed past delays to reach a readout it flagged as an enabler of a filing for FDA approval. The biotech was targeting a $650 million to $850 million near-term potential market opportunity in the U.S. alone. Instead, the trial failed, leaving GlycoMimetics looking to a phase 2/3 National Cancer Institute (NCI) trial for salvation. 

The NCI trial is testing uproleselan in a different patient population: newly diagnosed AML patients. The NCI suspended the study in November 2021 after reaching the end of the phase 2 portion of the trial. GlycoMimetics said results of a preplanned phase 2 event-free survival interim analysis will be reported when available.

The clock is ticking. GlycoMimetics ended March with $31.3 million in cash and equivalents. The biotech previously told investors that the money it had at the end of last year would fund operations through the fourth quarter of 2024.

https://www.fiercebiotech.com/biotech/glycomimetics-fails-phase-3-blood-cancer-trial-causing-investors-sour-stock

TC BioPharm in 2nd Non-Binding Letter of Intent for CAR-T Acquisition

 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announced the execution of a non-binding letter of intent to acquire a privately-held biotechnology company pursuing the development of innovative Chimeric Antigen Receptor T-cell (CAR-T) therapies for the treatment of refractory cancers and solid tumors.

This agreement is the second such agreement in as many months shows TCBP's commitment to its M&A strategy aimed at expanding its therapeutic platform. 

CAR T-cell therapy modifies a patient's own immune cells to provide a heightened ability to identify and eliminate cancer cells. 

The target acquisition has developed a number of proprietary approaches to re-engineer CARs to better target solid tumors. The Company has generated pre-clinical proof of concept data that demonstrates the therapeutic potential of its lead CAR-T candidate for a range of solid tumors including colorectal, pancreatic, mesothelioma, ovarian and breast cancer. In addition, the target acquisition is also developing a novel, allogeneic CAR-T for the treatment of autoimmune diseases.

https://www.prnewswire.com/news-releases/tc-biopharm-announces-execution-of-second-non-binding-letter-of-intent-for-acquisition-targeting-innovative-car-t-therapies-302136232.html

Sunday, May 5, 2024

Cannabis businesses subject to federal marijuana laws under rescheduling: CRS

 Although the DEA is poised to move marijuana from a Schedule I to a Schedule III controlled substance, a recent report from the Congressional Research Service noted that cannabis businesses would still be subject to federal laws regarding marijuana.

https://seekingalpha.com/news/4100054-cannabis-business-subject-federal-marijuana-laws-under-rescheduling


Steward Health Care expected to file for bankruptcy as soon as Sunday

 Steward Health Care System, the largest U.S. physician-owned hospital operator, is expected to file for chapter 11 bankruptcy as soon as Sunday, according to a WSJ report, which cited people familiar with the matter.

Steward Health Care is the largest tenant of Medical Properties Trust (NYSE:MPW). Steward Health Care hired restructuring advisers to improve its liquidity and restore its balance sheet in January.


Steward Health Care in late March struck a deal to offload its physician network to UnitedHealth's (UNH) Optum Care arm. The deal was expected to help indebted Steward to resolve its immediate financial issues and allow it to repay all outstanding obligations to Medical Properties Trust (MPW).


Lawmakers, including Senator Elizabeth Warren (D-MA), urged regulators to "closely scrutinize" the transaction. The lawmakers laid out the anticompetitive impacts of the deal, noting that UnitedHealth (UNH) already has "massive market power" and this merger would further expand its consolidation of the market.


Medical Properties Trust (MPW) plunged 29% on January 5 after the REIT said it had taken steps to recover uncollected rents from Steward. Steward said it was pursuing strategic transactions to improve liquidity and restore its balance sheet, including the potential sale or re-tenanting of certain hospital operations and the divestiture of non-core operations.

https://seekingalpha.com/news/4100060-steward-health-care-expected-to-file-for-bankruptcy-as-soon-as-sunday-wsj



Appeals Court Hammers Prosecution About FBI Conduct In Whitmer Kidnap Plot

 The much-anticipated appeal hearing was held Thursday for Barry Croft and Adam Fox, the alleged “ringleaders” of the 2020 militia conspiracy to kidnap Michigan Gov. Gretchen Whitmer.

Croft and Fox were convicted of plotting to kidnap Whitmer after their second trial in late 2022. At their first trial earlier that year, a jury acquitted two other men while failing to reach a verdict for Croft and Fox.

The two men appealed their convictions on multiple grounds. Thursday’s hearing focused largely on the conduct of FBI informants and their handling agents.

Croft’s attorney, Timothy Sweeney, argued that his client should get a retrial because he wasn’t allowed to introduce numerous text messages that showed improper conduct by the FBI.

Those text messages showed how FBI informants were pressuring Fox and Croft to formulate a plan against Whitmer. A list of the texts can be found in this document.

Representing the government, Assistant U.S. Attorney Nils Kessler argued that the FBI text messages were irrelevant because Fox and Croft were already predisposed to committing an act of terrorism.

All the [FBI] statements identified by defense go to inducement. If jury found they were predisposed [to kidnapping Whitmer], none of that matters,” Kessler said. “This court has held that entrapment can only happen if the government plants an idea in an innocent persons’ head.”

The appeals justices expressed skepticism about Kessler’s argument. One justice disagreed with the prosecutor’s reading of the law.

“They’re saying the jury didn’t see all the pressure, all the government informants pounding on them. Surely that’s relevant?” the justice asked Kessler, to which he responded: “Theoretically, yes, but they don’t identify any statements where an informant actually put that kind of pressure to go kidnap the governor.”

The justices then identified several statements where informants pressured the defendants to move forward with a plot against Whitmer. For example, FBI informant Steve Robeson said in August 2020: “If we don’t talk about actually doing what the fuck we need to be doing, I’m done with meetings.”

Kessler argued that Robeson was only pressuring the defendants to disclose their plan, but the appeals justice seemed to disagree. “I’m reading this as, ‘We need to make a plan,’” she said.

The appeals justices presiding over the case were Judge Joan Larsen, Judge Chad Readler, and Judge Stephanie Davis. Audio, but not video, of the hearing was streamed, making it difficult to identify which justices were speaking.

A recap of the hearing can be found here:

The court reserved its decision for a later date.

Ken Silva is a staff writer at Headline USA.

https://www.zerohedge.com/political/appeals-court-hammers-prosecution-about-fbi-conduct-whitmer-kidnap-plot

TX AG Threatens "Every Possible Response" As Defiant Austin Allows Minors "Gender Affirming Care"

 Texas Attorney General Ken Paxton has responded to a defiant decision by the Austin City Council (ACC), which voted on Thursday to ignore a state law which prohibits "gender transitioning or gender reassignment procedure or treatment" for minors under the age of 18.

In a 10-1 vote, the ACC passed the resolution which directs city resources away from SB 14.

Paxton Responds

"On May 2, 2024, the Austin City Council passed a resolution that purportedly directs the city manager and city employees not to comply with Texas’s prohibition of puberty blockers, cross-sex hormones, and invasive surgeries for children who believe their gender is different than their biological sex," Paxton said in response.

"Riddled with problems, the resolution starts with the falsehood that such prohibited treatments have ‘proven to be evidence-based, medically necessary, and lifesaving.’ In addition to a growing body of medical research rejecting such claims, Texas concluded that the proposed treatments for minors are dangerous, and banned the practices by passing SB 14," he said.

Paxton says his office stands ready to ensure Austin follows state law.

"If the City of Austin refuses to follow the law and protect children, my office will consider every possible response to ensure compliance," he said. "Texas municipalities do not have the authority to pick and choose which state laws they will or will not abide by. The people of Texas have spoken, and the Austin City Council must listen."

As the Epoch Times notes further, the resolution was introduced by Council Member Chito Vela, who represents District 4. It was co-sponsored by four other council members—Ryan Alter, Zo Qadri, José Velásquez, and Vanessa Fuentes.

The one no vote was Council Member Mackenzie Kelly of District 6.

“Except to the extent required by law, it is the policy of the City that no City personnel, funds, or resources shall be used to investigate, criminally prosecute, or impose administrative penalties upon: (1) a transgender or nonbinary individual for seeking healthcare, or (2) an individual or organization for providing or assisting with the provision of healthcare to a transgender or nonbinary individual,” the resolution states.

It also directs Austin police to make enforcement of SB 14 their lowest priority.

According to Mr. Paxton, the resolution is nothing more than an “empty political statement” citing that each clause in the resolution directs the city manager to defy SB 14 with the qualifying statement “except to the extent required by law.” He said the ACC would order the city manager and employees to follow the law while pretending to say the opposite.

The vote by the Austin City Council today to support sex change operations for kids is infuriating but comes at no surprise. Repeatedly, Austin City Council has cared more about virtue signaling than the health and safety of its citizens,” Mary Elizabeth Castle, director of Government Relations for Texas Values, told The Epoch Times via email.

Austin City Council Members | Facebook

Ms. Castle said: “the resolution by its nature does not address the specific enforcement of law and instead directs entities like the local police department and the district attorney, who were not given enforcement power by SB 14, to ignore the law. The resolution is mostly a shell game to make it seem like Austin City Council will not comply with the law.”

In previous years, Ms. Castle said the ACC’s measures with pro-life laws and defunding the police have directed law enforcement to “either ignore complaints regarding laws on social issues they do not agree with or push them to the bottom of the stack.

Today’s action signals to the larger Austin community that sex change operations for kids are no big deal, when in fact transitioning a child can be deadly and dangerous,” said Ms. Castle.

A new long-term study out of the Netherlands found many adolescents who have doubts about their identity and gender identity grow out of it. The study also found it is normal to have doubts about one’s identity and it is actually relatively common.

In 2023, Mr. Abbott signed SB 14 into law. The law prohibits any physician or health care provider from “transitioning a child’s biological sex as determined by the sex organs, chromosomes, and endogenous profiles of the child or affirming the child ’s perception of the child ’s sex if that perception is inconsistent with the child ’s biological sex.”

The law prohibits doctors from performing numerous procedures on minors as part of gender transitioning including castration, hysterectomy, metoidioplasty, orchiectomy, among others.

Prescription drugs associated with transitioning such as puberty blockers and supraphysiologic doses of testosterone to females or estrogen to males were also prohibited in Texas.

https://www.zerohedge.com/political/texas-ag-threatens-every-possible-response-after-defiant-austin-allows-gender-affirming

What is Biden’s endgame in bringing in terrorists?

 The ruling class left has seen the importation of thousands, if not millions of military-aged men from enemy nations. 

And now in a move that dials the insanity up to eleventy, they want to bring in supporters of Hamas, if not the terrorists themselves. Everyone is anticipating an October 7-type attack in the states that will make 9/11 look like a pinprick by comparison. 

So, how do they think they are going to politically survive bringing on such an attack after importing these people in?  

What is their plan, and what is their endgame after the inevitable terrorist attack that they’ve facilitated?

It’s a mind-boggling move to bring in people who overwhelmingly support a terrorist organization. 

But with the ever-present warnings of the growing threat of terrorism and the looming election, it easily pushes the insanity off the scale.

It’s axiomatic that the people who caused a problem are incapable of providing a solution, so how do they expect to remain in control after their open border and terror importation policies are implicated in the deaths of thousands of American citizens? 

How do they expect to survive politically – if not stay out of federal prison – for the abject national security negligence in causing a terrorist attack in the states? No one should have any doubts that they will try at least for the better part of a few nanoseconds to try and blame an attack on ‘white supremacists’ or some other similarly outrageous lie.  But even the national socialist media won’t want to carry that line of BS.  Do they think they’re going to survive this politically?

Trying to figure out what is going to happen is akin to analyzing a complex physics or engineering problem, taking into consideration the forces involved and how they interact to yield a final prediction result.  

These would be the various terrorist groups that the Biden regime and Democrats have insanely let into the country.  The terrorists know this is the best opportunity they’ve ever had.  They can bring in how many and almost whoever they need to carry out an attack.  Biden and the Democrats are even flying them around the country without the need for documentation on the taxpayer dime, so they are as close to carrying out 9/11-style attacks as they have been in almost 23 years.  The open border also means they can bring in whatever destructive materials they need – including nuclear materials

Biden and the Democrats are also helpfully moving military-aged men around the country, again on the backs of the taxpayers.  And it’s been reported that they supply them with phones so that their attacks can be coordinated and in multiple locations.

The terrorists of Hamas had to break through the border to carry out the October 7 attacks.  Biden and the Democrats are inviting them in and making sure they reach the target destination of their choice.  In many cases, supplying them with food, housing assistance, and even cash cards because they wouldn’t want those people to worry about such things when making their plans.

The terrorists and just about everyone else know that the party is going to be over after any kind of attack.  Democrats are suddenly, and miraculously going to be very interested in not just border security, but shutting it down completely.  They will of course already have their imported underclass in undocumented Democrats, so it won’t matter as much.  But everyone is going to look at them for causing the attack, so they will have to act faster than Biden losing his way in walking a straight line.  

This means the terrorists are going to take full advantage of the situation to carry out as much murder and mayhem they can.  They will want to set a new standard of destruction, and you can be sure it will be with the full approval of Red China.  (Red as in communist, before the left decided to deceive everyone and switch the colors in the 2000 election).  

They are going to attack places with as many people as possible and avoid locations where people can be armed.  They aren’t going to be deterred by ridiculous rules or silly ‘gun free’ zone signs. They are looking to create maximum casualties and chaos, so they are going to be looking for large crowds.  They may also attack infrastructure targets as well as create mass casualty events since Biden and the Democrats have so helpfully provided them with the resources to do this.

Since they ostensibly won’t have a fixed base to which they can return as with the Gaza in the October 7 attacks, they aren’t as likely to take hostages.  Unless they have very ambitious plans to have such bases in place for their attacks.

These are the general considerations, but as far as specifics are concerned the terrorists have a large target area, so they have most of the advantages – with a lot of help from Biden and the Democrats.

So, we’ve looked at how the terrorists are going to take full advantage of the situation, and it would seem to be very bad news for Biden.  But somehow, they don’t seem worried.  The FBI has issued repeated warnings about terrorism from our open border and yet the border remains wide open and Biden's team is working overtime to bring in more potential threats, so what do they know that we don’t?

A wide-open border in the face of a terrorist threat and flying potential terrorists around without paperwork would be the last thing a sane society would do in this situation, so what is their plan?  How do Biden and the Democrats expect to politically survive this? 

Are they planning on the exploitation of a serious crisis to require a COVID-type shutdown to cheat their way back into power?   They caused the crisis in the first place, so why should they decide the solution?

D. Parker is an engineer, inventor, wordsmith, and student of history, former director of communications for a civil rights organization, and a long-time contributor to conservative websites.  

https://www.americanthinker.com/blog/2024/05/what_is_biden_s_endgame_in_bringing_in_terrorists.html