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Wednesday, January 27, 2021

Proud Boys leader was ‘prolific’ informer for law enforcement

 Enrique Tarrio, the leader of the Proud Boys extremist group, has a past as an informer for federal and local law enforcement, repeatedly working undercover for investigators after he was arrested in 2012, according to a former prosecutor and a transcript of a 2014 federal court proceeding obtained by Reuters.

In the Miami hearing, a federal prosecutor, a Federal Bureau of Investigation agent and Tarrio’s own lawyer described his undercover work and said he had helped authorities prosecute more than a dozen people in various cases involving drugs, gambling and human smuggling.

Tarrio, in an interview with Reuters Tuesday, denied working undercover or cooperating in cases against others. “I don’t know any of this,” he said, when asked about the transcript. “I don’t recall any of this.”

Law-enforcement officials and the court transcript contradict Tarrio’s denial. In a statement to Reuters, the former federal prosecutor in Tarrio’s case, Vanessa Singh Johannes, confirmed that “he cooperated with local and federal law enforcement, to aid in the prosecution of those running other, separate criminal enterprises, ranging from running marijuana grow houses in Miami to operating pharmaceutical fraud schemes.”

Tarrio, 36, is a high-profile figure who organizes and leads the right-wing Proud Boys in their confrontations with those they believe to be Antifa, short for “anti-fascism,” an amorphous and often violent leftist movement. The Proud Boys were involved in the deadly insurrection at the Capitol January 6.

The records uncovered by Reuters are startling because they show that a leader of a far-right group now under intense scrutiny by law enforcement was previously an active collaborator with criminal investigators.

Washington police arrested Tarrio in early January when he arrived in the city two days before the Capitol Hill riot. He was charged with possessing two high-capacity rifle magazines, and burning a Black Lives Matter banner during a December demonstration by supporters of former President Donald Trump. The D.C. Superior Court ordered him to leave the city pending a court date in June.

Though Tarrio did not take part in the Capitol insurrection, at least five Proud Boys members have been charged in the riot. The FBI previously said Tarrio’s earlier arrest was an effort to preempt the events of January 6.

The transcript from 2014 shines a new light on Tarrio’s past connections to law enforcement. During the hearing, the prosecutor and Tarrio’s defense attorney asked a judge to reduce the prison sentence of Tarrio and two co-defendants. They had pleaded guilty in a fraud case related to the relabeling and sale of stolen diabetes test kits.

The prosecutor said Tarrio’s information had led to the prosecution of 13 people on federal charges in two separate cases, and had helped local authorities investigate a gambling ring.

Tarrio’s then-lawyer Jeffrey Feiler said in court that his client had worked undercover in numerous investigations, one involving the sale of anabolic steroids, another regarding “wholesale prescription narcotics” and a third targeting human smuggling. He said Tarrio helped police uncover three marijuana grow houses, and was a “prolific” cooperator.

In the smuggling case, Tarrio, “at his own risk, in an undercover role met and negotiated to pay $11,000 to members of that ring to bring in fictitious family members of his from another country,” the lawyer said in court.

In an interview, Feiler said he did not recall details about the case but added, “The information I provided to the court was based on information provided to me by law enforcement and the prosecutor.”

An FBI agent at the hearing called Tarrio a “key component” in local police investigations involving marijuana, cocaine and MDMA, or ecstasy. The Miami FBI office declined comment.

There is no evidence Tarrio has cooperated with authorities since then. In interviews with Reuters, however, he said that before rallies in various cities, he would let police departments know of the Proud Boys’ plans. It is unclear if this was actually the case. He said he stopped this coordination after December 12 because the D.C. police had cracked down on the group.

Tarrio on Tuesday acknowledged that his fraud sentence was reduced, from 30 months to 16 months, but insisted that leniency was provided only because he and his co-defendants helped investigators “clear up” questions about his own case. He said he never helped investigate others.

That comment contrasts with statements made in court by the prosecutor, his lawyer and the FBI. The judge in the case, Joan A. Lenard, said Tarrio “provided substantial assistance in the investigation and prosecution of other persons involved in criminal conduct.”

As Trump supporters challenged the Republican’s election loss in often violent demonstrations, Tarrio stood out for his swagger as he led crowds of mostly white Proud Boys in a series of confrontations and street brawls in Washington, D.C., Portland, Oregon, and elsewhere.

The Proud Boys, founded in 2016, began as a group protesting political correctness and perceived constraints on masculinity. It grew into a group with distinctive colors of yellow and black that embraced street fighting. In September their profile soared when Trump called on them to “Stand back and stand by.”

Tarrio, based in Miami, became the national chairman of the group in 2018.

In November and December, Tarrio led the Proud Boys through the streets of D.C. after Trump’s loss. Video shows him on December 11 with a bullhorn in front of a large crowd. “To the parasites both in Congress, and in that stolen White House,” he said. “You want a war, you got one!” The crowd roared. The next day Tarrio burned the BLM banner.

Former prosecutor Johannes said she was surprised that the defendant she prosecuted for fraud is now a key player in the violent movement that sought to halt the certification of President Joe Biden.

“I knew that he was a fraudster – but had no reason to know that he was also a domestic terrorist,” she said.

https://www.reuters.com/article/us-usa-proudboys-leader-exclusive/exclusive-proud-boys-leader-was-prolific-informer-for-law-enforcement-idUSKBN29W1PE

Stifel sticks to Buy on Rhythm Pharma

 Stifel analyst Derek C. Archilia reiterated a Buy rating on Rhythm Pharmaceuticals (NASDAQ: RYTM).

https://www.streetinsider.com/Analyst+Comments/Stifel+Reiterates+Buy+Rating+on+Rhythm+Pharmaceuticals+%28RYTM%29%2C+Remains+on+Select+List/17862789.html

Pfizer Xeljanz fails safety study, makes rivalry with AbbVie Rinvoq tougher

 Pfizer has had a tough couple of years marketing its rheumatoid arthritis drug Xeljanz, as regulatory agencies have slapped warnings on the JAK inhibitor about potential cardiovascular side effects and cancer risk.

A new study promises to make the marketing challenge even greater.

The study, which was a post-marketing trial required by the FDA, compared Xeljanz to a TNF inhibitor in more than 4,300 patients over age 50 who had RA and at least one cardiovascular risk factor. There were 98 cases of cardiovascular events among the Xeljanz patients, versus just 37 in the TNF inhibitor group. And 122 patients taking Xeljanz developed cancers, compared with 42 on TNF inhibitors.

Xeljanz thus missed the trial's primary endpoints, which were to show non-inferiority to TNF inhibitors in both cardiovascular and cancer risk. Two doses were tested, and both missed the mark, Pfizer said.

The result wasn’t entirely surprising, given the pileup of warnings on JAK inhibitors in recent years. In 2019, the FDA warned of an increased risk of blood clots and possibly death for patients taking 10 mg of Xeljanz twice daily. Pfizer had already flagged the safety issue and switched patients in a postmarketing study to the 5 mg dose, but the FDA was concerned enough to slap the dreaded “black box” warning on the drug.

The European Medicines Agency followed a few months later with a warning suggesting Xeljanz at any dose should be used with caution in patients who face a high risk of blood clots.


And these days, Pfizer isn’t just facing competition from TNF inhibitors like AbbVie’s Humira.  It also has a tough rival in AbbVie’s JAK inhibitor Rinvoq, already approved to treat RA.

AbbVie is also pursuing an ulcerative colitis approval for Rinvoq. In December, the Illinois-based drugmaker released results from a phase 2b/3 study showing Rinvoq helped 26% of patients achieve remission at eight weeks, versus just 5% of patients taking a placebo.

It wasn't good news for Pfizer. Bernstein analyst Ronny Gal hailed Rinvoq’s "clear efficacy signal, better than Xeljanz, and within the ballpark of what has been seen across the UC field."

Pfizer has many second-generation JAK inhibitors in the pipeline, Gal acknowledged in a December report. “However, the field is getting more crowded with the approval of AbbVie's Rinvoq and multiple additional entrants in the next 18 months, and we are uncertain if Pfizer's strategy will play out.”

Gal estimates that Pfizer will report 2020 sales of Xeljanz of $2.4 billion and that the product will peak at just $2.8 billion in 2025 before losing patent protection in 2026.


Among Pfizer’s follow-ups in JAK inhibition is abrocitinib. The company is expecting an FDA decision on the drug in atopic dermatitis in April. That would pit Pfizer against Sanofi and Regeneron’s blockbuster Dupixent, and possibly Rinvoq. AbbVie is also gunning for the atopic dermatitis market and is expecting a verdict from the FDA in the second half of the year.

Pfizer has told analysts it expects abrocitinib to hit $3 billion in annual sales in atopic dermatitis, but with so much competition, Gal is skeptical. He estimates the drug will peak at $2 billion in that indication.

And the safety concerns swirling around the entire JAK class continue to worry analysts. During the annual J.P. Morgan Healthcare Conference in January, Pfizer CEO Albert Bourla was asked how marketers of JAK inhibitors could overcome perceptions of safety issues among dermatologists. Bourla said he’s not worried.

“We will develop the data, because in this country, you need to bring data and this is the beautiful thing about science and discovery,” he said. “But I feel that the benefits that [JAK inhibitors] bring clearly will outweigh any potential risks… because the data are strong.”

https://www.fiercepharma.com/pharma/pfizer-s-xeljanz-hits-competitive-hurdle-race-against-abbvie-s-rinvoq-failure-safety-study

Lilly teams up with Glaxo, partner Vir for COVID-19 antibody cocktail test

 COVID-19 has been a real leveler in competitor terms; once warring Big Pharmas have joined forces for the greater good on vaccines, both in R&D and more recently on production, and now on treatments.

Today, Lilly penned a deal with GlaxoSmithKline and biotech partner Vir to wed the former’s emergency-cleared COVID-19 antibody bamlanivimab 700 mg with GSK/Vir’s experimental therapy VIR-7831 (aka GSK4182136) 500 mg.

The hope is that in the so-called Blaze-4 trial, which has been expanded to accommodate this combo, will see the two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein create better potency and make the virus less likely to evade, especially with new variants.

This is the first time that monoclonal antibodies from separate companies will be brought together in this way.

Bamlanivimab is a neutralizing antibody directed against the spike protein of SARS-CoV-2 designed to block viral attachment and entry into human cells, thus neutralizing the virus. Late last year, it nabbed an FDA emergency authorization in mild to moderate COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.

It has, like rival Regeneron which has its own cocktail antibody therapy authorized, struggled to get this therapy to patients across the U.S., and with vaccines now coming in full force, its already limited use will likely further diminish. It’s also contending with new viral variants that could also lessen the impact of the antibody.


This is one reason for tapping VIR-7831, which works as a dual-action monoclonal antibody that was “selected for clinical development based on its potential to both block viral entry into healthy cells and clear infected cells, as well as its potential to provide a high barrier to resistance,” Lilly said in a joint statement.

In early preclinical trials, it showed it could bind to an epitope on SARS-CoV-2 shared with SARS-CoV-1, indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop.

If it can work alongside Lilly’s med and work against new variants with all involved, including the federal government, able to help get patients to these infused therapies better, it could help lower deaths and severe disease. The Blaze-4 trial will run to tell us exactly that.

Just this week, Lilly said in a release (and with thin details) that its internal antibody cocktail bamlanivimab-etesevimab slashes deaths and hospitalizations in high-risk patients

"As the virus continues to evolve, we, along with Lilly and GSK, share the view that we should pursue all possibilities to help end the pandemic and maximize the number of lives that can be saved,” said George Scangos, Ph.D., CEO of Fierce 15 winner Vir.

“This trial is a first step to assess whether the administration of VIR-7831, with its high barrier to resistance and potent effector function, alongside bamlanivimab, which has strong outcomes data in early treatment, can provide potential benefits beyond monotherapy.”

This isn’t VIR-7831's only tango: The therapy is also paired up with a combination of two Brii Biosciences antibodies, namely BRII-196 and BRII-198, in patients hospitalized with COVID-19.

https://www.fiercebiotech.com/biotech/eli-lilly-teams-up-pharma-rival-gsk-and-partner-vir-for-covid-antibody-cocktail-test

CA Healthcare Acquisition Corp. Prices $100M IPO

 CA Healthcare Acquisition Corp. (the “Company”) announced today that it priced its initial public offering of 10,000,000 units at a price of $10.00 per unit. The units will be listed on the Nasdaq Capital Market (“Nasdaq”) and will begin trading tomorrow, Wednesday, January 27, 2021 under the ticker symbol “CAHCU.” Each unit consists of one share of the Company’s Class A common stock and one-half of one redeemable warrant. Each whole warrant entitles the holder thereof to purchase one share of Class A common stock at a price of $11.50 per share. Only whole warrants are exercisable. No fractional warrants will be issued upon separation of the units and only whole warrants will trade. Once the securities comprising the units begin separate trading, shares of the Class A common stock and warrants are expected to be listed on the Nasdaq under the symbols ‘‘CAHC’’ and ‘‘CAHCW,’’ respectively.

The offering is expected to close on Friday, January 29, 2021, subject to customary closing conditions.

The Company is a blank check company formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses. While the Company may pursue an initial business combination target in any business or industry, it intends to focus its search in the healthcare industry, specifically healthcare services, healthcare information technology, care management, medical distribution, behavioral health, medical devices, diagnostics, pharma services, health and wellness, and specialty pharmacy.

The Company is led by Chairman and Chief Executive Officer Larry J. Neiterman (most recently serving as the Chief Operating Officer of Deloitte Global Consulting) and President and Chief Financial Officer Jeffrey H. Barnes (most recently serving as the Chief Executive Officer of Philips Canada), in conjunction with members of Covington Associates and Pleasant Bay Capital Partners.

https://www.businesswire.com/news/home/20210126006151/en/CA-Healthcare-Acquisition-Corp.-Announces-Pricing-of-100-Million-Initial-Public-Offering

VBL Therapeutics Starts Phase 2 Study of VB-201 in COVID-19

 VBL Therapeutics (Nasdaq: VBLT) today announced the dosing of the first patient in a randomized controlled Phase 2 study of the Company’s proprietary investigational oral immune-modulator molecule, VB-201 for the treatment of COVID-19. The study will assess the ability of VB-201 to prevent clinical deterioration and reduce morbidity and mortality in patients with severe COVID-19.

"While vaccines offer a major development in this pandemic, there is still a crucial unmet global need for new treatments for severe COVID patients," said Prof. Dror Harats, Chief Executive Officer of VBL Therapeutics. "Manufacturing and cold-chain logistics limit access to vaccines in many regions in the world and at the same time, new and aggressive viral mutations are being identified. There is an understanding that the therapeutic arsenal against COVID must be enriched, both to combat the current pandemic as well as for future viral outbreaks. We believe that, as a safe and affordable oral therapy, VB-201 has the potential to bridge this gap by limiting the life-threatening hyper-inflammation in this deadly disease.”

VB-201 is designed to offer differentiation from other immune modulators evaluated as treatments for COVID, and its anti-inflammatory activity in the cardiovascular system may benefit patients with COVID-related Kawasaki-like multisystem inflammatory syndrome. Studied in over 600 subjects, VB-201 previously demonstrated proof of concept in a Phase 2 study in vascular inflammation, meeting the primary endpoint of the trial.

https://www.globenewswire.com/news-release/2021/01/27/2164946/0/en/VBL-Therapeutics-Treats-First-Patient-in-Phase-2-Randomized-Controlled-Study-of-VB-201-in-COVID-19-Patients.html

Lilly, Regeneron COVID-19 treatments may be weaker against South Africa variant

 COVID-19 antibody drugs developed by Eli Lilly and Co and Regeneron may be weaker against a new coronavirus variant found in South Africa, according to a study released on Tuesday based on laboratory tests.

Scientists have said new variants found in South Africa and Britain seem highly transmissible, raising concern that current drugs and vaccines might be rendered less effective.

The latest study comes as Eli Lily said on Tuesday it is moving a new antibody therapy to clinical trials targeting the South African variant.

The study, which was done outside human bodies using a pseudovirus containing mutations found in the two variants to test antibody treatments, showed the South Africa variant appeared to affect a broader range of antibodies than the U.K. variant and was more worrisome . A pseudovirus mimics live coronavirus and can be handled in labs at lower biosafety levels.

An antibody treatment developed by Lilly saw its neutralising effect severely diminished against the pseudovirus mimicking South African variant, according to the research, which has not yet been peer-reviewed but was published online on BioRxiv, a website for research.

When used in combination with a treatment from Shanghai Junshi Biosciences, its activity against the pseudovirus was still largely crippled, researchers from Columbia University, Vaccine Research Center, Regeneron and others said in the paper released.

But a cocktail of antibody treatments from Regeneron remained potent, although one of the two antibodies showed impaired activity.

The study said its findings suggest that antibody treatment may need to be modified in places where the South Africa variant is prevalent.

https://www.reuters.com/article/health-coronavirus-eli-lilly/eli-lilly-regenerons-covid-19-treatments-may-be-weaker-against-south-africa-variant-study-idUSL4N2K21MJ