Search This Blog

Friday, January 3, 2025

Regeneron builds in eye disease tech with Oxular takeover

 Regeneron has bought Oxular, a UK-based specialist in retinal diseases, in a move that bolsters its already strong position in ophthalmology therapies.

News of the takeover came in the form of a LinkedIn post from the UK company's former chief executive Mark Gaffney, now heading up Calluna Pharma, who wrote that the ophthalmology team at Regeneron is "uniquely positioned to maximise the use of Oxular's proprietary technologies." The terms of the acquisition have not been disclosed.

Oxular is working on the development of novel drug/device combinations for sight-threatening retinal disorders, which is a key area of focus for Regeneron. The US biopharma's biggest product is Bayer-partnered Eylea/Eylea HD (aflibercept), which is used to treat diseases including age-related macular degeneration (AMD) and diabetic macular oedema (DME) and had global sales of $9.4 billion in 2023.

Buying Oxular gives Regeneron access to a pair of technologies designed to unlock the potential of therapeutics for retinal diseases.

Oxuspheres are polymer-based drug delivery vehicles, small enough to be delivered by injection, that are designed to gradually release the active drug into the retina. They can extend the delivery from a single administration for up to a year and also reduce the chances that it will disperse to affect other tissues in the eye, according to Oxular.

The second technology platform is Oxulumis, a minimally invasive, semi-automated administration device for the delivery of therapeutics to the posterior suprachoroidal space of the eye using an illuminated microcatheter. The device can be used in a doctor's office and prevents release of the drug until the correct placement is confirmed visually.

Oxular's lead programme is OXU-001, a formulation of the corticosteroid dexamethasone that uses both of the company's technology platforms and which recently started the phase 2 OXEYE trial in DME.

The trial, which is in two parts, is designed to evaluate a single administration of suprachoroidal OXU-001 over 52 weeks. Part A is due to enrol 18 patients in the US who have been previously treated with anti-VEGF therapy like Eylea to one of two dose levels of OXU-001.

Part B will recruit 110 DME patients who have either been previously treated with anti-VEGF therapy or are treatment-naïve, who will be randomised to one of the two dose levels of OXU-001 or AbbVie's Ozurdex, a dexamethasone-based implant that has been approved for DME by the FDA for more than a decade.

Gaffney joined Oxular in September 2023, shortly before the start of OXEYE, and said at the time that Oxular was "the only clinical-stage company that is posteriorly delivering sustained-release therapies to the back of the eye, which should allow for fewer injections and a favourable safety profile compared with current treatment options."

https://pharmaphorum.com/news/regeneron-builds-eye-disease-tech-oxular-takeover

London-listed Poolbeg discussing Hookipa merger

 The UK's Poolbeg Pharma has disclosed that it is in talks over a possible combination with Hookipa, an Austrian biotech that is listed on the Nasdaq.

The all-share merger – which, if completed, would see Poolbeg de-list from the London Stock Exchange's AIM – would create a "strong clinical-stage biopharmaceutical company focused on developing and commercialising innovative medicines for critical unmet medical needs, with a special focus on next-generation immunotherapies for the treatment of cancer and other serious diseases," according to a statement.

Under the proposed terms, Poolbeg shareholders would receive 0.03 Hookipa shares for each Poolbeg share they own, resulting in Poolbeg backers owning 55% of the enlarged company, which would retain its Nasdaq listing. However, Hookipa has indicated it will raise $30 million in funding upon completion of the deal, which would reduce Poolbeg's stake to around 40%.

Poolbeg co-founder Cathal Friel would become executive chairman of the new company, according to the statement, with Hookipa's chief executive, Malte Peters, retaining that role if the transaction goes through.

The combined company would have an in-house pipeline that includes Hookipa's multi-KRAS targeting immunotherapy HB-700 for KRAS-mutated cancers, including pancreatic, colorectal, and lung cancer, which has generated preclinical results and is ready for phase 1 trials, and Poolbeg's small molecule POLB 001, an orally delivered p38 MAP kinase inhibitor therapy being developed for cancer immunotherapy-induced cytokine release syndrome that is heading for phase 2.

It would also have two Hookipa programmes partnered with Gilead Sciences, namely HB-500, an alternating, 2-vector arenaviral therapeutic vaccine that is being evaluated as part of a potential curative regimen for HIV, and HB-400, which is based on similar technology and is directed against hepatitis B virus (HBV).

The announcement comes a few weeks after Hookipa said it would pause the development of its former lead candidate eseba-vec, which had reached phase 1/2 testing for human papillomavirus type 16 (HPV16) positive cancers, and slash around 80% of its workforce as it turned its focus on HB-700. There was no mention of eseba-vec in the combined company's plans.

News of the merger discussions caused Poolbeg's share price to fall around 40%, while Hookipa remained largely unchanged, although, it remains at a fraction of its 52-week high point following the restructuring announcement.

Hookipa, which has set up a webpage to allow shareholders to track progress with the potential deal and associated fundraising, said that the merger would create a company with "clinical data expected across multiple programmes over the next 24 months in large therapeutic areas with unmet medical needs."

https://pharmaphorum.com/news/london-listed-poolbeg-discussing-hookipa-merger

Apple to pay $95 million in Siri spying lawsuit

 Tech giant Apple on Thursday agreed to pay $95 million to settle a proposed class action lawsuit that claimed its Siri voice assistant violated users' privacy.

preliminary settlement was filed Tuesday night at a federal court in Oakland, California, which will be subject to approval by U.S. District Judge Jeffrey White.

Mobile device owners who brought the complaint alleged that Apple had routinely recorded private conversations after they unintentionally activated Siri. The suit added that those conversations had then been disclosed to third parties, including advertisers who had served some users ads that had been tailored to conversations they had.

Voice assistants like Siri can be opened in response to certain verbal prompts that include "hot words" like "Hey, Siri."

Two of the plaintiffs claimed that their mentions of Air Jordan sneakers and Olive Garden restaurants had prompted them to receive targeted ads for those products. 

Another plaintiff alleged that he had received ads for a brand-name surgical treatment after he had discussed it in what he had thought had been a private conversation with his doctor.

TickerSecurityLastChangeChange %
AAPLAPPLE INC.243.85-6.57-2.62%

Class members, who were estimated to number in the tens of millions, may receive up to $20 for each Siri-enabled device they own, such as iPhones and Apple Watches. The class period runs from Sept. 17, 2014, to Dec. 31, 2024, and began when Siri incorporated the "Hey, Siri" feature.

Apple denied wrongdoing in agreeing to the settlement.

The $95 million settlement amounts to about nine hours' worth of profit for Apple, which had a net income of about $93.74 billion in its latest fiscal year.

Lawyers are seeking up to $28.5 million in fees, plus $1.1 million in expenses, as compensation from the settlement fund.

A similar lawsuit is pending on behalf of users of Google's Voice Assistant in a federal court in San Jose that is part of the same district as the Oakland court handling the Apple case. The plaintiffs in the Google case are represented by the same firms as in the Apple case.

https://www.foxbusiness.com/markets/apple-pay-95-million-siri-spying-lawsuit

Acelyrin.Virtual Investor Event on Phase 2 Data, Phase 3 Design for Thyroid Eye Disease

 ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced it will host a virtual investor event on Monday, January 6, 2025 at 4:30 PM ET to provide updated Phase 2 data for subcutaneous lonigutamab further supporting its potential for a best-in-class efficacy and safety profile in Thyroid Eye Disease (TED). The event will also feature external clinician perspectives on the continuing unmet needs in TED and disclose the design for the Phase 3 LONGITUDE program, which was developed following a successful End-of-Phase 2 meeting with the FDA to be the most inclusive registrational program to date in TED. To register, click here.

 A live question and answer session will follow the formal presentations and a recording of the webcast will be available and archived on the Company’s website for approximately 30 days.

https://www.globenewswire.com/news-release/2025/01/03/3003799/0/en/ACELYRIN-INC-to-Host-Virtual-Investor-Event-to-Share-new-Phase-2-Data-and-Phase-3-Program-Design-for-Subcutaneous-Lonigutamab.html

Don’t let the Left downplay the threat of Islamic radicalism

 by David Harsanyi

Not long ago, a Texas native named Shamsud-Din Jabbar pledged allegiance to the Islamic State group on Facebook. Now, perhaps if he had been an election-denying vaccine skeptic, Jabbar might have gotten himself noticed by law enforcement. Instead, Jabbar was free to ram his rented Ford pick-up truck into a crowd on Bourbon Street in New Orleans, murdering 15 people. Jabbar, who had guns and explosive devices in his truck, was killed in a shootout in which he wounded two police officers.

Law enforcement officials and media, as is their wont, reflexively downplayed the Islamic aspects of mass murder. The lead agent in the investigation initially declared that the FBI did not consider the attack a “terrorist event.” There was a small problem, however, as Jabbar had flown not an Appeal to Heaven or Gadsden flag, but one of those black ones favored by Sunni terrorist groups such as al Qaida and the Islamic State group on his truck. The FBI was quickly compelled to walk back its claim.

It is perhaps understandable why the Justice Department, which has spent years obsessing about white supremacists, allegedly the greatest threat to our way of life; orthodox Catholics; pro-lifers; parents who oppose COVID-19 restrictions imposed by school boards; and candidates of the opposition party, somehow missed this man. But the prevarications about the nature of Islamic terrorism are not.

You might recall former President Barack Obama, who once promised the world that the future wouldn’t belong to those “who slander the prophet of Islam,” refused to refer to the most violent ideology in the world as “radical Islam,” instead using a slew of euphemisms to conceal reality. This has become the norm.

As of this writing, I have learned much about Jabbar’s “checkered marital history” and “financial difficulty” but little about his radicalization at a mosque in Houston. Divorced men with debt typically do not, as most of you probably know, begin murdering infidels.

One suspects we will soon hear that Jabbar acted alone, as we did so many other Islamic terrorists. Just another member of the “United Amalgamated Union of Lone Wolves and Isolated Extremists,” as Mark Steyn once quipped.

New York Times columnist Charles Blow, who is incapable of processing any event without making it about race, contends that the “really big problem” on the domestic terrorism front “is young white men.” There is no global “young white man” terrorism work. There is no prevailing “young white man” theology that imbues theological or ideological legitimization to murder. There is no “young white man” state that funds or spreads extremism and is trying to obtain nuclear weapons. The men and women who murder in the name of Islam, on the other hand, are part of a worldwide, ideological, and political movement.

Yes, it’s complicated. And while it’s important to understand the theologically disparate groups that operate in the Middle East, it is insufferably pedantic to act as if we have a great responsibility to worry about which faction is yelling “Abu Akhbar” before plowing a truck into a crowd or a plane into a building.

The broader goal of the Islamic State group fanboy Jabbar and the Oct. 7, 2023, “militant” who guns down the elderly at a bus stop in southern Israel is the same. Jabbar’s intentions align with those of Hadi Matar, the jihadi who attempted to murder novelist Salman Rushdie, still under a four-decade-old fatwa issued by the religious authorities of the Iranian regime.

In March 2024, Jabbar’s theological compatriots attacked Crocus City Hall in the suburbs of Moscow, murdering over 130 civilians. In 2023, Sunni Islamists from Gaza murdered over 1,000 Israelis and engaged in other atrocities. In 2019, a series of Islamic State group bombings struck churches and hotels in Sri Lanka on Easter Sunday, killing over 250 civilians. Then, of course, there is endless violence in places such as Nigeria, Mali, and Burkina Faso, where 600 people were massacred in one event this summer.

Imagine if Islamists such as Jabbar were constantly plowing trucks into crowds, blowing themselves up in pizza parlors, and stabbing children indiscriminately in the streets. That might give you an idea of what Israel has been dealing with for decades. Islamic extremism is the leading cause of conflict in the world. By one count, between 1979, the year marking the Islamic revolutions, and 2021, there were at least 48,035 Islamist terrorists worldwide, leading to the deaths of over 210,000 people. This number does not include the human suffering and repression caused by repression in the Islamic world.

And you can bet your life, if they could, Islamists would bring that here.

One of the likely reasons elites underplay these dangers is to manage Americans, who they seem to believe will break out into spasms of violence against Muslims after every terrorist event. It is absurd.

Christopher Hitchens once called “Islamophobia” a “stupid neologism” that “aims to promote criticism of Islam to the gallery of special offenses associated with racism.” The “Islamophobia” accusation is meant to play on the tolerant nature of most Americans to chill debate. “Islamophobia” conflates criticism of an illiberal, often violent, theology and political belief system with hatred of people.

When Trump suggested an impractical “Muslim ban” in 2016, barring immigration from nations with high numbers of extremists, leftists compared it to the restrictive quotas of Jews in the 1930s that doomed thousands to perish under Nazi rule. Of course, the difference, need it be said, is that those who practice Islam in Syria and Judaism in Germany are not the same. Islam is unique among the major faiths in its reticence to modernity and embrace of violence.

Muslims are, and should be, protected equally by Western values that everyone else enjoys. More than that, it is a civic virtue to live with others peacefully. But no one gets special dispensation from debate or reality. Most American Muslims live perfectly normal, peaceful, and quite prosperous lives. As smart as anyone else, they are surely aware that Islam isn’t the same as Presbyterianism merely because both are faiths.

A significant majority of Muslims around the world believe Sharia should be the law of the land, according to the Pew Research Center’s exhaustive study on the matter. This is something to strongly consider when thinking about our immigration policy. Thus far, we have been far more successful than Europe in assimilating newcomers from the Middle East. That trend is in danger as we not only stop expecting immigrants to embrace American values but reject them ourselves. Does anyone watching how our elite universities function believe that we are doing a good job raising Americans who value these tenets?

It has always been a mystery why the Left feels compelled to grade the world’s most pervasive illiberal ideology on a steep curve. But these days, many progressives have taken it further and begun championing the jihadi cause. Only days after the Islamic attack in New Orleans, hundreds of “pro-Palestinian” protesters blocked Sixth Avenue in Manhattan, chanting, “Long live the intifada!”

Some Republicans have tried to tie the New Orleans attack to our broken border. It’s not true. Jabbar was an American who earned a degree from Georgia State University, served in the Army from 2006 to 2015, and had a job at Deloitte, which only demonstrates that the threat of Islamism is global.

Still, Jabbar’s attack is also an obvious warning as to why a rickety border is an invitation for another 9/11. Indeed, there have been numerous reports from the Biden administration about an “ISIS-affiliated human smuggling network” moving hundreds of people into the United States.

Of course, terrorism isn’t the most dangerous immediate problem for people in this country. There are more murders in New Orleans due to criminality in any given month than were from this terrorist attack. But Islamism is still one of our greatest menaces in the world. We shouldn’t be lulled into complacency or bullied into ignoring this truth.

https://www.washingtonexaminer.com/opinion/columnists/3274938/dont-let-the-left-downplay-islamic-radicalism/

MSM Not Only Hid Biden Health but Never Asked Who "Ruled in His Name"

Thursday on the RealClearPolitics podcast, Carl Cannon talks to RCP contributor J. Peder Zane about his latest article on the legacy media's failure to ask the right questions about obviously aging President Biden: New Year Offers Legacy Media a Chance for Redemption


"As I was thinking about the real failures that have been exposed in the mainstream coverage of the Biden White House in particular, the Wall Street Journal came out with a story that showed basically what we all knew. Not only had Biden been diminished for years, but the import of their reporting was getting people on the record to say what people close to Biden did, not only to cover this up but to govern in spite of the president's challenges," Zane explained.

"The fact that many of our colleagues in the legacy media, such as The New York Times, The Washington Post, NPR, and CNN, did not pursue this story at all and, in fact, worked to dismiss it and go after those who suggested the president was diminished is a huge scandal."


"But the hope that you've instilled in me, Carl, is that I think there's a chance for those same mainstream outlets -- who have phenomenal reporting shops -- to redeem themselves somewhat by pursuing this story of the effort to rule in Biden's name," he continued.

Carl Cannon presents the big question this raises: "Has Biden been running the country, or have these other people? If so, who? And by what right do they have to do that? What your column explores is the role of the media in, instead of exposing this, sort of covering it up. Is that too strong a term?"

"I think they absolutely were," Zane said. "The greatest evidence for that is that I don’t think the Wall Street Journal story was any surprise to people who read many of the links at RealClearPolitics or stories we’ve written at RealClear Investigations. This was not a secret, that this man was diminished. Certainly, when he was forced out of the race after his bumbling and stumbling -- to put it nicely -- debate performances, it was clear there was a problem. He was removed from the ticket not because of his policies but because of his diminished capacity."

"One point I didn’t make in my column is that because the media isn’t holding Democrats to account, it adds to the super-partisan nature of our politics," Zane further stated. "If they do nothing about this, it’s very likely that Republicans may feel the need to investigate what went on. That is, by its nature, partisan and political."

"One of the reasons, among many, that we’re so divided is that neither party wants to hold its own to account. When the press doesn’t hold people to account, politicians jump into the breach. If we had a media doing its job, we’d be a little less divided -- if they were doing it fairly. Hold Trump to account, totally, but also hold the other side."

"Look at how they covered Trump. Numerous stories about invoking the 25th Amendment over nothing. He’s a vigorous person. I don’t think Nancy Pelosi is the most articulate person in the world, but nobody can look at that 84-year-old woman and say she’s not capable of doing her job," he said. "Some older people are capable; some aren’t. It’s a case-by-case thing. But when you look at what they did when Trump maybe stumbled down a step once, and you compare it to how they covered up for Biden, it’s glaringly obvious. The contrast is so apparent."

"That’s what keeps coming out of all this -- it’s so obvious, and they’re so bad at it," he continued. "It’s like the emperor’s new clothes. You have these progressive elites seeing reality in a way that the rest of the country isn’t. Don’t forget, in February 2024, there was an ABC poll in which a vast majority of Democrats said Biden was too old to run for re-election."

"This wasn't an open secret," Cannon added. "It was only a secret among the Washington press corps!"

Covidiocy and Cancer

 by John Hinderaker

One of the worst aspects of the covid fiasco of 2020 was the shutting down of “nonessential” or “elective” medical care. Worldwide, many thousands of checkups, routine procedures and so on were foregone, with consequences that will unfold over the coming decades.

The World Health Organization has undertaken a study to find out how many cancer cases were “missed” during the covid epidemic, mostly because of shutdowns. The Telegraph relates the results:

Nearly a quarter of all new cancer cases may have been missed during the Covid pandemic, a World Health Organisation (WHO) study has found.

Researchers said lockdown restrictions and pressures on healthcare systems saw diagnoses of the disease drop by 23 per cent globally, suggesting it was not identified in around one million people.

A million cases of cancer that were not diagnosed in timely fashion, and in many cases remain undiagnosed today. WHO’s study was an analysis of “more than 240 different studies, providing the first comprehensive worldwide assessment of the impact of Covid on cancer care.” Here are the details:

The researchers found there had been a 23 per cent drop in the number of cancer diagnoses made after spring 2020, a 39 per cent decline in cancer screening, a 24 per cent drop in diagnostic procedures and a 28 per cent reduction in treatments.

The bottom line is a million cancer cases that were not timely identified. And this is a WHO study: if there is any group that is not anxious to reflect badly on governments’ covid decisions, it is WHO, which largely drove those decisions.

The Telegraph adds some data specific to Great Britain:

A previous study by the University of Oxford found there had been a “substantial impact” on cancer screening and diagnoses in the UK in 2020 and 2021 caused by the pandemic. It estimated that 18,000 breast, 13,000 colorectal, 10,000 lung, and 21,000 prostate cancer diagnoses were missed from March 2020 to December 2021.

The shutdowns that governments foolishly implemented as a result of the covid scare have had horrific consequences, and those consequences will continue to be felt for decades to come. Some of the negative fallout is quantifiable, like missed cancer diagnoses. Other consequences, like the impact on young people of missing a year or more of school, are harder to quantify but likely, in the long run, more devastating.

If there is a silver lining in this story, it lies in the fact that pretty much everyone now recognizes that the shutdowns, mask mandates and other voodoo medicine of the era of covid hysteria were worse than a mistake. They were particularly unforgivable, because they were contrary to many decades of public health experience, and contrary to the public health guidance that existed in various agencies as of 2020–guidance that was promptly overruled when covid hysteria took hold in certain quarters.

Happily, a new day has dawned. There is every prospect that federal policy, at least, will return to the conventional wisdom that grew out of centuries of public health experience. This return to normalcy is exemplified by Donald Trump’s nomination of Dr. Jay Bhattacharya, a leading voice of common sense, as Director of the National Institutes of Health, where he will be well positioned to lead resistance to whatever pseudo-science may spring up in response to the next global epidemic.

https://www.powerlineblog.com/archives/2025/01/covidiocy-and-cancer.php