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Wednesday, May 22, 2024

Evotec makes 'strategic exit' from gene therapy as part of wider shake-up

 A month after Evotec first alluded to a “strategic reset” to rebalance the company, the German biotech has revealed the end of its gene therapy aspirations.

The “strategic exit” from the gene therapy space is designed to “bring the focus on the company’s core modalities,” Evotec explained in a first-quarter earnings release. This will involve closing the company’s site in Orth an der Donau, Austria, which operates under the Evotec Gene Therapy banner.

Around 40 employees are based at the site who, according to the company’s website, “cover the full spectrum of services for end-to-end gene therapy development.” Evotec is “working closely with all stakeholders to minimize the impact” on these employees.

Evotec, which offers drug development services to all 20 of the largest pharmas as well as hundreds of biotech clients, first hinted at major changes to “rightsize our operational and corporate structure” last month. At the time, Interim CEO Mario Polywka said the company’s “central focus for 2024 is to protect our strong balance sheet and refocus the company on profitable growth.”

The major change unveiled in April was a consolidation of reporting structures, but more alterations were hinted at. Losing the gene therapy business means removing a business segment that offered a range of services to biopharma clients, including the design of viral AAV vectors for various therapeutic payloads, generating AAV material for research and non-clinical studies, in vitro and in vivo proof of concept studies for target validation, as well as conducting non-clinical gene therapy studies.

The decision was probably shaped by what Evotec described as a “challenging” first quarter. The company used the “c” word again to describe the current market for transactional businesses, which it blamed for shared R&D revenues dropping by 23% to 155.2 million euros ($168.1 million) in the first quarter of the year.

Despite this, the company continued to chalk up some big-name partnerships, including receiving a $25 million payment from Bristol Myers Squibb to dive deeper into their neuroscience collaboration.

https://www.fiercebiotech.com/biotech/evotec-makes-strategic-exit-gene-therapy-part-wider-shakeup

DHS Admits Border Has Been Open To Criminals And Terrorists

 by James Breslo via The Epoch Times,

The Biden administration’s experiment with a relatively open southern border has been shocking in the sheer number of people who have come across in just over three years, estimated to be about ten million. But the most shocking thing about the border policy may have just been revealed.

The Department of Homeland Security (DHS), headed by the impeached Alejandro Mayorkas, recently proposed a new rule. In a statement announcing the rule, DHS unwittingly revealed that it has not been doing background checks on these millions of illegal immigrants in order to immediately deport those with criminal records or terrorism ties. Instead, they have been leaving that determination until the asylum hearing, which occurs many years down the road. In the meantime, they remain in the U.S. awaiting the hearing.

First, it should be noted that the whole premise upon which these millions of illegal immigrants are permitted to enter the United States is absurd. People are free to cross almost anywhere they please along our nearly 2,000-mile southern border. They are typically not required to enter through an official entry point. Cross the desert, the mountains, or the river at a place of your choosing (or, more accurately, at the drug cartel’s choosing). No problem, we will bring border patrol to you and gladly process you right there and allow immediate entry.

They are processed and allowed in because they are being treated as refugees seeking asylum, not illegal immigrants as before. That is the hook and the key to the open border experiment. U.S. immigration law (Title VIII, Section 1158(b)) provides, “To establish that the applicant is a refugee ... the applicant must establish that race, religion, nationality, membership in a particular social group, or political opinion was or will be at least one central reason for persecuting the applicant.”

But the vast majority of these immigrants are not coming here to escape persecution. They are coming because they are poor, which has never been grounds for asylum. If they were escaping persecution, where are the reports of millions of central and south Americans being persecuted because of their race? Where are the reports of millions being persecuted because of their religion?

The vast majority of illegal immigrants will be denied asylum at their hearing years down the road because they do not qualify. But now we learn that not only does DHS allow people to remain in this country for years despite knowing they do not qualify for asylum, DHS allows known dangerous immigrants to remain here.

“Federal law bars individuals who pose a national security or public safety risk from asylum,” DHS states.

Yet, the agency acknowledges, “the asylum eligibility determination is not currently made until later in the process—at the merits adjudication stage of the asylum and withholding of removal claims.”

We know that only occurs years later. The statement announces that the “proposed rule would permit Asylum Officers to consider these bars to asylum and withholding of removal during initial credible fear screening, which happens just days after an individual is encountered.” This, according to the statement, “will allow DHS to expeditiously remove individuals who pose a threat to the United States much sooner than is currently the case, better safeguarding the security of our border and our country.”

After over three years of allowing in millions of illegal immigrants, DHS has just now come up with the idea that maybe, just maybe, it is a good idea to deport those with violent criminal histories and ties to terrorism immediately instead of after their asylum hearing years down the road.

It gets worse.

They still have not changed the policy. Incredibly, they propose this as an administrative rule change, requiring a period for public comment. Comments are due by June 12. Thus, the rule cannot even take effect until later this summer.

If President Biden can overturn former President Trump’s remain-in-Mexico order with his own order on day one, a move upheld by the U.S. Supreme Court, why can he not issue another order changing this policy immediately? Of course he can, but this administration, while seeking to now look tough on illegal immigration just in time for the election, is not in any hurry to reduce the number of immigrants coming across.

According to the statement, “Noncitizens who present a national security or public safety risk remain in DHS custody while their cases are referred for full immigration hearings before an immigration judge, a process that can take years and is resource intensive.” Thus, some illegal immigrants are currently not released into the country, according to DHS. Instead, apparently, taxpayers foot the bill for their room and board for years while they await their asylum hearing, which DHS often already knows they will fail because of their criminal or terror related past.

But there is good reason to believe they are not all, in fact, detained. A DHS senior official recently told reporters on a call about the proposed rule: “I will say this is really intended to be a national security and public safety measure. And so it is intended to ensure that, again, the individuals that we are most concerned about that we encounter—people with serious criminal histories or links to terrorism—can be removed as early as possible in the process.”

If they are detained for years until their hearing as they claim, then how is this a national security and public safety issue? Clearly, because this has not always happened, and it appears DHS now realizes they have a serious security problem.

Just look at the case of Jose Ibarra, the alleged murderer of Laken Riley, a nursing student who went out for a jog on the University of Georgia campus and never returned. He was first arrested in September 2022 by Customs and Border Patrol officials near El Paso after crossing the border illegally. He came from Venezuela. He was then “paroled and released for further processing,” according to border officials. Paroled means you are free, awaiting your asylum hearing years down the road. He was put on a bus to New York. There he was arrested for endangering a minor. Since New York is a sanctuary city, ICE was not notified. He was arrested again in Athens, Georgia for shoplifting. Athens is a sanctuary city. Again, ICE was not notified. He then allegedly killed Ms. Riley.

There are no reports about his criminal record in Venezuela, but considering his criminal record over a period of months here, odds are he has one.

In likely related news, the FBI and DHS recently issued a joint public service announcement warning that foreign terrorist organizations could target events during Pride Month. In particular officials cited “ISIS messaging” focused on “anti-LGBTQIA+ rhetoric.” Why is the FBI and DHS suddenly concerned about ISIS in the U.S.? Could it be that people with ties to ISIS have crossed our southern border in the last three years?

And we learned last week that two illegal immigrants tried to drive a box truck past security guards and onto a Marine base in Quantico, Virginia earlier this month. The Potomac Local News reported that one of them is a Jordanian national who had recently crossed the border, and that at least one was on the U.S. government’s terrorist watch list. A similar incident occurred in March when an illegal immigrant from China forced his way onto a Marine base in Twentynine Palms, California.

Now that we know how DHS has been handling illegal immigrants with criminal records or terrorism ties, this all makes sense. The agency clearly has a major problem on its hands.

*  *  *

https://www.zerohedge.com/political/dhs-admits-border-has-been-open-criminals-and-terrorists

Moderna's Big AI News

 Moderna (NASDAQ: MRNA) isn't new to artificial intelligence (AI). The biotech best known for its billion-dollar coronavirus vaccine has been using this hot technology for years to help it save crucial time in the laboratory.

For example, Moderna uses AI to produce mRNAs for researchers to work with, so they no longer have to create mRNA manually to run experiments.

And last year, it signed a deal with International Business Machines to use its AI and quantum computing tools to advance the biotech's research. CEO Stéphane Bancel has spoken often about his commitment to this technology and even set up an AI academy to educate employees about ways to integrate it into their jobs on a daily basis.

But the latest AI announcement could be its biggest yet. A few weeks ago, Moderna said it has expanded its collaboration with OpenAI, and their work together is bearing fruit. The company not only expects AI to help advance the drug discovery process, but also says the technology already is making the entire company more efficient.

The biotech could become an AI winner down the road, but does this make the stock a buy? 

Moderna's peak vaccine revenue

First, a quick summary of where Moderna stands right now. The company generated billions of dollars in revenue from its coronavirus vaccine, with annual sales peaking at more than $18 billion.

But as we move toward a post-pandemic world, demand for vaccination is on the decline, and revenue has followed. In the most recent quarter, management reported $167 million in vaccine sales and predicted product sales of $4 billion for the full year.

But Moderna never planned on being a one-product company, and its solid late-stage pipeline shows that it has what it takes to continue toward its goal. Bancel says the aim is to launch as many as 15 products in the coming five years, including more vaccines in the respiratory category -- such as treatments for respiratory syncytial virus (RSV) and flu -- as well as products in other treatment areas.

Moderna says these products could deliver as much as $30 billion in annual revenue after a few years. Even if the company makes it part of the way to this goal, we could be looking at significant revenue growth over time.

Meanwhile, it has focused on investing in AI, and this brings me to the OpenAI collaboration. Moderna has rolled out AI throughout every department to gain in efficiency. Just a few months after signing on to ChatGPT Enterprise, the biotech constructed more than 750 large language models to be used for various tasks, like legal matters and payment processes.

Choosing the best vaccine dose with AI

The technology is making a difference in the laboratory, too, with ChatGPT's analytics tools helping Moderna choose the best vaccine dose for a clinical trial, for example. This is a key decision that could determine whether a particular candidate succeeds or fails in development. So this saves time and increases the chances of success.

This recent and ongoing investment in AI already is showing results, reducing Moderna's need for purchased services and outside consulting. This helped lower selling, general, and administrative expenses by 10% in the first quarter.

Considering the company just started working with ChatGPT Enterprise, it's likely that the efficiency gains and cost savings are in their early stages, so more could be on the way. At the same time, Moderna's use of ChatGPT tools and its alliance with IBM also could improve the drug development process.

All of this means that, at the very least, the business should be more efficient and cut costs thanks to its investment in AI. In a best-case scenario, the company might develop and bring better products to market more quickly. In either case, we're looking at a win.

Is Moderna a buy?

But does this make Moderna a buy? I wouldn't buy the stock just for the investment in AI. It's also important to look at a biotech's pipeline and its potential to bring some of those candidates to market. As mentioned above, these indicators look positive for the company.

Investors might now be starting to take notice of this long-term potential. After a couple of years in the doldrums, the stock has climbed about 40% this year. Positive momentum could be resuming, making now a great time to get in on this innovative biotech and hold on to benefit from all of the potential products that could drive lasting revenue growth.

https://finance.yahoo.com/m/408ac81f-e8ae-3f28-acab-d34637e31a49/moderna-has-big-ai-news.-is.html

IGM Biosciences up 40% following Biogen HI-Bio buy

 IGM Biosciences stock surged 45% as investors speculate it may become an M&A target following Biogen's acquisition deal.

https://seekingalpha.com/news/4109393-igm-biosciences-up-40-following-biogen-hi-bio-buy

'Better Buy: Inovio Pharmaceuticals vs. Novavax'

 The COVID-19 vaccine was worth tens of billions of dollars, but most of it went into the hands of Moderna and Pfizer. Smaller biotechs that tried to dominate this market were much less successful. That group includes Novavax (NASDAQ: NVAX) and Inovio Pharmaceuticals (NASDAQ: INO). The former did launch a coronavirus vaccine in the U.S., but the latter never got that far.

Both have substantially lagged the market over the past three years, but they now seem to be experiencing significant rebounds; shares of Novavax and Inovio have soared since 2024 started. Which of these two biotechs can outperform the other moving forward? Let's take a look.

NVAX Chart
NVAX Chart

The case for Novavax

Novavax earned approval for its COVID-19 vaccine, Nuvaxovid, in various countries. In the U.S., it is still under Emergency Use Authorization. However, the biotech is now seeking full approval. Novavax generated almost $1 billion in total revenue last year. In the first quarter, its top line came in at $93.9 million, higher than the $81 million reported in the prior-year period.

Novavax initially projected that it would record sales of at most $1 billion this year. That was before striking a major agreement with Sanofi, a biotech giant headquartered in France. Sanofi will pay Novavax $500 million up front for the rights to distribute Nuvaxovid in most countries worldwide, an exclusive license to use Novavax's adjuvant technology (designed to boost efficacy) in flu vaccines, and a non-exclusive license to use the technology in non-flu vaccines. Sanofi also acquired a 4.9% stake in Novavax for $70 million.

Novavax could receive up to $700 million in development milestone payments from this deal. The biotech will also earn royalties from the sale of marketed vaccines developed by Sanofi that use the adjuvant technology. This partnership will improve Novavax's financial situation and prospects.

Elsewhere, the biotech is racing toward the start of a phase 3 study for its combined COVID-19/flu vaccine, which it plans to kick off during the second half of the year.

Finally, Novavax has implemented a more disciplined approach, reducing unnecessary expenses and costs over the past 18 months. While the business was at risk of going under in early 2023, that's no longer the case. If Novavax can continue down the same path it has so far this year, it could deliver outsize returns to investors.

The case for Inovio Pharmaceuticals

Inovio Pharmaceuticals is developing several promising products. The most advanced is INO-3107, an investigational therapy for human papillomavirus (HPV)-associated recurrent respiratory papillomatosis (RRP), a rare disease that causes non-cancerous tumors to grow in the respiratory tract. RRP can cause difficulty performing otherwise routine tasks, such as breathing, swallowing, or speaking.

Inovio estimates an annual prevalence of 14,000 cases in the U.S. Following a successful phase 1/2 clinical trial for INO-3107, regulators told the company that the data from this study would be enough to support accelerated approval. True, Inovio will still need to perform a late-stage study to confirm the results from the earlier trials and earn full approval. However, the accelerated pathway could allow INO-3107 to reach the market at least a year before it otherwise would have.

The developments surrounding INO-3107 are behind Inovio's surging stock price this year. The biotech does have several other candidates in phase 1 and phase 2 testing, but its performance in the mid-term will likely largely depend on INO-3107. Considering that Inovio's market capitalization is just $310 million, consistent clinical and regulatory progress could send the stock price soaring even more.

The verdict

Novavax currently generates much higher revenue than Inovio. The former also has more cash on hand, and its partnership with Sanofi improves its prospects.

NVAX Revenue (Quarterly) Chart
NVAX Revenue (Quarterly) Chart

Though INO-3107 looks like it is making solid progress, its target population is small, and there are still plenty of potential clinical and regulatory pitfalls ahead for Inovio Pharmaceuticals. That's why Novavax is a better bet among these two companies, even though its market capitalization is much higher at $1.87 billion. With that said, Novavax and Inovio Pharmaceuticals both look like risky options. There are much more attractive stocks in the biotech industry.

https://finance.yahoo.com/m/bee62305-7d30-31eb-b36c-12d0664cef3e/better-buy%3A-inovio.html

FDA staff flags risk of low blood sugar for Novo Nordisk's weekly insulin

 The U.S. Food and Drug Administration's staff said on Wednesday the use of Novo Nordisk's long-acting weekly insulin had an increased risk of low blood sugar in patients with type 1 diabetes, who are more insulin-dependent.

Novo is aiming to become the first to bring to the market a weekly insulin product, offering an alternative to the daily insulin injections for millions of patients with type 1 diabetes and the more common type 2 patients.

The company has proposed a label to suggest the use of continuous glucose monitoring devices for measuring blood sugar, among other methods, in type 1 diabetes patients, the FDA reviewers said.

The FDA staff, however, said there was no clinical data to support Novo's proposed methods for mitigating the risks associated with hypoglycemia, a condition in which blood sugar levels drop below the standard range.

Novo has tested its weekly insulin icodec in six late-stage trials involving more than 4,000 adults with diabetes, out of which only one tested it in patients with type 1 diabetes.

In the trial, patients with type 1 diabetes on insulin icodec showed 50% to 80% more clinically significant or severe hypoglycemia compared to once-daily insulin degludec, which Novo sells under the brand name Tresiba.

Patients with type 1 diabetes definitely are at a higher risk for hypoglycemia, Richard Siegel, associate professor at Tufts University School of Medicine, told Reuters ahead of the review documents.

"There probably should be discussions as to how much of a change week to week should be made if blood sugars are not necessarily at goal," Siegel said.

A panel of independent FDA advisers will meet on Friday to vote if insulin icodec's benefits outweigh its risks.

The FDA is not obligated to follow the advisory panel's recommendations, but it usually does.

Rival Eli Lilly is also developing its own once-weekly insulin injection, efsitora, which has shown blood sugar reduction consistent with commonly used daily insulins in two studies, in patients with type 2 diabetes.

https://www.yahoo.com/news/us-fda-staff-flags-risk-132641521.html

Amid 'Ozempic babies' questions, women account for over 75% of young adults on GLP-1 drugs: study

 For patients anxious about fertility and pregnancy outcomes, a 'frustrating' lack of data

More than three out of four young adults prescribed GLP-1 drugs last year were women, new research shows, raising questions about how societal views of women's weight may influence use of these medications and underscoring the need to better understand how the drugs may affect fertility, pregnancy, and longer-term health outcomes, researchers say.

Women accounted for 76% of the 18- to 25-year-olds who were prescribed a GLP-1 drug in 2023, according to the study by researchers at University of Michigan Medical School and Yale School of Medicine and published in JAMA Wednesday. Six out of 10 adolescents prescribed GLP-1 medications last year were also female, the study found.

The total number of adolescents and young adults prescribed GLP-1 drugs, which are used to treat obesity as well as type 2 diabetes, jumped 594% between 2020 and 2023, the researchers found. In both the adolescent and the young-adult age group, the number of prescriptions for females grew significantly faster over that period than prescriptions for males.

Given that the prevalence of obesity in these age groups is roughly equal between males and females, the surging prescriptions for young women "probably reflects some societal bias" around females' weight, said Joyce Lee, co-author of the study and a University of Michigan Medical School professor and faculty investigator with the Susan B. Meister Child Health Evaluation and Research Center. Lee notes, however, that the study didn't examine whether the drugs were prescribed for weight loss or diabetes.

Data on the GLP-1 gender gap are emerging as social-media platforms are abuzz with talk of "Ozempic babies" - surprise pregnancies among GLP-1 users. Some women suspect that the drugs helped them get pregnant after years of trying, while others taking GLP-1 medications say they got pregnant despite taking birth-control pills.

While the trend is largely anecdotal, there are reasons to believe GLP-1 drugs may contribute to unplanned pregnancies, experts say. Obesity is linked with polycystic ovary syndrome, a condition associated with irregular periods. Weight loss may help restore normal ovulation in patients who have irregular cycles, and "no doubt that's contributing to what we may refer to as 'Ozempic babies,'" said Daniel Drucker, who helped discover GLP-1 and is senior investigator at Lunenfeld-Tanenbaum Research Institute in Toronto.

The drugs also slow stomach emptying and may affect the absorption of other medications that patients are taking orally - including, in some cases, birth control pills. Prescribing information for Eli Lilly & Co.'s (LLY) weight-loss drug Zepbound and diabetes treatment Mounjaro warns specifically that the medications may reduce the efficacy of oral contraceptives. Tirzepatide, the active ingredient in Mounjaro and Zepbound, acts on both GLP and GIP gut hormones. The prescribing information for Novo Nordisk (NVO) GLP-1 drugs Ozempic and Wegovy, meanwhile, includes a general warning that the medications may impact absorption of oral drugs.

As is common in drugmakers' clinical trials of experimental treatments, Novo Nordisk's Ozempic and Wegovy trials and Lilly's tirzepatide trials excluded people who were pregnant. Wegovy and Zepbound prescribing information says that, based on animal studies, there may be risks to the fetus from exposure to the drugs during pregnancy but notes that there's not enough data on the drugs' use in humans to evaluate the risks of birth defects or miscarriage.

Women should generally stop taking GLP-1 drugs about two months before trying to get pregnant, or in the case of an unplanned pregnancy, as soon as they realize they're pregnant, doctors say. "We don't want women who are pregnant to be eating less and providing less energy and nutrition to a developing fetus," Drucker said.

Better data on pregnancy and GLP-1 drugs is on the horizon. Novo Nordisk has a pregnancy registry for Wegovy that is collecting data on maternal, fetal and infant outcomes for women exposed to the medication during pregnancy. Results will be publicly disclosed at the end of the study, Novo Nordisk said.

Lilly also plans to launch a pregnancy exposure registry for Zepbound, a spokesperson told MarketWatch.

"We need to learn a lot more" about how GLP-1 drugs may affect pregnancy, Drucker said. For people who are currently interested in the medications but also trying to get pregnant, the lack of extensive data is "understandably a bit frustrating," he said.

More broadly, the rising numbers of GLP-1 prescriptions among teenagers and young adults underscores the need to better understand the long-term effects of the medications, Lee said. Wegovy, which was first approved for adults in 2021, got FDA approval for treatment of obesity in patients 12 and older in late 2022.

In terms of long-term side effects, "we have yet to understand what will unfold" in the coming years," Lee said. "And if you start adolescents or young adults on the medication, are we going to put them on this indefinitely?"

https://www.morningstar.com/news/marketwatch/20240522327/amid-ozempic-babies-questions-women-account-for-more-than-75-of-young-adults-taking-glp-1-drugs-study-finds