Opko unit Secures BARDA Contract to Develop Novel Multispecific Antibodies Against Viral Infectious Disease

 ModeX Therapeutics Inc., an OPKO Health, Inc. company (NASDAQ: OPK), has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services (HHS), to advance a platform and specific candidates designed to address a range of public health threats in viral infectious diseases.

The awarded funding will enable research, development and clinical evaluation of potent multispecific antibodies, based on ModeX proprietary MSTAR technology. MSTAR is a flexible plug-and-play platform able to incorporate four to six independent antibody binding sites into a single molecule, dramatically expanding their therapeutic potential while enabling rapid responses to emerging infections and their viral variants, including COVID-19, influenza, and other pathogens.

The SARS-CoV-2 program is supported by HHS’ Project NextGen, which is dedicated to advancing a pipeline of innovative vaccines and therapeutics against COVID-19. The BARDA contract includes an initial $59 million for the development, manufacturing, and execution of a Phase 1 clinical trial for a next-generation MSTAR multispecific antibody with broad neutralizing activity against known variants of SARS-CoV-2. Such antibodies have the potential for both treatment and prevention of COVID-19.

This initiative builds on a collaboration between ModeX and the Vaccine Research Center of the National Institutes of Health (NIH) for the discovery and characterization of novel therapeutic antibodies against SARS-CoV-2. Additional funding of up to $109 million may be available from BARDA upon achieving particular milestones to develop multispecific antibodies targeting other viral pathogens such as influenza. As part of the research program, gene-based delivery methods for the multispecific antibodies will be developed using mRNA or DNA vectors to leverage the body’s natural protein production processes.

https://www.globenewswire.com/news-release/2023/09/28/2751634/0/en/ModeX-Therapeutics-Secures-BARDA-Contract-to-Develop-Novel-Multispecific-Antibodies-Against-Viral-Infectious-Disease-Threats.html

German court suspends mRNA patent trial against BioNTech

 A German court on Thursday put on hold a patent trial brought by German biotech firm CureVac against domestic rival BioNTech over the use of mRNA technology in COVID-19 vaccines, weighing on CureVac's shares.

The Duesseldorf regional court said it suspended its proceedings until the German and the European patent offices decide on a legal challenge filed by BioNTech over the validity of CureVac's intellectual property rights.

CureVac's Germany-traded shares slumped 18% to their lowest in almost nine months, while BioNTech shares slipped 0.6%.

CureVac's efforts to develop an mRNA based COVID-19 vaccine did not succeed during the pandemic, while BioNTech generated about 17 billion euros ($17.96 billion) and 19 billion euros in annual sales in 2022 and 2021, respectively, thanks to its successful coronavirus vaccine business with partner Pfizer.

Analysts have previously said that much is at stake in the legal dispute for CureVac because being awarded even a small fraction of the revenues could transform its financial position.

A separate patent infringement case brought by CureVac was previously suspended by the Duesseldorf court because a higher court first needs to review that patent's validity. A decision on that is expected in December.

https://finance.yahoo.com/news/1-german-court-suspends-mrna-152710507.html

GSK lifts growth target for HIV business on demand for long-acting drug

 GSK on Thursday lifted its medium-term growth forecast for its HIV drugs business ViiV, encouraged by strong sales of long-acting injections that aim to replace daily pills for preventing and treating the infection.

The ViiV business, in which Pfizer and Shionogi hold small stakes, is a key element of a push by group CEO Emma Walmsley to improve investor confidence in the strength of GSK's drug development pipeline, which has lagged that of its rivals.

Strong sales of medicines for HIV, the virus that causes AIDS, were one of the drivers behind the company's improved guidance for 2023 earnings, issued in July, alongside continued growth in demand for GSK's shingles vaccine.

The HIV business, the focus of a GSK's capital markets day on Thursday, is now targeting annual rates of sales growth of between 6% and 8%, to reach between 6 billion pounds ($7.31 billion) and 7 billion pounds in 2026, up from "mid-single-digit" percentage growth seen previously.

GSK said its Apretude injection, an alternative to daily pills to prevent the viral infection, continues to gain acceptance among the targeted at-risk population.

A different version of the drug, established brand Cabenuva, has been in use for longer as an anti-HIV treatment.

In the prevention setting, known as pre-exposure prophylaxis, GSK's Apretude competes with Gilead's daily pill, Truvada, and a cheaper generic version sold by Teva as Atripla.

"We have broad reimbursement in the U.S. and uptake has been extremely positive," said ViiV CEO Deborah Waterhouse. Apretude won U.S. approval in late 2021 and in Europe this month.

"We will now talk country-by-country to each of the European nations to see what the situation is from a reimbursement perspective," she added.

Following up on the success of Apretude, which is injected every other month, GSK said it was aiming to launch a prevention drug in 2026 to be taken once every four months, and another one for every six months towards the end of the decade.

https://finance.yahoo.com/news/1-gsk-lifts-growth-target-151016191.html

Novo Nordisk India head eyes 2026 Wegovy launch, warns against copycats

 Danish drugmaker Novo Nordisk aims to bring its blockbuster weight-loss drug Wegovy to India in 2026, after securing regulatory approvals and ensuring it has enough supply to meet demand, a top company official told Reuters

The market opportunity for the drug is huge in the world's most populous country, where obesity rates are high especially among women. Illegal copycat versions of Wegovy are already being sold through online sites.

"I think there would be quite a lot of patients and quite a lot of doctors who would be interested in this therapeutic area," said Novo Nordisk's India Managing Director Vikrant Shrotriya.

"It will open up a new horizon for healthcare itself, because till now the horizon was only limited to alternative therapies and bariatric surgery, right?"

He urged patients not to buy copycat versions of Wegovy, warning they could be unsafe.

"They should not take it," Shrotriya said in an interview. "It is not licensed. For most of these products, we also do not know any kind of a cold chain and how it has been insured during transportation." Novo holds the patent in India for the active ingredient in Wegovy called semaglutide but has not taken any legal action against the counterfeiters so far. "We have not been able to take legal action because we have not been able to catch them," Shrotriya said, adding that while the illegal sellers were "difficult to trace", the company had not seen any large syndicates selling the drug in India.

He declined to comment on how Wegovy would be priced in India. Novo charges more than $1300 in the U.S. for a monthly supply and about 300 euros ($317) a month in Germany. "When it comes to Wegovy, we have to see the ecosystem at that point of time in 2026," Shrotriya told Reuters, adding that the company would price it "to justify the innovation but also work for access in India".

Wegovy, a weekly injection, is the most effective treatment approved for weight-loss to date at a time when global obesity rates are at a record high.

The drug, along with Novo's diabetes drug Ozempic and Eli Lilly's Mounjaro, belongs to a class of therapies known as GLP-1 receptor agonists that slow digestion, helping patients feel full for longer.

Clinical trials showed Wegovy helped users lose about 15% of their body weight. A large study also showed the obesity treatment had a clear cardiovascular benefit.

Novo first launched Wegovy in the U.S. in 2021 and has introduced it in several European markets, including the UK and Germany. It has struggled to produce enough of Wegovy to meet demand in those countries and said it was unlikely to sell the drug in developing nations for a very long time.

Demand in India could be high. The prevalence of abdominal obesity in India was found to be 40% in women and 12% in men, an article in the medical journal the Lancet said, citing data from a National Family Health Survey for 2019-2021.

https://sports.yahoo.com/news/novo-nordisk-india-head-eyes-054421483.html

Former Target exec says internet, social media driving 'acceleration' in organized retail theft

 The former vice chairman of Target spoke out against spiraling theft nationwide as the popular retailer announced it would close its doors in a series of liberal cities amid public safety concerns. 

Gerald Storch reacted to the news during "FOX & Friends," saying the announcement makes him "want to cry" as the "acceleration in crime" continues to impact giant retailers across the country. 

"It just makes you want to cry because we have worked so hard to get stores into markets like this," Storch told Steve Doocy Wednesday. "Every company I've ever worked at we worked so hard because it's good for the community to have stores that can offer products with great value in these environments. We know it's going to be tough, but it's good for business, and it's good for the community. What's going on right now, though, is an acceleration in crime."

Target announced Tuesday it would close nine stores across San Francisco, Oakland, Seattle, New York City and Portland. 

"We cannot continue operating these stores because theft and organized retail crime are threatening the safety of our team and guests, and contributing to unsustainable business performance," the company said in a statement. 

Storch noted that retail theft has "gone through the roof" because of social media and the internet.

"Why is the internet a bad thing? Usually, it's a good thing. First of all, it helps all the gangs organize. So they get together through social media and say, 'show up here now and let's do it together.' Secondly, the marketplace on the internet is the ultimate fencing operation. It's like a flea market on steroids for getting rid of the product. So anything you steal, you can monetize it really fast on the internet," he explained, adding that there is a "sophistication" to the organized criminal operations.

A U.S. Marshal is pictured on the scene of a reported shooting at a Target store in Omaha, Neb., on Tuesday, Jan. 31, 2023. Omaha Police Chief Todd R. Schmaderer says city police confronted and shot a man with an assault rifle. (Chris Machian/Omaha W (Chris Machian/Omaha World-Herald via AP) / AP Newsroom)

"It's not… just simple, like people do locally, just steal stuff, post it on the internet, get the money. Sometimes it's many, many layers of distribution before it even gets anywhere near a marketplace, and by the last layer could be a legitimate business person who's buying this from some guy with a warehouse.

"You can say they should know it's stolen. I would know it's stolen," he continued. "If someone's offering stuff for cheaper than the vendor can offer it for, but they buy it there and they're legitimate business people. They're the last leg, so it's really tough to pin it down. That's what the problem is."

Target's major announcement came as retailers in Philadelphia were reeling from an alleged teen mob that ransacked several stores in a widespread looting operation.

At about 8 p.m. Tuesday, police responded to reports of large crowds of juveniles allegedly looting stores in the Center City business corridor of the 9th District. They targeted popular retailers like the Apple Store, Lululemon and Footlocker. 

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Police confirmed between 15 and 20 people were arrested during the looting and at least two firearms were recovered.

"Ultimately, it comes down to… really good police work," Storch said. "When I say police work, and this is one thing retailers are behind, it's really national work. Going after these organized crime rings and trying to tear them apart the way you used to do the mafia or someone like that, because that's where the volume really lies. You can go after it and get it."

Storch argued the monetary component of theft is driving criminals to continue the acts since they believe they can "get away with it."

"Criminals are just like anyone else," he said. "They're economic entities. And so when they do the math, it says, I can do this and get away with it. I'm going to do it."

https://www.foxbusiness.com/media/former-target-exec-says-internet-social-media-driving-acceleration-organized-retail-theft

Four Neurodegenerative Trials to Watch in Q4

 Several late-stage clinical trials are expected to produce data in the final months of 2023 that could spell new approaches to treating Alzheimer’s disease, amyotrophic lateral sclerosis, Huntington’s disease and multiple sclerosis. 

Mizuho Securities recently published a report highlighting some of the trials to watch as the year comes to a close, and BioSpace spoke with Graig Suvannavejh, managing director of equity research in biopharmaceuticals and biotechnology at the firm, to find out more.

Alzheimer’s Disease

Eisai and Biogen’s subcutaneous Leqembi

In July, the FDA fully approved Leqembi (Lecanemab), a monoclonal antibody developed by Eisai and Biogen that binds to soluble and insoluble amyloid-beta peptides to treat Alzheimer’s. Leqembi is currently administered only through intravenous injection, which limits the locations where patients can obtain treatment.

To enhance its accessibility, the partners launched an open-label, randomized Phase I clinical trial in September 2022 to evaluate the bioequivalence of a single subcutaneous dose (720 milligrams) of Leqembi compared to an equivalent dose delivered through intravenous injection.

Data from the subcutaneous study are anticipated in October 2023, and regulatory submissions for the maintenance dosing regimen and subcutaneous formulation are expected in the first quarter of 2024.

Currently, to receive treatment, “You have to drive to an infusion center and sit in a chair for a few hours,” Suvannavejh told BioSpace. He emphasized the strategic value of a treatment that could be administered under the skin at home by a caregiver and said this readout is important for Leqembi’s commercial success.

Huntington’s Disease

Wave Life Sciences’ WVE-003

WVE-003, developed by Wave Life Sciences, is an allele-selective oligonucleotide that attacks mutant proteins that produce the symptoms of Huntington’s disease (HD). It is designed to target the huntingtin (HTT) mRNA that carries a single nucleotide polymorphism that appears on the mutant HTT (mHTT) allele. By lowering the quantity of the mutant form of this protein, WVE-003 allows the wildtype (wtHTT) allele to function, preserving its beneficial effects in the central nervous system.

“HD is a tragic and unrelenting disease that passes through generations of families and has been compared to having ALS, Parkinson’s and Alzheimer’s all at once,” Paul Bolno, Wave’s president and CEO, told BioSpace by email. “Currently, there are no disease-modifying treatments for HD, so our primary goal is to develop a treatment that slows or stops progression of the disease.”

The Phase Ib/IIa SELECT-HD trial is evaluating WVE-003’s ability to reduce mutant HTT in the cerebrospinal fluid compared to a placebo. The study aims to optimize the dose level—30 mg, 60 mg or 90 mg—and frequency of WVE-003 administration to reach the desired early indicators.

"If WVE-003 is successful in the clinic, it has potential to be truly transformational,” Bolno said. Beyond treating symptomatic disease, he said Wave’s mHTT-lowering approach, which spares wtHTT, may also be beneficial in treating patients earlier, perhaps before symptoms of the disease present. “We are resolutely focused on what clinical success would mean to these families—and to future generations.”

Wave expects to deliver additional single-dose and available multi-dose biomarker and safety clinical data in the second half of 2023.

Amyotrophic Lateral Sclerosis

Seelos Therapeutics Inc.’s SLS-005

Developed by Seelos Therapeutics, SLS-005 (Trehalose) is being evaluated in the HEALEY ALS Platform Trial, a novel approach by which companies can conduct ALS clinical trials more efficiently.

“Currently, there are no treatments available that address the entire broad spectrum [of] patients with ALS,” Seelos Founder and CEO Raj Mehra told BioSpace in an email. “SLS-005, if successful in the HEALEY trial, would become the first drug to treat the broad ALS population based on a well-established and specific mechanism of action," he said. 

The registrational Phase II/III trial is examining the effectiveness of SLS-005 at stabilizing proteins and promoting autophagy in the brain to clear toxic protein aggregations characteristic of ALS. The results compare disease severity following a 90.5 mg/mL infusion of SLS-005 or a placebo for 24 weeks.

Seelos plans to release top-line data from the trial before the end of 2023. The company initiated an Expanded Access Program in April 2023 for ALS patients who are ineligible for the clinical trial.

“SLS-005 is not just one drug for one disease but one drug for multiple diseases,” Mehra said. The company is also evaluating SLS-005 in a late-phase registration-directed trial for SCA3 (or Machado-Joseph disease), an autosomal dominant cerebellar ataxia that occurs due to CAG repeat expansions in the ataxin protein. SLS-005 received the FDA’s Orphan Drug designation in 2020.

Multiple Sclerosis

Atara Biotherapeutics’ ATA188

Developed by Atara Biotherapeutics, ATA188 is a T-cell immunotherapy that targets Epstein-Barr virus (EBV)-infected B cells to treat nonactive secondary progressive multiple sclerosis (MS) and nonactive primary progressive MS.

Most treatment options for relapsing-remitting MS reduce flares but do not inhibit the worsening of disability in progressive forms of the disease. Current research supports the role that EBV plays in the development of MS. ATA188 is composed of T-cells obtained from healthy donors previously infected with EBV. The cells are primed to recognize and attack EBV proteins to potentially slow or halt disease progression.

Atara initiated the Phase I/II EMBOLD clinical trial in 2017 to determine the safety, tolerability and optimal dose of ATA188 and to evaluate its effect on clinical disability using the Expanded Disability Status Scale. The second half of the study evaluated the drug in participants with progressive forms of MS. Data from this phase, which will detail the drug’s ability to ease disease-related disability, is anticipated in November 2023.

https://www.biospace.com/article/four-highly-anticipated-neurodegenerative-disease-data-releases-/

Fani Swatted After CNN Legal Expert Calls Trump Charges 'Unnecessary'

 by Jack Phillips via The Epoch Times (emphasis ours),

A prominent media analyst and former prosecutor suggested this week that the charges made by the district attorney in Fulton County, Georgia, against former President Donald Trump under the state's racketeering law are "unnecessary" and only add to Mr. Trump's allegations of a "Democratic Party pile on."

Elie Honig, a former federal prosecutor and now a media legal analyst, told a podcast this week that federal special counsel Jack Smith already charged the former president with alleged election-related offenses "and in seven states in particular, including Georgia."

Notably, Mr. Honig, a former assistant U.S. attorney for the Southern District of New York, has been publicly critical of the former president, and he is now a senior legal analyst for CNN. He's also penned a critical book about former Trump Attorney General William Barr called "Hatchet Man."

He asked whether Fulton County District Attorney Fani Willis' indictment is for the "greater good and why is it promoting public confidence in the fairness of this [process] to have one of those seven state prosecutors pile on with a charge of her own? I don't think it serves any greater good," he stated, adding that Ms. Willis indicted him on partisan grounds.

"I disagree with the exercise of prosecutorial discretion by an elected county prosecutor, a partisan, with a D next to her name," he said, referring to the Democratic Party.

There are differences between the Georgia and the federal election cases, he then claimed, saying they essentially serve the same purpose.

"I think it makes Trump's chances of being convicted and punished higher if that's the only goal here. If that's the only goal, all seven states: Michigan, New Mexico, and on down the line, should be charging him too, but that would be ludicrous," the former prosecutor said.

Last month, the Fulton County District Attorney's office indicted President Trump and 18 co-defendants under Georgia's expansive anti-racketeering law, claiming that he and the others engaged in efforts to illegally overturn the 2020 election results in the state. All have pleaded not guilty and some defendants have attempted to get their charges thrown out.

Federal Judge Steve Jones last week rejected the attempt by Trump White House chief of staff Mark Meadows to move his case to federal court and sent it back to state court, but Meadows is appealing that ruling. The four others who have already filed notice to move their cases have hearings before Jones scheduled for next week.

It came after a Fulton County grand jury last month accused them of participating in an illegal scheme to keep the incumbent Republican president in power after the election against President Joe Biden.

Republicans in her state and in Congress have accused Ms. Willis's office of engaging in a politically motivated attack on the former president as he ramps up his 2024 presidential campaign as the leading GOP candidate.

In August, State Sen. Colton Moore, a Republican from Georgia’s northwest corner, recently doubled down on his calls for a special session to take money away from Willis’ office and consider her impeachment.

“Fani Willis is spending millions of our taxpayer dollars to take on political prisoners. It’s the most un-American thing that we’ve ever seen in our lifetime,” Mr. Moore told the crowd at a rally near the state Capitol last month.

However, Republican Gov. Brian Kemp dismissed the calls in a news conference in which he angrily criticized state Republicans for running a “grifter scam” to raise money from Trump supporters. Without Kemp’s support, a special session is impossible unless Republicans can get 60 percent of all legislators in each house of Georgia’s General Assembly to support it.

Meanwhile, Ms. Willis said last month in announcing the charges that she wanted to try all 19 defendants together, including President Trump and other high-profile individuals such as former Mayor Rudy Giuliani and attorney Sidney Powell.

Two of the people charged have filed speedy trial demands, and Judge Scott McAfee set their trial for Oct. 23. At a hearing last week, he said it seemed “a bit unrealistic” to imagine that all of the defendants could be tried that soon and asked prosecutors for a brief explaining why they felt that was necessary.

Lawyers Kenneth Chesebro and Sidney Powell are the two who have filed speedy trial demands. They also requested to be tried separately from each other, but Judge McAfee denied that request. Mr. Chesebro is accused of working on the coordination and execution of a plan to have 16 Georgia Republicans sign a certificate declaring that President Trump won in 2020. Mrs. Powell is accused of participating in an alleged breach in rural Coffee County.

https://www.zerohedge.com/political/fani-swatted-after-cnn-legal-expert-calls-trump-charges-unnecessary