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WILMETTE, Ill., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, today announced the first patient ever dosed with MNPR-101-Lu. This novel therapeutic radiopharmaceutical combines MNPR-101, Monopar’s antibody that selectively targets the urokinase plasminogen activator receptor (uPAR), with the therapeutic radioisotope lutetium-177. uPAR is involved in tumor growth and metastasis, and is found in some of the most aggressive, deadly cancers, including pancreatic, ovarian, triple negative breast, and colorectal cancers. The MNPR-101-Lu intravenous infusion was well-tolerated with no serious adverse reactions reported. This patient, dosed under a compassionate use protocol in the US, has metastatic pancreatic cancer, and prior to dosing, the cancer was imaged using MNPR-101-Zr (a zirconium-89 imaging radioisotope conjugated to MNPR-101) with a PET/CT scanner and showed uPAR expression. “As a result of encouraging biodistribution and dosimetry clinical data we recently reported ( link ) with our radiodiagnostic, MNPR-101-Zr, we have been eagerly looking forward to initiating treatment of patients with MNPR-101-Lu, hopeful it may provide an important therapeutic benefit to a group of cancer patients very much in need,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer. “We are thrilled to have dosed this patient with MNPR-101-Lu, and believe this may be the world’s first dosing of a patient with a uPAR-targeted therapeutic radiopharmaceutical,” said Andrew Cittadine, Monopar’s Chief Operating Officer. Monopar is actively enrolling participants in two Phase 1 clinical studies in Australia, evaluating MNPR-101-Zr for imaging and MNPR-101-Lu for treatment of advanced solid tumors. Further information about the MNPR-101-Lu Phase 1a trial is available at www.ClinicalTrials.gov under study identifier NCT06617169 . Further information about the MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial is available at www.ClinicalTrials.gov under study identifier NCT06337084 . About Monopar Therapeutics Inc. Monopar Therapeutics is a clinical-stage biotechnology company with ALXN-1840 for Wilson disease which has completed a Phase 3 trial, and radiopharma programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers. For more information, visit: www.monopartx.com . Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include statements concerning: the MNPR-101-Lu intravenous infusion was well-tolerated with no serious adverse reactions reported; that as a result of recently reported encouraging biodistribution and dosimetry clinical data with Monopar’s radiodiagnostic, MNPR-101-Zr, the Company has been eagerly looking forward to initiating treatment and to seeing if the Company can bring an important therapeutic benefit to a group of cancer patients very much in need; and the Company believes this may be the world’s first dosing of a patient with a uPAR-targeted therapeutic radiopharmaceutical. The forward-looking statements involve risks and uncertainties including, but not limited to: that the patient may develop a serious adverse event in the future to MNPR-101-Lu; that radiation dosimetry analytics in the future may not be consistent with the estimated data generated thus far; that Monopar may not find enough patients to successfully enroll its MNPR-101-Lu therapeutic study; that the Phase 1 imaging and dosimetry clinical trial in advanced cancer patients with MNPR-101-Zr may not yield consistently satisfactory results; that future preclinical or clinical data may not be as promising as the data to date; that MNPR-101-Zr and/or MNPR-101-Lu may cause unexpected serious adverse effects or fail to be effective against the cancer tumors in humans; that the trials could result in a clinical hold should there be a Serious Adverse Event; Monopar’s ability to raise sufficient funds in order for the Company to support continued clinical, regulatory and commercial development of its programs and to make contractual future milestone payments, as well as its ability to further raise additional funds in the future to support any future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization; uncertainties related to the regulatory discussions that Monopar intends to initiate related to ALXN-1840 and the outcome thereof; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which Monopar receives marketing approval, and Monopar’s ability to competitively market any such products as compared to larger pharmaceutical firms; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. CONTACT: Monopar Therapeutics Inc. Investor Relations Karthik Radhakrishnan Chief Financial Officer karthik@monopartx.com Follow Monopar on social media for updates: Twitter: @MonoparTx LinkedIn: Monopar TherapeuticsAn FBI agent charged in Maryland with sexually assaulting two women contacted his alleged victims through social media with a promise to give them free tattoos and modeling work, police said Tuesday as they encouraged other potential victims to come forward. Neither woman knew that their alleged assailant, Eduardo Valdivia, was an FBI agent, Montgomery County Assistant Police Chief Nicholas Augustine said during a news conference. Valdivia used aliases, including Lalo Brown, as he contacted the women through an Instagram account for a tattoo parlor in Gaithersburg, Maryland, according to police. Valdivia sexually assaulted the women -- both of whom are in their 20s -- during photo shoots at a tattoo studio and at a hotel, police said. Valdivia presented the women modeling contracts and threatened to take legal action if they didn't return to model for him, Augustine said. Police detectives suspect that Valdivia may have sexually assaulted other women under similar circumstances, according to the assistant chief. "I would like to thank the victims that did come forward. They have now stopped this contact going on in our community and being brave to come forward to notify the police about what was going on, which most likely saved other people from being victimized," Augustine said. Valdivia has been suspended by the FBI pending the conclusion of the police investigation. "The FBI takes allegations of criminal violations and misconduct very seriously," an FBI spokesperson said in a statement Monday. "Because this is an ongoing investigation, the FBI cannot comment further." Valdivia, 40, of Gaithersburg, previously was charged and acquitted in 2022 of attempted second-degree murder and other charges stemming from an off-duty shooting aboard a moving Metro train near Washington, D.C. Online court records show Valdivia now faces felony and misdemeanor charges, including two counts of second-degree rape. The alleged offenses date to May 2024 and September 2024. Defense attorney Robert Bonsib, who represented Valdivia in the shooting case, confirmed that his client was arrested Monday on sexual assault charges. "We don't accept at first blush any of the allegations until all of the evidence is in," Bonsib said Monday. Police began investigating in October. The women were initially reluctant to come forward because they felt "held back" by language in contracts they signed to do modeling work, Augustine said. "We don't know how long the business had been open, but he has been doing tattoos at least since February," Augustine said. Valdivia was ordered held in custody after his initial court appearance Monday, Bonsib said. A bond hearing was scheduled for Tuesday afternoon. Bonsib has said Valdivia joined the FBI in 2011 and was promoted to supervisory special agent at the FBI headquarters in 2019. On Dec. 15, 2020, a confrontation between Valdivia and an unarmed passenger swiftly escalated from a testy exchange of words to a shooting on a train approaching the Medical Center station in Bethesda, Maryland. Valdivia shot and wounded the man from a distance of roughly 2 to 3 feet (0.6 to 0.9 meters) after repeatedly telling the man to back up, county prosecutor Robert Hill said in court. The wounded man had part or all of his spleen, colon and pancreas removed during surgery after the shooting, Hill said. Bonsib has said Valdivia acted in self-defense as the man approached him at the rear of a train car. "The law does not require that you wait to be struck before you take action. Had this resulted in a hands-on fight and a struggle for Agent Valdivia's gun, only God knows what could have happened," Bonsib said after Valdivia was charged.
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DETROIT (AP) — If Donald Trump makes good on his threat to slap 25% tariffs on everything imported from Mexico and Canada, the price increases that could follow will collide with his campaign promise to give American families a break from inflation. Economists say companies would have little choice but to pass along the added costs, dramatically raising prices for food, clothing, automobiles, booze and other goods. The president-elect floated the tariff idea, including additional 10% taxes on goods from China, as a way to force the countries to halt the flow of illegal immigrants and drugs into the U.S. But his posts Monday on Truth Social threatening the tariffs on his first day in office could just be a negotiating ploy to get the countries to change behavior. High food prices were a major issue in voters picking Trump over Vice President Kamala Harris, but tariffs almost certainly would push those costs up even further. For instance, the Produce Distributors Association, a Washington trade group, said Tuesday that tariffs will raise prices for fresh fruit and vegetables and hurt U.S. farmers when other countries retaliate. “Tariffs distort the marketplace and will raise prices along the supply chain, resulting in the consumer paying more at the checkout line,” said Alan Siger, association president. Mexico and Canada are two of the biggest exporters of fresh fruit and vegetables to the U.S. In 2022, Mexico supplied 51% of fresh fruit and 69% of fresh vegetables imported by value into the U.S., while Canada supplied 2% of fresh fruit and 20% of fresh vegetables. Before the election, about 7 in 10 voters said they were very concerned about the cost of food, according to AP VoteCast, a survey of more than 120,000 voters. “We’ll get them down,” Trump told shoppers during a September visit to a Pennsylvania grocery store. The U.S. is the largest importer of goods in the world, with Mexico, China and Canada its top three suppliers, according to the most recent U.S. Census data. People looking to buy a new vehicle likely would see big price increases as well, at a time when costs have gone up so much they are out of reach for many. The average price of a new vehicle now runs around $48,000. About 15% of the 15.6 million new vehicles sold in the U.S. last year came from Mexico, while 8% crossed the border from Canada, according to Global Data. Much of the tariffs would get passed along to consumers, unless automakers can somehow quickly find productivity improvements to offset them, said C.J. Finn, U.S. automotive sector leader for PwC, a consulting firm. That means even more consumers “would potentially get priced out,” Finn said. Hardest hit would be Volkswagen, Stellantis, General Motors and Ford, Bernstein analyst Daniel Roeska wrote Tuesday in a note to investors. “A 25% tariff on Mexico and Canada would severely cripple the U.S. auto industry,” he said. The tariffs would hurt U.S. industrial production so much that “we expect this is unlikely to happen in practice,” Roeska said. The tariff threat hit auto stocks on Tuesday, particularly shares of GM, which imports about 30% of the vehicles it sells in the U.S. from Canada and Mexico, and Stellantis, which imports about 40% from the two countries. For both companies, about 55% of their lucrative pickup trucks come from Mexico and Canada. GM shares were down more than 8% and Stellantis was off over 5%. It’s not clear how long the tariffs would last if implemented, but they could force auto executives to move production to the U.S., which could create more jobs in the long run. But Morningstar analyst David Whiston said in the short term automakers probably won’t make any moves because they can’t quickly change where they build vehicles. Millions of dollars worth of auto parts flow across the borders with Mexico and Canada, and that could raise prices for already costly automobile repairs, Finn said. Story continues below video The Distilled Spirits Council of the U.S. said tariffs on tequila or Canadian whisky won’t boost American jobs because they are distinctive products that can only be made in their country of origin. In 2023, the U.S. imported $4.6 billion worth of tequila and $108 million worth of mezcal from Mexico and $537 million worth of spirits from Canada, the council said. “At the end of the day, tariffs on spirits products from our neighbors to the north and south are going to hurt U.S. consumers and lead to job losses across the U.S. hospitality industry,” the council said. Electronics retailer Best Buy said on its third-quarter earnings conference call that it runs on thin profit margins, so while vendors and the company will shoulder some increases, Best Buy will have to pass tariffs to customers. “These are goods that people need, and higher prices are not helpful,” CEO Corie Barry said. Walmart also warned this week that tariffs could force it to raise prices, as did Footwear Distributors and Retailers of America. Canadian Prime Minister Justin Trudeau, who talked with Trump after his call for tariffs, said they had a good conversation about how the countries can work together. “This is something that we can do, laying out the facts and moving forward in constructive ways. This is a relationship that we know takes a certain amount of working on and that’s what we’ll do,” Trudeau said. Trump’s threats come as arrests for illegally crossing the border from Mexico have been falling . The most recent U.S. numbers for October show arrests remain near four-year lows. But arrests for illegally crossing the border from Canada have been rising over the past two years. Much of America’s fentanyl is smuggled from Mexico, and seizures have increased. Trump has sound legal justification to impose the tariffs, even though they conflict with a 2020 trade deal brokered in large part by Trump with Canada and Mexico, said William Reinsch, senior adviser at the Center for Strategic and International Studies and former trade official in the Clinton administration. The treaty, known as the USMCA, is up for review in 2026. In China’s case, he could simply declare Beijing hasn’t met its obligations under an agreement he negotiated in his first term. For Canada and Mexico, he could say the influx of migrants and drugs represent a national security threat, and turn to a section of trade law he used in his first term to slap tariffs on steel and aluminum. The law he would most likely use for Canada and Mexico sets out a legal process that often takes as long as nine months, during which time Trump would likely seek a deal. If talks failed and the duties were imposed, all three countries would likely retaliate by putting tariffs on U.S. exports, said Reinsch, who believes Trump’s tariffs threat is a negotiating ploy. U.S. companies would lobby the Trump administration intensively against tariffs, and would seek to have products exempted. Some of the biggest exporters from Mexico are U.S. firms that make parts there. “Our economies really are integrated,” Reinsch said. Longer term, Mary Lovely, a senior fellow at the Peterson Institute for International Economics, said the threat of tariffs could make the U.S. an “unstable partner” in international trade. “It is an incentive to move activity outside the United States to avoid all this uncertainty,” she said. Trump transition team officials did not immediately respond to questions about what he would need to see to prevent the tariffs from being implemented and how they would impact prices in the U.S. Mexican President Claudia Sheinbaum suggested Tuesday that Mexico could retaliate with tariffs of its own. Sheinbaum said she was willing to talk about the issues, but said drugs were a U.S. problem. ___ Rugaber reported from Washington. AP reporters Dee-Ann Durbin in Detroit, Stan Choe and Anne D’Innocenzio in New York, and Rob Gillies in Toronto contributed to this report.
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Redefining the Future of Shopping: Jingo Gains Silicon Valley's BackingBy the time our AOL 5.0 calendars or Palm Pilot devices reached the date of Dec. 31, 1999, most of our fears about a worldwide Y2K meltdown had been alleviated, in large part because technology companies and the government had taken preemptive measures. Still, we weren’t certain until we were certain. It was all hands on deck in most newsrooms; in my capacity as a news columnist for the Sun-Times, I spent New Year’s Eve 1999 bouncing around the city, spending time with families, churchgoers, revelers and police, just in case chaos erupted. I later wrote, “New Years Eve 1999 was destined to be a night of colorful merriment, marred by only the occasional glitch,” and “In the real-life movie of Y2K ... we survived the big doomsday scenario with our computerized society intact.” Now comes the movie-movie of Y2K. Some 25 years (!) later, “SNL” alum Kyle Mooney directs, co-writes and plays a supporting role in the disaster comedy “Y2K,” which re-imagines a world in which the Year 2000 problem not only became a reality but threatened to end humanity. It’s a clever premise — basically, Skynet invades a “Booksmart” storyline — and for a while, the affectionate satire and the steady stream of pop-culture references and the grisly shocks carry the day. Unfortunately, “Y2K” fizzles out somewhere around the halfway point, in part because the characters aren’t fleshed out much beyond familiar tropes, and the screenplay seems not quite finished. It’s as if the filmmakers ran out of fresh ideas at some point but just plowed ahead anyway. Popping with the images and sounds of pixilated videos, dial-up modem ringtones, “The Macarena” and “Tubthumping,” camcorders and mix tapes, “Y2K” instantly establishes the time period as the story kicks off on New Year’s Eve 1999, with a cast of talented young actors doing fine work playing familiar types. Jaeden Martell is the sweet and shy Eli and Julian Dennison is Eli’s best buddy Danny, with a sly sense of humor and no shortage of self-confidence. Rachel Zegler, who continues to demonstrate movie-star talent and presence, is Laura, who is gorgeous and popular and a secret computer nerd, and of course Eli is in love with Laura and of course Eli can barely muster the courage to say two words to her. Add some bullies and a dumb jock and a few other tropes and let’s get this party, i.e., a house party in the suburbs, started. At the stroke of midnight, it appears as if technology has indeed crashed — but then the machines come to “life” and start slicing and dicing up the humans, in gruesomely comedic fashion. The crude and ridiculous killing devices are initially amusing, though the joke wears thin as “Y2K” segues into a “Cabin in the Woods”-type horror film. Fred Durst has an extended, one-joke cameo as Fred Durst, which might have seemed original if we hadn’t already seen Bill Murray as himself in “Zombieland,” and Seth Rogen, James Franco, Jonah Hill, et al., playing themselves in “This Is the End.” In another bit of miscalculation, arguably the most likable and interesting character in the film is dispatched far too early. Like a slow-loading image on a home computer in the late 1990s, “Y2K” seems kinda cool, but the payoff isn’t worth the wait.