Monopar Positive Early Human Clinical Data Validating Candidate Tumor Targeting

 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced positive early data from its ongoing open-label MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial confirming MNPR-101-Zr’s tumor targeting ability in humans.

MNPR-101 is Monopar’s proprietary first-in-class humanized monoclonal antibody that targets cancers expressing the urokinase plasminogen activator receptor (uPAR). These include a majority of all triple-negative breast, colorectal, bladder, ovarian, gastric, and pancreatic cancers.

https://www.globenewswire.com/news-release/2024/09/12/2945115/0/en/Monopar-Announces-Positive-Early-Human-Clinical-Data-Validating-the-Tumor-Targeting-Ability-of-MNPR-101-Zr.html

Tenon publishes on Joint Fusion System

  Interim Patient Outcomes Demonstrate Significant Improvements in Pain (VAS) and Disability (ODI), Along with High Patient Satisfaction and Safety Profile at Primary 6-month Analysis ~

~ Preliminary SI Joint Fusion Results Based on Independent Radiologist Review Indicate Evidence of Fusion at 12-Months Post-Procedure ~

https://finance.yahoo.com/news/tenon-r-medical-announces-first-230300568.html

Stellantis Dealers Blame Death Spiral Of US Brands On CEO

 Carlos Tavares was named CEO and Chairman of Group PSA in 2014. When the French conglomerate merged with Fiat-Chrysler Automobiles in 2021, he became the first CEO of Stellantis. But American dealers aren't exactly thrilled with how the 66-year-old Portuguese businessman is steering the ship.

 

In an open letter to Tavares, the US Stellantis National Dealer Council accused the CEO of leading the world's fourth-largest automaker toward a "disaster." Dealers are particularly unhappy with how the head honcho banked nearly $40 million last year. In addition, the big boss is criticized for causing the "rapid degradation" of Jeep, Ram, Dodge, and Chrysler.

Jeep sales fell 9% in the first half of 2024 while Ram dropped by 26%. Chrysler suffered an 8% decline while Dodge was down by 16%. Fiat was up 67% but that sounds better than it actually is since the Italian brand only sold 316 cars in the US through June. As for Alfa Romeo, deliveries rose by 2%.

Available in PDF format and dated September 10, the open letter highlights the huge concerns dealers in the United States have about where Stellantis is heading:

"The market share of your brands has been slashed nearly in half, Stellantis stock price is tumbling, plants are closing, layoffs are rampant, and key executives fleeing the company. Investor lawsuits, supplier lawsuits, strikes–the fallout is mounting. Your own distribution network, your dealer body, has been left in an anemic and diminished state."

Stellantis has already issued a response:

"At Stellantis, we don’t believe that public personal attacks, such as the one in the open letter from the NDC president against our CEO, are the most effective way to solve problems. We have started a path that will prove successful. We will continue to work with our dealers to avoid any public disputes that will delay our ability to deliver results."

But not everything is gloom and doom at Stellantis. This week, it announced plans to invest $406 million at three Michigan plants to build electric vehicles alongside their combustion-powered counterparts. One of the factories is Sterling Heights where Tavares recently said that too many trucks need repairs right after leaving the assembly line.

For more good news, none of the 14 brands underneath the corporate umbrella will be axed. Although Tavares said in July that unprofitable automakers would be eliminated, a subsequent official statement from Stellantis reiterated the company is sticking with its original plan announced in 2021.

When the automotive juggernaut was created in early 2021, Tavares pledged to pour money into all brands for 10 years. That means struggling brands such as Chrysler in the US as well as Lancia and DS Automobiles in Europe should be safe until at least the end of the decade.

Stellantis appears to be making efforts to boost quality, so much so that the Wagoneer S could be delayed until the first Jeep EV for America delivers "perfect quality."

US dealers want Tavares to make the right decisions so that Stellantis can regain the lost market share and fully utilize the available production capacity. How? By getting "your employees, our employees, and your suppliers' employees back to work by building and selling cars that Americans want to buy and can afford."

The US Stellantis National Dealer Council says it saw this unfortunate situation coming and "has been sounding this alarm" to the executive team for more than two years. They accuse the CEO of setting a course that "was going to be a disaster in the long run. A disaster not just for us, but for everyone involved–and now, that disaster has arrived."

Stellantis' rival Volkswagen Group is also going through difficult times. Finance boss, Dr. Arno Antlitz, said last week that the company has "one, maybe two" years to turn things around.

https://www.motor1.com/news/733456/stellantis-dealers-blame-ceo-disaster/

Aura Positive Phase 2 End of Study Results in First-Line Treatment for Choroidal Melanoma

 Bel-sar Demonstrated 80% Tumor Control Rate, 90% Visual Acuity Preservation, and a Highly Favorable Safety Profile

Aura to Host a Virtual Ocular Oncology Investor Event Featuring Key Opinion Leaders Today at 8:00 am ET

Aura will host a virtual ocular oncology investor event featuring Dr. Ivana Kim, MD (Mass Eye and Ear) and Dr. Prithvi Mruthyunjaya, MD, MHS (Stanford University Byers Eye Institute) to discuss the Phase 2 end of study data on Thursday, September 12, 2024, at 8:00 am Eastern Time. To register for the event, click here. A live question and answer session will follow the formal discussion.

The live webcast of Aura’s virtual ocular oncology investor event will be available on the “Investors & Media” page under the “Events & Presentations” section of Aura’s website at https://ir.aurabiosciences.com/events-and-presentations, where a replay of the webcast will be archived for 90 days following the presentation date.

https://www.globenewswire.com/news-release/2024/09/12/2945023/0/en/Aura-Biosciences-Reports-Positive-Phase-2-End-of-Study-Results-Evaluating-Bel-sar-as-a-First-Line-Treatment-for-Early-Stage-Choroidal-Melanoma.html

CureVac Partner GSK Positive Phase 2 Data from Seasonal Influenza mRNA Vax

 

• Phase 2 data demonstrated positive immune responses to A and B strains, with acceptable safety and reactogenicity profile, meeting all pre-defined study endpoints

• Vaccine candidate based on CureVac's proprietary second-generation mRNA backbone

• GSK confirmed data support advancing program to Phase 3; dosing of first Phase 3 participant is associated with a significant milestone payment for CureVac

• In July 2024, GSK assumed full control for the development, manufacturing and commercialization of influenza vaccines through new licensing agreement

https://www.accesswire.com/916683/curevac-partner-gsk-announces-positive-phase-2-data-from-seasonal-influenza-mrna-vaccine-program

Sanofi’s Phase III CSU treatment trial meets endpoints

 Sanofi has reported that its Phase III LIBERTY-CUPID Study C of Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU) met primary and key secondary endpoints.

The study focused on biologic-naïve patients with uncontrolled CSU receiving background therapy with antihistamines.

Study C, part of the LIBERTY-CUPID Phase III programme, was a double-blind, randomised, placebo-controlled trial.

It assessed the efficacy and safety of Dupixent as an add-on to standard-of-care antihistamines versus antihistamines alone in 151 patients aged six years and above.

The primary endpoint was the change from baseline in itch severity at 24 weeks.

Additionally, a key secondary endpoint included the change from baseline in both itch and hives at the same timeframe.

Results at 24 weeks showed an 8.64-point decline in itch severity following Dupixent treatment compared to a 6.10-point reduction with placebo.

For urticaria activity, there was a 15.86-point reduction with Dupixent versus an 11.21-point reduction with placebo.

Notably, 30% of patients treated with Dupixent reported no urticaria, which was a complete response, compared to 18% of those on placebo.

The safety results were found to be generally in line with the known safety profile of Dupixent in its approved indications in the dermatology field.

Treatment-emergent adverse events were observed at a rate of 53% for both Dupixent and placebo arms.

Injection site reactions, accidental overdose, and Covid-19 infection were found to be the adverse events observed with Dupixent in the trial.

This positive outcome confirms the results from Study A, the first Phase III study of Dupixent in this setting.

Earlier this year, Japan approved Dupixent for adult and adolescent CSU patients based on results from Study A.

Sanofi Development global head and chief medical officer Dietmar Berger said: “The positive pivotal data from this study reinforce the potential of Dupixent to offer a new treatment option for the many people suffering from chronic spontaneous urticaria who do not respond to standard-of-care antihistamines.

“With clinically meaningful reductions in itch and hives for patients receiving Dupixent, we look forward to sharing these data with the FDA to bring Dupixent to patients with CSU in the US as soon as possible. With Dupixent now treating one million patients across seven approved indications, these new results underscore there are still many more patients that Dupixent can potentially benefit.”

The latest development comes after the company reported data from the Phase III trials of tolebrutinib for treating multiple sclerosis.

https://finance.yahoo.com/m/d80657eb-60e4-310d-aa2e-f1bc4362da32/sanofi%E2%80%99s-phase-iii-csu.html

Zelensky Disappointed After Blinken Visit, Despite Getting $1.5 Billion More

 The end result of US Secretary of State Antony Blinken's visit to Kiev Wednesday alongside British Foreign Secretary David Lammy was... (big surprise) Ukrainian President Volodymyr Zelensky getting a huge amount of money.

During the rare joint trip, the US and UK pledged nearly $1.5 billion in additional aid, though it remains that Ukraine still didn't get quite what it wanted: authorization to use US-made long-rage missiles against Russian territory.

"Speaking for the United States, we have adjusted and adapted as needs have changed, as the battlefield has changed. And I have no doubt that we’ll continue to do that as this evolves," Blinken told a press briefing, after President Biden earlier said the question of long-rage strikes is being worked out. But there was no big announcement from Kiev on the controversial issue.

Not content with the announcement of $1.5 billion in American and British taxpayer funds, Zelensky said of the long-range weapons issue: "Let’s count on some strong decisions, at least," adding that "For us, it’s very important."

Blinken additionally said he'll take the issue "back to Washington to brief the president" and that "no doubt" Biden and UK Prime Minister Keir Starmer will discuss the issue when they meet at the White House Friday.

While Kiev might see it as a consolation prize, the US cut of the new pledge to Ukraine comes in at more than $700 million in humanitarian aid, while Lammy pledged another $782 million in assistance and loan guarantees.

The West has been seeking to rapidly bolster Ukraine's energy grid after constant waves of Russian aerial attacks which has left the country subject to rolling emergency blackouts. All of this has happened ahead of what's expected to be a very tough winter.

Upon wrapping up his visit to Kiev, Blinken made his way over to Warsaw where he is meeting with Polish leadership. The Associated Press says it's expected that the NATO 'eastern flank' member will press the issue of Zelensky's request to hit Russia hard with long-range missiles.

"NATO member Poland, which shares a border with Ukraine, has been supportive of the Ukrainians and Blinken is likely to hear further requests for easing weapons-use restrictions from Polish President Andrzej Duda, Prime Minister Donald Tusk and Foreign Minister Radek Sikorski," AP reports.

But the consensus even among hawkish Washington foreign policy pundits is that long-range strikes into Russia will not change the battle lines in eastern Ukraine, where the fate of the war is being decided. Instead, it will only make escalation between NATO and Moscow much more unpredictable.

https://www.zerohedge.com/geopolitical/zelensky-disappointed-after-blinken-visit-despite-getting-15-billion-more