ASCO Highlights

 The American Society of Clinical Oncology 2023 annual meeting kicked off Friday in Chicago, and BioSpace’s Greg Slabodkin spoke with leading biopharma analysts about the most-anticipated ASCO abstracts.

Keep checking back for more ASCO highlights.

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June 2.: Novartis presented early data from a Phase III trial of Kisqali (ribociclib) in HR-positive HER2-negative early-stage breast cancer. The addition of Kisqali in the adjuvant setting reduced patients’ risk for recurrence by 25% compared to those on the endocrine therapy alone.

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June 2

 

In March, BioNTech dropped $200 million upfront for exclusive global rights to OncoC4’s anti-CTLA-4 monoclonal antibody candidate, ONC-392. On Friday, the development partners reported positive early data to be presented at ASCO from a Phase I/II trial studying the drug—now BNT316/ONC-392—in metastatic, PD-(L)1-resistant non-small cell lung cancer (NSCLC). 

 Data from 27 patients showed an overall response rate of 29.6% and a disease control rate of 70.4%. One patient had a complete response, seven saw a partial response and 11 patients had stable disease. BioNTech and OncoC4 called the safety profile “manageable” with Grade 3 or 4 Immune-related adverse events occurring in 10 patients.  

“Responses were observed regardless of PD-L1 status, and among those who failed multiple lines of immunotherapy and chemotherapy, including PD-1 and CTLA-4 combination therapy,” Pan Zheng, chief medical officer and co-founder at OncoC4, said in a prepared statement.   

A pivotal Phase III trial is expected to begin in the third quarter of 2023, according to the press release.  

https://www.biospace.com/article/asco-highlights-/

Russia's Taman port set to suspend LPG exports over drone danger

 Russia's Black Sea port of Taman is poised to suspend exports of highly-explosive liquefied petroleum gas (LPG) because of concerns linked to drone attacks, three sources with knowledge of the situation told Reuters on Friday.

Russia has come under repeated attack in recent weeks, suffering a major cross-border incursion and drone attacks including on Moscow, oil refineries in southern Russia and a fuel depot near a strategic bridge that links Russia's mainland with Crimea.

Russia says Ukraine was behind the attacks, including on the Kremlin last month. Kyiv denies it.

Rail operators in Russia and Kazakhstan have already declared plans to restrict cargo shipments towards Taman, which accounts for around 7.5% of Russia's total LPG exports.

Three sources with direct knowledge of the situation told Reuters that Taman will suspend handling of LPG, also referred to as propane and butane, because of the explosive nature of the fuel. All the sources spoke on condition of anonymity due to the sensitivity of the situation.

"Taman is suspending LPG transhipment as it is dangerous after all those (drone) attacks - the gases are most explosive," one of the sources said.

The sources did not specify when the port would stop handling LPG, saying existing stockpiles would be shipped first.

Tamanneftegaz, the operator of the Taman transhipment complex, which also handles crude oil and oil products, did not respond to a request for comment.

The concerns over drone attacks on Russian infrastructure are the latest instance of how the conflict in Ukraine affects energy supplies and how dependent they are on security in the Black Sea through which Russia sends fuel to world markets.

LPG is mainly used as fuel for cars, heating and to produce other petrochemicals.

Two of the sources said LPG operations at the Taman transhipment complex, which has a capacity of 20 million tonnes of cargoes per year, would be mothballed indefinitely.

https://news.yahoo.com/exclusive-russias-taman-port-set-124932343.html

S&P spares France from rating downgrade

 Ratings agency S&P spared France on Friday the embarrassment of downgrading the country's sovereign debt, but remained cautious about the outlook on account of strained public finances.

S&P left the country's AA rating untouched after a regular review and said that the outlook remained negative due to "downside risks to our forecast for France's public finances amid its already elevated general government debt."

A downgrade would have been the second in six weeks after rival agency Fitch cut its rating at the end of April to AA- over concerns about potential political paralysis and social unrest after a recent unpopular pension reform was passed.

Finance Minister Bruno Le Maire told weekend newspaper Le Journal du Dimanche that S&P's decision to keep its AA rating was a "positive signal" and that the government's public finance strategy was credible.

S&P said that potential triggers for a downgrade could come in the form of prolonged economic slowdown or failure to rein in the public finances, notably by leaving public spending high.

Le Maire said that "several billion euros" in budget savings would be detailed later this month after a spending review for which he has asked each ministry to identify cutbacks worth 5% of their budget.

S&P said that it now expects a slightly smaller public sector budget deficit following a recent update of the government's long-term financial plans that aim to cut the deficit to 2.7% of economic output in 2027 from 4.9% this year.

The ratings agency also said that it looked positively on a reform of unemployment benefits last year and a law passed this year to raise the retirement age two years to 64, which sparked weeks of protests and strikes.

https://www.marketscreener.com/news/latest/S-P-spares-France-from-rating-downgrade--44029828/

Drugmaker Mallinckrodt may file for bankruptcy again

 Pharmaceutical company Mallinckrodt Plc is considering options including filing for bankruptcy again as a $200 million opioid settlement payment is due within weeks, the Wall Street Journal reported on Friday citing people familiar with the matter.

The drugmaker is required to make the payment to an opioid-victims compensation trust by mid-June as part of its chapter 11 exit plan, the newspaper said.

Mallinckrodt did not immediately respond to a Reuters request for comment outside office hours.

The company filed for bankruptcy protection nearly three years ago. It reached a $1.7 billion nationwide settlement as part of its bankruptcy reorganization plan and emerged from Chapter 11 last year.

Shares of Mallinckrodt closed 5.4% lower at $2.45 apiece on Friday. The stock has plunged 68% so far this year.

https://www.marketscreener.com/quote/stock/MALLINCKRODT-PLC-139700961/news/Drugmaker-Mallinckrodt-may-file-for-bankruptcy-again-WSJ-44030801/

Texas becomes largest state to ban transgender care for minors

 Texas Governor Greg Abbott on Friday signed a bill that bans transgender healthcare including puberty blockers and hormone therapy for minors, making Texas the largest of the 20 states to have outlawed gender-affirming care.

Republican lawmakers across the country have promoted similar bills, saying they mistrust the consensus among major medical associations that endorse gender-affirming care as needed and even life-saving for trans youth after extensive evaluation.

Texas, the second most-populous U.S. state, has an estimated 29,800 transgender youth aged 13 to 17, according to the Williams Institute of UCLA.

The American Civil Liberties Union and other groups have pledged to fight the law in court, as they have similar legislation in other states.

"They (Texas lawmakers) are hellbent on joining the growing roster of states determined to jeopardize the health and lives of transgender youth, in direct opposition to the overwhelming body of scientific and medical evidence," the ACLU said in a statement when the bill passed the legislature.

The Texas law creates exceptions for minors who began treatment before June 1 or for those who attended 12 or more sessions of mental health counseling or psychotherapy for at least six months.

But those patients "shall wean off the prescription drug over a period of time," the law says.

Backers of such laws say government must intervene against the wishes of parents and doctors because they fear it will cause irreparable harm and say children are incapable of acceding to such decisions.

Groups including the American Medical Association, the American Psychological Association and the American Academy of Pediatrics oppose the legislation.

Republicans introduced more than 500 bills affecting LGBTQ people in 2023, with more than 50 passing, according to the Human Rights Campaign, an LGBTQ rights group. Those numbers are up from 315 bills introduced and 29 passed in 2022.

https://www.marketscreener.com/news/latest/Texas-becomes-largest-state-to-ban-transgender-care-for-minors--44030821/

Mexico to fight US dispute over GM corn after formal consultations fail

 Mexico said on Friday it would counter U.S. arguments over agriculture biotech measures, including plans to limit its use of genetically modified (GM) corn, in trade dispute settlement consultations requested by Washington earlier in the day.

The consultation request comes as the North American neighbors inch toward a full-blown trade dispute under the U.S.-Mexico-Canada Agreement (USMCA) over Mexico's policies to limit the use of GM corn, which it imports from the U.S.

If the consultations fail to resolve disagreements within 75 days, Washington can request a dispute settlement panel to decide the case.

Mexico said it was committed to "constructive dialogue" regarding U.S. concerns and to "reach a mutually satisfactory agreement."

Asked if Canada would take similar action to the U.S., a spokesperson for the Trade Ministry said Canada is "considering its next steps" and would be "guided by what is in the best interest of our farmers and the Canadian agriculture sector."

The United States requested formal trade consultations in March over objections to Mexico's plans to limit imports of GM corn and other agricultural biotechnology products. Those consultations took place, but failed to resolve the matter, senior officials of the U.S. Trade Representative's office said.

Mexico's agriculture ministry declined to comment, but the minister this week expressed confidence that the dispute with the U.S. would not escalate to a dispute settlement panel.

The conflict comes amid other disagreements between the U.S. and Mexico, most notably over energy in which the U.S. has argued that Mexico's nationalist policy prejudices foreign companies.

Despite February changes to Mexico's decree on GM corn, the U.S. said the Latin American country's policies are not based on science and appear inconsistent with its commitment under the USMCA.

The new decree eliminated a deadline to ban GM corn for animal feed and industrial use, by far the bulk of its $5 billion worth of U.S. corn imports, but maintained a ban on GM corn used in dough or tortillas.

Mexico argued on Friday the ban will not affect trade with the U.S., as Mexico produces more than enough white corn used for tortillas.

A senior Mexican executive, speaking before consultations were requested, said that because Mexico is not formally preventing sale of U.S. GM corn, any dispute panel would 

likely find little material damage had been done to U.S. business.

Mexican President Andres Manuel Lopez Obrador has also said GM seeds can contaminate Mexico's age-old native varieties and has questioned their impact on human health.

February's revised "decree does call for a gradual substitution and eventual banning of biotech corn, and this part of the measure itself is not science-based," said a senior USTR official.

The consultations will also address Mexico's rejection of new biotech seeds for products like soybeans, cotton and canola, U.S. officials said.

Mexico argued on Friday that the decree "encourages Mexico to preserve planting with native seeds, which is done in compliance with the USMCA's environmental regulations."

Some sector experts have expressed concern that the move could set a precedent among other countries, which would disrupt the global corn trade.

The National Corn Growers Association, which represents U.S. farmers, praised the U.S.' move.

"Mexico's actions, which are not based on sound science, have threatened the financial wellbeing of corn growers and our nation's rural communities," association President Tom Haag said in a statement.

https://www.marketscreener.com/quote/future/CORN-FUTURES-ZC-CBE--16213/news/Mexico-to-fight-US-dispute-over-GM-corn-after-formal-consultations-fail-44029154/

Tanks, F-16 Jets Won't Be Ready For Ukraine Counteroffensive: Pentagon

 Ukraine continues to tout that its planned major counteroffensive is coming and is imminent, event after Russia's significant victory over the strategic Donetsk oblast city of Bakhmut. 

But Joint Chiefs chairman Gen. Mark Milley has been quoted in The Associated Press this week as confirming that US Abrams tanks and F-16 fighter jets which the US and Western countries have previously promised Ukraine will not be ready in time for the counteroffensive. He said the approved training on these sophisticated and advanced weapons systems for Ukrainians has begun, but that it will take "considerable time".

"Everyone recognizes Ukraine needs a modernized Air Force," Milley said. "It’s going to take a considerable amount of time." 

President Biden had last month belatedly approved giving European countries the ability to transfer F-16s to Ukraine, but Ukrainian pilots - long experienced only on Soviet and Russian-made aircraft, must be trained extensively on the US-designed and produced aircraft. This could take six months to a year or more.

According to the AP, "Milley said detailed planning on class sizes, the types of flying tactics and locations for training was underway now between the U.S. and allies such as the Netherlands and the U.K. that have already pledged to provide F-16s."

It's as yet unclear whether the US itself is going to eventually provide the jets directly to Ukraine forces, or if simply it will support third party countries giving them. 

The U.S. has not said yet whether or not it will provide jets, but President Joe Biden has said the U.S. will support F-16 training.

As for Abrams tank training, which has already been underway, "About 200 Ukrainian soldiers began an approximately 12-week training course in Germany on the U.S. tanks over the weekend to teach them how to maneuver, fire and conduct combined arms operations with the advanced armored system," the AP details. Support crew for tank fueling and fuel truck maintenance are also undergoing instruction, and that makes up another 200 troops. 

In total about 300 tanks have been pledged by the Western allies, including German-made Leopard 2 tanks and UK Challenger main battle tanks. Washington is expected to deliver 31 seventy-ton Abrams tanks to Kiev by the fall.

https://www.zerohedge.com/geopolitical/tanks-f-16-jets-wont-be-ready-ukraine-counteroffensive-pentagon