WORLD NEWS FLASH
UNITED STATES
CAMBRIDGE, MA and RAHWAY, NJ / ACCESSWIRE / December 13, 2022 – Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Merck (NYSE:MRK), known as MSD outside of the United States and Canada, announced that the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with KEYTRUDA®, Merck’s anti-PD-1 therapy, demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of recurrence-free survival (RFS) versus KEYTRUDA alone for the adjuvant treatment of patients with stage III/IV melanoma (skin cancer) following complete resection. Adjuvant treatment with mRNA-4157/V940 in combination with KEYTRUDA reduced the risk of recurrence or death by 44% (HR=0.56 [95% CI, 0.31-1.08]; one-sided p-value=0.0266) compared with KEYTRUDA alone.
“Today’s results are highly encouraging for the field of cancer treatment. mRNA has been transformative for COVID-19, and now, for the first time ever, we have demonstrated the potential for mRNA to have an impact on outcomes in a randomized clinical trial in melanoma,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We will begin additional studies in melanoma and other forms of cancer with the goal of bringing truly individualized cancer treatments to patients. We look forward to publishing the full data set and sharing the results at an upcoming oncology medical conference, as well as with health authorities.”
“These positive findings represent an important milestone in our collaboration with Moderna,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “Over the last six years, our teams have worked closely together combining our respective expertise in mRNA and immuno-oncology with a focus on improving outcomes for patients with cancer. We look forward to advancing this program into the next phase of development.”
“The results of this randomized Phase 2b trial are exciting for the field. These data provide the first evidence that we can improve on the rates of recurrence-free survival achieved by PD-1 blockade in resected high-risk melanoma. These findings also provide the first randomized evidence that a personalized neoantigen approach may be beneficial in melanoma,” said Jeffrey S. Weber, MD, PhD, principal investigator of the study and Deputy Director of the Perlmutter Cancer Center at NYU Langone. Dr. Weber is a paid consultant for Merck and Moderna.
Adverse events observed with mRNA-4157/V940 in KEYNOTE-942 were consistent with those previously reported in a Phase 1 clinical trial. The safety profile of KEYTRUDA was consistent with that observed in previously reported studies. Serious treatment-related adverse events occurred in 14.4% of patients who received the combination arm of mRNA-4157/V940 and KEYTRUDA versus 10% with KEYTRUDA alone.
The companies plan to discuss the results with regulatory authorities and initiate a Phase 3 study in melanoma patients in 2023.
In October of this year, the companies announced that Merck had exercised its option to jointly develop and commercialize mRNA-4157/V940. Merck and Moderna will share costs and any profits equally under this worldwide collaboration.
Personalized cancer vaccines are designed to prime the immune system so that a patient can generate a tailored antitumor response specific to their tumor mutation signature. mRNA-4157/V940 is designed to stimulate an immune response by generating specific T cell responses based on the unique mutational signature of a patient’s tumor. KEYTRUDA is an immunotherapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Based on early clinical studies, combining mRNA-4157/V940 with KEYTRUDA may potentially provide an additive benefit and enhance T cell-mediated destruction of tumor cells.
WORLD
GLOBAL TRADE DROPS
Global trade is set to reach almost $32 trillion this year, but inflation has reversed some of the gains made in recent months.
That’s according to UN trade and development agency, UNCTAD, whose analysts said that global growth “turned negative” during the second half of 2022.
The UN agency said that trade in goods and services is expected to reach $25 trillion and $7 trillion respectively, by the end of the year.
The downturn began in the third quarter of the year, with goods trading about one percent lower than from March to May.
In its global trade update, UNCTAD said that although services actually increased by 1.3 per cent in the third quarter, both goods and services are expected to fall in value in the run-up to the end of the year.
Demand for foreign goods “proved resilient” through 2022, the trade and development update said, with trade volumes overall increasing by three percent.
Trade volumes of east Asian economies have shown resilience, while South-South trade lagged during the third quarter.
Overall, “geopolitical frictions, persisting inflation, and lower global demand are expected to negatively affect global trade during 2023,” said UNCTAD in its report highlights.
Among the negative factors teased out, are lower economic growth forecast through 2023 due to high energy prices, rising interest rates, sustained inflation in many economies and the depressive impact of the war in Ukraine.
Prices of components and consumer goods are expected to dampen demand for imports and lead to a declining volume of international trade.
Record levels of global debt and increased interest rates, “pose significant concerns for debt sustainability,” increasing pressure on those governments most in debt, and “amplifying vulnerabilities.”
On the upside, ports and shipping companies have adjusted to the supply chain crunch provoked by the COVID-19 pandemic, with new ships entering service, and port congestion, largely resolved, said UNCTAD.
Recently signed trade agreements such as the Regional Comprehensive Economic Partnership in the Asia-Pacific (RCEP), and the African Continental Free Trade Area (AfCFTA), “should come to fruition and provide some momentum” for the whole international system, the report highlights.
EUROPE
RUSSIAN OFFICIALS & OTHERS HIT WITH SANCTIONS
On Dec. 13 the UK announced a new package of 16 sanctions targeting senior Russian commanders for their involvement in the Russian military, and Iranian businessmen and officials involved in the production and/or supply of drones to the Kremlin.
The announcement comes as Russia steps up its campaign of terror against Ukraine, striking at crucial energy infrastructure and plunging its people into the dark and freezing cold of winter.
Twelve senior commanders of Russian military forces, including units implicated in attacks on Ukrainian cities, have been sanctioned. Major General Robert Baranov, identified by a Bellingcat investigation as the commander of a unit responsible for programming and targeting Russian cruise missiles, is among those targeted.
More than 6,000 Ukrainian civilians are estimated to have died since the beginning of Russia’s invasion, primarily as a result of Russian missile and artillery strikes. Intentionally directing attacks against civilians and civilian objects is a serious violation of International Humanitarian Law – those responsible must be held to account.
Iranian-manufactured drones have played a central role in these evil attacks on civilians. On Dec. 9, the US released information showing Iran has become one of Russia’s top military backers, sending hundreds of drones to Russia in violation of its international legal obligations, which have been used to attack Ukraine’s critical infrastructure and kill civilians.
Foreign Secretary James Cleverly said, “The UK stands with Ukraine. Russian forces’ calculated attacks on cities and innocent civilians in Ukraine will not go unanswered.
“The Iranian regime is increasingly isolated in the face of deafening calls for change from its own people and is striking sordid deals with Putin in a desperate attempt to survive.
“Putin wants to break Ukraine’s spirit, but he will not succeed. Ukraine will win, and Ukraine will rebuild.
“The Iranian regime’s brutal repression of its own people and the threat it poses in the Middle East have left Iran isolated internationally and in desperate need of support from Putin. Today’s sanctions include individuals facilitating the production of these drones, including the co-owner and Managing Director of MADO, the company responsible for manufacturing engines for the drones which have been used by Russia in Ukraine.”
UK sanctions are taking the wheels off the Russian war machine and forcing its military to compromise on vital weaponry and equipment. Defense Intelligence reports suggest that Russian armed forces are struggling to replenish their missile reserves, while they are increasingly forced to rely on second rate drones supplied by Iran to keep up their inhumane bombardments of the Ukrainian people.
MIDDLE EAST
DEADLY ATTACKS UNDER INVESTIGATION
UN Secretary-General António Guterres has welcomed the decision by the Government of the Democratic Republic of the Congo (DRC) to investigate recent deadly attacks allegedly committed by the M23 armed group.
Mr. Guterres has strongly condemned the attacks, which occurred on November 29 and 30 in the villages of Kishishe and Bambo, located in Rutshuru territory, North Kivu province, in the volatile eastern part of the country.
At least 131 civilians were killed, including 17 women and 12 children, and eight others were injured.
“The Secretary-General expresses his deepest condolences to the families of the victims and wishes a swift recovery to the injured,” UN Spokesperson Stéphane Dujarric said in a statement on Dec. 9.
“He welcomes the decision of the Congolese authorities to investigate these incidents with a view to bringing those found responsible to justice.”
Meanwhile, the UN’s human rights office in the DRC, and its peacekeeping operation there, MONUSCO, will continue to support the Government in these efforts.
“The Secretary-General urges the M23 and all other armed groups immediately cease hostilities and disarm unconditionally,” the statement continued.
Mr. Guterres also called on all parties to facilitate humanitarian access to affected communities and to ensure the protection of civilians and respect for international humanitarian law.
He also underlined the UN’s ongoing commitment to support the Congolese Government and people in their efforts to bring about peace and stability in the east of the country.
The attacks are the latest in a series of violence inflicted on civilians by armed groups in eastern DRC.
