From Buy
Monday, December 2, 2024
Purple Biotech Positive Final Results of Phase 2 Study of CM24 in Second Line Pancreatic Cancer
- Final data demonstrate CM24 in combination with nivolumab and Nal-IRI/5FU/LV chemotherapy clear and consistent improvement across all efficacy endpoints
- A biomarker enriched patient population analysis based on pretreatment ranges of serum CEACAM1 demonstrated significant improvement in the treatment arm over the control of 79% reduction in risk of death (HR 0.21, P = 0.04) with median OS improvement of 5.1 months and over 90% reduction in risk of progression or death (HR < 0.1, P = 0.003) with median PFS improvement of 2.9 months and improvement in the treatment arm over the control in ORR of 50% vs. 0%.
- Phase 2b clinical study is planned in multiple selected indications, potentially targeting patients based on biomarkers
Senti Bio Positive InitialData in Phase 1 Cell Therapy for Malignancies Including AML
– 2 of 3 patients achieved MRD negative CR in the first dose level evaluated in the trial with a generally well-tolerated preliminary safety profile –
– Dose escalation is continuing with additional response and durability data expected in 2025 –
– Conference call scheduled on December 3 at 7:30am ET –
Conference Call Information
Senti Bio management and Dr. Strickland will discuss the SENTI-202 results on December 3, 2024 at 7:30am ET. To access the live webcast, please register online on the Events and Presentations page of Senti Bio’s website. The webcast may also be accessed as follows:
Conference ID: 1202759
United States - New York +1.646.968.2525
USA & Canada - Toll-Free +1.888.596.4144
Live webcast: https://edge.media-server.com/mmc/p/q37k42qa
An archived webcast and accompanying slides will be available on the Company’s website approximately one hour after the event.
Sunday, December 1, 2024
Taiwan President Speaks About China With Ex-Speaker Pelosi While in Hawaii
Taiwan President Lai Ching-te held a 20-minute call with former U.S. House of Representatives Speaker Nancy Pelosi on Sunday during a visit to Hawaii, during which they discussed China's military threats, the official Central News Agency reported.
Lai is making what is officially a stopover in Hawaii while on a week-long visit to the Pacific, a trip that China has condemned saying it opposes any such transit stops by Taiwanese leaders on U.S. territory.
China claims democratically governed Taiwan as its own territory, a position Lai and his government reject.
Taiwan's Central News Agency, citing presidential office spokesperson Karen Kuo, said the conversation between Lai and Pelosi was warm and cordial, and the two talked about semiconductors, AI and China's military threat to Taiwan.
Pelosi remains a senior member of the Democratic Party.
China held war games around the island in 2022, furious at then-Speaker Pelosi's trip to Taiwan.
Security sources have told Reuters that China could hold more drills around Taiwan to coincide with Lai's Pacific trip.
The United States is Taiwan's most important international backer and arms supplier, even in the absence of formal diplomatic ties.
From Hawaii, Lai goes on to Marshall Islands, Tuvalu and Palau, three of the 12 countries to retain official relations with Taipei.
He will also make a stop over in the U.S. territory of Guam.
Philippines' Marcos says presence of Russian submarine 'very worrisome'
Philippine President Ferdinand Marcos on Monday described as "very worrisome" the presence of a Russian attack submarine off the country's coast in the disputed South China Sea.
The UFA 490 submarine was spotted 148 kilometres (92 miles) west of Cape Calavite on Thursday, the Philippine military said.
"Any intrusion into the West Philippine Sea, of our EEZ (Exclusive Economic Zone), of our baselines is very worrisome," Marcos told reporters.
The Philippines dispatched a plane and a warship to the submarine, where the crew said they were awaiting good weather before proceeding to Russia's Vladivostok, the Philippine Navy said in a Monday statement.
Roy Vincent Trinidad, spokesman for the navy in the South China Sea, said the incident is "not alarming".
"But we were surprised because this is a very unique submarine," he told AFP.
The 74-metre (243-foot) long vessel is armed with a missile system that has a range of 12,000 kilometres, according to Russia's state-run TASS news agency.
The submarine was last seen in Philippine waters on Sunday, Trinidad said.
Russia's embassy in Manila and the Philippine foreign ministry did not immediately respond to AFP requests to comment on the matter.
https://sg.news.yahoo.com/philippine-president-says-russian-submarine-062631204.html
At least 25 killed as Russian, Syrian jets intensify bombing of Syrian rebel territory
At least 25 people were killed in northwestern Syria in air strikes carried out by the Syrian government and Russia, the Syrian opposition-run rescue service known as the White Helmets said early on Monday.
Russian and Syrian jets struck the rebel-held city of Idlib in northern Syria on Sunday, military sources said, as President Bashar al-Assad vowed to crush insurgents who had swept into the city of Aleppo.
The army also said it had recaptured several towns that rebels had overrun in recent days.
Residents said one attack hit a crowded residential area in the centre of Idlib, the largest city in a rebel enclave near the Turkish border where around four million people live in makeshift tents and dwellings.
At least seven people were killed and dozens injured, according to rescuers at the scene. The Syrian army and its ally Russia say they target the hideouts of insurgent groups and deny attacking civilians.
Ten children were among the dead in the air strikes in and around Idlib and other targets in rebel-held territory near Aleppo on Sunday, according to the White Helmets.
The total death toll from Syrian and Russian strikes since Nov. 27 had climbed to 56, including 20 children, the group added in a statement on X.
Reuters could not independently confirm the battlefield accounts.
The insurgents are a coalition of Turkey-backed mainstream secular armed groups along with Hayat Tahrir al-Sham, an Islamist group that has been designated a terrorist outfit by the U.S., Russia, Turkey and other states.
In a joint statement, the United States, France, Germany, and Britain urged "de-escalation by all parties and the protection of civilians and infrastructure to prevent further displacement and disruption of humanitarian access".
The insurgents seized control of all of Idlib province in recent days, the boldest rebel assault for years in a civil war where front lines had largely been frozen since 2020.
They also swept into the city of Aleppo, east of Idlib, on Friday night, forcing the army to redeploy.
In remarks published on state media, Assad said: "Terrorists only know the language of force and it is the language we will crush them with".
The Syrian army said dozens of its soldiers had been killed in the fighting in Aleppo.
Russian war bloggers reported on Sunday that Moscow had dismissed Sergei Kisel, the general in charge of its forces in Syria. Reuters has requested comment from the Russian defence ministry.
LEAVING ALEPPO
Inside Aleppo city, streets were mostly empty and many shops were closed on Sunday as scared residents stayed at home. There was still a heavy flow of civilians leaving the city, witnesses and residents said.
Rebel fighters waving the opposition flag drove through the city, Yusuf Khatib, a resident, told Reuters by phone. Some rebels took up positions on street intersections, he added.
Ahmad Tutenji, a merchant in the affluent New Aleppo neighbourhood, said he was surprised how quickly the army left. "I am shocked at how they fled and abandoned us."
Syrian troops who had withdrawn from the city were now regrouping and reinforcements were also being sent to help in the counter-attack, army sources said.
Aleppo had been firmly held by the government since a 2016 victory there, one of the war's major turning points, when Russian-backed Syrian forces besieged and laid waste to rebel-held eastern areas of what had been the country's largest city.
A lack of that manpower contributed to the speedy retreat of Syrian army forces in recent days, according to two army sources.
The rebel gains came after Israel stepped up its strikes on Iranian bases in Syria and Iran-backed Hezbollah forces in Lebanon. Militias allied to Iran, led by Hezbollah, have had a strong presence in the Aleppo area.
The head of the U.S.-backed Syrian Democratic Forces (SDF) said in a statement on Monday that its fighters in northwestern Syria were facing intense attacks on multiple fronts.
SDF commander Mazloum Abdi said the group had tried to establish a "humanitarian corridor" linking Kurdish-held northeastern regions to Tel Rifaat, a strategic area northwest of Aleppo to "protect our people from potential massacres".
"However, attacks by armed groups supported by the Turkish occupation have disrupted this corridor," Abdi said, adding that "our forces continue to resist to protect our people in the Kurdish neighbourhoods of Aleppo".
Turkey considers Kurdish militant groups the Kurdistan Workers Party (PKK) and the Syrian Kurdish YPG as terrorist organisations, as well as Hayat Tahrir al-Sham.
Syrian rebels backed by Turkey had blocked an attempt by Kurdish groups to establish a corridor connecting Tel Rifaat to northeastern Syria, Turkish security sources said on Sunday.
Turkish Foreign Minister Hakan Fidan told U.S. Secretary of State Antony Blinken on Sunday that Turkey would not allow what he called terrorist threats targeting its security or Syrian civilians, Turkish diplomatic sources said.
The war, which has killed hundreds of thousands of people and displaced many millions, has ground on since 2011 with no formal end. Most heavy fighting halted years ago after Iran-backed militias and Russian air power helped Assad win control of all major cities.
Iranian Foreign Minister Abbas Araqchi, visiting Damascus on Sunday, said the situation in Syria was "difficult" but the Assad government would prevail.
https://www.yahoo.com/news/least-25-killed-russian-syrian-025101808.html
Kisqali gets early breast cancer approval in Europe
Novartis has unlocked another growth driver for its fast-growing breast cancer therapy Kisqali with EU approval as an adjuvant therapy for patients with early-stage disease.
The European Commission has cleared use of CDK4/6 inhibitor Kisqali (ribociclib) to reduce the risk of recurrence in patients with stage 2 or 3, HR-positive/HER2-negative early breast cancer, based on the results of the NATALEE trial.
The green light in Europe comes a few weeks after Kisqali was cleared for this indication in the US and will raise the competitive pressure on class rival Verzenio (abemaciclib) from Eli Lilly, which claimed a similar adjuvant indication last year.
The two drugs are both big sellers, with Kisqali growing 43% to $787 million in the third quarter, while Verzenio grew by 32% to $1.36 billion, and are also used as first- and second-line therapies for advanced HR+/HER2- breast cancer.
Novartis' drug has been benefitting from the launch in early breast cancer and its Category 1 recommendation in National Comprehensive Cancer Network (NCCN) guidelines for HR+/HER2- metastatic breast cancer.
It is currently the only drug in the CDK4/6 inhibitor class with that level of recommendation as a first-line therapy in combination with an aromatase inhibitor for advanced cases of this form of breast cancer and was added to the guidance for adjuvant use last month.
Novartis has estimated that the early breast cancer indication doubles the number of patients that are eligible for Kisqali versus its use in metastatic disease and, according to chief executive Vas Narasimhan, is "a three times larger population than is currently labelled for the competitor product in the class in early breast cancer."
In the NATALEE trial, adding Kisqali to standard treatment with adjuvant endocrine therapy (ET) resulted in a 25.1% reduction in the risk of cancer recurrence compared to ET alone after three years of follow-up.
"For many patients diagnosed with stage 2 or 3 HR+/HER2- early breast cancer, the risk of their cancer coming back despite treatment with endocrine therapy remains high, even after decades," said Michael Gnant of the Medical University of Vienna, Austria, who is president of the Austrian Breast and Colorectal Study Group.
"This approval represents a positive milestone for the early breast cancer community in Europe, including physicians who now have a new option to help reduce the risk of recurrence in a broader population of patients," he added.
Around 70% of breast cancer cases in Europe are diagnosed at the early stages and the five-year survival rate for this group is pretty high overall at 99%. However, between 30% and 60% of patients with stage 2 or 3 HR+/HER2- early breast cancer will eventually see their cancer return.
https://pharmaphorum.com/news/kisqali-gets-early-breast-cancer-approval-europe
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