KalVista: Positive Phase 1 Data for Oral Hereditary Angioedema Therapy

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced positive phase 1 data for an orally disintegrating tablet (ODT) formulation for its lead compound sebetralstat. Sebetralstat is currently being developed in the phase 3 KONFIDENT clinical trial as a potential on-demand treatment for hereditary angioedema (HAE) attacks.

https://finance.yahoo.com/news/kalvista-pharmaceuticals-announces-positive-phase-104500309.html

Instil: Pause of Enrollment in Ongoing Clinical Trials Related to Manufacturing

 

• Voluntarily paused enrollment in ITIL-168 and ITIL-306 trials pending outcome of manufacturing analysis and implementation of corrective actions
  
  

• No regulatory agency, including the FDA, has notified the Company of a clinical hold in any of its clinical trials
  
  

• Observed decreased rate of successful manufacturing of ITIL-168 for patients recently enrolled in DELTA-1 trial
  
  

• Company intends to provide an update on the manufacturing analysis by early Q1 2023
  
  

• Company confirms cash runway into 2025 upon the successful completion of a potential sale-leaseback transaction of its Tarzana manufacturing facility

https://finance.yahoo.com/news/instil-bio-announces-voluntary-pause-110000465.html

ESSA Provides an Update on its Clinical Collaboration with Janssen

 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced that Janssen Research and Development ("Janssen") is suspending enrollment into the Phase 1 clinical study of EPI-7386 with apalutamide or EPI-7386 with abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer ("mCRPC") patients as a result of operational recruitment challenges.

Before suspending enrollment, Janssen treated three mCRPC patients (pre-chemotherapy) with the combination of EPI-7386 and apalutamide or abiraterone acetate plus prednisone for up to four months of therapy. In all three patients, the combination of both investigational drug products was safe and well tolerated, and yielded sufficient exposures of each investigational drug product, indicative of pharmacological activity. Initial clinical activity was observed in some patients, with two of the three patients achieving a prostate-specific antigen ("PSA") reduction of 90% ("PSA90") within 12 weeks.

https://finance.yahoo.com/news/essa-provides-clinical-collaboration-janssen-110000259.html

Finland Says Ukraine Arms Ending Up In Hands Of Criminal Gangs

 Critics of the massive US weapons pipeline to Ukraine have long pointed out there's no accountability or appropriate tracking once those arms enter the country, presenting ripe opportunities for criminals, terrorists, or lucrative black market arms sellers to take advantage. 

So it was perhaps only a matter of time before headlines like this began showing up in international publications - "NBI: Arms sent to Ukraine in criminal hands." The NBI is Finland's federal National Bureau of Investigation, and the report is from Finland's national public broadcasting company Yle, and provides confirmation that arms intended for Ukrainian forces are going outside the country.

The recovered weapons featured in the weekend national police statement include assault rifles which were meant for Ukrainian forces. Further neighboring countries have recorded instances of West-provided arms proliferating from the Ukrainian battlefield and into the hands of criminals in neighboring Sweden and Denmark as well.

"Weapons shipped [by various countries] to Ukraine have also been found in Sweden, Denmark and the Netherlands," NBI Detective Superintendent Christer Ahlgren was quoted in the Finnish publication as saying. 

"We've seen signs of these weapons already finding their way to Finland," Ahlgren added. Some of this illicit arms trafficking is being brokered in online forums frequented by criminal gangs. According to more from the NBI lead investigator: 

"Three of the world's largest motorcycle gangs—that are part of larger international organizations—are active in Finland. One of these is Bandidos MC, which has a unit in every major Ukrainian city," he explained. "We know that contacts and routes are being warmed up, so that they're in place." 

"Ukraine has received a large volume of weapons and that's good, but we're going to be dealing with these arms for decades and pay the price here," Ahlgren added. 

"Criminal organizations have their networks in Finnish commercial ports. Stopping this is in everyone's interest," the detective continued, underscoring that police work and investigations have been greatly ramped up since the start of the Ukraine war, especially when it comes to monitoring the nation's points and ports of entry. He declined to provide a detailed list of the types of arms which have made their way into Finland, however.

Washington and NATO countries have over the past eight months since the Russian invasion began pumped tens of billions of dollars in light and heavy weaponry into Ukraine. From the start, Pentagon officials as well as media pundits have warned of the likelihood that many of these weapons would end up outside of Ukraine. 

All the way back in April, one White House official even warned in speaking to CNN, "we have fidelity for a short time, but when it enters the fog of war, we have almost zero. It drops into a big black hole, and you have almost no sense of it at all after a short period of time."

The question remains, who could have seen this coming? The answer is everyone with common sense. 

https://www.zerohedge.com/geopolitical/finland-says-ukraine-arms-ending-hands-criminal-gangs

Thermo Fisher Said to Near $2.3 Billion Deal for Binding Site

 Thermo Fisher Scientific Inc. is nearing a deal to acquire Birmingham, England-based diagnostic firm Binding Site for more than £2 billion ($2.3 billion) from private equity fund Nordic Capital, according to people familiar with the matter.

The agreement could be announced as early as this week and would mark a revival to dealmaking in Europe where volumes collapsed this quarter, said the people, who asked not to be identified. The talks are advanced but there’s no certainty the deal will go through, they said.

A representative for Waltham, Massachusetts-based Thermo Fisher declined to comment, while Nordic Capital couldn’t immediately be reached.

Thermo Fisher, which makes scientific instruments and helps manufacture drugs, is among the most acquisitive life-sciences companies. Last year it bought PPD Inc., a provider of clinical and research services, for about $20 billion. In January it bought PeproTech, a closely held provider of recombinant proteins, for about $1.85 billion cash.

Binding Site is developing diagnostic products to detect immune-system disorders and caters to clinicians and laboratory professionals. A deal for the company would be the latest example of health-care transactions still being an active sector for merger activity and a sign of US-based buyers benefiting from a strong dollar, particularly when paying for a pound-denominated asset.

Nordic Capital has recently raised a new buyout fund of 9 billion euros despite a challenging fundraising environment as investors keep cash, cut allocations to private equity and wait for funds to return money before reinvesting. The Stockholm-based firm has a track record in the health care space and is widely regarded as one of the most successful PE funds in that space. It initially invested in Binding Site 11 years ago.

https://finance.yahoo.com/news/thermo-fisher-said-near-2-194624952.html

Actinium: Positive Top-line Results from Pivotal Phase 3 Trial of Iomab-B in Acute Myeloid Leukemia

  Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, today announced positive top-line results from the pivotal Phase 3 trial for its lead product candidate Iomab-B. The SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory AML) trial was conducted in patients 55 years of age or older who had active disease (relapsed or refractory AML). The SIERRA trial is a randomized, multi-center, controlled study which compared Iomab-B as a conditioning regimen prior to a Bone Marrow Transplant (BMT) versus a control arm which allowed all current means of conventional care with the intent to transplant these patients. The SIERRA trial met its primary endpoint of durable complete remission or dCR of 6 months post initial remission after a BMT in Iomab-B arm compared to conventional care arm demonstrating statistical significance p<0.0001.

https://finance.yahoo.com/news/actinium-announces-positive-top-line-100000664.html

China COVID-19 curbs hit iPhone output, shut Shanghai Disney

 China’s COVID-19 curbs forced the closure of Disney’s Shanghai resort on Monday, while production of Apple Inc iPhones at a vast contract manufacturing facility could drop by 30% next month due to coronavirus restrictions, a source told Reuters.

Rising case numbers from numerous outbreaks across China have prompted a tightening of local curbs and lockdowns, including in parts of big cities such as the southern metropolis of Guangzhou, as the economic toll of the country’s zero-COVID policy mounts.

Data released on Monday showed that Chinese factory activity unexpectedly fell in October, dragged down by softening global demand and strict domestic COVID-19 curbs, which hit production, travel and shipping in the world’s second-largest economy.

"With the zero-COVID policy here to stay, we think the economy will continue to struggle heading into 2023," Zichun Huang, economist at Capital Economics, said in a research note.

At this month’s twice-a-decade Communist Party Congress, President Xi Jinping reiterated China’s commitment to its zero-COVID policy, disappointing investors and countless Chinese frustrated by lockdowns, travel curbs and testing.

"We don’t expect the zero-COVID policy to be abandoned until 2024, which means virus disruptions will keep in-person services activity subdued," said Huang from Capital Economics.

DISCONTENT

In the central city of Zhengzhou, a Foxconn plant that makes iPhones and employs about 200,000 people has been rocked by discontent over stringent measures to curb the spread of COVID-19.

A person with direct knowledge of the matter said iPhone production at the plant could drop as much as 30% in November, and that Taiwan-based Foxconn, formally Hon Hai Precision Industry Co Ltd, is working to boost production at a factory in Shenzhen to make up for the shortfall.

In Shanghai, the city’s Disney Resort abruptly suspended operations on Monday to comply with COVID-19 prevention measures, with all visitors at the time of the announcement required to stay in the park until they return a negative test for the virus.

Videos circulating on China’s Twitter-like Weibo, which could not be independently verified, showed people rushing to the park’s gates, which were already locked. Videos of people fleeing malls and office buildings for fear of being locked in have become commonplace on Chinese social media this year.

New cases in mainland China hit 2,898 on Sunday, topping 2,000 for a second straight day, a tiny number by global standards.

In Guangzhou, one of China’s biggest cities and an economic powerhouse, the number of new locally-transmitted cases totalled 1,110 from Oct. 24-30, up from 402 in the previous seven-day period, with the district of Haizhu, home to 1.8 million people, under lockdown.

A Guangzhou resident named Ye said he was in a suburban quarantine hotel after being told on Oct. 27 that he was deemed a close contact by virtue of walking on the same street three days earlier around the same time as someone who tested positive.

"I do not know how they calculated that. Also there is no room for you to query or dispute it. If they say that’s what you are, then that’s final," said Ye, an artist in his 50s.

WIDESPREAD FLARE-UPS

Over the past week, authorities have raced to get a handle on rising cases in cities across China, including Datong, Xining, Nanjing, Xian, Zhengzhou and Wuhan, forcing temporary lockdown measures.

Du Fan, 40, founder of Wuhan Small Animals Protection Association, which won praise from animal lovers during the pandemic’s first lockdown in the central city in early 2020, said his residential compound had been locked down on Saturday.

"My biggest worry at the moment is that if this continues for too much longer, I’m afraid we won’t be able to continue rescuing the animals, because there’s no way to carry out a lot of work," he said.

In the Chinese-controlled territory of Macau, authorities reinstated curbs including locking down a major casino over the weekend after a handful of cases were detected. Macau had been COVID-free for more than three months.

However, in Beijing the Universal Resort theme park reopened on Monday after being shut last week because one visitor had tested positive for coronavirus.

Mudanjiang in Heilongjiang province, bordering North Korea, extended a lockdown of some areas, according to local media. Dandong, Suihua, Ruili – cities bordering North Korea, Russia and Myanmar respectively – are also experiencing outbreaks.

https://www.moneycontrol.com/news/world/china-covid-19-curbs-hit-iphone-output-shut-shanghai-disney-9419151.html