Target to $43 from $33
Tuesday, January 26, 2021
Sanofi, after R&D setback, to produce covid shots for vax rival Pfizer
Following its midstage coronavirus R&D setback, vaccine giant Sanofi is still looking for ways to help in the world’s effort to beat back the pandemic. It’s teaming up with leading vaccine players Pfizer and BioNTech to produce 100 million doses of the rival vaccine—even as Sanofi works to push its own programs through clinical testing.
After Sanofi's weak trial showing in December forced the company to delay its own vaccine development, the French drugmaker approached Pfizer and BioNTech about helping with mRNA shot production, CEO Paul Hudson said in an interview with the Le Figaro newspaper.
A Sanofi spokesman confirmed the manufacturing partnership, saying Sanofi will provide BioNTech “access to our established infrastructure and expertise to produce over 100 million doses of COVID-19 vaccine in Europe in 2021.” The first batches will be delivered from Sanofi’s site in Frankfurt by August, he said.
“While our utmost priority remains to advance our two COVID-19 vaccine programs, we recognize that some companies are facing challenges with their production,” he said. “Therefore, where we have the right manufacturing capabilities, without compromising other essential medicines and vaccines, and where we believe we can make a difference, we are stepping forward to do more for the fight against COVID and show solidarity across the industry.”
The company sees the partnership as “feasible” from a “technological and from a timing perspective,” he added.
The news comes after Sanofi’s December disclosure that lackluster phase 1/2 data had forced the company and its adjuvant partner, GlaxoSmithKline, to delay their COVID-19 vaccine development. With the setback, the company pushed its anticipated launch to late 2021, rather than the middle of 2021 as originally expected.
Now, the partners are gearing up for a phase 2b study set to begin next month; investigators anticipate including a comparison against an existing authorized vaccine in the trial, according to Sanofi’s website. Earlier in the pandemic, the company teamed up with GSK to utilize that vaccine rival's adjuvant technology.
Aside from Sanofi’s GSK-partnered vaccine, the company has an mRNA vaccine in the pipeline through its partnership with Translate Bio. That vaccine has shown early promise in preclinical trials.
The Sanofi tie-up comes as mRNA partners Pfizer and BioNTech work to scale up production to 2 billion global doses in 2021. Amid that push, the companies temporarily reduced shipments to Europe this month, causing some countries to push back at the move. Meanwhile, AstraZeneca has suffered a manufacturing issue that will force it to reduce first-quarter deliveries to Europe.
Brazil's Bolsonaro OKs private sector buying COVID-19 shots, AstraZeneca balks
Brazil’s President Jair Bolsonaro on Tuesday said he has approved a group of private sector companies to buy 33 million vaccine doses from AstraZeneca Plc, something the British drugmaker firm said cannot happen “at this moment.”
Speaking at a virtual event hosted by Swiss investment bank Credit Suisse, Bolsonaro said half of the shots would be for employees of the companies buying them, and the other half would go to the government’s national immunization program.
Newspaper Folha de S. Paulo reported that the proposal came from a group of business leaders on a conference call on Monday to discuss which firms and organizations would participate.
“I want to make it very clear that the federal government is in favor of this group ... bringing the vaccine here to immunize 33 million people, at zero cost for the federal government,” Bolsonaro said.
AstraZeneca, however, said in a statement on Tuesday that all of its vaccine supply “at this moment” is only available to governments and multilateral organizations around the world. “It is not possible to make vaccines available to the private sector,” it said.
Several companies denied reports that they had joined the initiative, including hospital group DASA SA, which said in a statement it is seeking to understand the commercial availability of vaccines through its suppliers.
Brazil’s nationwide vaccination process got underway just over a week ago but has been slow and patchy thus far, with shipments of doses from India and China subject to delay.
Bolsonaro said the business group made its proposal to the government last week. One of Bolsonaro’s conditions in return for his support is that private sector employees are not obliged by their companies to take the vaccine.
Bolsonaro, who has played down the severity of COVID-19, has insisted he will not take a vaccine.
Meanwhile, Brazilian biomedical center Butantan expects supplies for around 8.5 million doses of China’s CoronaVac vaccine made by Sinovac Biotech to arrive by Feb. 3, its director said on Tuesday.
Butantan Director Dimas Covas said he hopes the initial shipment of about 5,400 liters of active ingredients, enough to fill and finish some 8.5 million doses, would be followed by a similar load shortly after.
He also said Butantan plans to have a factory fully producing the Chinese vaccine by early next year.
Growing share of lung cancer cases turning up in unexpected population
Breast cancer wouldn’t have surprised her; being among the 1 in 8 women who develop it over their lifetime isn’t statistically improbable. Neither would have colorectal cancer; knowing the risk, Mandi Pike “definitely” planned to have colonoscopies as she grew older.
But when a PET scan in November 2019 revealed that Pike, a 33-year-old oil trader, wife, and mother of two in Edmond, Okla., had lung cancer — she had been coughing and was initially misdiagnosed with pneumonia — her first reaction was, “but I never smoked,” she said. “It all seemed so surreal.”
Join the club. Cigarette smoking is still the single greatest cause of lung cancer, which is why screening recommendations apply only to current and former smokers and why 84% of U.S. women and 90% of U.S. men with a new diagnosis of lung cancer have ever smoked, according to a study published in December in JAMA Oncology. Still, 12% of U.S. lung cancer patients are never-smokers.
Scientists disagree on whether the absolute number of such patients is increasing, but the proportion who are never-smokers clearly is. Doctors and public health experts have been slow to recognize this trend, however, and now there is growing pressure to understand how never-smokers’ disease differs from that of smokers, and to review whether screening guidelines need revision.
“Since the early 2000s, we have seen what I think is truly an epidemiological shift in lung cancer,” said surgeon Andrew Kaufman of Mount Sinai Hospital in New York, whose program for never-smokers has treated some 3,800 patients in 10 years. “If lung cancer in never-smokers were a separate entity, it would be in the top 10 cancers in the U.S.” for both incidence and mortality.
A 2017 study of 12,103 lung cancer patients in three representative U.S. hospitals found that never-smokers were 8% of the total from 1990 to 1995 but 14.9% from 2011 to 2013. The authors ruled out statistical anomalies and concluded that “the actual incidence of lung cancer in never smokers is increasing.” Another study that same year, of 2,170 patients in the U.K., found an even larger increase: The proportion of lung cancer patients who were never-smokers rose from 13% in 2008 to 28% in 2014.
“It is well-documented that approximately 20% of lung cancer cases that occur in women in the U.S. and 9% of cases in men, are diagnosed in never-smokers,” Kaufman said.
To a great extent, this is a function of straightforward math, said epidemiologist Ahmedin Jemal of the American Cancer Society. Fewer people smoke today than in previous decades — 15% in 2015, 25% in 1995, 30% in 1985, 42% in 1965. Simply because there are fewer smokers in the population, out of every 100 lung cancer patients, fewer will therefore be smokers. And that means more of them will be never-smokers.
There are also hints that the absolute incidence of lung cancer in never-smokers has been rising, said oncologist John Heymach of MD Anderson Cancer Center. Some data say it has, but other data say no. The stumbling block is that old datasets often don’t indicate a lung cancer patient’s smoking status, Heymach said, making it impossible to calculate what percent of never-smokers in past decades developed lung cancer.
Jemal, however, cautions that it is not the case that a never-smoker has a greater chance of developing lung cancer today than never-smokers did in the past.
Current cancer screening guidelines recommend a CT scan for anyone 50 to 80 years old who has smoked at least 20 pack years (the equivalent of one pack a day for 20 years, or two packs a day for 10 years, and so on) and who is still smoking or quit less than 15 years ago. Screening is not recommended for never-smokers because the costs of doing so are deemed greater than the benefits, Jemal said; thousands of never-smokers would have to be screened in any given year to find one lung cancer.
Still, low-dose CT can catch lung cancer in a significant number of never-smokers. A 2019 study in South Korea diagnosed lung cancer in 0.45% of never-smokers, compared to 0.86% of smokers. The researchers urged policymakers to “consider the value of using low-dose CT screening in the never-smoker population.”
“It used to be that the high-risk group” for whom CT screening is recommended “was the vast majority of lung cancer patients,” Heymach said. “But now that so many lung cancer cases are in nonsmokers, there is absolutely a need to reevaluate the screening criteria.”
Researchers are trying to improve screening by reducing the incidence of false positives — when CT finds lung nodules “or an old scar that you got 20 years ago,” he said. Those don’t pose a threat but have to be biopsied to ascertain that. Screening never-smokers would also be more efficient than it is today “if we could identify who, among nonsmokers, are at higher risk,” he said.
Cancer doctors already know part of the answer: women. Worldwide, 15% of male lung cancer patients are never-smokers. But fully half of female lung cancer patients never smoked. And women never-smokers are twice as likely to develop lung cancer as men who never put a cigarette to their lips.
Beyond sex, “nothing stands out as a single large risk factor that, if we only got rid of it, we would solve the problem” of lung cancer in never-smokers, said Josephine Feliciano, an oncologist at Johns Hopkins University School of Medicine. “But air pollution, radon, family history of lung cancer, [and] genetic predispositions” all play a role. Chronic lung infections and lung diseases such as chronic obstructive pulmonary disorder (COPD) also seem to increase risk.
None of those, with the possible exception of genetics and indoor pollution (cooking fires in some low-income countries), affect women more than men. So what’s going on?
At least one biotech believes that biological differences between lung cancer in never-smokers and smokers merits a new drug, and one that might be especially effective in women. “A different disease needs a different drug,” said co-founder and CEO Panna Sharma of Lantern Pharma. In fact Lantern, which is developing a drug for lung cancer in female never-smokers, believes that disease is so different it recently tried to convince the U.S. Food and Drug Administration to designate it an orphan disease, said Sharma.
Called LP-300, the Lantern drug increased overall survival from 13 months to more than 27, compared to chemotherapy alone, in female nonsmokers, in a small trial. It “targets molecular pathways that are more common in female nonsmokers than in any other group,” said Sharma, targeting the mutations EGFR, ALK, MET, and ROS1 (common in never-smokers) directly and boosting the efficacy of other drugs that attack them, such as erlotinib and crizotinib. Lantern plans a larger trial this year.
Smokers’ tumors tend to have more mutations overall, thanks to mutagen-packed cigarette smoke attacking their lungs, but scientists have developed more drugs for never-smokers’ lung tumors than for smokers’. For instance, EGFR and ALK mutations are more common in never-smokers. (Mandi Pike had the EGFR mutation, which was relatively fortunate: A drug targets it, and she has been cancer-free since November.)
The targeted drugs bollix up each mutation’s cancer-causing effects. KRAS mutations are more common in smokers’ lung tumors, and there are no KRAS drugs. (A KRAS drug for lung cancer is imminent, though, said thoracic oncologist Ben Creelan of Moffitt Cancer Center in Tampa, Fla.)
According to national guidelines, lung cancer in never-smokers should be treated the same as in smokers, said Creelan. “But I think we should reconsider this,” he said.
Because never-smokers have fewer tumor mutations, it’s harder to find them. So he said clinicians should be more aggressive about looking for actionable mutations in these patients. “I keep looking for a mutation until I find something important,” he said, adding that doctors might need better biopsy material or to use a different sequencing method in never-smokers.
In a cruel twist, the breakthrough drugs that take the brakes off immune cells, which then attack the tumor, are less effective in never-smokers’ lung cancer than in smokers’. The reason seems to be that smokers’ tumors have more mutations, said Mount Sinai’s Kaufman; the mutations often cause the tumor cells to have molecules on their surface that the immune system perceives as foreign and revs up to attack. Never-smokers’ tumors have few, if any, of those “come and get me” molecules. Immune cells therefore ignore them.
“In smokers, conversely, with more mutations, there is more for the immune system to recognize as bizarre and foreign, and so to provoke” an attack, Creelan said.
In contrast, never-smokers’ tumors are more likely to respond to targeted drugs, and as a result to be in remission for a long time or even cured. That’s because with fewer mutations, never-smokers’ tumors are more likely to have an “oncogene addiction,” Heymach explained: They are propelled by only one mutation. The plethora of mutations in smokers’ tumors means that there is usually a back-up cancer driver if a targeted drug eliminates cells with only one. “When a tumor has more and more mutations, blocking one is less likely to have an impact,” Heymach said. “But in nonsmokers, it can.”
Heymach called for more funding to study lung cancer in never-smokers. It “is an area that’s underserved and deserves more investment,” Heymach said. “It should be commensurate with the public health threat it represents.”
https://www.statnews.com/2021/01/26/growing-share-of-lung-cancer-turning-up-in-never-smokers/
Covid pandemic' has pushed lung cancer services back 20 years'
Governments must act to restore the damage done to lung cancer services during the pandemic in order to reduce further avoidable deaths, according to a report drawn up as part of this week’s World Economic Forum in Davos.
The report, Learning Lessons from Across Europe – Prioritising Lung Cancer after COVID-19, highlights how lung cancer progress in diagnosis has been pushed back, with further impact on treatment likely, the longer the pandemic continues.
The document has been developed by the Davos World Economic Forum (WEF) and the Lung Ambition Alliance, in collaboration with AstraZeneca.
According to the report, over 40% of countries surveyed said there has been a complete or partial disruption to lung cancer services due to the pandemic.
Leading experts in health care provision, patient representation, policy and industry from across Europe – France, Germany, Italy, Spain, the United Kingdom – met regularly to discuss the current global healthcare environment and plan for the future in improving the resilience of lung cancer services.
In the UK, referrals to a lung cancer specialist fell by 75% in some areas and in Spain the number of new cancer patients fell by 21% during the first wave of the pandemic compared with the previous year, the report found.
David Baldwin, chair of the UK Clinical Expert Group for Lung Cancer and Mesothelioma and member of the report’s task force, said: “We clinicians are seeing similar late presentations of lung cancer to those that were the norm 20 years ago.
“With disruptions at an unprecedented level, lung cancer patients simply can’t afford to have the clock wound back to where things were.”
Authors made a series of recommendations to restore services in the short and medium term.
The most immediate concerns are ensuring the public has the information to allow people to spot the differences between COVID-19 and lung cancer, and which services to access.
Patients need reassurance that lung cancer services are safe and there needs to be investment in COVID-19 free clinical spaces, backed with communication about how services are kept safe.
There needs to be more public health information campaigns about lung cancer to raise awareness of the signs and symptoms.
In the longer term there needs to be more investment in screening and diagnosis, with authors noting that there is a need for better data at national and local level to assess the impact of COVID-19 on lung cancer services.
Further investment is needed in primary care to ensure patients with suspected lung cancer can be swiftly referred to specialist care, they added.
Arnaud Bernaert, Head of Health and Healthcare at the World Economic Forum said: “Producing and rolling out a COVID-19 vaccine within one year required public-private cooperation on a global scale – it showed what we can do together.
“This report highlights policy priorities that can be put into place so cancer patients can access the care they need.
“The pandemic has strained our health and health systems, but there are lessons that can be applied in parallel with treating COVID-19. We hope that the public and private sectors can work together in the year ahead.”
Evotec shares rise amid speculation Melvin Capital closing short positions
* Evotec, Varta, CD Projekt shares rise sharply
* Traders speculate Melvin Capital unwinding shorts (Recasts, adds details)
Evotec rose sharply on Tuesday amid market speculation that Melvin Capital Management was unwinding its positions in the German drugmaker after some of its investments turned sour.
Evotec’s shares jumped 10% at one point on Tuesday with three traders saying the move was likely linked to Melvin Capital closing out its shorts following losses on GameStop and other investments.
Battery maker Varta surged for a similar reason, a German-based trader said, while shares in Polish videogame firm CD Projekt also saw strong demand. Over the last two sessions Varta and CD Projekt shares have both risen nearly 20%.
Melvin Capital, founded in 2014 by Gabriel Plotkin, said it does not comment on positions and trading.
Regulatory filings in Germany and Poland show that Melvin currently holds a short position of 6.2% in Evotec, of 4.35% in Varta and of 1.05% in CD Projekt.
As of last Friday, nearly 70% of Evotec’s shares available to borrow were already out on loan, data from FIS Astec Analytics showed. Shares worth almost $660 million were out on loan -- or nearly 13% of the company’s market capitalisation.
Melvin said on Monday it would receive a $2.75 billion investment from Citadel, the Chicago-based hedge fund led by Ken Griffin, and billionaire investor Steven A. Cohen’s Point72 Asset Management.
The infusion is expected to help stabilise the hedge fund.
PharmaMar: Paper in journal Science confirms drug's efficacy
Spanish pharmaceutical company PharmaMar said on Tuesday that peer review journal Science has published a paper that confirms its drug Plitidepsin has a “potent preclinical efficacy” against COVID-19.
A study carried out in vitro and in vivo by a team of scientists in New York, San Francisco and Paris showed the drug leads to a reduction of viral replication, resulting in a 99% reduction of viral loads in the lungs of Plitidepsin-treated animals, the Science paper reported, according to a PharmaMar statement.
“We believe that our data and the initial positive results from PharmaMar’s clinical trial suggests that Plitidepsin should be strongly considered for expanded clinical trials for the treatment of COVID-19,” PharmaMar quoted Science as saying.
The drug, already authorised in some markets to treat tumours, blocks a protein associated with the COVID-19 virus. Toxicity of the drug is well known and the doses used in COVID-19 trials are well tolerated in humans, the company said.
PharmaMar said it was in talks with various regulatory agencies to start Phase III trials.
Subscribe to:
Posts (Atom)