Clover Biopharmaceuticals,
a global clinical-stage biotechnology company focused on developing
novel and transformative biologic therapies, announced today that it has
successfully produced its trimeric Spike-protein (“S-Trimer”) subunit
vaccine candidate for 2019-nCoV via a mammalian cell expression system.
In addition, Clover scientists have used the newly obtained S-Trimer and
successfully detected antigen-specific antibody in sera from multiple
fully recovered patients who were previously infected by the virus.
Importantly, Clover is the first company in the world to disclose a
2019-nCoV vaccine candidate that can successfully be recognized by
antibodies produced by previously-infected patients, supporting that
S-Trimer has preserved the native structure of the viral spike (S)
protein and thus may elicit a protective-immune response as a vaccine.
This work was carried out with the support of leadership teams from
Chengdu Hi-Tech Park and Chengdu Clinical Center for Public Health in
China.
Similar to other enveloped RNA viruses such as HIV, RSV and
Influenza, 2019-nCoV is also an RNA virus that has a trimeric spike (S)
protein on its viral envelope. The trimeric S protein of 2019-nCoV is
responsible for binding to host cell surface receptor ACE2 and
subsequent viral entry. Symptoms in infected patients include fever,
coughing and breathing difficulties, and it can be fatal.
Upon knowing the genomic DNA sequence of this newly identified
2019-nCoV last month, Clover scientists immediately started designing
the viral S-protein construct and completed its gene synthesis.
Utilizing our patented Trimer-Tag© technology, Clover has
produced a S-Trimer subunit vaccine that resembles the native trimeric
viral spike via a rapid mammalian cell-culture based expression system.
Having one of the largest in-house, commercial-scale cGMP
biomanufacturing capabilities in China, Clover could potentially be able
to rapidly scale-up and produce large-quantities of a new coronavirus
vaccine.
Clover has previously developed recombinant subunit-Trimer vaccines for RSV and Influenza viruses utilizing its Trimer-Tag©
technology and has demonstrated that they are able to evoke protective
neutralizing antibody responses in multiple animal models.
https://www.biospace.com/article/releases/clover-successfully-produced-2019-ncov-subunit-vaccine-candidate-and-detected-cross-reacting-antibodies-from-sera-of-multiple-infected-patients/
Monday, February 10, 2020
Inovio OKd on Phase 1/2 Trial for DNA Medicine for Rare Disease
- Respiratory Papillomatosis (RRP) is a rare, potentially fatal orphan disease caused by Human Papillomavirus (HPV) 6 and 11
- Inovio’s DNA medicine pipeline includes 15 clinical programs focused on HPV-associated diseases, cancer, and infectious diseases, including the novel coronavirus (2019-nCoV)
The open-label, multicenter Phase 1/2 trial will enroll approximately 63 subjects in the U.S. and will evaluate the efficacy, safety, tolerability, and immunogenicity of INO-3107 in subjects with HPV 6 and/or 11-associated RRP who have required at least two surgical interventions per year for the past three years for the removal of associated papilloma(s). For this study, adult subjects will first undergo surgical removal of their papilloma(s) and then receive four doses of INO-3107, one every three weeks. The primary efficacy endpoint will be a doubling or more in the time between surgical interventions following the first dose of INO-3107 relative to the frequency prior to study therapy. Upon obtaining sufficient safety and potential efficacy data in adults, Inovio plans to expand the trial to include pediatric patients as well as a potential booster regimen.
“Inovio’s investigational DNA medicine INO-3107 is designed to destroy and clear tumors caused by HPV 6 and 11 infections from the body exactly where they are hiding,” said Jeffrey Skolnik, M.D., Inovio’s Vice President of Clinical Development. “We believe this DNA medicine has the potential to provide people living with RRP a long-term, if not life-long, improvement in their disease, especially as an alternative to often successive and debilitating surgeries that may temporarily remove HPV growths from the airways but do not address the underlying recurring virus.”
https://www.biospace.com/article/releases/inovio-receives-authorization-from-the-u-s-fda-to-begin-phase-1-2-clinical-trial-for-ino-3107-a-dna-medicine-to-treat-a-rare-disease-recurrent-respiratory-papillomatosis-rrp-/
Nissan to halt production at Japan factory due to coronavirus
Nissan Motor Co (7201.T)
will temporarily halt production at its plant in Kyushu, southwestern
Japan, due to the coronavirus, the Japanese automaker said on Monday, as
the outbreak starts to strain the global supply chain.
In a statement, Nissan, the first automaker to halt production at a plant in Japan because of the outbreak, said that output would be affected on Friday and Feb. 17, due to supply shortages of parts from China.
The stoppage could impact production of around 3,000 vehicles, the Nikkei newspaper reported said, underlining the extent to which manufacturers in the world’s third-largest economy are reliant on China for supplies.
Nissan’s Kyushu plant produces models including the Serena minivan
for the Japanese market and the Rogue SUV crossover, Nissan’s
top-selling car in the United States. It has an annual capacity of
530,000 vehicles.
Two production lines at the Kyushu plant would be halted on Feb. 14, the Nikkei said, adding that another line which mainly cars for export, would be stopped on Feb.17.
Nissan said it was preparing to restart production in China at the earliest from Feb. 17 at its plants in Huadu, Guangdong Province and Dalian, Liaoning Province, while restart dates for other plants had yet to be confirmed.
The coronavirus outbreak – declared a global health emergency by the
World Health Organization – has disrupted Chinese manufacturing and that
is having an effect on plants abroad.
In South Korea, Hyundai Motor (005380.KS), Kia Motors (000270.KS) and Renault subsidiary RSM have all announced closures citing disruption to supply of parts from China.
https://www.reuters.com/article/us-china-health-nissan/nissan-to-halt-production-at-japan-factory-due-to-coronavirus-idUSKBN20419A
In a statement, Nissan, the first automaker to halt production at a plant in Japan because of the outbreak, said that output would be affected on Friday and Feb. 17, due to supply shortages of parts from China.
The stoppage could impact production of around 3,000 vehicles, the Nikkei newspaper reported said, underlining the extent to which manufacturers in the world’s third-largest economy are reliant on China for supplies.
Two production lines at the Kyushu plant would be halted on Feb. 14, the Nikkei said, adding that another line which mainly cars for export, would be stopped on Feb.17.
Nissan said it was preparing to restart production in China at the earliest from Feb. 17 at its plants in Huadu, Guangdong Province and Dalian, Liaoning Province, while restart dates for other plants had yet to be confirmed.
In South Korea, Hyundai Motor (005380.KS), Kia Motors (000270.KS) and Renault subsidiary RSM have all announced closures citing disruption to supply of parts from China.
https://www.reuters.com/article/us-china-health-nissan/nissan-to-halt-production-at-japan-factory-due-to-coronavirus-idUSKBN20419A
Apple iPhone maker Foxconn restarts key China plant with 10% of workers
Apple’s biggest iPhone maker Foxconn got approval to resume production at a key plant in China after being forced to shut it following the coronavirus outbreak, but only 10% of the factory’s workforce has managed to return so far, a source told Reuters.
Taiwan’s Foxconn, the world’s largest contract electronics maker, got
the green light to restart production in the eastern central Chinese
city of Zhengzhou, said the person with direct knowledge of the matter.
The company, however, has not yet been allowed to restart production in
Shenzhen, a southern manufacturing hub, the source said.
The two factories together make up the bulk of Foxconn’s assembly lines for Apple’s iPhones, and the delays are likely to impact global shipments.
Market research firm Trendforce on Monday cut its March-quarter forecast for iPhone production by about 10% to 41 million handsets.
Apple itself gave a wider-than-usual revenue outlook range for the March quarter last month to factor in uncertainty due to the virus that has claimed more than 900 lives and infected over 40,000 people.
An Apple spokeswoman in Shanghai was not immediately available for comment.
Apple rival and China’s biggest smartphone maker, Huawei, said last week it had resumed production of consumer devices and carrier equipment, and operations were running normally.
About 16,000 people, or under 10% of Foxconn’s workforce in Zhengzhou have returned to the plant, the source said, adding that company executives were trying very hard to negotiate with authorities to resume production in other parts of China, including Kunshan, in southeastern Jiangsu province.
“Our request to resume production (in Shenzhen) was disapproved. We need to improve our virus control measures for another check,” said the person who declined to be identified because they are not authorised to speak publicly on the matter.
Shenzhen authorities will conduct checks at the plant again later this week, the person said.
Employees in Shenzhen were told not to return to work on Tuesday, according to an internal memo seen by Reuters.
The coronavirus outbreak – declared a global health emergency by the World Health Organization – has disrupted Chinese manufacturing and forced companies such as Hyundai Motor to halt production of cars in some factories.
Some companies including Samsung Electronics limped back to work on Monday but hundreds of factories and stores remain shut across China.
Foxconn, formally Hon Hai Precision Industry Co Ltd, said in a statement that employee safety was top priority and that it was working with authorities to meet requirements to resume production across China “in a staggered and orderly manner”.
Foxconn employees who returned to work on Monday following an extended Lunar New Year holiday have been told to wear masks, undergo temperature checks and adhere to a specified dining system, according to internal memos seen by Reuters.
Most senior Taiwanese officials have been told to refrain from returning to China and those who needed to do so required approval from Chairman Liu Young-Way, the person said.
Foxconn, which makes devices for global electronics firms, has built its own production lines in the southern province of Guangdong to make masks for its hundreds of thousands of employees, targeting two million masks a day by late February, the memos showed.
The company reported an 11.96% drop in its January revenue from a year ago to T$364.6 billion ($12.12 billion), according to a Foxconn filing to the Taiwan stock exchange. It did not give further details.
Foxconn shares fell as much as 2.4% in Monday trade, lagging a 0.3% decline in the broader market. They have fallen more than 11% since the market reopened following the Lunar New Year break.
https://www.marketscreener.com/FIH-MOBILE-LIMITED-1412618/news/Top-Apple-iPhone-maker-Foxconn-restarts-key-China-plant-with-10-of-workers-29968042/?countview=0
The two factories together make up the bulk of Foxconn’s assembly lines for Apple’s iPhones, and the delays are likely to impact global shipments.
Market research firm Trendforce on Monday cut its March-quarter forecast for iPhone production by about 10% to 41 million handsets.
Apple itself gave a wider-than-usual revenue outlook range for the March quarter last month to factor in uncertainty due to the virus that has claimed more than 900 lives and infected over 40,000 people.
An Apple spokeswoman in Shanghai was not immediately available for comment.
Apple rival and China’s biggest smartphone maker, Huawei, said last week it had resumed production of consumer devices and carrier equipment, and operations were running normally.
About 16,000 people, or under 10% of Foxconn’s workforce in Zhengzhou have returned to the plant, the source said, adding that company executives were trying very hard to negotiate with authorities to resume production in other parts of China, including Kunshan, in southeastern Jiangsu province.
“Our request to resume production (in Shenzhen) was disapproved. We need to improve our virus control measures for another check,” said the person who declined to be identified because they are not authorised to speak publicly on the matter.
Shenzhen authorities will conduct checks at the plant again later this week, the person said.
Employees in Shenzhen were told not to return to work on Tuesday, according to an internal memo seen by Reuters.
The coronavirus outbreak – declared a global health emergency by the World Health Organization – has disrupted Chinese manufacturing and forced companies such as Hyundai Motor to halt production of cars in some factories.
Some companies including Samsung Electronics limped back to work on Monday but hundreds of factories and stores remain shut across China.
Foxconn, formally Hon Hai Precision Industry Co Ltd, said in a statement that employee safety was top priority and that it was working with authorities to meet requirements to resume production across China “in a staggered and orderly manner”.
Foxconn employees who returned to work on Monday following an extended Lunar New Year holiday have been told to wear masks, undergo temperature checks and adhere to a specified dining system, according to internal memos seen by Reuters.
Most senior Taiwanese officials have been told to refrain from returning to China and those who needed to do so required approval from Chairman Liu Young-Way, the person said.
Foxconn, which makes devices for global electronics firms, has built its own production lines in the southern province of Guangdong to make masks for its hundreds of thousands of employees, targeting two million masks a day by late February, the memos showed.
The company reported an 11.96% drop in its January revenue from a year ago to T$364.6 billion ($12.12 billion), according to a Foxconn filing to the Taiwan stock exchange. It did not give further details.
Foxconn shares fell as much as 2.4% in Monday trade, lagging a 0.3% decline in the broader market. They have fallen more than 11% since the market reopened following the Lunar New Year break.
Biohaven down 17% premarket on failed troriluzole study
Biohaven Pharmaceutical Holding Company (NYSE:BHVN) announces that a Phase 3 clinical trial
evaluating troriluzole as monotherapy in patients with generalized
anxiety disorder (GAD) failed to sufficiently separate from placebo on
the primary endpoint of total HAM-A score at week 8.
The company will terminate development for
monotherapy use in GAD. Several studies in other diseases and with
different dosing approaches are in process.
The company says troriluzole is a third-generation
prodrug that modulates an excitatory neurotransmitter called glutamate
by reducing its levels at nerve synapses.
Shares down 17% premarket on average volume.
https://seekingalpha.com/news/3539972-biohaven-down-17-premarket-on-failed-troriluzole-studyFDA accepts Aquestive’s Libervant NDA; shares up 6% premarket
The FDA accepts for review Aquestive Therapeutics’ (NASDAQ:AQST) marketing application seeking approval of Libervant (diazepam) Buccal Film for the management of seizure clusters.
The agency’s action date is September 27.
Shares up 6% premarket on modest volume.
https://seekingalpha.com/news/3539984-fda-accepts-aquestives-libervant-nda-shares-up-6-premarketAnalyst action, Feb. 10
Abeona Therapeutics (NASDAQ:ABEO) initiated with Outperform rating and $6 (139% upside) price target at SVB Leerink. Shares up 8% premarket.
Akero Therapeutics (NASDAQ:AKRO) initiated with Buy rating and $36 (38% upside) price target at Canaccord Genuity.
Ardelyx (NASDAQ:ARDX) initiated with Outperform rating at Cowen and Company.
Well Health Technologies (WELL CN) initiated with
Hold rating and C$1.80 (5% downside risk) price target at Canaccord.
U.S. ticker: (OTCPK:WLYYF).
Adverum Biotechnologies (NASDAQ:ADVM) upgraded to Overweight with a $21 (105% upside) price target at Cantor Fitzgerald. Shares up 20% premarket on positive gene therapy data.
https://seekingalpha.com/news/3539998-cantor-upgrades-adverum-on-positive-advmminus-022-data
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