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China Launches First Human Trials For ‘Nasal Spray’ COVID-19 Vaccine

China Launches First Human Trials For ‘Nasal Spray’ COVID-19 Vaccine

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China Launches First Human Trials For 'Nasal Spray' COVID-19 Vaccine Tyler Durden Fri, 09/11/2020 - 20:40

Markets were already heading lower earlier this month when AstraZeneca announced that the vaccine it had been developing in partnership with Oxford University had hit an unexpected snag: a patient showed an unexpected "adverse reaction" resembling a form of meningitis. Suddenly, all the skeptics' warnings about a vaccine not being available for months, perhaps even years, are ringing in professionals' heads again.

But in China, regulators within the CCP have allowed vaccine maker Beijing Wantai Biological Pharmacy to launch "Phase 1" human trials of a nasal spray vaccine, which is being co-developed by researchers at Xiamen University and Hong Kong University.

Intranasal spray has previously been developed as a vaccine for the flu and is recommended for use among children and adults who want to avoid the more common needle injection. While it is not the most frequent choice for delivery, scientists around the world are working to develop sprays as an alternative to muscle jabs for all sorts of vaccines.

It's China's tenth vaccine candidate to proceed to human testing, though Beijing has much more sway to "relax" certain standards than the FDA, as the world recently learned. And with the AZ-Oxford vaccine now on hold, Beijing now has a chance to close the gap.

The new spray contains weakened copies of the virus implanted with the genetic segments of the coronavirus’s spike protein that will allow it to take hold inside the patient's nasal passage.

Once administered, the vaccine mimics the natural infection of respiratory viruses to stimulate the body’s immune response against the pathogen that causes COVID-19, according to Science and Technology Daily, a paper affiliated with China’s Ministry of Science and Technology.

Some scientists hope a vaccine that gets sprayed through the nose may have a better chance of stopping the spread of the virus because, as we continue to learn, the virus appears to primarily spread through the air via aerosol infection.

Intranasal spray has previously been developed as a vaccine for the flu and is recommended for use among children and adults who want to avoid the more common needle injection. While it is not the most frequent choice for delivery, scientists around the world are working to develop sprays.

China's new nasal spray vax project joins about 35 other candidates currently in human testing, as the global race to be first with an effective vaccine intensifies, with the candidate from Russia so far holding its own alongside a battery of projects developed in the West. In the wake of AstraZeneca’s setback, China’s most advanced vaccine developers, including CanSino Biologics Inc. and state-owned China National Biotec Group Co., have emphasized the safety of their own shots.

CNBG said the two shots it is testing are effective in staving off infection. None of the Chinese diplomats and workers traveling to virus hot spots overseas has reported infections several months after receiving the vaccines, Zhou Song, CNBG’s general counsel, said.

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Acta Pharmaceutica Sinica B Volume 11, Issue 9 publishes

Acta Pharmaceutica Sinica B publishes a special column on ‘Novel Peptides and Peptidomimetics in Drug Discovery’ edited by Jianfeng Cai and Lulu Wei from the Department of Chemistry, University of South Florida, Tampa, FL, USA. Topics include current…

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Acta Pharmaceutica Sinica B publishes a special column on ‘Novel Peptides and Peptidomimetics in Drug Discovery’ edited by Jianfeng Cai and Lulu Wei from the Department of Chemistry, University of South Florida, Tampa, FL, USA. Topics include current research accomplishments and current challenges in the field of peptidomimetics.

Credit: APSB

Acta Pharmaceutica Sinica B publishes a special column on ‘Novel Peptides and Peptidomimetics in Drug Discovery’ edited by Jianfeng Cai and Lulu Wei from the Department of Chemistry, University of South Florida, Tampa, FL, USA. Topics include current research accomplishments and current challenges in the field of peptidomimetics.

In 2021 Acta Pharmaceutica Sinica B (APSB) is celebrating its 10th anniversary. The journal was founded with the goal of creating a global high-level forum centred around drug discovery and pharmaceutical research/application. APSB was included by Chemical Abstracts in 2011, accepted by PubMed Central in 2015, indexed by Science Citation Index in 2017 and has evolved to become one of the most important international journals in the field of pharmaceutical sciences.

APSB is a monthly journal, in English, which publishes significant original research articles, rapid communications and high quality reviews of recent advances in all areas of pharmaceutical sciences — including pharmacology, pharmaceutics, medicinal chemistry, natural products, pharmacognosy, pharmaceutical analysis and pharmacokinetics.

Featured papers in this special column are:

 

Peptidomimetic-based antibody surrogate for HER2 by Mengmeng Zheng, Chunpu Lia, Mi Zhou, et al. (https://doi.org/10.1016/j.apsb.2021.04.016). Inhibition of human epidermal growth factor receptor 2 mediated cell signaling pathway is an important therapeutic strategy for HER2-positive cancers. Although monoclonal antibodies are currently used as marketed drugs, their large molecular weight, high cost of production and susceptibility to proteolysis could be a hurdle for long-term application. In this study, we reported a strategy for the development of artificial antibody based on γ-AApeptides to target HER2 extracellular domain (ECD).

 

Design of ultrahigh-affinity and dual-specificity peptide antagonists of MDM2 and MDMX for P53 activation and tumor suppression by authors Chenglong Gao, Yazhou Xu, Zhuangzhuang Liang et al. (https://doi.org/10.1016/j.apsb.2021.06.010). LFHP-1c directly binding to PGAM5 inhibits PGAM5 enzyme activity and impairs PGAM5 interaction with NRF2, promoting NRF2 transcription activity to protect against blood–brain barrier disruption and ischemic brain injury.

Regular articles of interest in this issue:

 

Repurposing carrimycin as an antiviral agent against human coronaviruses, including the currently pandemic SARS-CoV-2 by Xiang Lia, Neelakshi Gohain, Si Chen et al. (https://doi.org/10.1016/j.apsb.2021.02.024). CFDA-approved drug carrimycin is repurposed as an antiviral agent against human coronaviruses, including the currently pandemic SARS-CoV-2, through inhibition of post-entry replication events of human coronavirus infection.

Design, synthesis, and biological evaluation of multiple targeting antimalarials by authors Yiqing Yang, TongkeTang, Xiaolu Li et al. (https://doi.org/10.1016/j.apsb.2021.05.008). A highly potent antimalarial compound, RYL-581, has a potential multi-targeting mechanism of action by simultaneously binding to three pockets (allosteric site of PfNDH2, Qo and Qi sites of Pfbc1).

 

Other articles published in the issue include:

 

Special Column “Novel Peptides and Peptidomimetics in Drug Discovery”

Editorial

Novel Peptides and Peptidomimetics in Drug Discovery

 

Review

Membrane-disruptive peptides/peptidomimetics-based therapeutics: Promising systems to combat bacteria and cancer in the drug-resistant era

Liming Lin, Jiaying Chi, Yilang Yan, Rui Luo et al.

 

Original Articles

Apoptosis-inducing activity of synthetic hydrocarbon-stapled peptides in H358 cancer cells expressing KRASG12C

Cuicui Li, Ni Zhao, Luyan An, Zhen Dai et al.

 

A novel ω-conotoxin Bu8 inhibiting N-type voltage-gated calcium channels displays potent analgesic activity

Jinqin Chen, Xinhong Liu, Shuo Yu, Jia Liu et al.

 

An optimized derivative of an endogenous CXCR4 antagonist prevents atopic dermatitis and airway inflammation

Mirja Harms, Monica M.W. Habib, Simona Nemska, Antonella Nicolò et al.

 

Discovery of a potent and dual-selective bisubstrate inhibitor for protein arginine methyltransferase 4/5

Ayad A. Al-Hamashi, Dongxing Chen, Youchao Deng, Guangping Dong, Rong Huang

 

Short communication

Facile synthesis of insulin fusion derivatives through sortase A ligation

Maria M. Disotuar, Jake A. Smith, Jinze Li, Steve Alam et al.

 

Regular Content

Reviews

Integrins as attractive targets for cancer therapeutics

Meng Li, Ying Wang, Mengwei Li, Xuezhen Wu et al.

 

Cyclin-dependent kinases-based synthetic lethality: Evidence, concept, and strategy

Kailin Li, Jieqiong You, Qian Wu, Wen Meng et al.

 

Clinical efficacies, underlying mechanisms and molecular targets of Chinese medicines for diabetic nephropathy treatment and management

Guoyi Tang, Sha Li, Cheng Zhang, Haiyong Chen et al.

 

Gasdermin D in pyroptosis

Brandon E. Burdette, Ashley N. Esparza, Hua Zhu, Shanzhi Wang

 

The biology, function, and applications of exosomes in cancer

Jinyi Liu, Liwen Ren, Sha Li, Wan Li et al.

 

Receptor-mediated targeted drug delivery systems for treatment of inflammatory bowel disease: Opportunities and emerging strategies

Peng Liu, Caifang Gao, Hongguo Chen, Chi Teng Vong et al.

 

Original articles

Combination therapy with miR34a and doxorubicin synergistically inhibits Dox-resistant breast cancer progression via down-regulation of Snail through suppressing Notch/NF-κB and RAS/RAF/MEK/ERK signaling pathway

Xiaoxia Yang, Pengfei Shang, Bingfang Yu, Qiuyang Jin et al.

 

Tryptophan 2,3-dioxygenase 2 controls M2 macrophages polarization to promote esophageal squamous cell carcinoma progression via AKT/GSK3β/IL-8 signaling pathway

Yumiao Zhao, Jiaxin Sun, Yin Li, Xiuman Zhou et al.

 

Novel compound FLZ alleviates rotenone-induced PD mouse model by suppressing TLR4/MyD88/NF-κB pathway through microbiota–gut–brain axis

Zhe Zhao, Fangyuan Li, Jingwen Ning, Ran Peng et al.

 

Lonicerin targets EZH2 to alleviate ulcerative colitis by autophagy-mediated NLRP3 inflammasome inactivation

Qi Lv, Yao Xing, Jian Liu, Dong Dong et al.

 

Simultaneous improvement to solubility and bioavailability of active natural compound isosteviol using cyclodextrin metal-organic frameworks

Xiaojin Chen, Tao Guo, Kaikai Zhang, Jiacai Chen et al.

 

Self-propelled nanomotor reconstructs tumor microenvironment through synergistic hypoxia alleviation and glycolysis inhibition for promoted anti-metastasis

Wenqi Yu, Ruyi Lin, Xueqin He, Xiaotong Yang et al.

 

Transdermal delivery of Chinese herbal medicine extract using dissolvable microneedles for hypertrophic scar treatment

Xiaoyu Ning, Christian Wiraja, Wan Ting Sharon Chew, Chen Fan, Chenjie Xu

 

Reconstitution of biosynthetic pathway for mushroom-derived cyathane diterpenes in yeast and generation of new “non-natural” analogues

Ke Ma, Yuting Zhang, Cui Guo, Yanlong Yang et al.

 

# # # # # #

The Journal of the Institute of Materia Medica, the Chinese Academy of Medical Sciences and the Chinese Pharmaceutical Association.

For more information please visit https://www.journals.elsevier.com/acta-pharmaceutica-sinica-b/

Editorial Board: https://www.journals.elsevier.com/acta-pharmaceutica-sinica-b/editorial-board

 

APSB is available on ScienceDirect (https://www.sciencedirect.com/journal/acta-pharmaceutica-sinica-b).

 

Submissions to APSB may be made using Editorial Manager® (https://www.editorialmanager.com/apsb/default.aspx).

 

CiteScore: 12.5

Impact Factor: 11.413

 

ISSN 2211-3835

 # # # # #


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Apps to reach record highs in Q3 of 36B downloads and $34B in consumer spending

A new forecast on the state of the app economy indicates the third quarter will see record-breaking revenues spent on apps and games. According to App Annie, consumers worldwide will spend $34 billion on apps and games in Q3, a 20% year-over-year increase

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A new forecast on the state of the app economy indicates the third quarter will see record-breaking revenues spent on apps and games. According to App Annie, consumers worldwide will spend $34 billion on apps and games in Q3, a 20% year-over-year increase on spending. The increase indicates that the COVID-19 pandemic’s impact on consumer habits and behavior is having a lasting effect when it comes to how people are now using apps for entertainment, shopping, work, education and more.

App Annie, we should note, made headlines last week for having massaged its data in earlier years using confidential sources, then misrepresented this to its trading firm clients as having been statistically modeled with internal controls to prevent such a thing from occurring. This resulted in a $10+ million securities fraud settlement with the SEC, as firms used the data to make investment decisions, as a result.

But App Annie data today still remains a fairly accurate representation of the mobile market, despite these manipulations, and for now is still one of many top companies that supply large app publishers, marketers and investors with information related to the mobile ecosystem.

The firm said that the largest contributor to app revenue in Q3 continues to be in-game spending and mobile subscriptions — the latter, a focus of lawsuits and increased regulation as both Apple and Google fight to retain their right to a cut of the purchases flowing through their app store platforms. Gaming continues to account for the majority of consumer spend, though non-gaming spending has grown its share over the past few years, thanks to subscriptions.

Android also still continues to outpace iOS on downloads, but the reverse is true when it comes to consumer spending.

Image Credits: App Annie

Downloads in Q3 will have grown by 10% year-over-year to reach a record high of 36 billion, driven by Google Play and particularly downloads in emerging markets like India and Brazil. The strongest growth was also seen in Brazil, the Philippines and Mexico, and the Latin American market has begun to catch the attention of global publishers now, as well, as one with growth potential.

Industries driving download growth include travel, education and medical — all three of which have had pandemic impacts. Travel app downloads grew 35% quarter-over-quarter on Google Play and 15% on iOS as the summer travel season has picked up amidst widespread vaccine rollout. Medical and education apps, of course, have pandemic ties, as users turned to mobile technology to keep up with online learning and with doctors’ appointments, COVID testing and vaccine appointments.

But iOS still reigns when it comes to revenue generated by mobile apps, accounting for 65% of app stores’ consumer spending globally, which is in line with the past four quarters.

Image Credits: App Annie

Consumer spending on iOS apps grew 15% year over year to $22 billion, and 15% year-over-year on Google Play to reach around $12 billion. Most of this revenue is generated by gaming apps, which account for 66% of the spend across both apps stores. In terms of non-gaming apps, iOS commands 76% of consumer spending. Much of the growth outside of gaming, across both platforms, comes from entertainment apps, photo and video apps, social media and dating apps, the firm says.

The U.S. and China are the largest iOS markets for consumer spending, with Japan, the U.S. and Taiwan accounting for the strongest growth. On Google Play, the U.S., Japan and South Korea were the largest markets by consumer spend, but Japan, Russia and Australia drove the growth.

While examinations of revenue and downloads have historically helped to paint a broad picture of the state of the mobile economy, as markets mature there’s greater interest in user engagement with apps — like those consumers already have installed on their devices.

A report from an App Annie competitor Sensor Tower, also out today, dives into active users, sessions and retention metrics for games and non-games alike. The firm found that the top 500 apps worldwide now average 91.7 million monthly active users and this number has grown by 8.4% year-over-year during the second quarter, up from 84.6 million in Q2 2020.

Image Credits: Sensor Tower

Business apps saw the highest compound annual growth rate (CAGR) between Q1 2018 and Q2 2021, climbing nearly 42% over that time frame, Sensor Tower said. Meanwhile, consumers in Q2 2021 spent the most time in entertainment apps, with each of the top 100 seeing nearly 29 minutes of daily usage, on average.

Image Credits: Sensor Tower

Among games, shooter genre games — like PUBG Mobile and Garena Free Fire — saw the most daily active users in Q2, as the top 50 games in this genre averaged 7.6 million daily active users. In terms of weekly actives, however, hypercasual games came out on top.

Sensor Tower also credits earlier increases in active users across apps to the COVID-19 pandemic as users who turned to mobile devices during lockdowns. But after a slight dip in Q3 2020, growth in active users has now returned to pre-pandemic levels, it said.

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A new oral antiviral drug for COVID is being tested in humans – can it make a difference?

Molnupiravir is showing promise for treating and controlling the spread of COVID-19.

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Despite the effectiveness of vaccines, we still need drugs to treat COVID. Even people who have been double vaccinated stand a small chance of getting COVID and ending up moderately or even severely ill. There are drugs to treat COVID, but they have to be given in hospital.

One promising drug that could improve things is molnupiravir, an antiviral that’s moving into the final stages of testing in humans. Researchers are hoping it can be used both to treat and prevent COVID. Importantly, it can be taken as a pill – meaning people wouldn’t need to be hospitalised to receive it.

This drug reduces the ability of SARS-CoV-2, the virus that causes COVID, to replicate. It works by mimicking one of the building blocks of the virus’s genetic material. When the virus reproduces, it builds a new copy of its RNA, and the drug ends up being incorporated into it.

When the virus then reproduces, the molnupiravir causes mutations to accumulate in the virus’s RNA, which increase every time it replicates. Eventually, this causes an “error catastrophe”, where excessive mutations stop the virus from being able to reproduce altogether, and it dies off.

How well does it work?

So far, a small trial has looked at the effects of molnupiravir in 202 COVID patients (not in hospital) who had started having symptoms. Participants were randomly allocated to receive molnupiravir or a placebo, with different doses of the antiviral being tested.

The trial’s results have been published as a preprint, meaning they are yet to be formally reviewed by other scientists. Still, the trial showed that after three days of treatment, infectious SARS-CoV-2 virus was found significantly less often in participants taking 800mg of molnupiravir (2%) compared to those taking a placebo (17%).

By day five, the virus was not detected in any participants receiving 400mg or 800mg of molnupiravir, but was still found in 11% of those taking a placebo. The trial, therefore, suggests that molnupiravir can reduce and eliminate infectious SARS-CoV-2 in patients with mild COVID. Indeed, it’s the fact that molnupiravir speeds up the clearance of the virus that suggests it could be useful not just for treating COVID but also lessening the chance of it spreading.

Having worked well in patients with mild COVID-19, the next question is whether molnupiravir can help those who are severely ill. faboi/Shutterstock

But to know just how useful it will be, we need to see what happens in further trials. Molnupiravir is currently also being assessed in newly hospitalised patients with COVID, with this study aiming to find out if early molnupiravir treatment can reduce the time it takes for patients with severe COVID to clear the virus. No results have been disclosed so far.

A larger trial, with 1,850 participants, is now looking to see if molnupiravir is better than a placebo at preventing serious disease and death in non-hospitalised adults with COVID. And a phase 3 trial (the final stage of human testing) is now recruiting participants – across 17 different countries – to see whether early molnupiravir treatment of COVID-positive people prevents others living in the same household from getting infected. Previous research has already shown molnupiravir can stop SARS-CoV-2 spreading in this manner among ferrets.

If it performs well in these trials, molnupiravir’s impact could be huge. Given the severity of illness that can be caused by SARS-CoV-2, an effective antiviral would be a valuable weapon to have in the clinical armoury – particularly if molnupiravir continues to be as fast acting as it has so far in testing. Patients suffering from COVID can become very sick very quickly.

The fact that it is taken orally is also potentially very helpful, as this would make it easy to use in the early stages of infection, as it could be self-administered outside of hospital. Also, molnupiravir can be produced in large quantities and doesn’t require cold transportation. Vaccines and physical measures to control the spread of the virus would still be the primary tactics for managing COVID, but this drug could complement both.

Where did it come from?

Developing antiviral drugs notoriously takes a long time. The fact that molnupiravir is available 18 months into the pandemic is because it wasn’t developed specifically for COVID. It is a broad-spectrum antiviral – meaning it can act against a wide variety of viruses. Its development started back in 2013 at Emory University in the US.

A woman with a viral infection blowing her nose
Because of how it works, molnupiravir is a promising treatment for a number of illnesses caused by RNA viruses. Dragana Gordic/Shutterstock

The focus then was on finding an antiviral drug for the treatment of equine encephalitis virus infection, a major threat for human and animal public health in the Americas. The initial antiviral drug in development was known as EIDD-1931. Broad testing confirmed that it was able to inhibit several RNA viruses from replicating, including influenza virus, multiple coronaviruses and respiratory syncytial virus.

However, when EIDD-1931 was given orally to monkeys it was quickly metabolised, decreasing its antiviral activity. To address this, scientists created an inactive drug (known as a prodrug) that is then converted into the active drug in the body. EIDD-1931’s prodrug is molnupiravir.

Initially, molnupiravir’s developers applied to the US Food and Drug Administration for permission to test it in humans as a treatment for seasonal influenza. However, after COVID emerged, and it was shown to have an effect against SARS-CoV-2, a request was submitted to test it against this virus too. One day, it’s possible that it could be used to treat a number of different diseases.

Peter Barlow is currently in receipt of funding from the Medical Research Council for projects unrelated to this piece. He has previously received funding from the Chief Scientist Office (Scotland) on a project investigating host defence peptides as therapeutics for rhinovirus infection (ETM/389). He is currently chair of the British Society for Immunology Inflammation Affinity Group.

Filipa Henderson Sousa does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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