Let us look at the biggest biotech developments in the past week. While most of the world is primarily interested in the Covid-19 therapies, vaccine rollout and the discussion surround the most effective ways to tackle the pandemic, there is a series of other innovations and announcements from the biotech companies worth looking at. Novartis announced that their experimental prostate cancer therapy is showing very promising results, FDA approved the MS treatment developed by Johnson & Johnson, and the world was tricked with the alleged information that genetically modified mosquitoes were released in Africa. Meanwhile, in the Covid-19 world, we deal with the AstraZeneca suspicions after WHO, British, and European regulators all issued their statements, we discuss the latest AstraZeneca large clinical trial, look at the CureVac vaccine that is about to seek an emergency approval, experimental inhalation vaccines, and antibody therapies are increasing, and more countries are in late-stage trials of home-grown vaccines.
CureVac Establishes A Precursor For Seeking Approval For Its Covid-19 Vaccine
CureVac, a German drugmaker has established its first Swiss business unit. The move comes as a step before seeking emergency approval for its Covid-19 vaccine from the Swiss drug regulator, Swissmedic.
Established on Monday in Basel, “The company aims to research, develop and market biotechnological products,” as the description of the purpose said.
CureVac has still not formally applied for the emergency approval for its mRNA vaccine, however, they needed to enter the commercial registry as it is one of the official conditions in the process. Without being registered, the company would not be apple to seek a license for a medicinal product from the national drug regulator.
A business must be in the commercial registry as a condition of applying for a licence for a medicinal product from Swissmedic.
“Concerning a potential application … we are currently in discussions with Swissmedic,” a spokesman for CureVac said.
This week, the news with allegations about Australia releasing genetically modified insects have circulated online. A Facebook user had posted a number of screenshots that are supposedly from the World Mosquito Programme (WMP). However, Reuters has since discredited the news.
The post first appeared on Facebook, starting the craze after the total of seven screenshots were posted on March 13. Five come from the WMP webpage discussing the release of bacteria-laden mosquitoes in northern Australia. One is from British tabloid The Sun, which has the headline: “Bill Gates donates £3 million to create mosquitos that kill each other using SEX”. The final screenshot shows another headline taken from CBS Miami. It reads: “Bill Gates fights for end to mosquito-borne illness”.
While many have assumed that the screenshots are a prof of WMP releasing the genetically modified insects, Reuters have since factchecked it and provided the full version of the story confirmed by the WMP. To start with, WMP and the screenshots that the user pasted into his post are not even connected to genetic engineering. It discusses the process of breeding Aedes Aegypti mosquitoes that are infected with Wolbachia, a type of bacteria that renders the insect less likely to pass specific viruses onto humans (here).
“The mosquitoes we release are not genetically modified,” a WMP spokesperson told Reuters. “Wolbachia is a naturally occurring bacteria in 60% of insects. Our process of injecting Wolbachia into Aedes Aegypti mosquitoes does not alter the genetic material of either the Wolbachia bacteria or the mosquito.”
The WMP’s project has been a huge contribution to eliminating dengue virus in the especially vulnerable areas.
“There was a significant public health response at the time, and this was followed by the World Mosquito Program (WMP), formerly Eliminate Dengue, releasing mosquitoes with bacteria called Wolbachia, in 2011,” said Dr. Richard Gair, the director of Tropical Public Health Services in Cairns, Australia. “Together with our monitoring and spraying program, the implementation of the WMP’s Wolbachia approach has proved highly effective in preventing outbreaks recurring in this region.”
The other two screenshots in the original Facebook post that included the Sun and the CBS headline are connected to Bill Gates donating to either fight tropical disease or a UK-based company researching genetically modified mosquitos.
Based on Reuters’ research, no genetically modified mosquitos have been released in Australia so far. While the genetically engineered insects were released by a different biotech company, the British Oxitec. However, the release of the mosquitoes with a self-limiting gene took place in Brazil, Cayman Islands, and Panama exclusively.
On Tuesday, the Chinese CanSino Biologics announced it got approval to conduct a clinical trial on it inhalation Covid-19 vaccine.
The National Medical Products Administration approved the trial of a vaccine that was developed through a cooperation by CanSinoBIO and the Beijing Institute of Biotechnology, the company said.
The previously developed injection vaccine was approved for emergency use in Hungary.
Vir Biotechnology and the British GSK are about to seek emergency use approval for the experimental Covid-19 antibody therapy. The preliminary data showed 85% of reduction in hospitalization and deaths among patients.
The approval would be a milestone in the battle against the Covid-19 pandemic. Apart from the treatment developed by Vir Biotechnology and GSK, Eli Lilly and Regeneron Pharmaceuticals have created similar treatments. The latter two were already recommended by both U.S and European health regulators.
Vir Chief Executive George Scangos said on Thursday that the company is already in process of contract talks with numerous governments and that the promising data from their latest clinical trial will speed up the process of reaching a deal.
The goal of the antibody treatment is decreasing the severity among the already diagnosed Covid-19 patient. The studies have showed that the Vir and GSK joined therapy is effective against the original Covid-19 strain, as well as the more contagious UK, South Africa, and Brazil variants.
“We don’t yet have data to definitely say the antibody is as effective against variants of the virus as it is against prototypic strains. It appears that way from preclinical research,” Scangos said.
On Wednesday, Kaleido Biosciences, announced very promising results regarding its experimental oral treatment for Covid-19. The treatment cuts recovery time and the number of needed hospitalizations. The number of hospitalizations was decreased by 51%.
KB109, the treatment developed by Kaleido Biosciences, works on a basis of changing the composition and metabolic output of microbes in the gut. The molecules that can be produced by gut microbes can decrease responses such as aggressive immune response that can cause respiratory failure.
Kaleido Biosciences was registered in a study with the U.S. Food and Drug Administration, so for as a trial of a food compound. The registration for a drug will start later this year.
“We believe based on this data that we can go directly to phase three (study),” Chief Executive Officer Daniel Menichella told Reuters.
Novartis, the Swiss drugmaker, announced on Tuesday that its experimental Lu-PSMA-617 radioligand therapy showed to improve survival chances of the prostate cancer patients that suffer from the hard-to-treat form of the illness.
Novartis started working on a therapy after acquiring the cancer drugmaker Endocyte in a $2.1 billion deal in 2018. The therapy therapy has shown to substantially improve survival and radiographic progression-free survival (rPFS) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer.
The exact survival data will be announced in a medical conference in the next weeks. Novartis hopes that Lu-PSMA-617 will gradually gain the status of a targeted treatment for over 80% of patients that suffer from advanced prostate cancer, if the approval goes through.
“We intend to submit these data to regulatory authorities as soon as possible,” John Tsai, the group’s Head of Global Drug Development and Chief Medical Officer, said in the statement. “Patients with metastatic castration-resistant prostate cancer have a less than 1 in 6 chance of surviving 5 years and need new treatment options,”
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Another Swiss drug maker, Roche, announced on Monday that it would drop the late-stage trials of the Huntington’s disease hopeful tominerson. The news comes as a big surprise as the drug was so far showing very promising results and gave hope to the patients around the world as there are no treatments that can stop or reverse the disease so far.
The drug, an antisense oligonucleotide originally developed by Ionis and licensed for $45 million in 2017 showed promising results in earlier trials.
“This is very unfortunate news to deliver on the tominersen Phase III study and we know it will be especially difficult for people with Huntington’s disease to hear,” said Levi Garraway, Roche’s chief medical officer.
Having said that, Roche is not giving up on finding a treatment for the Huntington disease entirely. It still works on the Spark gene therapy.
On Monday, KM Biologics CO announced they are in process of human trial for their Covid-19 vaccine. The announcement makes them the third Japanese company that will advance to clinical trials.
The vaccine will require two doses that will be given with a 27-day interval. The trial will be a combined Phase 1 and Phase 2 involving 210 participants.
Apart from KM Biologics, AnGes Inc and Shionogi & Co are the other Japanese companies that advanced their research to the human trial level.
On Monday, Thailand started human trials of their home-grown Covid-19 vaccine. The vaccine is expected to deploy next year as Thailand hopes that domestically developed vaccines will allow for more freedom with the vaccination policy.
The vaccine is developed by the state drug maker the Government Pharmaceutical Organization (GPO), in cooperation with Mahidol University’s Tropical Medicine Department and an American non-profit. An inactivated virus is used to trigger the immunity among the vaccinated.
“The vaccine, produced by Thais for Thais, is expected to be used next year,” Piyasakol Sakolsatayadorn, chairman of the Mahidol University Council, said.
“Even though we can produce vaccines in the country, it is from technology transfer and under management of brands,” Health Minister, Anutin Charnvirakul, said. “But today, if we are successful we can set our own direction.”
There is another domestically developed candidate that uses the mRNA technology. The vaccine is created by the Chulalongkorn University and will also start their human trials soon.
After the concerns about blood clotting, several countries have temporarily paused their AstraZeneca vaccine rollout and claimed more data is needed.
On Friday, the World Health Organization (WHO) urged the world to keep using the AstraZeneca vaccine, after the European and British regulators both have done the same. All three organizations claimed that the safety pannels did not point to an overall increase in blood clotting. The regulators also pointed out that that the benefits largely outweighed the risks.
“We urge countries to continue using this important COVID-19 vaccine,” WHO Director-General Tedros Adhanom Ghebreyesus, said “The AstraZeneca vaccine is especially important because it accounts for more than 90% of the vaccines being distributed through COVAX.”
“There is no question. COVID-19 is a deadly disease, and the Oxford-AstraZeneca vaccine can prevent it. It’s also important to remember that COVID-19 itself can cause blood clots and low platelets.” Tedros added.
The WHO’s global advisory committee on vaccine safety said in a statement that the AstraZeneca vaccine had a “positive benefit-risk profile” and “tremendous potential” to prevent infections and reduce deaths.
The WHO independent panel of 12 experts who reviewed all the safety data from Europe, the United Kingdom, India, and the global panel said,
“While very rare and unique thromboembolic events in combination with thrombocytopenia, such as cerebral venous sinus thrombosis (CVST), have also been reported following vaccination with the AstraZeneca COVID-19 vaccine in Europe, it is not certain that they have been caused by vaccination,” it said.
Johnson & Johnson can now enter the Multiple Sclerosis Treatment, after the U.S Food and Drug Administration have administered the J&J treatment on Friday.
The treatment, Ponvory, is a oral drug that should be administered daily to treat relapsing types of MS. The ease of administering the treatment could give J&J a competitive advantage over Roche’s Ocrevus and Novartis’ Kesimpta that are currently dominating the market. Kesimpta is injected by patients while Ocrevus has to be administered as an infusion in a clinic or a hospital.
The FDA approval came after a two-year late stage study where the Ponvory showed a superior efficiency and reduced annual relapses by approvimately 30% as compared to Sanofi’s approved MS drug Aubagio. Ponvory has also showed promising results in reducing fatigue, as compared to Aubagio.
Ponvory is currently under review by the European Medicines Agency (EMA) as well.
After the latest major U.S. trial, the AstraZeneca vaccine showed to be 76% effective at preventing symptomatic Covid-19 illness.
Mene Pangalos, Executive Vice President of Biopharmaceuticals R&D at AstraZeneca said,
“The primary analysis is consistent with our previously released interim analysis, and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over. We look forward to filing our regulatory submission for Emergency Use Authorization in the US and preparing for the rollout of millions of doses across America.”
Experts say that the news should help to secure the approval in the United States, as well as increase the global trust in the AstraZeneca vaccine.
“I think that this will pour some oil on the troubled waters,” William Schaffner, Professor of Infectious Diseases at the Vanderbilt Universite School Of Medicine said. “The vaccine efficacy against severe disease, including death, puts the AZ vaccine in the same ballpark as the other vaccines. The company continues to intend to submit the data to the FDA and its external advisory committee for an EUA which I expect to be granted.”