After 1,5 years of constant fight against the Covid-19 pandemic, the biotech companies continue to work on developing possible treatments, whether it is in form of vaccines, booster shots, or antivirals. Today, we will look at some of the latest announcements from the biotech companies that reveal their progress on the therapies. One of the biggest headlines this week was the FDA’s approval of Monoclonal antibody therapy for Covid-19. Meanwhile, Sanofi and GlaxoSmithKline are ready to launch a large phase 3 trial, only weeks after the phase 2 trial showed promising results. Novartis is also ready to launch a phase 2 and phase 3 study of their Covid-19 drug and Queensland scientists have developed two separate peptide-based drugs that can prevent the contraction of the virus and slow the spread for the people who have already contracted the virus. Meanwhile, the vaccine candidates that are already used across the world are doubling their efforts to efficiently test whether the vaccines can be used in children and teens, with Bharat Biotech set to start the clinical trials in patients aged 2-18. Apart from the newest headlines in the Covid-19 treatments, we will also look at Jansen’s Crohn Disease therapy and its first promising results and FDA approving an AI-powered breast cancer detection tool by the Israel-based biotech.
Johnson & Johnson’s Janssen has released the first data regardings its therapy for patients with Crohn’s Disease. It is the first head-to-head study of biological therapies in patients with Crohn’s Disease.
According to the data, treatment with Jansen’s STELARA leads to a high chance of clinical remission, corticosteroid-free remission, clinical response, and endoscopic response.
“As the first head-to-head study of biologic therapies in Crohn’s disease, SEAVUE is filling an important knowledge gap in the gastrointestinal community,” said Bruce E. Sands, M.D., M.S., Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai Hospital and the Dr. Burrill B. Crohn Professor of Medicine (Gastroenterology), at the Icahn Institute for Medicine at Mount Sinai, and SEAVUE study principal investigator.a “SEAVUE has generated data that confirm STELARA as an important option for people living with moderately to severely active Crohn’s disease who are new to biologic therapy.”
Yesterday, the U.S. Food and Drug Administration has granted an emergency use authorization for the monoclonal antibody therapy that treats mild and moderate Covid-19 cases with patients 12 years and older.
The therapy, Sotrovimab, continues to be tested for effectiveness and safety and it is not authorized for patients that require hospitalization or require oxygen due to Covid-19 contraction.
“With the authorization of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States.”
Monoclonal antibodies are laboratory-made proteins that are able to imitate the immune system’s response in fighting viruses. The Sotrovimab is specifically designed to fight against the SARD-CoV-2 protein.
Sanofi and GlaxoSmithKline start the phase 3 trial for their Covid-19 vaccine, hoping to get full approval by the end of the year. Only two weeks ago, the companies have announced the positive data from the small phase 2 trials, where the jab “achieved strong rates of neutralizing antibody responses”.
With only 800 participants in the phase 2 trials, the British and French big pharmas wil now include over 35 000 individuals from across the world. The two companies will also start an additional trial testing their vaccine as a booster shot to the other vaccines. As the vaccine candidate of Sanofi and GSK is already months behind the other vaccines that are approved or are in the process of approval, the main possibility for the companies is using it as a booster shot for patients that received other vaccines doses before.
“We are encouraged to see first vaccinations starting to take place in such an important, pivotal phase 3 study, as we believe that our unique technology platform will provide a clinically relevant vaccine option,” said Thomas Triomphe, EVP and global head of Sanofi Pasteur.
“We have adapted our vaccine development strategy based on forward-looking considerations as the virus continues to evolve, as well as anticipating what may be needed in a post-pandemic setting. This trial is testament to the urgency and agility in our approach to help overcome the ongoing impact of this pandemic.”
If the phase 3 trials show as promising results as the phase 2 trials, the companies plan to get the vaccine authorized in Q4 of 2021 and the manufacturing is set to start in the coming weeks.
Novartis starts a phase 2/ 3 trial of their Covid-19 drug, testing whether it can prevent patients from being hospitalized and suffer from a severe case of the disease. Novartis plans to enroll 2100 patients in the trial.
Part 2 is expected to finish in August and move into phase 3. If the data is promising, Novartis wants to immediately seek emergency approval from the FDA.
“By virtue of its tri-specific design, ensovibep was built to resist viral mutations and indeed shows potent inhibition of all variants of concern to date, with the potential to maintain activity also for future variants,” said Molecular Partners CEO Patrick Amstutz, in a statement. “This type of broad spectrum activity is essential for any treatment of relevance for patients with COVID-19.”
Ibex was just granted an EU approval for their AI tool that detects breast cancer through pathology. In contrast to most AI-powered cancer detection methods that utilize radiological scans, Ibex’s tool uses ML and deep learning to analyze biopsies. That allows them not only to identify the cancer but also its severity.
“We are impressed with the successful study outcomes and performance of Galen Breast, which were in near-perfect concordance with the consensus diagnosis between pathologists in distinguishing between malignant and benign biopsies, and between invasive and in-situ carcinoma and other histological types,” Anne Vincent-Salomon, principal investigator in the study, said in a release.
“Our team demonstrated that Ibex’s AI technology goes beyond detecting cancer and provides accurate insights on the type of tumor, the nuclear grading of in situ carcinomas and more,” Vincent-Salomon added.
After being granted regulatory approval for its AI-powered tool to detect prostate cancer, the Israel-based biotech raised $38 million to develop cancer detection tools.
On Tuesday, the U.S. Food and Drug Administration announced they may refuse to review the applications for emergency use authorization of Covid-19 vaccine candidates.
In the United States, three vaccines are currently approved: Pfizer, Moderna, and Johnson & Johnson.
However, Novavax, Medicago, and AstraZeneca all were in the discussion phase with the regulators to receive the emergency use authorization.
So far, Novavax said it does not expect to seek regulatory approval in the US until Q3 of 2021, Medicago is in the preliminary talks for their plant-based vaccine, and AstraZeneca allegedly wants to skip the U.S. authorization that it was initially planning and focus on application for a full-fledged license that will allow them to sell the jab.
Queensland scientists have developed two drugs that can not only stop the spread of Covid-19 among patients that have contracted the virus, it can also prevent other patients from getting Covid. Through research conducted using human cells and models of the SARS-CoV-2 virus, the research team discovered two peptide-based drugs that target the human cells’ response to Covid-19.
Senior Researcher at QIMR Berghofer, Professor Sudha Rao, said that while the first drug aims at preventing infection, the second one prevents the spread within cells.
“The first treatment works by blocking the virus from entering as it effectively acts as a padlock on the human cells,” she said.”And the second drug, if the virus does enter, it prevents the virus from replicating.
“They are really what we call early intervention drugs, so they really are there to reduce the severity of the disease,” she adds.
“We know that the ACE2 receptor is the critical entry point as to how the virus enters. What we’ve really uncovered is the way the virus is able to exploit the human cells and allow the ACE2 door to become fully open, and therefore the virus can rapidly enter. Once it enters it can use the cellular machinery in the human cells to replicate. And knowing that … one drug really acts like a cloak around the human cell and therefore prevents the virus from entering through the ACE2 receptor. Whereas the second drug … if the virus does enter, the drug is specifically there to prevent the virus from replicating,” Rao says.
While the researchers believe it is a crucial step forward in tackling Covid-19, there is still a lot of additional research that needs to be done to determine whether the drug is effective and safe for use in humans.
The researchers expect to start clinical trials within a few months.
Bharat Biotech is about to start the trials of its Covid-19 vaccine among children aged 2-18. The trials are set to begin in June after Covaxin got approval from the Drugs Controller General of India (DCGI) to begin the trials.
Biotech’s head of business development and international advocacy, Raches Ella said the trial will start on June 1st.
“Bharat Biotech may get the license in the third quarter of this year,” Ella said.
She added that Bharat has begun the process to receive approval for Covaxin from the World Health Organization (WHO)
“A few of our products in the past got their approval. We expect approval for Covaxin (from WHO) by the end of Q3 or Q4,” Ella added.