Below is a round up of the latest COVID-19 news from our research partners in industry.
- COVID-19 antibody test approved for use in the UK
- Elecsys Anti-SARS-CoV-2 antibody test has a specificity greater than 99.8% and 100% sensitivity (14 Days post-PCR confirmation) and can help assess patients’ immune response to the virus. As more is understood about immunity to SARS-CoV-2, the test may help to assess who has built up immunity to the virus
- The test is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2
Pfizer and BioNTech
- Announced that the first patient in the US had been dosed with BNT162 vaccine, an mRNA designed to protect against COVID-19
- Phase 1/11 is a clinical trial that has already been initiated in German participants, as the company looks to recruit 360 healthy individuals to test the vaccine
- UK biotech Synairgen has started dosing patients in its phase 2 trial of SNG001, an inhaled formulation of interferon beta-1a that aims to treat coronavirus infections
- The drug is already widely used in an injectable form for multiple sclerosis, and Synairgen has already tested its inhaled version in clinical trials involving more than 200 asthma patients with a cold or flu infection, showing improvements in lung function
- gp96 COVID-19 vaccine program is focused on providing prophylactic protection to elderly patients and those with underlying health conditions, the very group of patients with an increased risk of complications and death from COVID-19 infection
- New data suggest that both T-cell (cellular immunity) and antibody (humoral immunity) are required for effective prophylactic protection against COVID-19
- Heat’s vaccine is being designed to clear virus infected cells by promoting long-term cellular immunity, which is essential for preventing the spread of re-infection in susceptible individuals such as the elderly and other high-risk patients with relevant comorbidities
The GPU maker has joined the COVID-19 High Performance Computing Consortium group tackling the disease; that group plans to support researchers by giving them time with 30 supercomputers offering a combined 400 petaflops of performance.
NVIDIA will add to this by providing expertise in AI, biology and large-scale computing optimizations.
NVIDIA is also providing access to its own SaturnV supercomputer, but the primary focus is on its AI experience.
Johnson & Johnson
Signed a deal with Emergent BioSolutions to boost manufacturing of the New Jersey drugmaker’s top COVID-19 vaccine candidate, which the company hopes to move into phase 1 trials.
In September the company announced it had started pre-clinical testing on multiple candidates in Boston and later revealed that it had selected its lead vaccine candidate, with two back-ups.
The company has announced that it is partnering with the University of Miami, US, to develop a vaccine for COVID-19. Its vaccine candidate, gp96, has been added to the World Health Organization’s (WHO) draft landscape of 41 candidate vaccines.
The company has also joined the Alliance for Biosecurity, which could help it secure funding to support the rapid development and distribution of its COVID-19 vaccine.
Company announced a partnership with Emergent BioSolutions to help develop and manufacture its oral vaccine candidate, which will take the form of a room temperature stable tablet.
The company suggests that an oral vaccine will offer a significant logistical advantage in the provision of mass vaccination campaigns.
Emergent BioSolutions announced that it has begun the development of two candidate hyperimmune products against the disease.
These therapeutics will aim to leverage the immune response in order to combat COVID-19 and are derived from antibodies found in the blood of patients who have tested positive for the virus.
Geovax is using its expertise in human immunotherapies to develop a candidate vaccine for COVID-19.
The company announced that they had identified three possible vaccine candidates and are working on narrowing these down to the most effective option based on the results of animal studies. Once the final candidate is selected, Geovax intends to proceed directly to manufacturing and human testing
Curevac has begun work on its COVID-19 vaccine and plans to enter clinical trials with its lead vaccine candidate in June 2020.
Curevac has received funding from CEPI and the EU to allow the company to quickly scale up its production.
- Anti-viral compounds show activity against SARS-CoV-2 in preclinical screening
- Pfizer and BioNTech enter into collaboration agreement to co-develop potential COVID-19 vaccine
- Company shares additional data and analysis of azithromycin
- Launch of two new studies to provide insights on the interaction between S. pneumoniae and SARS-CoV-2
- Pfizer explores studies of JAK inhibitor tofacitinib in patients with COVID-19-related pneumonia
Early peek at data on Gilead coronavirus drug suggests patients are responding to treatment.
- Rivals Nvidia and AMD are teaming up with some of the world’s largest cloud service providers to lend supercomputing resources to accelerate research of the novel COVID-19 coronavirus
- The goal of the consortium, which was formed two weeks ago, is to expedite research on ways to detect, treat and contain COVID-19
- Roche develops new serology test to detect COVID-19 antibodies
- The new Elecsys Anti-SARS-CoV-2 serology test can support the detection of antibodies against SARS-CoV-2 in patients who have been exposed to the virus which causes COVID-19
- The detection of these antibodies could help indicate if a person has gained immunity against the virus and inform treatment decisions
- Roche aims to have this test available by early May, in countries accepting the CE mark1 and is actively working with the US Food and Drug Administration for an Emergency Use Authorisation2
In response to intensifying demand, Gilead Sciences has been ramping up production of its experimental remdesivir treatment that is being tested to combat the novel coronavirus.
The drug maker now has 1.5 million individual dosages that could be used for more than 140,000 patients and is supplying the medicine, which is being made available through clinical trials and special access programs, at no charge.
Germany is hoping that a malaria drug called Resochin from pharmaceutical company Bayer could be used to treat severe cases of COVID-19.
More studies are needed as all drugs have side effects. However, it is expected that an effective drug to treat COVID-19 can arrive on the market much earlier than a vaccine.
Privately-held drugmaker EUSA Pharma has announced initial preliminary findings from the SISCO study of siltuximab as a treatment for severe COVID-19.
Interim data from the trial enrolling 21 people show that 16 had either stable or improved disease, while five either had disease worsening or died.
UK biotech Synairgen has started dosing patients in its phase 2 trial of SNG001, an inhaled formulation of interferon beta-1a that aims to treat coronavirus infections.
The drug is already widely used in an injectable form for multiple sclerosis, and Synairgen has already tested its inhaled version in clinical trials involving more than 200 asthma patients with a cold or flu infection, showing improvements in lung function.
Johnson & Johnson (J&J)
J&J is the latest to announce a promising vaccine candidate, planning human testing by September 2020, with the hopes of having more than one billion doses of a vaccine available for emergency use by early 2021.
Bayer is undertaking further measures to support the fight against the coronavirus pandemic. At various sites in Germany, the company is making available more than 40 virus diagnostics devices from its research operations, enabling the nationwide COVID-19 analysis capacity to be increased by several thousand tests daily.
They are also freeing up specially trained personnel for this purpose. At its Berlin campus, Bayer is establishing a two-story testing laboratory, and in North Rhine-Westphalia, the company is providing equipment to certified external testing laboratories.
Has received expedited approvals from the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) to conduct a trial of SNG001 in COVID-19 patients to potentially assist with the global outbreak of the virus.
(SNG001 is an inhaled formulation of interferon-beta-1a).
Announced the initiation of the Papa Giovanni XXIII Hospital sponsored study of siltuximab, an interleukin (IL)-6 targeted monoclonal antibody, for the treatment of patients with COVID-19 who have developed serious respiratory complications (Siltuximab In Serious COVID-19; SISCO Study).
Parabricks genome-sequencing software available at no charge to researchers sequencing the coronavirus and the genomes of those suffering from COVID-19.
2 studies to be taking place in NW London to look at the Antiviral Activity of Remdesivir (GS-5734™) to see how it compares to the usual treatment for COVID.
Roche has now announced the initiation of a Phase III clinical trial of Actemra/RoActemra (tocilizumab) in hospitalised patients with severe COVID-19 pneumonia.
The pharma giant says that it is working with the Food & Drug Administration (FDA) to initiate the randomised, double-blind, placebo-controlled study, to evaluate the safety and efficacy of the drug in combo with standard of care.
This is the first global study of Actemra/RoActemra in this setting and is expected to begin enrolling as soon as possible in early April with a target of approximately 330 patients globally, including the US.
Roche has confirmed that primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.
Offers up talents, tools and manufacturing capabilities in call for wide COVID-19 collabs. It is openly sharing its drug development talents, tools and expertise, as well as its manufacturing capabilities, with any companies working on promising anti-COVID-19 candidates—and it’s calling on the entire biopharma industry to do the same.
Read more here.
BioNTech SE and Pfizer Inc
Pfizer said it would help develop and distribute BioNTech SE’s COVID-19 vaccine candidate, though the deal excludes China. BioNTech plans to put the vaccine candidate into clinical trials in late April.
Read more here.
Medicago is developing drug candidates against COVID-19 after having produced Virus-Like Particles (VLP) of the coronavirus. The company has formed a collaboration with the Laval University’s Infectious Disease Research Centre to develop antibodies against SARS-CoV-2.
Airway Therapeutics is exploring its novel human recombinant protein named AT-100 (rhSP-D) as a treatment for coronavirus. The company has announced a filing with the Respiratory Diseases Branch of the National Institutes of Health to evaluate the drug. AT-100 has shown efficacy in preclinical studies in reducing inflammation and infection in the lungs, while also generating an immune response against various respiratory diseases.
BPI-002 is a small molecule agent indicated for treating various infections including COVID-19. It has the ability to activate CD4+ helper T cells and CD8+ cytotoxic T cells and generating an immune response in the body.
If combined with another COVID-19 vaccine, the drug has the ability to generate long-term protection against viral infections. BeyondSpring has filed US patent protection for the drug for treating viral infections.
Read more here.
The company is preparing a large donation of malaria medicine chloroquine. Chloroquine isn’t approved to treat patients suffering from novel coronavirus infections, but some early studies have shown promise.
Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US to begin patient testing under FDA Emergency Use Authorization
A Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is funding the trial. KPWHRI is part of NIAID’s Infectious Diseases Clinical Research Consortium.
The open-label trial will enroll 45 healthy adult volunteers ages 18 to 55 years over approximately 6 weeks. The first participant received the investigational vaccine today.
Japan’s biggest drugmaker – has revealed that it is initiating the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) for the virus.The plasma-derived therapy has previously been shown to be effective in the treatment of severe acute viral respiratory infections, and is said to be a potential treatment for COVID-19, also referred to as coronavirus.
Is collaborating with Duke-NUS Medical School to develop a COVID-19 vaccine based on the company’s STARR Technology.
The STARR platform combines self-replicating RNA with the lipid-mediated LUNAR nanoparticle delivery system to generate an immune response or drive therapeutic protein expression. As a result, the business says the technology “is expected to provide lower dose requirements [and] sustained protein expression compared to non-self-replicating RNA-based vaccines, and potentially enable us to produce vaccines more quickly and simply.”
The cloud-computing company for pharma and life sciences – is offering its remote engagement technology for free, in order to help pharma companies and HCPs battle the virus.
The firm says that offering its ‘Veeva Engage’ technology up is a response to the potentially “crippling effect” that the outbreak could have on how patients receive care, giving reps and doctors the opportunity to meet online through their preferred mobile devices to keep delivering care.
Crescent Pharma Limited
Has developed a drug which is currently being used in clinical trials in China. Their substance is an antimalarial drug derived from quinolone called chloroquine phosphate.
Randomised Evaluation of COVID-19 Therapy (RECOVERY trial)
The RECOVERY trial taking place in sites in NW London aims to take all adult inpatients in NHS Trusts with COVID-19 and randomise to no additional treatment vs. a range of intervention arms.