Stand van zaken

Welke bedrijven doen wat ?

Bedrijven bezig met  vaccins :

• AbbVie (ABBV) has a two-drug HIV regimen Kaletra (lopinavir-ritonavir combo), in combination with the steroid dexamethasone, that is in clinical trial at UK’s Oxford University. 
• Altimmune (ALT) is trying to leverage its proprietary technology used in the development of its flu vaccine candidate NasoVAX (currently in phase 2 clinical trial). Altimmune COVID-19 vaccine is in pre-clinical phase.
• Applied DNA Sciences (APDN) & Takis Biotech, an Italian biotech company, joined forces to develop a linear DNA COVID-19 vaccine using Applied DNA Sciences’ patented and proprietary platform. It’s currently at the pre-clinical stage.
• AstraZeneca (AZN), thru its proprietary antibody discovery technology, is researching novel coronavirus neutralizing antibodies as a preventive treatment. They are still in the identification phase of monoclonal antibodies that can target SARS-CoV-2, the virus responsible for COVID-19. Upon completion of the identication process, they move into clinical trial evaluation.
• BioNTech (BNT) & Pfizer (PFE) have teamed up to work on a mRNA type vaccine they are calling BNT162. It is currently in the pre-clinical phase with plans to start clinical trials in April.
• GlaxoSmithKline (GSK), in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), is providing their vaccine adjuvant technology to vaccines developers. Vaccine adjuvants are added to a vaccine formula to improve immune response. It also provides the added benefit of requiring less vaccine per dose which allows more people to be vaccinated.
• Heat Biologics (HTBX) is leveraging it proprietary Heat’s gp96 platform to develop its COVID-19 vaccine and is currently in pre-clinical trial.
• Inovio Pharmaceuticals (INO) is working on a COVID-19 vaccine they named INO-4800. Inovio Pharmaceuticals is one of several companies developing a COVID-19 vaccine with the help of a multi-million dollar grant from the Coalition for Epidemic Preparedness Innovations (CEPI). A phase 1 clinical trial is planned for April.
• Johnson & Johnson (JNJ), thru its Janssen Pharmaceutical companies and in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), has been working on a vaccine which they hope will be ready for human trials in November 2020.
• Moderna (MRNA) is currently working on a mRNA type vaccine they have named mRNA–1273 — currently in phase 1.
• Novavax (NVAX) is developing a vaccine derived from coronavirus spike (S) protein and using their proprietary Matrix-M adjuvant to boost immune responses. They received a multi-million dollar grant from the Coalition for Epidemic Preparedness Innovations (CEPI) to support their research. Novavax vaccine candidates are currently in pre-clinical studies with a phase 1 clinical trial planned before June.
• Sanofi (SNY) thru Sanofi Pasteur, the vaccines global business unit of Sanofi, is working with Biomedical Advanced Research and Development Authority (BARDA) to use its DNA recombinant technology platform to produce a COVID-19 vaccine. It is also working with BARDA on building state of the art facilities in the US for the production of an adjuvanted recombinant vaccine. Initially, these facilities were planned to be used in the event of a flu pandemic but these facilities could also be used for COVID-19 vaccines.
• Vaxart (VXRT) and Emergent BioSolutions (EBS) have entered into an agreement whereby Emergent BioSolutions would help develop and manufacture Vaxart’s oral vaccines which are currently being evaluated.
• Vir Biotechnology (VIR) and Biogen (BIIB) signed a letter of intent for the development and clinical manufacture of a COVID-19 vaccine derived from Vir Biotechnology’s proprietary antibody platform.

Bedrijven bezig met geneesmiddelen : 

• Gilead Sciences (GILD) received FDA approval to test its experimental drug Remdesvir which is currently in clinical trials (two phase 3 trials and one phase 2 trial). Initially developed as potential treatment against Ebola, it is now being tested to determine if it can safely be used as a treatment for COVID-19.
• Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) are working together to study how the Kevzara, a drug approved by the FDA for rheumatoid arthritis can be used to treat severely ill COVID-19 patients. The Biomedical Advanced Research and Development Authority (BARDA) is providing its support for a U.S. phase 2/3 clinical trial. Regeneron and Sanofi who developed Kevzara in collaboration back in 2017 will continue their collaboration with Regeneron leading U.S. clinical trials and Sanofi leading clinical trial outside the US.
• Takeda Pharmaceutical (TAK) initiated the development of a plasma-derived immune globulin therapy drug to treat high-risk individuals suffering from COVID-19. Takeda named this drug TAK-888. Takeda is currently in discussions with various governmental and health care stakeholders worldwide to discuss the best way to proceed with the development of TAK-888.
• Teva (TEVA) and Mylan (MYL) are planning to jump start manufacture of hydroxychloroquine, a drug that is typically produced in limited amount due to its intended purpose (i.e. FDA approved for malaria, lupus and rheumatoid arthritis). Studies are underway to evaluate its effectiveness and safety when combined with antibiotics. FDA will have to approve its potential use for Covid-19 treatment but in the meantime, Teva and Mylan are stepping up production and distribution.

Bedrijven bezig met diagnostica : 

• Abbott (ABT) received FDA Emergency Use Authorization for its newly launched COVID-19 molecular test: the RealTime SARS-CoV-2 EUA which identified SARS-CoV-2, the virus responsible for COVID-19. These tests can be used on Abbott’s m2000 RealTime System which hospitals are already using to diagnose other infectious diseases. Abbott will also step up production of the their m2000 RealTime System so more tests can be processed.
• Applied DNA Sciences (APDN) has completed the design of its COVID-19 detection assay and subsequently filed a provisional patent for high sensitivity COVID-19 diagnostic assay. They are in the process of manufacturing testing kits which will be sent to hospitals in New York State and Italy for validation.
• Bioamerica (BMRA) has developed a 10 minute disposable point-of-care serology test to identify if a patient has been exposed to COVID-19 or has been recently infected. Bioamerica applied for a COVID-19 Emergency Use Authorization (EUA) to get the test in the US. Right now, it is only shipped outside the US and is not allowed for sale or use in the US.
• Cepheid (DHR) developed a 45 minutes rapid diagnostic test for COVID-19 which received FDA’s Emergency Use Authorization (EU). This test can be used in Cepheid’s GeneXpert diagnostic platform which is already in use by hospitals and laboratories. Cepheid is a subsidiary of Danaher (DHR) which acquired Cepheid on November 4, 2016.
• Heat Biologics (HTBX) expanded its partnership with the University of Miami to also develop a speedier point-of-care diagnostic test. The test results would be available on-the-spot in less than 30 minutes.
• PerkinsElmer (PKI) received FDA Emergency Use Authorization (EUA) for its new coronavirus RT-PCR test (the PerkinElmer New Coronavirus Nucleic Acid Detection Kit). In the US, per the EUA, this test can only by done in clinical laboratories certified to perform high complexity tests under the Clinical Laboratory Improvement Amendments (CLIA).
• Roche (ROG) received FDA Emergency Use Authorization for its cobas SARS-CoV-2 test to detect novel coronavirus using Roche’s cobas 6800/8800 Systems. Test results can be obtained in three and half hours.

Kickstart 26/03 Wat koop ik - positie 4