Alliance members tackling COVID-19 pandemic from all angles

   Several working in conjunction with each other, US government   

The nineteen member companies of the Alliance for Biosecurity, the United States’ leading counter-pandemic coalition, provided a joint update on Wednesday of their progress and activity in countering the COVID-19 pandemic and preventing future pandemics.

“From developing several of the leading vaccine candidates, to readying distribution of any vaccine, to keeping our eyes downfield and getting ahead of the next pandemic, the members of the Alliance for Biosecurity are as active as ever in keeping the American people safe,” said Alliance spokesman and former Congressman Jack Kingston.

Below is just a glimpse into what we are working on:

Bavarian Nordic has recently entered into an agreement with AdaptVac to further develop their COVID-19 vaccine. The first clinical study of the vaccine is planned to be initiated during the fourth quarter of 2020, with data expected to become available early in 2021.

Baxter International, Inc. has boosted its capacity and production to address a significantly increased demand for its life-saving medicines and medical devices since the emergence of COVID-19 and associated surge of patient hospitalizations.

BioCryst is currently conducting a randomized, double-blind, placebo-controlled clinical trial to assess the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-19. The trial is being funded by the NIAID.

Chimerix was approved by the FDA in May to test its anti-inflammatory cancer drug Dociparstat sodium on COVID-19 patients. Chimerix is confident that their drug has the potential to address lung inflammation and blood coagulation associated with the virus.

Elusys Therapeutics has received multiple development grants and procurement contracts from BARDA, the National Institutes of Health, and the U.S. Department of Defense to treat infectious disease and protect the public from the threat of bio-warfare if an agent like anthrax was used in an intentional attack.

Emergent BioSolutions is developing two investigational plasma-based treatments for COVID-19, working with four innovators to develop and manufacture COVID-19 vaccine candidates, and is in a landmark CDMO public-private partnership with the U.S. government’s Operation Warp Speed.

GSK is collaborating with companies and research groups across the world working on promising COVID-19 vaccine candidates through the use of our innovative vaccine adjuvant technology. The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people. 

Hawaii Biotech is developing a second generation COVID-19 vaccine, leveraging their previous vaccine development experience with Dengue, Ebola, and a variety of viral respiratory diseases. The vaccine is continuing to undergo animal efficacy evaluation.

Heat Biologics is completing the preclinical validation of their COVID-19 vaccine (focused on elderly patients and those with underlying health conditions), moving into manufacturing with Waismann Biomanufacturing, and beginning clinical trials as soon as possible.

iBio is working on multiple COVID-19 vaccines and therapeutics. If any biopharmaceutical development program(s) move into clinical trials, iBio’s “FastPharming” System has unique capabilities to manufacture product candidates at clinical and commercial scales.

The Janssen Pharmaceutical Companies of Johnson & Johnson have developed a potential COVID-19 vaccine currently undergoing in-human trials after a positive pre-clinical study. Provided it proves safe and effective, they aim to manufacture and distribute over 1 billion doses through 2021.

Opiant Pharmaceuticals, Inc., is working with the National Institute on Drug Abuse and BARDA to develop OPNT003 (nasal nalmefene) to treat opioid overdoses, an epidemic being exacerbated by the COVID-19 pandemic as 40+ states report increases in opioid deaths since Match.

Roche Diagnostics actively manufactures and distributes millions of high-volume molecular tests to detect the COVID-19 virus, and they’ve introduced a highly reliable antibody test, which may help to determine the spread of COVID-19 disease. 

Sanofi Pasteur is developing an adjuvanted vaccine for COVID-19 in collaboration with GSK. They were recently selected for Operation Warp Speed, expect a Phase 3 study by the end of 2020, and have committed to supplying 100 million doses. They are also building state of the art facilities in the United States for domestic, sustainable vaccine production.

SCYNEXIS focuses on preventing difficult-to-treat and drug resistant infections. As a drug developer on the frontline, SCYNEXIS is working every day to address the growing threat that resistant infections pose to our society – a threat more evident now than ever.

SIGA Technologies, Inc. developed TPOXX, the first and only US FDA approved treatment for smallpox.  SIGA continues to focus on providing solutions for unmet needs in health security, developing medical countermeasures for the next chemical, biological, radiological, and nuclear (CBRN) threat, as well as emerging infectious diseases.

The Texas A&M University System is actively responding to COVID-19 on many levels, from aiding coordination of the state’s response to a $265-million-dollar task order from Operation Warp Speed to produce vaccines.

 

Tonix Pharmaceutical’s lead COVID-19 vaccine candidate (of four in development) is TNX-1800, a live replicating vaccine based on their horsepox viral vector platform. They expect data from non-human studies late 2020 and tentatively plan to have a Phase 1 clinical trial in 2021.

Venatorx Pharmaceuticals’ key innovation is the development of candidate drugs that overcome major factors involved in the development of antibacterial resistance. They have in their pipeline a clinical development program for hospital-acquired and ventilator-associated bacterial pneumonia.