Biopharma Update on the Novel Coronavirus: March 31
EUA for Hydroxychloroquine Sulfate and chloroquine Phosphate: On March 28, 2020, the FDA issued an Emergency Use Authorization for hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile(SNS) to be distributed and used for certain hospitalized patients with COVID-19
EUA for Battelle Decontamination System: The FDA adjusted the EUA for the Battelle Decontamination System for use to decontaminating N95 respirators. Those respirators would then be able to be reused by health care professionals during the COVID-19 pandemic.
Warning Letters for Two Companies: The FDA and FTC issued warning letters to both Corona-cure.com and Carahealth for using misleading claims of prevention and/or treatment of COVID-19 for their products.
Updated Guidance: The FDA updated guidance for “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.”
Diagnostics Update: The FDA has worked with more than 230 test developers who plan to submit EUA requests to detect COVID-19. Also, 20 EUAs have been issued. The FDA has also announced an expedited review of diagnostic tests.
Alberta Health Services (AHS): AHS has partnered with Spartan Bioscience to create a rapid testing device. The company is creating a handheld device that can detect the COVID-19 virus in less than one hour and may help eliminate the need for lab samples.
Luminex received FDA EUA for its NxTAG CoV Extended Panel test for SARS-CoV-2. It can diagnose up to 96 patients in about 4 hours. It can be run in parallel with the NxTAG Respiratory Pathogen Panel (RPP).
Testing Therapies, Antivirals and Vaccines
BioSpace’s Genetown Hotbed is at the very heart of the biopharma industry in the United States, largely in the Boston area. As the biopharma industry responds to the COVID-19 pandemic, some of the area’s companies are at the very frontlines of drug development against the disease, while others play supporting roles for the entire industry.
Generation Bio / Vir Biotechnology: Both companies announced a collaborative research agreement to examine the potential for Generation Bio’s non-viral gene therapy platform to encompass the impact of Vir Biotechnologies’ human monoclonal antibodies (mAb) to help fight SARS-CoV-2.
Clara Biotech: Clara Biotech, based out of Lawrence, KS indicated it has developed a way to target infected lunch tissue using exosomes. Clara Biotech is in the process of seeking clinical trials for the therapy that could reduce more complicated symptoms of COVID-19.
Cue Health was awarded a $13 million contract to accelerate the development, validation and FDA clearance of a portable molecular diagnostic test for COVID-19 in less than 25 minutes.
Vaxart produced 5 COVID-19 vaccine candidates for testing in its preclinical models. The development has started on its development program for cGMP production of the vaccine with Emergent BioSolutions and expects to initiate a Phase I trial in the second half of 2020.
Bionano Genomics launched the largest study to date to identify genomic variants and novel active substances that influence resistance or sensitivity to the novel coronavirus that causes COVID-19. The first study is underway in Wuhan, China. The Hannover Medical School is now launching a study involving 1,000 patients and controls.
BioMedInnovations: A North Carolina life science startup, BioMedInnovations has designed a low-cost device used to help people breathe. The company shifted its focus from making equipment to prolong organ life for transplants to respiratory medical devices due to the COVID-19 pandemic.
Bermuda-based Kiniksa Pharmaceuticals saw early evidence treatment response from its experimental drug mavrilimumab in the care of COVID-19 patients. Mavrilimumab is an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony-stimulating factor receptor alpha (GM-CSFRα). Patients treated with the asset had pneumonia and hyperinflammation associated with COVID-19. To date, six patients have been treated with mavrilimumab in the treatment protocol. All patients showed an early resolution of fever and improvement in oxygenation within 1-3 days. None of these patients have progressed to require mechanical ventilation. Mavrilimumab has been well-tolerated.
China’s Sartorius is teaming up with Tianjin CanSino Biologics and the Institute of Bioengineering at the Academy of Military Medical Sciences in China to develop a vaccine candidate against COVID-19. CanSinoBIO and the Institute of Bioengineering used Sartorius’ BIOSTAT STR single-use bioreactor system for the upstream preparation of the recombinant vaccine, thus ensuring the rapid linear amplification of the adenovirus vector, Ad5-nCoV.
ViGene Biosciences is providing 2020 GMP manufacturing slots now to help manufacture the vaccines for COVID-19. The company’s manufacturing is aimed at three different categories: Adenovirus GMP production expressing certain COVID-19 antigen; GMP AAV-delivered COVID-19 vaccine; and GMP Plasmid or Bacmid based COVID-19 vaccine.
San Diego-based Arcturus Therapeutics is working with Duke University to develop a vaccine for COVID-19. Duke-NUS, a partnership between Duke and the National University of Singapore, developed a process to track genetic changes and their correlations that augment testing of vaccines. These gene expression changes can be measured within the first 5 days following vaccination and the data may also guide dose selection. Arcturus is also developing its own vaccine, LUNAR-COV19, which is based on its STARR and LUNAR technologies.
Reata: Due to the COVID-19 pandemic and after consulting with the trial’s Data Safety Monitoring Board (DSMB), Reata has halted the Phase III CATALYST trial of bardoxolone methyl in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH). These patients have compromised cardiopulmonary function often treated with immunosuppressants, putting them at high risk of infections. Reata decided that it was an unacceptable risk bringing these patients to clinics or in-person visits during the pandemic.
Amgen is evaluating how the COVID-19 pandemic is affecting its operations, supply chain and clinical trial programs. The Phase II trial of AMG 510 in lung cancer is continuing uninterrupted, as is its Phase III trial with AstraZeneca of tezepelumab in asthma, which is also fully enrolled and the company does not expect delays. And, the Phase III heart failure trial in collaboration with Cytokinetics of omecamtiv mecarbil is also fully enrolled and expected to continue uninterrupted.
Exicure updated its response to the COVID-19 pandemic. Its Phase Ib/II trial of AST-008 in Merkel cell carcinoma and in cutaneous squamous cell carcinoma is beginning the Phase II, which is continuing as expected.
HiFiBIO Therapeutics is running experiments with researchers at ESPCI Paris – PSL and others to identify immune system activity to COVID-19 at the cellular level with its CelliGO platform, a novel droplet-based microfluidics technology.
As the COVID-19 pandemic continues, Moderna, Inc. said it remains committed to its clinical development plans and is using a risk-based framework to evaluate new participant enrollment and new site initiation on a case-by-case basis. The pandemic has caused the company to pause enrollment in a Phase I rare disease trial for its pediatric respiratory vaccine. It is also suspending new enrollment of participants in the on-going hMPV/PIV3 study. Moderna has also paused enrollment in other trials. It is monitoring its Phase II CMV and Phase I Zika trials, both of which have been fully-enrolled. The company’s work on mRNA-1273, its vaccine candidate against the novel coronavirus continues to progress, Moderna said. While much of the company has gone to a remote-work situation, Moderna said essential in-person laboratory, manufacturing and related functions continue on site.
Other Industry News
The pandemic has forced pharma sales teams to harness virtual platforms since face-to-face interactions have been halted due to concerns over the spread of the virus. Could an increased reliance on virtual meetings last beyond the pandemic? Time will tell.