Biopharma Update on the Novel Coronavirus: April 10

CV Update_April 10

News information is not all-inclusive. Please check back for updates.

FDA Actions

Blood Purification System: The FDA issues and EUA for a blood purification system to treat adults who have tested positive for COVID-19, admitted to the ICU with confirmed or imminent respiratory failure.

Warning Letter: The FDA and the FTC issued a warning letter to Free Speech Systems LLC, DBA Infowars.com for selling fraudulent COVID-19 products.

Diagnostics Update: The FDA has worked with more than 270 test developers who plan to submit EUA requests to detect COVID-19. Also, 32 EUAs have been issued. The FDA has been notified that more than 150 laboratories have begun testing under the policies set forth in its COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.

Portable Cryogenic Oxygen and Nitrogen Containers: The FDA issues guidance to address the demand and availability of portable cryogenic oxygen and nitrogen containers.

Fecal Microbiota for Transplantation (FMT): The FDA updated the information in regards to safety precautions regarding the use of FMT, due to the potential risk of transmission of COVID-19. This update follows a safety alert posted on March 23, 2020.

Diagnostics

The College of American Pathologists (CAP) released a new proficiency testing (PT) program to detect COVID-19. Microbiology Committee members piloted the new program with a group of laboratories before making it available. The program is for nucleic and amplification testing and provides samples that are non-infectious and target consensus gene regions N, E, RdRp, and ORF1a, and allows labs to evaluate their entire workflow from nucleic acid extraction through detection.

Testing Therapies, Antivirals and Vaccines

As the COVID-19 pandemic continues globally, biopharma companies have rushed to develop vaccines, new drugs and repurpose old drugs in an attempt to slow, halt and prevent the disease. Several hundred clinical trials have been initiated to test drugs and vaccines. But one obstacle for sponsor organizations is simply finding the resources—experienced clinical trial sites. Boston-based Care Access Research, which develops and manages clinical research sites, launched the COVID-19 Clinical Trials Alliance. 

CanSino: CanSino plans to advance its COVID-19 vaccine candidate into Phase II soon, the company said following preliminary data from its Phase I trial. This will mark the first mid-stage vaccine candidate for the novel coronavirus. 

Samsung Biologics/Vir Biotechnology: Both companies announced a manufacturing agreement. Samsung Biologics will provide large scale manufacturing services for Vir’s COVID-19 development candidates. The lead SARS-CoV-2 mAb development categories are VIR-7831 and VIR-7832. Vir plans to enter directly into a phase II clinical trial within the next three to five months.

At least three different biotech companies are working on two ACE2-related drugs to find a solution to the COVID-19 pandemic. They are Vienna, Austria’s Apeiron Biologics, Cambridge, Massachusetts-based Alnylam Pharmaceuticals, and San Francisco-based Vir Biotechnology. Apeiron’s approach is to actually flood the body with more ACE2 in order to confuse the virus. Alnylam and Vir are taking a markedly different approach, instead of offering more ACE2, they are attempting to decrease the amount of available ACE2.

Hackensack Meridian Health researchers are searching COVID-19 survivors for therapeutic antibodies. It is believed these could be developed to treat the most severely affected patients.

Immunomic Therapeutics: Immunomic announced the collaboration with EpiVax and PharmJet. The collaboration will help to rapidly develop its nucleic acid vaccine candidate against COVID-19 leveraging its investigational UNITE platform.

BioCryst Pharmaceuticals announced that the company opened enrollment for a clinical trial assessing the safety, efficacy and antiviral effects of galidesivir in patients with COVID-19. Galidesivir is an investigational broad-spectrum antiviral drug that was safe and well tolerated in previously reported Phase I trials in healthy subjects. Galidesivir has demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including the coronaviruses that cause MERS and SARS.

Biocept, Inc. has verified a COVID-19 molecular diagnostic test, and plans to begin accepting physician-ordered testing requests for processing beginning on April 15.

Company Actions

Celularity: Celularity announced an expansion to its collaborative license agreement with Lung Biotechnology PBC. The extension will now include the treatment of COVID-19 and Acute Respiratory Distress Syndrome (ARDS). Lund Biotechnology PBC is a wholly-owned subsidiary of United Therapeutics Corporation.

10x Genomics provided a business impact update. It has worked to ensure the availability of its instruments and reagents to clinicians and researchers, including its Chromium Controller instruments used in Biosafety Level 3 (BSL3) facilities; worked to allow as many staffers as possible to work remotely, and is reviewing operating expenses to manage costs during the pandemic.

Aerie Pharmaceuticals offered updated guidance, noting sales of its Rhopressa and Rocklatan for ophthalmic conditions have declined, but it was partially offset from increasing 90-days’ supply activity. But since many eye doctors are closed, new prescription growth has slowed. It has seen no supply chain disruptions for the production of the drugs and says the European regulatory review of Roclanda is on track, and results for the drug’s Mercury 3 trial is now expected in late 2020 or early 2021.

Active Motif: Active Motif announced the launch of a portfolio of recombinant COVID-19 antibodies. Back in February, it announced the isolation of antibodies from patients in China recovering from COVID-19 related pneumonia. The portfolio of antibodies is now available for research and commercial applications.

LabCorp and Ciox Health will collaborate on a comprehensive U.S.-based COVID-19 patient data registry. This registry will house curated, HIPAA-compliant de-identified data sets to expedite clinical research and analyses related to COVID-19. This patient data registry is expected to enable researchers to better understand and characterize COVID-19 diagnoses and treatments and generate insights that will aid ongoing and future pandemic preparedness and prevention efforts.

Anyone who breathes is at risk for contracting COVID-19, the disease caused by the novel coronavirus, and the estimated 36 million Americans who have lung diseases are even more at risk for developing severe complications related to the disease. That was the dire statement from Harold Wimmer, president and chief executive officer of the American Lung Association. Wimmer made the comment during a Thursday afternoon conference call when the century-old organization announced a $25 million initiative to support the fight against COVID-19

Other Industry News

On Thursday, the American Medical Association (AMA) doubled down on its stance against using off-label medicines like hydroxychloroquine and chloroquine to treat COVID-19 patients.

As COVID-19 has swept across the world, companies have had to make significant adjustments to the way business is conducted in a global economy. It has impacted all types of operations, including clinical trials.

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones including COVID-19 lockdown’s impact on mental health.

Prior to the pandemic, the biopharma industry was something of a political punching bag for presidential candidates and the public, largely over drug prices. There appears to be a shift, as everyone looks to the industry to come up with solutions for preventing or treating the disease ranging from vaccine development to new antivirals or repurposed drugs. Some of the political changes include the Trump administration pivoting on its funding cuts to the CDC and the National Institute of Allergy and Infectious Disease, and the CARES Act passed by Congress includes funding for private research companies. Despite that, there is concern that government controls on pricing and development of some of these projects will act as a disincentive for companies to initiate or continue this work.

MedAxiom, an American College of Cardiology Companysurveyed its members to determine the impact of COVID-19 on cardiovascular organizations. They found that more than 20% of members programs have closed or plan to close 50% or more of their CV clinics, are seeing a 50 to 75% reschedule rates for CV procedures, and expect to see a significant revenue decline with the biggest impact—so far—expected in the second quarter. About 70% of the CV programs are leading on telehealth services and about 60% have changed physician staffing coverage.

The Institute of Human Virology (IHV) at the University of Maryland School of Medicine, along with researchers from Trieste, Italy, announced that they characterized a novel mutation in the RNA polymerase of specific viral strains of SARS-CoV-2 in patients in Europe and North America. The data shows the virus is evolving quickly and there may be different strains coexisting in Europe, North America and Asia, but more research is necessary to understand if there are biological significance between the mutations.

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