Keeping tabs on Covid-19: Five-dollar antigen test, next-gen Covid-19 vaccine prospect and therapeutic program for patients with respiratory distress

Last week’s focus honed in on how the pharma industry is boosting its manufacturing and delivery efforts to patients in need of a cure. This week, Pharma IQ outlines some of the most recent developments in the global fight to combat the Covid-19 pandemic from major biotech, pharma and medtech companies.

Abbott’s 15-minute Covid-19 antigen test received FDA emergency use authorization

Abbott has announced the US Food and Drug Administration (FDA) has issued Emergency Use Authorization for its BinaxNOW Covid-19 Ag Card test for detection of the Covid-19 infection. Abbott claimed the card-sized test can provide results in 15 minutes and will sell to patients in the US for US$5 per use.

Using the same technology at a pregnancy test, the portable device can be used by healthcare professionals in point-of-care settings that are qualified to have the test performed and aims to help manage risk and quickly identity infectious people so they don’t spread the disease to others. 

Abbott has also planned to launch a complementary mobile app alongside the device to allow people who have tested negative to display a temporary digital health pass. Organizations will be able to use this information to aid entry into facilities along with hand washing, social distancing, enhanced cleaning and mask-wearing.

In data submitted to the FDA, Abbott claimed BinaxNOW demonstrated a sensitivity of 97 per cent (positive percent agreement) and specificity of 98 per cent (negative percent agreement) in patients suspected of Covid-19 by their healthcare provider within the first seven days of symptom onset.

Robert B. Ford, president and chief executive officer at Abbott, said: “BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a complimentary digital health tool to help us have a bit more normalcy in our daily lives. The test has been designed to offer a comprehensive testing solution to help Americans feel more confident about their health and lives.”

Q BioMed announce GMP production of Covid-19 therapeutic clinical trial program 

Q BioMed, a commercial-stage biotech company, has announced alongside its technology partner, Mannin Research, a GMP production contract for MAN-19, a clinical-grade therapeutic intended to treat complications such as respiratory distress and vascular symptoms caused by Covid-19.

The Phase 1 clinical trial has been slated to begin patient enrollment in February 2021.

Mannin has claimed its therapeutics-based Tie2 platform has the potential to offer clinicians the chance to stabilize patient’s surfing from vascular leakage, pulmonary pathology and acute respiratory distress syndrome in hospital settings such as intensive care units, and improve outcomes for patients suffering from the coronavirus.

Denis Corin, chief executive officer at Q BioMed, stated: “There has been much talk of vaccines, but treatments are always going to be needed for people affected by these types of diseases, whether it's SARS-Cov-2 or another pathogen resulting in similar symptoms and complications. The Mannin Tie2 platform is designed to address life-threatening complications from a number of infectious diseases, including future potential viral threats. With the support of regulators, we expect this treatment to be in the clinic very early next year.”

Vaccitech awarded government grant to advance next-gen Covid-19 vaccine prospect

Vaccitech Ltd., a clinical-stage biopharmaceutical company, has received a non-dilutive government grant from the UK to support research with its next-generation technology platform to protect against Covid-19.

With the grant proceeds, Vaccitech has intended to complete preclinical studies and manufacture sufficient quantities required to initiate a Phase 1 clinical study of its new Covid-19 vaccine candidate in 2021.

Depending on clinical success, the vaccine could be a standalone product candidate and could be used to improve regimens of first-generation Covid-19 vaccines. If successful, the same technology platform could also be used in future epidemics to produce a vaccine against the relevant infectious agent quickly and effectively.

Bill Enright, chief executive officer at Vaccitech, said: “We are excited to support and rapidly advance our innovative technologies and potentially bring additional tools in the fight against this global pandemic.”

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