The Need for Comprehensive Diagnostics Remains as Cases Spike Once More - BioNTech (NASDAQ:BNTX)

NEW YORK, April 20, 2021 /PRNewswire/ -- The Director of the U.S. National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, and many other experts have warned that rapid reopening and lifting of pandemic restrictions in many states, as well as the proliferation of more contagious variants, will likely result in ongoing and increased spread of the virus in hot spots around the country. The pandemic remains a very real threat as the number of new cases spiked in the United States once again. Dr. Abdul El-Sayed, a former health commissioner for Detroit, explained, according to a report by CNN, that "vaccines don't work until they hit people's arms - and we just don't have enough vaccinations in people's arms yet to be able to achieve the kind of herd immunity that we need." Sunshine Biopharma Inc. SBFM, Fluidigm Corporation FLDM, BioNTech SE BNTX, Vaxart, Inc. VXRT, Vir Biotechnology, Inc. VIR

Overall, several developments have been made in the testing and treatment segments, as diagnostic testing has improved over the course of the last several months. Experts say that people who exhibit symptoms consistent with the infection, such as cough, fever, congestion, fatigue, headache or loss of sense of smell should get tested even if they have been vaccinated or previously had been diagnosed with the virus. Ahmad Gaber, Chief Executive Officer of Wellhealth and founder of GoGetTested, explained according to Healthline that "testing is important for two reasons. It warns the individual person, and it provides surveillance that allows us to find out what we can do about the disease from a public health perspective."

Sunshine Biopharma Inc. SBFM announced yesterday that, "it has successfully completed a Maximum Tolerated Dose (MTD) study in mice. Sunshine Biopharma is pleased to report that the MTD results are favorable and fall within the optimum range for use in humans. Next, Sunshine Biopharma will use the test dose indicated by these results to conduct the efficacy studies in hACE2-transgenic mice.

Sunshine Biopharma's COVID-19 treatment is an inhibitor of PLpro, a protease present only in the SARS Coronaviruses (Betacoronaviruses) and is an important antiviral target as it is involved in shutting down the host innate immune system thereby causing significantly greater morbidity.

'MTD is defined as the highest dose of a drug that does not cause unacceptable side effects or overt toxicity in a specific period of time. The MTD studies we conducted were designed with a minimum number of animals and included endpoints such as clinical observations and blood tests for liver function,' said Dr. Steve Slilaty, CEO of Sunshine Biopharma. 'We are delighted that our compounds passed this critical toxicology step with flying colors,' he added.

About Sunshine Biopharma's Coronavirus Treatment

Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) is the causative agent of the ongoing COVID-19 pandemic that has claimed the lives of over 3 million people worldwide since it first appeared in December 2019. There are currently no drugs that can effectively arrest replication of the virus in people who have contracted the illness. On May 22, 2020, Sunshine Biopharma filed a patent application for several molecules which were designed to inhibit the Coronavirus PLpro protease, thus shutting down the ability of the virus to multiply. PLpro is present only in the SARS Coronaviruses (Betacoronaviruses) and is an important antiviral target as it is involved in shutting down the host innate immune system. On February 1, 2021, Sunshine Biopharma entered into an exclusive license agreement with the University of Georgia for two additional Anti-Coronavirus compounds which the University of Georgia had previously developed and patented. Sunshine Biopharma is currently advancing the development of these two compounds in parallel with the Company's own (SBFM-PL4) by conducting a transgenic mice study in collaboration with the University of Georgia. The goal of the ongoing study is to determine if our protease inhibitors will protect the hACE2-transgenic mice from disease progression and death following infection with SARS-CoV-2. Should these mice studies prove successful, Sunshine Biopharma plans to submit the results to the FDA and Health Canada for authorization to conduct testing on actual COVID-19 patient volunteers in a Phase I clinical trial setting."

Fluidigm Corporation FLDM announced on March 1st, that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the AZOVA™ COVID-19 Test Collection Kit for use with the Fluidigm® Advanta™ Dx SARS-CoV-2 RT-PCR Assay on the company's Biomark™ HD platform. "We are excited about this collaboration with Fluidigm," said Cheryl Lee Eberting, MD, Founder and CEO of AZOVA. "Our goals are to enable any CLIA-certified laboratory that meets the requirements to perform high-complexity tests to process our home collection kits, and to make this kit accessible to as many consumers as possible. By combining a powerful digital health platform with this assay, AZOVA and Fluidigm are opening up much greater access to COVID-19 testing solutions.

BioNTech SE BNTX and Pfizer Inc. announced on March 26th, that the European Medicines Agency (EMA) approved storage of COMIRNATY® at -25°C to -15°C for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers. The new data is a testament to the companies' ongoing commitment to developing this vaccine further and collecting data in order to support broader and more flexible vaccine distribution and inoculation. "From the beginning our goal was to make our vaccine broadly available to people around the world. This approval by the EMA will enable us to access important additional channels to distribute and administer our vaccine," said Ugur Sahin, CEO and Co-founder of BioNTech. "It comes at an important point in time, as governments now have more flexibility to move from inoculations in vaccination centers to a more decentralized vaccine roll-out through local doctors and general practitioners to accelerate our path out of the pandemic."

Vaxart, Inc. VXRT announced last month preliminary data from its Phase 1 study of VXA-CoV2-1 showing that its oral COVID-19 tablet vaccine candidate was generally well-tolerated, and immunogenic as measured by multiple markers of immune response to SARS-CoV-2 antigens. "Our Phase I results highlight the importance of our differentiated vaccine design, as they suggest VXA-CoV2-1 could have broad activity against existing and future coronavirus strains. These results are timely, as we are seeing the emergence of new variants less responsive to first generation vaccines, thus making potential cross-reactivity another important advantage of next-generation vaccines," said Andrei Floroiu, Vaxart's Chief Executive Officer.

Vir Biotechnology, Inc. VIR and GlaxoSmithKline plc GSK provided back in March an update on the VIR-7831 (GSK4182136) arm of the National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. The companies were informed that while VIR-7831 met initial pre-specified criteria to continue to the next phase of the ACTIV-3 trial and there were no reported safety signals, sensitivity analyses of the available data raised concerns about the magnitude of potential benefit. The independent Data and Safety Monitoring Board (DSMB) has recommended that the VIR-7831 arm of the trial be closed to enrollment while the data mature. The companies will continue discussions with the NIH about appropriate ways to further assess the potential of VIR-7831 in the hospitalized population as all parties gain a fuller understanding of the still-emerging data. The DSMB recommendation was based on a routine, pre-planned safety and efficacy data review of the first 300 patients hospitalized with COVID-19 enrolled in ACTIV-3.

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