Biotechs and Big Pharma in a Race Against Time Battling Global Health Crisis

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Mar 23, 2020, 08:45 ET

PALM BEACH, Florida, March 23, 2020 /PRNewswire/ -- In the months since the global public health crisis rose from a regional crisis to a global threat, drug makers large and small have scrambled to advance their best ideas for thwarting a pandemic. The crisis has catalyzed the development of novel vaccines across the biotech industry, both by pharmaceutical companies and research organizations such as the National Institutes of Health (NIH), U.S. Some are taking a cue from older antivirals. Some are tapping tried-and-true technologies, and others are pressing forward with futuristic approaches to human medicine. These major drugs that pharmaceutical companies across the world are developing have the potential to become major vaccines or antivirals for treating this crisis. The first vaccine in China is expected to be ready for clinical trials by the end of April according to Xu Nanping, China's vice-minister of science and technology. Inovio Pharmaceuticals plans to begin clinical trials on a vaccine in April this year. Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Sorrento Therapeutics, Inc. (NASDAQ: SRNE), Moderna, Inc. (NASDAQ: MRNA), Gilead Sciences, Inc. (NASDAQ: GILD), Inovio Pharmaceuticals, Inc. (NASDAQ: INO).

Health officials from WHO have noted that Gilead's remdesivir has demonstrated efficacy in treating the coronavirus infection. The President of the United States, Donald Trump, announced on 19 March that chloroquine (hydroxychloroquine/Plaquenil), a drug used to treat malaria and arthritis, was approved by the US Food and Drug Administration (FDA) to be tested as a treatment for crisis. Chloroquine is being tested in various clinical trials conducted by government agencies and academic institutions. Other antivirals drugs are also planned to be fast-tracked for testing.

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS: CNS Pharmaceuticals Signs Agreement with WPD Pharmaceuticals to Develop Drug Candidates for a Range of Viruses including Coronavirus for International Markets - CNS Pharmaceuticals, a biopharmaceutical company primarily specializing in the development of novel treatments for cancers of the brain and central nervous system, announces it has entered into an agreement with WPD Pharmaceuticals Inc. (CSE: WBIO) for the development of several preclinical drug candidates including WP1122, which is being tested on a range of viruses including the coronavirus SARS-CoV-2. WPD Pharmaceuticals previously licensed rights to a portfolio of drug candidates, including WP1122, from Moleculin Biotech, Inc. for certain territories. WPD Pharmaceuticals was founded by Dr. Waldemar Priebe.

According to WPD Pharmaceuticals, WP1122 is a prodrug of 2-DG (2-deoxy-D-glucose) that, based on recently developed preclinical data, appears to overcome 2-DG's lack of drug-like properties and is able to significantly increase tissue/organ concentration.

"We are pleased to expand our relationship with WPD Pharmaceuticals and to broaden our product pipeline to include antiviral drug candidates," commented John M. Climaco, CEO of CNS Pharmaceuticals. "While our primary focus remains in oncology, given our expertise in working with compounds like WP1122 we are grateful to be able to help in the urgent fight against deadly viral infections such as the coronavirus that causes Covid-19. This agreement complements our existing clinical programs by expanding our potential market opportunities."

Under the terms of the agreement, CNS agreed to fund a portion of the development costs of WP1122 and other drug candidates for antiviral indications in exchange for certain economic rights. CNS made an upfront cash payment of $225,000 and committed to a milestone payment of $775,000 to WPD Pharmaceuticals upon the successful completion of a Phase 2 study. In return, CNS is entitled to receive 50% of the net sales, less WPD's license costs, of resulting commercial products in WPD's licensed territories, other than Poland. Those territories include 29 countries in Europe and Asia, including Russia. Read this and more news for CNSP at: https://www.financialnewsmedia.com/news-cnsp/

Other recent developments in the biotech industry include:

Sorrento Therapeutics, Inc. (NASDAQ: SRNE) recently announced it has produced a preclinical batch of the STI-4398 (COVIDTRAP) protein to immediately commence testing its neutralization and blocking activity in preventing SARS-CoV-2 virus from infecting ACE2-expressing cells.

STI-4398 is a proprietary ACE2 (angiotensin-converting enzyme 2)-Fc fusion protein (COVIDTRAP). The STI-4398 protein binds to the S1 domain of the spike protein, which is expected to block the spike protein of the SARS-CoV-2 virus to bind the ACE2 receptors present on the target respiratory epithelial cells. Without the ability to penetrate target cells, the SARS-CoV-2 virus cannot replicate and spread itself. By interfering with the viral infection cycle, STI-4398 might be the most effective way to prevent an infection to progress to a fully advanced COVID-19 disease. This approach could be ideal in generating passive immunity and shielding at-risk populations, including healthcare providers, the elderly population or patients with compromised immune systems, from developing the COVID-19 disease after viral exposure.

Moderna, Inc. (NASDAQ: MRNA) recently announced that the first participant has been dosed in the Phase 1 study of the Company's mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2). This Phase 1 study is being conducted by the National Institutes of Health (NIH) under its own Investigational New Drug (IND) application.

The Phase 1 study is evaluating the safety and immunogenicity of three dose levels of mRNA-1273 (25, 100, 250 μg) administered on a two-dose vaccination schedule, given 28 days apart. A total of 45 healthy adults will be enrolled in the study. Participants will be followed through 12 months after the second vaccination. The primary objective is to evaluate the safety and reactogenicity of a two-dose vaccination schedule of mRNA-1273. The secondary objective is to evaluate the immunogenicity to the SARS-CoV-2 S protein.

Gilead Sciences, Inc. (NASDAQ: GILD) recently announced data from clinical and preclinical studies exploring the use of GS-6207, an investigational, novel, first-in-class inhibitor of HIV-1 capsid function, as a potential long-acting therapy for people living with HIV. Results from a Phase 1b proof-of-concept study of a subcutaneous formulation showed antiviral activity with GS-6207 through the last day of monotherapy, Day 10, with significantly greater reductions in HIV-1 RNA versus placebo across all treatment groups (20 to 750 mg; all p<0.0001). These data were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2020 in Boston.

"The antiviral activity and safety profiles demonstrated in these early preclinical and clinical studies suggest the potential of GS-6207 as a long-acting treatment for people living with HIV, including those with multi-class drug resistance," said Eric S. Daar, MD, Chief of the Division of HIV Medicine at Harbor-UCLA Medical Center, Chief of HIV Services at the Lundquist Institute for Biomedical Innovation, Professor of Medicine at UCLA. "A long-acting therapy could offer an important option for people living with HIV who are unable to take a daily pill. These findings are an encouraging step toward ensuring more treatment options to fit the diverse needs of people living with HIV."

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) recently announced that it has received a new $5 million grant from the Bill & Melinda Gates Foundation to accelerate the testing and scale up of CELLECTRA® 3PSP proprietary smart device for the intradermal delivery of INO-4800, a DNA vaccine for COVID-19. INO-4800 is in preclinical studies and is planned to advance into Phase 1 clinical trials in the U.S. in April.

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