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April 8 COVID-19 roundup: National Academy of Sciences says COVID-19 could continue through summer; plus HHS, SAb-CSL, Vanda-UIC, Avacta-Cytiva and more

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As companies and academic groups continue to form new partnerships and identify new drug targets to combat COVID-19, a National Academy of Sciences committee has warned there’s no guarantee the pandemic will be completely contained in the U.S. over the next few months.

A report from a National Academies of Sciences, Engineering, and Medicine (NASEM) committee found that the U.S. should not count on warmer weather to slow the spread of COVID-19.

The rapid expert consultation found that while “there is some evidence to suggest that the COVID-19 virus may transmit less efficiently in environments with higher ambient temperature and humidity,” the reduction in transmission efficiency “may not lead to a significant reduction in disease spread without the simultaneous adoption of major public health interventions.”

Published natural history studies have conflicting results and are hampered by poor data quality, the committee found. Additionally, while lab studies have shown a relationship between higher temperatures and humidity levels and reduced SARS-CoV-2 survival, there are many other factors that influence transmission rates among humans.

The report further pointed to Australia and Iran, countries currently with summer climates. Because the pair are experiencing rapid virus spread, “a decrease in cases with increases in humidity and temperature elsewhere should not be assumed.”

The committee also noted that the SARS and Middle East respiratory syndrome (MERS) coronaviruses “have not demonstrated any evidence of seasonality following their emergence.”

Separately, HHS on Wednesday authorized, under the Public Readiness and Emergency Preparedness Act, pharmacists to order and administer COVID-19 tests that have been authorized by FDA.

Trio of deals

SAb Biotherapeutics Inc. partnered with the CSL Behring unit of CSL Ltd. (ASX:CSL) to develop SAB-185, which is slated to enter the clinic mid-year. CSL has provided an undisclosed amount of seed funding, adding to the $7.2 million SAb said on April 2 it had secured via a collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense.

SAb will use the federal funds to complete manufacturing and preclinical studies of SAB-185, which comprises human polyclonal antibodies against SARS-CoV-2 directly produced by immunized, transgenic cows. CSL will contribute clinical, regulatory, manufacturing and supply chain expertise and resources.

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) is collaborating with the University of Illinois at Chicago to use high-throughput screening to identify compounds that block CTSL from cleaving SARS-CoV-2 glycoproteins involved in viral fusion. Deal terms weren’t disclosed.

Avacta Group plc (LSE:AVCT) partnered with Cytiva -- formerly GE Healthcare Life Sciences -- to develop and manufacture a point-of-care COVID-19 test using the former’s Affimer reagent technology. Avacta aims to have developed reagents that detect SARS-CoV-2 by the end of May, which can then be implemented in a test strip.

The pair plan to develop a test capable of diagnosing infection in minutes using a respiratory sample such as saliva.

Frankfurt study sparks Moleculin

Moleculin Biotech Inc. (NASDAQ:MBRX) said University of Frankfurt scientists showed in a preprint of a manuscript submitted to Nature Research that 2-deoxy-D-glucose -- of which the company’s WP1122 is a prodrug -- prevented SARS-CoV-2 replication in cell culture with an IC50 of 9.09 mM. The IC50 is a non-toxic concentration of the glucose analog that inhibits hexokinase and therefore blocks glycolysis.

Moleculin is conducting safety studies of WP1122 ahead of IND submission.

The University of Frankfurt team also suggested additional cellular functions that could be blocked to prevent SARS-CoV-2 replication. They reported that four other compounds via three mechanisms of action blocked viral replication with IC50 values of 0.007 μM to 0.47 μM: cycloheximide and emetine, which inhibit translation; pladeinolide B, which blocks a splicing factor; and a tool compound that interferes with proteostasis.

Moleculin gained $0.71 (126%) to $1.27 Wednesday giving it a market cap of about $70 million.

INDs from I-Mab, Bellerophon

FDA approved an IND from I-Mab Biopharma (NASDAQ:IMAB) for a clinical trial of TJM2 to treat cytokine release syndrome associated with severe COVID-19. I-Mab’s double-blind, three-arm study will test whether the neutralizing antibody against GM-CSF reduces the severity of COVID-19 complications as well as levels of multiple cytokines.

Separately, Bellerophon Therapeutics Inc. (NASDAQ:BLPH) submitted to FDA an IND to run the open-label PULSE-CVD19-001 study of INOpulse, a portable inhaled nitric oxide system, in COVID-19 patients who require supplemental oxygen. The adaptive trial in up to 500 patients will compare INOpulse with standard of care treatment.

FDA had already permitted treatment of COVID-19 patients with INOpulse via an expanded access program.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

Targets

CTSL - Cathepsin L

GM-CSF (CSF2) - Granulocyte macrophage colony-stimulating factor

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