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Novartis Gains Synthetic Protein Therapies for Covid-19

SARS-CoV-2 and cell

Scanning electron microscope image shows SARS-CoV-2 viruses emerging from the surface of cells cultured in the lab. (NIAID, NIH)

28 Oct. 2020. Global drug maker Novartis is gaining access to two Covid-19 therapy candidates made from a library of synthetic protein components. The option-licensing and investment deal with Novartis, in Basel, Switzerland could bring biotechnology company Molecular Partners in Zurich as much as CHF 210 million ($US 230 million) if all aspects of the agreement are fulfilled.

Molecular Partners develops treatments for cancer and eye disorders, as well as antiviral therapies for Covid-19, from synthetic protein components, assembled to address specific disease targets and other product needs. These protein modules that the company calls DARPins are simplified, scaled-down proteins, one-tenth the size of full antibodies, designed to bind to a single domain on their targets.

The company says it maintains a library of 1012 (1 trillion) DARPin components that can be assembled in combinations of six modules to meet specific targeting and treatment requirements, as well as meet other product specifications, such as limiting off-target effects, extended activity in the body, or longer shelf life. DARPin-based therapies are currently in clinical trials for the eye disorders age-related macular degeneration and diabetic macular edema, as well as blood-related and solid-tumor cancers.

For Covid-19, Molecular Partners is developing two DARPin therapies code-named MP0420 and MP0423. The synthetic proteins are designed to protect ACE2 receptors in human cells, their main target, from SARS-CoV-2 coronaviruses responsible for Covid-19 infections. The DARPin therapies also block the actions of the virus’s spike surface proteins, and prevent viral escape if the virus mutates. The company says its Covid-19 treatments are configured as well to bind to albumin, an abundant protein in the blood, to extend therapeutic activity in the body, and can be designed for a longer shelf life without refrigeration.

Earlier this month, Molecular Partners reported on preclinical tests of MP0420 and MP0423. In a study conducted at Free University of Berlin, lab hamsters were infected with SARS-CoV-2 viruses, then given three doses of MP0420, MP0423, or a placebo in a 24 hour period. All animals receiving MP0420 or MP0423 recovered and survived, while most of the placebo recipients became diseased and were euthanized. The findings were company-reported and not peer-reviewed.

“As a class, DARPin therapeutics have demonstrated over years of clinical research a number of characteristics that enhance their profile as antiviral therapeutics for a global pandemic,” says Molecular Partners CEO Patrick Amstutz in a statement. “We have built on this long-term research with these two candidates, which have demonstrated extremely potent neutralization of the virus through inhibiting multiple viral mechanisms.”

The agreement gives Novartis an option to license MP0420 and MP0423, and during that period Molecular Partners will continue development of MP0420, including an early-stage clinical trial, and complete preclinical work on MP0423. Molecular Partners is receiving an initial cash payment of CHF 20 million, with Novartis taking a 6 percent equity stake in Molecular Partners valued at CHF 40 million.

If Novartis exercises the option to license the Covid-19 therapies, Molecular Partners will be eligible for CHF 150 million in milestone payments as well as 22 percent royalties on sales, although Molecular Partners agreed to forego royalties from lower income countries. Novartis will conduct mid- and late-stage clinical trials of MP0420 and MP0423. Molecular Partners will work with Novartis’s Sandoz division to scale up manufacturing for worldwide distribution.

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