- Ensovibep is shown in vitro to maintain inhibition against all variants of concern known to date
- The Company is also presenting a Trial in Progress poster on the EMPATHY clinical trial at the conference
ZURICH-SCHLIEREN, Switzerland, Oct. 20, 2021 (GLOBE NEWSWIRE) -- Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin ® therapeutics, today announced the presentation of in vitro data describing the inhibition capabilities of ensovibep against COVID-19 variants of concern at the International Society for Influenza and other Respiratory Virus Diseases (ISIRV) and World Health Organization (WHO) COVID-19, Influenza and RSV: Surveillance-Informed Prevention and Treatment conference, October 19-21, 2021. The results were selected for oral presentation. In addition, the Company will present a Trial in Progress poster on the EMPATHY clinical trial, conducted in collaboration with Novartis.
"As the pandemic progresses, the combination of insufficient vaccination rates with novel variants that can spread faster and break through patients' immunity results in a global patient population with a high, unmet need for treatment solutions, especially in the more severe cases," said Patrick Amstutz, Ph.D., Molecular Partners' CEO. "Our lead candidate, ensovibep, is currently being tested in two late-stage clinical trials, facing a very different patient population than the one that existed even half a year ago; New variants are continually evolving, and some, including most recently the Delta variant, impacting the way the disease behaves and spreads. As such, we must continually test ensovibep against new variants to ensure it has the potential to still be relevant for current and future patients. The results presented today, thanks to the massive efforts of our collaborators and our team, show that ensovibep maintains inhibition against these new variants, and remains highly relevant in this evolving field."
Inhibition of COVID-19 SARS-CoV-2 variants of concern: Ensovibep was designed with three DARPin domains that can bind to SARS-CoV-2 's spike trimer Receptor Binding Domains (RBD) simultaneously and cooperatively, and inhibit the virus from binding to the human ACE2 receptor. Molecular Partners, in collaboration with the NIH (ACTIV), the Spiez Laboratory and the University Hospital Center and University of Lausanne, has been continually analyzing the in vitro viral inhibition capabilities of ensovibep against newly discovered SARS-CoV-2 variants of concern. The Company and collaborators continually contribute data on ensovibep's performance to the comparative NIH database, which may be viewed here - NIH open data Therapeutic Activity Navigator.
In the results presented today, neutralization assays demonstrate ensovibep's ability to potently neutralize SARS-CoV-2 when testing the Wuhan or a reference strain. Further, as a multi-domain single molecule, ensovibep retains high in vitro potency against all frequent variants of concern, including those containing mutations where individual DARPin domains partially lose activity (e.g., E484K or Q493R/K). The Company believes this retention of potency for ensovibep is likely due to the cooperative binding and complementarity of the three DARPin units all working in a single molecule. Surface Plasmon Resonance (SPR) - an in vitro binding assay, as well as viral neutralization data from cell assays, reveal that mutations of the viral amino acid F486, reduces ensovibep binding. However, this protein site is crucial for the interaction with the ACE2 receptor, making the spread of these mutations unlikely. Finally, viral passaging experiments show ensovibep as comparable to monoclonal antibody cocktails with respect to minimizing the development of escape mutants.
Presentation details: Oral presentation title: Pre-clinical data of ensovibep, a multi-specific DARPin® therapeutic with high potency against all frequent SARS-CoV-2 variants Date and Time: October 20, 2021 16:00-16:15 (CET) Presenter: Francesca Malvezzi, Ph.D.
EMPATHY Trial in Progress: Molecular Partners and Novartis are collaborating on the development of ensovibep and are evaluating it in global late-stage study. The trial in progress poster presentation will summarize the study design of the ongoing double-blind, placebo-controlled EMPATHY ( NCT04828161) clinical trial, conducted by Novartis and sponsored by Molecular Partners. Part A of EMPATHY is enrolling approximately 400 ambulatory adult patients with symptomatic COVID-19, randomized 1:1:1:1 to a single, intravenous administration of ensovibep at three dose levels (75mg, 225mg, and 600mg) or placebo. The primary objective of Part A is to demonstrate superiority of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8. Based on Part A results, Molecular Partners and Novartis will decide which dose to take forward to Part B of EMPATHY, designed to demonstrate superiority of ensovibep, compared to placebo, in reducing the occurrence of hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29. Specific features of the trial include the need for a positive rapid antigen test on the day of dosing, and an exploratory standardized assessment for incidence of "Long COVID".
Trial In Progress details - Poster title: EMPATHY: A Ph2-3 Randomized, Placebo-Controlled Trial Evaluating Safety and Efficacy of Ensovibep in Ambulatory COVID-19 Patients Poster number: 114 Date and Time: Posters are accessible during the conference and so is the pre-recoded 3min video that includes a short sequence of the MoA video(Poster viewing time slots as per agenda start day 1 (19 th Oct) at 17:35, day 2 (20 th Oct) at 17:30) Authors: Marianne Soergel, Richa Chandra, Shantha Rao, Charles G. Knutson, Georg Hofstetter, Vaia Stavropoulou, Nina Stojcheva, Philippe Legenne, Jeff Kingsley
About Molecular Partners AG Molecular Partners AG is a clinical-stage biotech company developing DARPin® therapeutics, a new class of custom-built protein drugs designed to address challenges current modalities cannot. The Company has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics in the areas of ophthalmology, oncology and infectious disease, and has compounds in various stages of clinical and preclinical development across multiple therapeutic areas. www.molecularpartners.com; Find us on Twitter - @MolecularPrtnrs
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