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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.
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 (19th Oct) at 17:35, day 2 (20th 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
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the clinical development of Molecular Partners’ current or future product candidates, including expectations regarding timing of ongoing clinical trials, including receipt of data for such trials, and the potential therapeutic and clinical benefits of Molecular Partners’ product candidates. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, “would” and similar expressions, and are based on Molecular Partners AG’s current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Some of the key factors that could cause actual results to differ from our expectations include our plans to develop and potentially commercialize our product candidates; our reliance on third party partners and collaborators over which we may not always have full control; our ongoing and planned clinical trials and preclinical studies for our product candidates, including the timing of such trials and studies; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future clinical trials; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; the extent of clinical trials potentially required for our product candidates; the clinical utility and ability to achieve market acceptance of our product candidates; the potential impact of the COVID-19 pandemic on our operations or clinical trials; our plans and development of any new indications for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property position; our ability to identify and in-license additional product candidates; and other risks and uncertainties that are described in the Risk Factors section of Molecular Partners’ Registration Statement on Form F-1 filed with Securities and Exchange Commission (SEC) on June 14, 2021 and other filings Molecular Partners makes with the SEC. These documents are available on the Investors page of Molecular Partners’ website at http://www.molecularpartners.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Molecular Partners as of the date of this release, and Molecular Partners assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
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