MOLN Molecular Partners AG
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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Ensovibep (EMPATHY)
COVID-19
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Phase 2/3
Phase 2/3
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Sotrovimab (VIR-7831 / GSK4182136) - (ACTIV-3)
Mild to moderate COVID-19
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Phase 3
Phase 3
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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MP0274
HER2-positive cancers
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Phase 1
Phase 1
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Phase 1 trial has been completed.
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MP0250
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Phase 2
Phase 2
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Phase 2 trial has been completed.
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ABICIPAR
Age-related macular degeneration (AMD)
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CRL
CRL
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CRL issued June 26, 2020.
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MP0317
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Phase 1
Phase 1
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Phase 1 trial planned.
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AMG 506 (MP0310)
FAP-positive cancers
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Phase 1
Phase 1
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Phase 1 trial ongoing.
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Ensovibep
COVID-19
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Phase 2
Phase 2
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Phase 2 trial initiated April 2021 in Netherlands.
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Latest News
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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.
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 (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 KingsleyAbout 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 - @MolecularPrtnrsCautionary 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.
For further details, please contact: Seth Lewis seth.lewis@molecularpartners.com Tel: +1 781 420 2361 Shai Biran, Ph.D. shai.biran@molecularpartners.com Tel: +1 978 254 6286 Thomas Schneckenburger, European IR & Media thomas.schneckenburger@molecularpartners.com Tel: +41 79 407 9952
- Ensovibep is shown in vitro to maintain inhibition against all variants of concern known to date
-
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ZURICH-SCHLIEREN, Switzerland, Sept. 03, 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 that its Chief Executive Officer, Patrick Amstutz, Ph.D., will present at two upcoming virtual healthcare investor events in September 2021.
Conference Presentation Details:
- Event: Morgan Stanley 19th Annual Global Healthcare Conference
- Date/Time: Friday, September 10, 11:00 AM – 11:45 AM ET (5:00 PM – 5:45 PM CET)
- Event: H.C. Wainwright 23rd Annual Global Investment Conference
- Date/Time: September 13-15, 2021; Presentation available on demand from Sept. 13, 7:00 AM ET (1:00 PM CET)
All webcasted presentations will be made available on the Molecular Partners website.
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; Follow the Company on Twitter at @MolecularPrtnrs.
FOR FURTHER DETAILS, PLEASE CONTACT: Seth Lewis, SVP IR, Comms, & Strategy seth.lewis@molecularpartners.com Tel: +1 781 420 2361 Shai Biran, Ph.D., Associate Dir. IR & Comms shai.biran@molecularpartners.com Tel: +1 978 254 6286 Thomas Schneckenburger, European IR & Media thomas.schneckenburger@molecularpartners.com Tel: +41 79 407 9952
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- Global rights to registrational-stage ophthalmology drug return to Molecular Partners
- Improvements in manufacturing and formulation have been made and tested in pre-clinical models with the potential to overcome inflammatory side effects
- Ongoing research discovery alliance with AbbVie in ophthalmology to continue
ZURICH-SCHLIEREN, Switzerland, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to Art. 53 LR
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, announced today the receipt of notification from its partner, AbbVie Inc., regarding its termination of the license and collaboration agreement for the investigational drug abicipar pegol for the treatment of neovascular age-related macular degeneration (nAMD) and Diabetic Macular Edema (DME). As such, Molecular Partners will regain the development and commercial rights of abicipar on a worldwide basis."There remains a significant unmet medical need for patients living with nAMD and DME, and we remain confident in abicipar's potential to offer these patients a differentiated treatment option over existing therapies," said Patrick Amstutz, Chief Executive Officer of Molecular Partners. "Our focus for this program will be determining the best path to value creation within the context of our expansive portfolio of antiviral and immuno-oncology therapies in development."
Molecular Partners will form a special committee to evaluate the program and determine appropriate next steps. In addition, Molecular Partners and AbbVie will continue their ongoing discovery alliance, in which AbbVie will continue to evaluate additional DARPin® candidates for ophthalmic indications. The return of the abicipar program is not expected to impact Molecular Partners' financial outlook for 2021 or previously issued guidance.
Abicipar is a long-acting anti-VEGF DARPin® molecule which was invented by Molecular Partners and initially licensed to Allergan in 2011. The program has been through two positive Phase 3 studies, CEDAR and SEQUOIA, which supported the non-inferior efficacy of the abicipar quarterly dosing regimen to maintain vision gains with more than 50 percent fewer injections versus ranibizumab (13 vs. 6) dosed monthly in the first year.
With the acquisition of Allergan by AbbVie, the rights to abicipar were transferred to AbbVie. In June 2020, AbbVie received a Complete Response Letter to the Biologics License Application for abicipar pegol, indicating that the rate of intraocular inflammation observed following administration of Abicipar pegol resulted in an unfavorable benefit-risk ratio in the treatment of nAMD (AMD), and that additional work would be required to demonstrate a lower rate of ocular inflammation than what was previously seen in the Phase 3 studies.
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. 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; 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; 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.
For further details, please contact:
Investors:
Seth Lewis
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361Media:
Shai Biran, Ph.D.
shai.biran@molecularpartners.com
Tel: +1 978 254 6286Thomas Schneckenburger, European IR & Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952
- Global rights to registrational-stage ophthalmology drug return to Molecular Partners
-
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- Ensovibep maintains potency in an in vitro assay and demonstrated full inhibition of all newly emerging known variants of concern, including the Delta variants of concern
- EMPATHY Phase 2/3 trial enrolling ambulatory patients in 5 countries with more countries to be added in the coming months, with interim data expected in H2 2021 and full topline data expected in early 2022
- ACTIV-3, a Phase 3 trial enrolling hospitalized patients across 4 countries with more countries expected to be added in the coming months, with topline data expected in 2022
- Subcutaneous formulation on track for initiation of clinical trials in H2 2021
ZURICH-SCHLIEREN, Switzerland, July 08, 2021 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to Art. 53 LR
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 reported on the clinical progress of its novel antiviral candidate, ensovibep, as part of a presentation with its partner Novartis at the 1st Credit Suisse ESG Forum Switzerland virtual event. Ensovibep is designed to bind and inhibit SARS-CoV-2, the virus that causes COVID-19. Ensovibep is currently being studied in a Phase 2 single-arm pilot study in ambulatory patients in the Netherlands; a global Phase 2/3 study in ambulatory patients, conducted in collaboration with Novartis (EMPATHY); and a National Institutes of Health (NIH)-sponsored global Phase 3 study in hospitalized patients as part of the ACTIV-3 master protocol.
During today's presentation, management outlined initiation of a subcutaneous program to align with the global registrational studies presently underway using administration via infusion. Initiating this year, the studies will evaluate ensovibep delivered subcutaneously to healthy individuals and subsequently to COVID-19 patients. Subcutaneous administration may increase ease and speed of administration to complement ensovibep's simple, high yield manufacturing process, stability, and potential inhibition of all major viral variants to-date.
"The need for antiviral treatment that is active against all viral variants emerging globally continues to be critical, especially in a context of mixed vaccination rates," said Patrick Amstutz, Ph.D., chief executive officer of Molecular Partners. "We continue to be encouraged by the in vitro data seen for ensovibep against all known viral variants of concern. As we and Novartis continue to open additional clinical sites in multiple countries, data such as these suggest we can offer a truly differentiated solution to patients in need."
The EMPATHY study is presently enrolling across 5 countries, with continued expansion expected into additional territories as the evolving pandemic dictates. The ACTIV-3 study is presently enrolling patients in the hospitalized setting for assessment with ensovibep across more than 50 centers in 4 countries. The ACTIV-3 study protocol is open for recruitment in the hospitalized setting across 120 centers presently with more centers to open in the coming months. The program is aimed to be active in countries where the virus has high case numbers and to cover emerging variants on a global level.
Finally, and in parallel to the clinical progress updated today, ensovibep continues to be evaluated for its potency and inhibition against all emerging and established variants of concern. These evaluations are conducted across multiple laboratories, including the NIH. In vitro data to date show that ensovibep retains full potency and viral inhibition against all known SARS-CoV-2 variants in circulation, including the key Delta variants containing the T478K and K417N mutations, presently a particular concern as it may be associated with higher infectivity rates, even in individuals who are vaccinated.
About Molecular Partners' anti-COVID-19 program
Molecular Partners' Molecular Partners' two antiviral DARPin® candidates, ensovibep and MP0423, are designed to target multiple different sites on the SARS-CoV-2 virus simultaneously for enhanced antiviral effects and potential use as both COVID-19 prophylaxis and treatment. The benefits of this multi-specificity include cooperative binding, high potencies and potential prevention of viral escape via mutations. The candidates are formatted with a DARPin® domain that binds to human serum albumin (HSA) to support a longer half-life and hence longer activity. All DARPin® candidates are constructed to benefit from high-yield and cost-effective manufacturing. Molecular Partners is investigating whether the high thermal stability of DARPin® molecules can be used to overcome cold-chain requirements.In March 2021, the Company announced positive initial data from its Phase 1 study of ensovibep in healthy volunteers, which showed that ensovibep was safe and well-tolerated with a half-life of 2-3 weeks. In October 2020, Molecular Partners entered into a collaboration with Novartis AG in the form of an option agreement to develop, manufacture and commercialize Molecular Partners' anti-COVID 19 DARPin® candidates. Per the terms of the agreement, Molecular Partners will conduct Phase 1 clinical trials for ensovibep and perform all remaining preclinical work for MP0423; Novartis will conduct Phase 2 and Phase 3 clinical trials, with Molecular Partners as sponsor of those trials. Upon option exercise, Novartis would be responsible for all further development and commercialization activities. Molecular Partners is also collaborating with AGC Biologics, Baccinex, and Ivers-Lee Clinical Supply Management (IL-CSM) to support development of its anti-COVID-19 program, and has reached an agreement with the Swiss Government regarding rights to purchase up to 3.2 million doses of ensovibep, if it is approved in Switzerland.
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 - @MolecularPrtnrsCautionary 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. 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; 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; 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.For further details, please contact: Investors: Seth Lewis seth.lewis@molecularpartners.com Tel: +1 781 420 2361 Media: Shai Biran, Ph.D. shai.biran@molecularpartners.com Tel: +1 978 254 6286 Thomas Schneckenburger, European IR & Media thomas.schneckenburger@molecularpartners.com Tel: +41 79 407 9952