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sonelokimab (M1095/ALX-0761) (IL-17 A/F Nanobody) (MoonLake / Avillion / Merck (DE) / Ablynx)
Next higher product group | Nanobodies® (Ablynx) | |
Status | 2021-07-01 development p2 existent | |
Organisation | MoonLake Immunotherapeutics AG (Nasdaq: MLTX) | |
Group | MoonLake Immunotherapeutics (Group) | |
Organisation 2 | Ablynx N.V. (Euronext Brussels: ABLX, Nasdaq: ABLX) | |
Group | Sanofi (Group) [since May 2011] | |
MoonLake Immunotherapeutics AG. (7/1/21). "Press Release: MoonLake Immunotherapeutics Appoints Jorge Santos da Silva as CEO and Matthias Bodenstedt as CFO". Zug.
> Expert leadership team will drive planned acceleration of clinical development program for potentially best-in-class Tri-specific Nanobody® Sonelokimab in multiple indications
> Sonelokimab in-licensed from Merck KGaA, Darmstadt, Germany, in May 2021 with goal of transforming treatment of AFIDs, or IL-17A/F Inflammatory Diseases.
MoonLake Immunotherapeutics AG, a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory skin and joint diseases, today announced key leadership appointments. MoonLake aims to optimize and accelerate the “pipeline within a product” development of the potentially best-in-class Tri-specific Nanobody® Sonelokimab, which was in-licensed from Merck KGaA, Darmstadt, Germany, in May 2021. Sonelokimab has clinically-demonstrated potential to drive disease modification in dermatology and rheumatology patients with major unmet need. The Company has appointed Jorge Santos da Silva as Chief Executive Officer and Matthias Bodenstedt as Chief Financial Officer. The expanded leadership team will join co-founders Arnout Ploos van Amstel MSc. Econ, Chief Operating Officer, and Prof Kristian Reich MD, PhD, Chief Scientific Officer, whose appointments were announced in May.
Dr. Jorge Santos da Silva, Founder and CEO, commented: “Sonelokimab has the potential to transform the lives of patients affected by IL-17A/F-driven inflammatory diseases (AFID), It can offer them the chance of better disease control and that is something that moves us at MoonLake. I am very happy to be part of this first-class team of immunology specialists with the expertise to drive a comprehensive Phase 2 clinical trial program in AFIDs. This program will build on exciting Phase 2 data with Sonelokimab in Psoriasis. Our management team has the full complement of R&D, regulatory, manufacturing, access and commercial expertise to unlock the full potential of Sonelokimab for the benefit of patients and investors. We have a clear and ambitious strategic plan to execute and I am looking forward to get going. ”
Jorge Santos da Silva was previously Senior Partner at McKinsey & Company, Inc. For almost 15 years, Jorge was a leader in McKinsey’s Pharmaceutical & Medical Products Practice and in the Company’s Zurich office. He led several key groups at McKinsey over the last decade, including the Biotech group and the Biosimilars group, leading the consultancy’s thinking in several biotech-related topics. Over the years, he advised international biopharma and biotechs, on corporate and business-unit strategy, commercial operating models, R&D, organizational design, M&A, joint ventures, and marketing and sales. Jorge is a Ph.D. in Neuroscience and has broad scientific experience in molecular-, cellular- and neuro-biology, with several high profiles peer-reviewed publications during his career in Academia. He performed his research and earned his degrees in different institutions including Cold Spring Harbor Laboratory, the European Molecular Biology Laboratory, and the Universities of Glasgow and Turin. Jorge is also a Professor and a Board advisor at the School of Medicine at the Minho University in Portugal.
Matthias Bodenstedt was previously a Partner at McKinsey & Company and brings deep experience in the biopharmaceutical industry with a focus on finance and commercial strategy. At McKinsey, Mr. Bodenstedt served a diverse set of clients, ranging from pre-revenue biotechs to large global pharmaceutical companies. He was a key advisor on many industry-shaping transactions on the sell- and buy-side,and worked closely with senior executives on topics such as financing, M&A, BD&L, portfolio strategy, and go-to-market strategy and execution. Mr. Bodenstedt holds an M.B.A. from Columbia Business School, New York, an MPhil in Finance from the University of Cambridge, UK, and a B.Sc. in Industrial Engineering from the University of Hannover, Germany.
MoonLake Immunotherapeutics was founded in 2021, backed by a Series A financing led by BVF Partners LP. Other investors include Merck KGaA, Darmstadt, Germany. The Company intends to accelerate the clinical development of Sonelokimab, an investigational IL-17A/IL-17F inhibitor with an albumin binding site, which has the potential to facilitate deep tissue penetration in the skin and joints. This group of IL-17A/F Inflammatory Diseases (also known as AFID) includes psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa – conditions affecting millions of people worldwide with a major need for improved treatment options. Multiple Phase 2 trials are expected to be launched soon.
The Company will build on robust clinical data generated by Merck KGaA, Darmstadt, Germany, and by Ablynx, a Sanofi company, which discovered the molecule. Full results of a Phase 2b study of Sonelokimab in psoriasis published in The Lancet in May showed impressive efficacy with a favorable safety profile, and numerical outperformance of the active control, secukinumab.
For enquiries, please contact:
MoonLake Immunotherapeutics AG
Arnout Ploos van Amstel
Kristian Reich MD PhD
E: [email protected]
Mo PR Advisory
Mo Noonan/Jonathan Birt
Tel: +44 (0) 7876 444977 / (0) 7860 361746
Notes to Editors
About AFID (IL-17A/F Inflammatory Diseases)
AFID is a novel concept aiming to classify inflammatory diseases in which over-expression of the cytokines IL-17A and IL-17F is a major driver of the pathophysiology. Millions of people are suffering from AFIDs and there are limited treatment options for high-level clinical improvement. AFIDs include:
> Psoriatic arthritis (PsA) (prevalence: up to 0.5% and ~20% of patients with psoriasis); up to 40% of patients with PsA have axial disease2,3
> Axial spondyloarthritis (axSpA) (prevalence up to 1.6%); split into non-radiographic axial SpA (nr-axSpA) and ankylosing spondylitis (AS, r-axSpa; prevalence: up to 0.3%)4
> Hidradenitis suppurativa (HS) (prevalence: up to 1.2%); currently underdiagnosed/undertreated with limited effective treatment options available5
> Psoriasis (prevalence: ~2.5%); more than 1/3 of patients living with psoriasis have psoriatic arthritis or other persistent manifestations, such as nail disease2
> Other potential AFIDs include palmoplantar pustulosis (PPP), generalized pustular psoriasis (GPP) and pyoderma gangrenosum (PG)
About Nanobodies® (single-domain antibodies)
A single-domain antibody (sdAb), also known as a Nanobody®, is an antibody fragment consisting of a single monomeric variable antibody domain. Like antibodies, Nanobodies® are able to bind selectively to a specific antigen with high affinity.
Whole antibodies are composed of two immunoglobulin heavy chains and two light chains. The first single-domain antibodies were engineered from heavy-chain only antibodies to create an antibody fragment – a Nanobody®. Nanobodies® have the same or higher affinity and specificity compared to traditional antibodies yet have approximately 1/10th of the molecular weight. They offer a number of potential advantages including an easier manufacturing process, a higher thermostability, and the potential to create multivalent molecules with enhanced ability to penetrate inflamed tissue, especially when containing an additional albumin binding domain such as Sonelokimab1.
The terms Nanbody® and Nanobodies® are trademarks of Ablynx, a Sanofi company.
About MoonLake Immunotherapeutics
MoonLake Immunotherapeutics AG, founded in 2021, is a clinical-stage biopharmaceutical company leveraging Nanobody® technology to develop next-level medicines for immunologic diseases, including inflammatory skin and joint diseases. MoonLake Immunotherapeutics has a portfolio of therapeutic programs based on Sonelokimab (M1095/ALX-0761), a biologic molecule potentially capable of driving disease modification in dermatology and rheumatology patients.
1) Papp KA et al. Lancet 2021; 397:1564-75
2) Coppegieters K et al., Arthritis Rheum 2006; 54:1856-66; Tijink BM, et al. Mol Cancer Ther. 2008;7:2288-97
3) Reich K, et al. Br J Dermatol. 2009; 160:1040-1047
4) Alinaghi F, et al. J Am Acad Dermatol. 2019; 80:251-265.
5) Dean LE et al. Rheumatology 2014; 53:650–657.
6) Nguyen TV, et al. J Eur Acad Dermatol Venereol. 2021; 35:50-61.
7) The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company
Record changed: 2023-07-10 |
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More documents for sonelokimab (M1095/ALX-0761) (IL-17 A/F Nanobody) (MoonLake / Avillion / Merck (DE) / Ablynx)
- [1] MoonLake Immunotherapeutics AG. (6/28/23). "Press Release: MoonLake Immunotherapeutics Announces Pricing of $400 Million Upsized Public Offering of Class A Ordinary Shares". Zug....
- [2] MoonLake Immunotherapeutics AG. (6/26/23). "Press Release: MoonLake Immunotherapeutics Announces Proposed Underwritten Public Offering". Zug....
- [3] MoonLake Immunotherapeutics AG. (6/25/23). "Press Release: MoonLake Immunotherapeutics Achieves Landmark Milestone with Positive Phase 2 Results for Nanobody Sonelokimab in Hidradenitis Suppurativa". Zug....
- [4] MoonLake Immunotherapeutics AG. (10/4/21). "Press Release: MoonLake Immunotherapeutics AG and Helix Acquisition Corp. Announce Business Combination Agreement to Create Publicly Listed Biotechnology Company Advancing Tri-specific Nanobody Sonelokimab". Zu...
- [5] MoonLake Immunotherapeutics AG. (8/10/21). "Press Release: MoonLake Immunotherapeutics Appoints Former Kymab CEO Simon Sturge as Chairman and Spike Loy to the Board of Directors". Zug....
- [6] MoonLake Immunotherapeutics AG. (5/6/21). "Press Release: MoonLake Immunotherapeutics Announces Publication in The Lancet". Zug....
- [7] MoonLake Immunotherapeutics AG. (5/3/21). "Press Release: MoonLake In-licensing and Launch". Zug....
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