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Molecular Partners AG is a clinical-stage biopharmaceutical company based in Zurich, Switzerland. The company is developing a new class of potent, specific and versatile small-protein therapies called DARPins, with potential clinical applications in a range of disease areas including ophthalmology, oncology and immunology. Molecular Partners currently has two DARPin molecules in clinical development, and a broad pipeline of molecules in preclinical development.

Contents

1.   History

2.   DARPins

3.   Areas of Focus

4.   Partnerships/Business Development

5.   References

History

Researchers at the University of Zurich, Switzerland formed Molecular Partners AG in 2004 while studying monoclonal antibodies. These scientists discovered and developed the DARPin technology and launched the company using this platform.

Molecular Partners became a publicly traded company in November 2014, when it was listed on the SIX Swiss Exchange.

DARPins

DARPins are genetically engineered antibody mimetic proteins typically exhibiting highly specific and high-affinity target protein binding. They are derived from natural ankyrin repeat proteins. Repeat proteins are among the most common classes of binding proteins in nature, responsible for diverse functions such as cell signaling and receptor binding. DARPins constitute a new class of potent, specific and versatile small-protein therapies, and are used as investigational tools in various therapeutic and diagnostic applications.

The simplest format of a DARPin is the mono-DARPin, consisting of one DARPin domain with specificity for one target. The molecular mass of a mono-DARPin is about 15 to 20 kDa (kilodaltons), depending on the exact design. Several mono-DARPins can be linked (genetically or chemically) to multi-DARPins, which then combine multiple activities in one therapy. This approach enables the design of medicines that can inhibit multiple disease-specific targets and may improve outcomes for patients living with cancer, ophthalmic diseases and other disorders.

Currently, Molecular Partners has two DARPin molecules in clinical development and a broad pipeline of molecules in preclinical development.

Areas of Focus

Molecular Partners is currently focusing its DARPin platform on the fields of ophthalmology, oncology and immunology.

Ophthalmology

Molecular Partners’ most advanced clinical candidate is abicipar (AGN-150’998, MP0112), an anti-VEGF (vascular endothelial growth factor) DARPin in late-stage development, in partnership with Allergan. In Phase 2b studies, abicipar was shown to provide equal or potentially higher vision gains with fewer injections in patients with wet AMD (wet age-related macular degeneration), compared to standard anti-VEGF treatment with ranibizumab (Lucentis).

Currently, abicipar is being investigated in four different clinical trials. The first two are Phase 3 safety and efficacy studies in patients with wet AMD; the aim of these studies is to test the safety and efficacy of abicipar in patients with wet AMD. The third clinical trial is a Phase 2 safety and efficacy study in patients with wet AMD, designed to establish comparability between Japanese and non-Japanese patients. The fourth study is a Phase 2 safety and efficacy of abicipar in patients with diabetic macular edema.

Oncology

Molecular Partners’ lead candidate in oncology is MP0250, a proprietary multi-DARPin designed to inhibit VEGF and hepatocyte growth factor (HGF). The compound is being investigated in a Phase 1 clinical study in various solid tumor types.

In preclinical studies, MP0274, a proprietary multi-DARPin with broad anti-HER2 activity, has shown promising data in model of HER 2-positive breast cancer, including those with lower levels of HER2 expression.

Immunology

Molecular Partners is collaborating with Janssen Biotech on the development of DARPins for the treatment of inflammatory and auto-immune diseases.

Partnerships/Business Development

Molecular Partners is working with several pharmaceutical companies in the fields of ophthalmology and immunology.

Molecular Partners has negotiated three agreements with Allergan to develop therapies for ophthalmology (including abicipar), one in 2011 and two in 2012. Additionally, Molecular Partners initiated two agreements with Janssen Biotech, one in 2007 and one in 2011 to develop immunology therapies.

References

1. ^ Plückthun A (2015). “Designed ankyrin repeat proteins (DARPins): binding proteins for research, diagnostics, and therapy”. Annu. Rev. Pharmacol. Toxicol. 55: 489-511. doi: 10.1146/annurev-pharmtox-010611-134654. .

2. ^ Binz HK, Stumpp MT, Forrer P, Amstutz P, Plückthun A (2003)."Designing repeat proteins: well-expressed, soluble and stable proteins from combinatorial libraries of consensus ankyrin repeat proteins". J. Mol. Biol. 332 (2): 489–503. doi:10.1016/S0022-2836(03)00896-9. PMID 12948497.

3. ^ Molecular Partners AG Annual Report 2014 (PDF). March 2015.

4. ^ “Initial public offering markets reopen to European biopharmaceutical firms”. BioWorld. January 5, 2015.

5. ^ “Molecular Partners Rises in Trading Debut on Allergan Support”. FirstWordPharma. November 5, 2014.

6. ^ Binz HK, Amstutz P, Kohl A, Stumpp MT, Briand C, Forrer P, Grütter MG, Plückthun A  (2004). "High-affinity binders selected from designed ankyrin repeat protein libraries". Nature Biotechnology 22 (5): 575–582. doi:10.1038/nbt962. PMID 15097997.

7. ^ Clinical trial number NCT02181517 for "A Safety and Efficacy Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration" at ClinicalTrials.gov.

8. ^ “Molecular Partners Corporate Presentation” (PDF). September 2015.

9. ^ Clinical trial number NCT0246928 for “A Safety and Efficacy Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration (CDER)" at ClinicalTrials.gov.

10. ^ Clinical trial number NCT02181504 for "A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration" at ClinicalTrials.gov.

11. ^ Clinical trial number NCT02186119 for "A Study of Abicipar Pegol in Patients With Diabetic Macular Edema" at ClinicalTrials.gov.

12. ^ Clinical trial number NCT02194426 for "First-in-human Study to Investigate the Safety, Tolerability and Blood Levels of the Test Drug MP0250 in Cancer Patients" at ClinicalTrials.gov.

13. ^ “Allergan Licenses Molecular Partners’ Phase II Eye Disease Protein Therapeutic for $45M”. Genetic Engineering and Biotechnology News. May 4, 2011.

14. ^ “Molecular Partners Gets $62.5M as Allergan Repeats on Darpins”. Bioworld. August 21, 2012.

15. ^ “Janssen, Molecular Partners Expand Agreement to Immunological Diseases”. Genetic Engineering and Biotechnology News. December 8, 2011.

External Links
 * Molecular Partners official website