- Nicolas Leupin, CMO, highlights progress in the development of all three DARPin® product candidates in clinical trials: MP0250 in phase 2 clinical development, MP0274 in phase 1, and MP0310 in co-development with Amgen
- Recent data presented for MP0250 in relapsed/refractory multiple myeloma at ASH underline the drug's unique ability to complement standard of care through its novel mechanism of action, focusing on the tumor microenvironment
- Following initial discussions with potential collaborators, strategic decision to engage in partnership evaluation for MP0250 in lieu of initiating MP0250/IMiD phase 2
- MP0317, a FAP x CD40 DARPin® molecule, nominated as the next IND candidate stemming from the company's immuno-oncology DARPin® toolbox
- Two-year data from the phase 3 trial on abicipar underline the drug's potential to be the first true 12-week anti-VEGF for wet AMD
- Daniel Steiner, SVP Research, highlights progress on novel therapeutic designs including tumor-localized immune-cell agonists, peptide-MHC complex DARPin® binders, and next-generation immune cell engagers
ZURICH-SCHLIEREN / ACCESSWIRE / December 12, 2019 / Molecular Partners AG (SIX:MOLN), a clinical-stage biotech company pioneering the use of DARPin® therapeutics to treat serious diseases, today announces the continued progress of its pipeline of proprietary therapeutic product candidates in oncology, as well as abicipar in ophthalmology.
"We are very proud to present the progress of our company over this past year. We continue to see success of our DARPin® platform, from its earliest inception, with abicipar, now on the verge of potential FDA approval, to the newest concepts of attacking previously unreachable targets in cancer, and beyond, with the emergence of our peptide-MHC platform. Our pipeline is set up to provide significant value for patients," said Patrick Amstutz, Ph.D., Chief Executive Officer of Molecular Partners. "Today we will hear from both world-class key opinion leaders as well as our own team highlighting our expertise in drug development and clinical execution and how we will continue to succeed into 2020 and beyond."
During its R&D Day in New York, entitled "Novel Therapeutic Designs Applied," the company will provide updates on its clinical and preclinical programs, including:
- Presentation of recently updated two-year results from CEDAR and SEQUOIA demonstrate that vision gains observed after one year with every 8-week and every 12-week dosing were maintained in the second year (presented at AAO 2019).
- Abicipar sustained vision gains in year two with quarterly injections compared to monthly ranibizumab.
- As stated at the 61st Annual Meeting of the American Society of Hematology (ASH) last week, MP0250 continues to show long-lasting and deepening responses across a variety of patients with multiple myeloma in the relapsed/refractory setting. MP0250 has a novel mechanism of action, designed to target both VEGF and HGF. This design makes MP0250 ideally suited to attack the underlying disease and potentially improve sensitivity, or re-sensitize patients, to existing and emerging treatments.
- The company also announced today its intent to evaluate partnering opportunities for MP0250. In conjunction with this endeavor, the company will not start the previously planned clinical trial investigating MP0250 in combination with an IMiD. This is aligned with the company's corporate strategy to pursue combination data for the most relevant clinical combinations of MP0250, which would be more appropriately determined in collaboration with a partner.
"Given the dynamic landscape of current and emerging treatments for multiple myeloma, along with our strong data recently presented at ASH, we believe that aligning with a partner with an existing hematology franchise will be the best way to accelerate the MP0250 program through the clinic and into the treatment paradigm. In recent discussions with potential collaborators, it is obvious that the time for evaluating this opportunity is now," said Nicolas Leupin, M.D., MBA, Chief Medical Officer of Molecular Partners.
- Also discussed today is MP0274, the second-most advanced DARPin® drug candidate in the oncology pipeline. It has broad anti-HER activity, inhibiting HER1, HER2 and HER3-mediated downstream signaling via HER2, leading to induction of apoptosis.
- The company continues to enroll patients and explore dosing in a phase 1 study.
- Current dose levels are presently up to 8mg/kg, and initial data is anticipated in H1 2020.
MP0310 (AMG 506):
- MP0310 is a multi-domain DARPin® targeting FAP x 4-1BB, designed to activate immune cells specifically in the tumor and not in the rest of the body, potentially delivering greater efficacy with fewer side effects. Preclinical studies of MP0310 have demonstrated immune T-cell activation restricted to solid tumor tissues, and strong CD8 T-cell activation and expansion in vitro and in vivo.
- The initial phase 1 study, being conducted by Molecular Partners, was initiated in mid-2019, and dose escalation is underway. Current clinical timelines are on track with initial data expected in H2 2020. In collaboration with Amgen, the clinical program is then expected to expand into additional combination cohorts, to be conducted by Amgen.
Beyond these clinical updates, the company will also detail its growing preclinical pipeline, including the data on FAP x CD40, now designated MP0317, a second multi-specific preclinical DARPin® designed for localized activation. In addition to these updates, the company will highlight advances in the DARPin® discovery platform, including the advent of peptide-MHC targeting and next-generation T-cell engagers.
In addition to an overview of the Molecular Partners clinical and preclinical pipeline, the R&D Day will feature presentations by the following experts:
- Dr. Jeremy Wolfe, Practicing Ophthalmology Specialist
- Dr. Stefan Knop, Department Head Hematology, University of Würzburg, Germany
- Dr. Jordi Rodon, Associate Professor, Department of Investigational Cancer Therapeutics, MD Anderson Cancer Center
The R&D Day for institutional investors, sell-side analysts, investment bankers, and business development professionals will take place at The Yale Club, 50 Vanderbilt Avenue, New York City, from 7:30 am - 10:00 am EST. To RSVP email Seth Lewis at [email protected]
Breakfast starts at 7:30 am EST. The presentations will begin at 8:00 am, followed by a Q&A session.
February 6, 2020
Publication of Full-year Results 2019 (unaudited)
April 29, 2020
Annual General Meeting
About the DARPin® Difference
DARPin® therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin® candidates can engage more than five targets, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin® technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.
With their low immunogenicity and long half-life in the bloodstream and the eye, DARPin® therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology and is advancing a proprietary pipeline of DARPin® drug candidates in oncology and immuno-oncology. The most advanced global product candidate in partnership with Allergan is abicipar, a molecule for which phase 3 data have been filed to the respective regulators in both the US and in Europe. Several DARPin® molecules for various ophthalmic indications are also in preclinical development. The most advanced DARPin® therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of hematological tumors. MP0274, the second-most advanced DARPin® candidate owned by Molecular Partners, binds to Her2 and inhibits downstream signaling, which leads to induction of apoptosis. MP0274 is currently in phase 1. The company's lead immuno-oncology product candidate MP0310 is a FAP x 4-1BB multi-DARPin® therapeutic candidate designed to locally activate immune cells in the tumor by binding to FAP on tumor stromal cells (localizer) and co-stimulating T cells via 4-1BB (immune modulator). Molecular Partners has closed a collaboration agreement with Amgen for the exclusive clinical development and commercialization of MP0310. The molecule has entered in phase 1 of clinical development in H2 2019. Molecular Partners is also advancing a growing preclinical and research pipeline in immuno-oncology that features its "I/O toolbox" and additional development programs such as novel therapeutic designs to target peptide-MHC complexes. DARPin® is a registered trademark owned by Molecular Partners AG.
About Molecular Partners AG
Molecular Partners AG is a clinical-stage biotech company that is developing a new class of therapies known as DARPin® therapeutics. The company continues to attract talented individuals who share the passion to develop breakthrough medicines for serious diseases. Molecular Partners has compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on oncology and immuno-oncology. The company establishes research and development partnerships with leading pharmaceutical companies and is backed by established biotech investors.
For more information regarding Molecular Partners AG, go to: www.molecularpartners.com.
For further details, please contact:
Seth Lewis, SVP IR, Comms, & Strategy
Tel: +1 781 420 2361
Lisa Raffensperger, International Media
Tel: +1 617 903 8783
Thomas Schneckenburger, IR & Media
Tel: +41 44 755 5728
This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Molecular Partners AG. This publication may contain certain forward-looking statements and assessments or intentions concerning the company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place reliance on these statements, particularly not in connection with any contract or investment decision. The company disclaims any obligation to update these forward-looking statements, assessments or intentions.
SOURCE: Molecular Partners AG