- First patient dosed in phase 2 Multiple Myeloma study
- IND submission to FDA in H2 2017 planned for MP0250 in EGFR-mutated Non-Small Cell Lung Cancer (EGFR mut NSCLC)
Zurich-Schlieren, May 30, 2017. Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin® therapies, today announced that the first patient was dosed in the phase 2 multiple myeloma study of its lead oncology asset MP0250. In the first phase 2 study, the efficacy and safety of MP0250 will be examined in combination with bortezomib (Velcade®) and dexamethasone in patients with multiple myeloma who have failed standard therapies. The study will be performed in three different countries: Germany, Poland and Italy. Initial safety data are expected in 2017 and efficacy data in 2018.
In addition, the company announced that MP0250 will also be further evaluated in solid tumors. Molecular Partners intends submit to the FDA in H2 2017 an Investigational New Drug Application (IND) for a phase 1b/2 trial of MP0250 in combination with osimertinib (Tagrisso®) in EGFR-mutated T790M-positive Non-Small Cell Lung Cancer (NSCLC) patients. Osimertinib, a third-generation TKI targeting EGFR (Epidermal Growth Factor Receptor), has recently become the standard treatment for those NSCLC patients which harbor a T790M mutation. Despite this novel treatment, patients eventually relapse and treatments become ineffective. MP0250 offers the possibility to target two of the described escape pathways – HGF and VEGF. The combination of MP0250 with osimertinib is expected to continuously block the EGFR-mutated pathway and simultaneously inhibit two additional non-EGFR related pathways of resistance.
“We are pleased and proud to have reached this important milestone to dose the first patient in our multiple myeloma phase 2 study. This is the first step to test our hypothesis that MP0250 can address resistance pathways in various hematological and solid tumors. The submission of an IND for the first solid tumor indication will be another important milestone in the development program of our lead oncology asset MP0250 later this year,” commented Dr. Andreas Harstrick, Chief Medical Officer at Molecular Partners.
|August 30, 2017||Publication of 2017 Half-year Results|
|October 26, 2017||Q3 2017 Management Statement|
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 are potent, specific, safe and very versatile. They can engage in more than 5 targets at once, 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 good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin® therapies 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. The most advanced global product candidate is abicipar, a molecule currently in Phase 3, in partnership with Allergan. Several DARPin® molecules for various ophthalmic indications are also in development. The most advanced systemic DARPin® molecule, MP0250, is in Phase 1 clinical development for the treatment of solid tumors and has entered into Phase 2 development for hematological tumors. In addition, Molecular Partners intends to further evaluate MP0250 for solid tumors in a phase 1b/2 trial for EGFR-mutated T790M-positive NSCLC. MP0274, the second-most advanced DARPin® drug candidate in oncology, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently moving into Phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin® is a registered trademark owned by Molecular Partners AG.
About Molecular Partners AG
MMolecular Partners AG is a clinical-stage biopharmaceutical company that is developing a new class of therapies known as DARPin® therapies. With a management team that includes many of the founding scientists, 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 ophthalmology and 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:
Dr. Patrick Amstutz, CEO
Tel: +41 (0) 44 755 77 00
Tel: +41 (0) 44 755 77 00
Tel: +41 (0) 43 344 42 42
Susan A. Noonan
S.A. Noonan Communications, LLC
Tel: +1 212 966 3650
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.