Molecular Partners and AstraZeneca announce collaboration on Molecular Partners’ ongoing oncology clinical study with MP0250 in EGFR-mutated NSCLC

ZURICH-SCHLIEREN, Switzerland I Apil 11, 2018 I Molecular Partners AG (ticker: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin® therapies*, announced today that Molecular Partners and AstraZeneca (LON: AZN) will collaborate on Molecular Partners’ ongoing phase 1b/2 clinical study of MP0250 with osimertinib (Tagrisso®) for the treatment of patients with EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) pre-treated with osimertinib. Under the collaboration, AstraZeneca will supply osimertinib (Tagrisso®) required for the clinical study. The clinical study is planned to enroll approx. 40 patients and is taking place in the United States.

“We are delighted to welcome AstraZeneca as collaboration partner for our second phase 2 study of MP0250. This underlines the growing interest in MP0250 and nicely documents the potential value of MP0250 in EGFR-mutated NSCLC,” said Dr. Andreas Harstrick, Chief Medical Officer at Molecular Partners.

MP0250 offers the possibility of targeting two main tumor escape pathways by blocking both hepatocyte growth factor (HGF) and vascular endothelial growth factor (VEGF) simultaneously while continued treatment with osimertinib suppresses EGFR-mutated NSCLC tumor cells.

Osimertinib is a third generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases, which demonstrated significant benefit in untreated EGFR-mutated NSCLC patients in a global phase 3 trial last year. Osimertinib is currently marketed globally, as Tagrisso®, for the treatment of locally advanced or metastatic EGFR T790M NSCLC.

The clinical study[1] consists of two parts: the dose-escalation phase (Part A), to establish a safe
recommended dose for MP0250 in combination with osimertinib. In the subsequent treatment
expansion phase (Part B), patients will be further evaluated for efficacy and safety.

[1] ClinicalTrials.gov identifier NCT03418532

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 in 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 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 has moved 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

Molecular 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.

SOURCE: Molecular Partners

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