On October 12, 2017 Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies, reported that the first patient was dosed in the phase 1 clinical study of its oncology asset MP0274. MP0274 is a proprietary DARPin drug candidate for the treatment of HER2-positive cancer with a new mode of action compared to current standard of care antibodies (Press release, Molecular Partners, OCT 12, 2017, View Source [SID1234520868]).
The phase 1 study of MP0274 is a two part study in patients with advanced HER2-positive solid tumors. Part 1 will be conducted in three sites in Germany, Switzerland and the UK all of which are open to recruitment, and will assess safety, tolerability, pharmacokinetics and establish the recommended dose for further development. Part 2 will be conducted in the initial three sites as well as in additional sites and is designed to confirm safety and to assess preliminary efficacy at the recommended dose. Initial safety data are expected in the first half of 2018 and initial efficacy data towards the end of 2018.
“We are very pleased to have reached this important milestone to dose the first patient in our phase 1 study for patients with advanced HER-2 positive solid tumors with our novel drug candidate MP0274,” commented Dr. Andreas Harstrick, Chief Medical Officer at Molecular Partners. “With this milestone, Molecular Partners significantly expands its clinical portfolio besides the ongoing MP0250 clinical trials.”
Financial Calendar October 26, 2017 Q3 2017 Management Statement October 31, 2017 Extraordinary General Meeting November 9, 2017 R&D Day in New York February 8, 2018 Publication of Full-year Results 2017 (unaudited) March 16, 2018 Expected Publication of 2017 Annual Report April 18, 2018 Annual General Meeting View Source
About the DARPin Difference DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multispecificity 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 has just 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.