On October 3, 2019 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of drugs known as DARPin therapies*, reported that the first patient has been enrolled and dosed in a Phase 1 first-in-human study of MP0310 as a single agent in patients with advanced solid tumors (Press release, Molecular Partners, OCT 3, 2019, View Source [SID1234655788]). The trial, entitled MP0310-CP101, will evaluate the optimal dose range of MP0310 in preparation for planned combination studies with Amgen’s oncology pipeline products.
MP0310 is the first product candidate in Molecular Partners’ DARPin immuno-oncology pipeline. It is 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. Additionally, preclinical data show MP0310 avoids strong systemic activation of CD8 T cells and, therefore, has lower risk of the systemic side effects and toxicities.

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"We are delighted to have reached this important milestone in the development of our first immuno-oncology DARPin therapeutic candidate. MP0310’s tumor-localized activation offers promising therapeutic potential both as a monotherapy and in combinations, where it may act to widen the therapeutic window of combination agents," said Nicolas Leupin, M.D., Chief Medical Officer of Molecular Partners. "We look forward to the emerging clinical data and to progressing this therapy to patients in need."
MP0310-CP101 intends to enroll up to 54 patients at three sites in France. The open-label, dose-escalation study will evaluate the safety, tolerability and pharmacokinetics of MP0310 administered as a single agent by intravenous (IV) infusion every three weeks (q3w) to patients with locally advanced or metastatic solid tumors. Patients will be treated until disease progression or trial discontinuation for any other reason.
"This is an important milestone as we jointly investigate MP0310 in preparation for future combinations with Amgen’s immuno-oncology pipeline products with the goal of bringing innovative immunotherapies to patients with cancer," said Dirk Nagorsen, Vice President, Early Oncology Development, Amgen.

For more information, visit: View Source

Financial Calendar
October 31, 2019 Interim Management Statement Q3 2019
December 12, 2019 R&D Day in New York
February 6, 2020 Publication of Full-year Results 2019 (unaudited)
April 29, 2020 Annual General Meeting
View Source

*DARPin is a registered trademark owned by Molecular Partners AG

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 is abicipar, a molecule currently in phase 3, in partnership with Allergan. 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 solid and 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. MP0310 is expected to enter into the clinic 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. DARPin is a registered trademark owned by Molecular Partners AG.