Oct 03 2019
Zurich-Schlieren, SWITZERLAND—Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of drugs known as DARPin® therapies*, today announced 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. 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.
“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: https://clinicaltrials.gov/ct2/show/NCT04049903