Zenocutuzumab (Zeno) granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration for NRG1+ pancreatic cancer treatment
Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company specializing in the development of innovative antibodies for cancer treatment, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for their drug zenocutuzumab (Zeno). This designation is specifically for the treatment of patients with advanced unresectable or metastatic NRG1 fusion (NRG1+) pancreatic cancer who have either experienced progression with prior systemic therapy or have no satisfactory alternative treatment options available.
The FDA's BTD is supported by data from the ongoing phase 1/2 eNRGy trial and Early Access Program (EAP), which are evaluating the safety and anti-tumor activity of Zeno as a monotherapy in NRG1+ cancer. This designation aims to expedite the development and review process for drugs targeting serious or life-threatening conditions, where preliminary clinical evidence suggests substantial improvement over existing therapies.
Zeno, an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics®, utilizes the Merus Dock & Block® mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions. Through its unique mechanism, Zeno has shown promising potential in inhibiting tumor cell proliferation and promoting tumor cell death in preclinical studies.
Merus is also exploring the use of Zeno in combination with androgen deprivation therapy for castration-resistant prostate cancer, regardless of NRG1+ status. This additional research aims to evaluate the effectiveness of Zeno in treating different types of cancers.
