Zenocutuzumab (Zeno) Has Been Granted a Second Breakthrough Therapy Designation by the U.s. Food & Drug Administration
Thursday, July 06, 2023
Merus N.V., a company focused on oncology research and development, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for their drug zenocutuzumab (Zeno). The designation is for the treatment of advanced unresectable or metastatic non-small cell lung cancer (NSCLC) patients with the NRG1 fusion (NRG1+), who have shown progression with previous systemic therapy.
The BTD for Zeno follows previous designations for the treatment of NRG1+ pancreatic cancer and metastatic solid tumors with NRG1 gene fusions. Zeno also received Orphan Drug Designation for pancreatic cancer treatment.
The BTD is based on data from the ongoing phase 1/2 eNRGy trial and Early Access Program (EAP), which investigate the safety and anti-tumor activity of Zeno as a monotherapy in NRG1+ cancer. The trial data has been presented at medical conferences, and over 175 NRG1+ cancer patients have received Zeno treatment as of June 2023.
Breakthrough Therapy Designation is granted to drugs that have the potential to provide significant improvements over existing therapies for serious or life-threatening conditions. It expedites the development and review process, allowing for closer guidance from the FDA and eligibility for priority review. Merus plans to engage in expedited discussions with the FDA and provide an update on the timeline for potential Biologics License Application (BLA) submission.
Merus intends to establish a commercialization partnership agreement to bring Zeno to NRG1+ cancer patients if it receives approval. The company plans to provide a clinical update on Zeno in NRG1+ cancer at a major medical conference in 2023.
In addition, Merus is evaluating Zeno in combination with androgen deprivation therapy for castration-resistant prostate cancer and in combination with afatinib for NRG1+ NSCLC patients. Clinical data on Zeno in castration-resistant prostate cancer is expected to be available in the second half of 2023.
Zeno is a Biclonics® antibody that enhances antibody-dependent cell-mediated cytotoxicity (ADCC) and inhibits the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions. Its unique mechanism of action makes it potentially effective against NRG1+ cancer by blocking tumor cell survival and inhibiting oncogenic signaling pathways.
Merus is currently enrolling patients in the eNRGy trial, which includes cohorts for NRG1+ pancreatic cancer, NRG1+ non-small cell lung cancer, and other NRG1+ cancers. More information about the trial can be found on the clinical trials registry website or Merus' trial website.
