Clinical Trials

Zeno (zenocutuzumab)

eNRGy clinical trial for cancer patients with solid tumors harboring NRG1 gene fusion

Zeno (zenocutuzumab, or MCLA-128) is an investigational therapeutic candidate being studied in the eNRGy trial, a phase 1/2 clinical study in cancer patients who have solid tumors that have a specific genetic abnormality called an NRG1 fusion. Zeno is believed to work by blocking the protein produced by the NRG1 fusion that has cancer-driving activity.

At this time, there is no approved therapy for the specific treatment of NRG1 fusion-positive (NRG1+) solid tumors.

The eNRGy trial is enrolling patients with NRG1+ cancers at more than 30 medical centers around the world. The eNRGy trial is assessing the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers, in patients across three cohort groups: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer; and NRG1+ other solid tumors.

Further details about the eNRGy clinical trial for Zeno, including current trial sites, can be found at Merus’ trial website www.nrg1.com or by calling 1-833-NRG-1234.

Information is also available at the clinicaltrials.gov website:
A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion

Expanded Access Program

Patients with NRG1+ solid tumors that are otherwise unable to participate in an applicable clinical trial may be eligible to participate in the Early Access program for zenocutuzumab (MCLA-128).

Further details about the Zeno expanded access program can be found at Merus’ trial website www.nrg1.com or by calling 1-833-NRG-1234. Details on Merus’ Expanded Access Policy are available here.

Information is also available at the clinicaltrials.gov website:
Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor

Learn more about NRG1 fusions in solid tumors

NRG1 fusions drive cancer in some patients

NRG1 fusions are genetic abnormalities found in a small percentage of patients with solid tumors. In these patients, too much of a variant form of the growth factor NRG1 (sometimes called heregulin) may be produced, which is capable of causing cancer cells to grow and divide in an uncontrolled manner. Blocking NRG1 fusions and its cancer-driving activity with a medicine may help fight a patient’s cancer.

Small percentages of multiple types of solid tumors have NRG1 fusions

A recent study identified the following tumor types that can harbor NRG1 fusions: non-small cell lung cancer, gallbladder cancer, renal cell carcinoma, bladder cancer, ovarian cancer, pancreatic cancer, breast cancer, neuroendocrine tumor, sarcoma, and colorectal cancer. A test of a patient’s cancer can be conducted to determine if his or her tumor has an NRG1 fusion.

MCLA-158

Phase 1 clinical trial in cancer patients with solid tumors

MCLA-158 is being developed for the potential treatment of solid tumors. Our phase 1 clinical trial of MCLA-158 is ongoing in the dose expansion phase of the open-label, multicenter trial. Enrollment of patients with gastro-esophageal and head-and-neck cancers continues and preliminary evidence of antitumor activity has been observed.

More information is available at the clinicaltrials.gov website:
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors

MCLA-145

Phase 1 clinical trial in cancer patients with solid tumors

MCLA-145 is currently being evaluated in a phase 1 open-label, multicenter, dose escalation study, including a safety dose expansion phase, in patients with solid tumors. MCLA-145 is the first drug candidate co-developed under the global collaboration and license agreement between Merus and Incyte Corporation for the development of antibodies from Merus’ Biclonics® platform.

More information is available at the clinicaltrials.gov website:
A Study of Bispecific Antibody MCLA-145 in Patients With Advanced or Metastatic Malignancies

Merus Early Access Policy

Unless otherwise noted, we are providing this information as of March 16, 2021, and expressly disclaim any duty to update any of the provided information. Merus’ product candidates pipeline will change over time as molecules move through the drug development process, including potentially progressing to market or failing in clinical trials, due to the nature of the development process. This description contains forward-looking statements that involve significant risks and uncertainties, including those discussed in Merus’ most recent Annual Report on Form 10-K and in Merus’ other periodic reports on Form 10-Q and Form 8-k filed with the SEC, and actual results may vary materially. Merus provides this information as of the date above and does not undertake any obligation to update any forward-looking statements contained on these tables as a result of new information, future events or otherwise.

All Company therapeutic candidates described or mentioned herein are investigational and have not yet been approved for marketing by any regulatory authority.