Merus Announces Collaborations in Israel, Italy and Spain to Increase Screening and Identification of Cancer Patients with NRG1 Fusion Tumors and to Raise Awareness of the Phase 1/2 eNRGy Clinical Trial

UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 13, 2021 (GLOBE NEWSWIRE) — Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics^® and Triclonics^®), today announced new collaborations in Israel, Italy and Spain to expand molecular screening opportunities for patients with cancers that may have neuregulin 1 (NRG1) fusions and to raise awareness of the Merus eNRGy clinical trial of its bispecific antibody zenocutuzumab (Zeno). In the collaborations, Merus plans to support molecular screenings for eligible patients with pancreatic adenocarcinoma in Israel and Italy, and with non-small cell lung cancer (NSCLC) in Spain, aimed to identify the presence of NRG1 fusions. Each collaborating organization in turn has agreed as follows:

• Progenetics, Ltd. plans to perform a nationwide campaign in Israel to raise awareness of the molecular screening offered by Merus for eligible pancreatic adenocarcinoma patients and availability of the eNRGy trial for eligible patients. Progenetics is a leading Israeli company in oncology testing, currently distributing diagnostic tests for nine American companies in the field of onco-diagnostics.
• Italian Association for the Study of Pancreas (AISP) plans to inform their nationwide network of oncologists, pancreatic cancer patients and patient associations in Italy of the molecular screening offered by Merus for eligible pancreatic adenocarcinoma patients and availability of the eNRGy trial for eligible patients.

  Dr. Michele Reni, a Principal Investigator on the eNRGy trial and physician at the San Raffaele Scientific Institute in Milan, has agreed to facilitate the collaboration with AISP and said, “Our collaboration with Merus, and the testing they are supporting, offers a unique opportunity to our patients and to physicians involved in the treatment of pancreatic cancer to help patients know their NRG1 fusion status and to potentially match patients with clinical trial opportunities that specifically target their unique tumor profiles.”

• Universidad de Navarra plans to provide Merus-funded molecular screening to eligible patients with NSCLC, through the Clínica Universidad de Navarra network in Spain, which may identify NRG1 fusions, and plans to inform patients with NRG1-fusion-positive cancer of their potential eligibility for the eNRGy trial. The Clínica Universidad de Navarra, based in Pamplona and Madrid, is a leading research hospital in Spain. A recognized institution for both its teaching and research work, and its trajectory in the diagnosis and treatment of highly complex pathologies, the Clínica Universidad de Navarra is characterized by the diagnostic speed achieved through multidisciplinary work and the acquisition of the latest technology to offer care in 46 different medical and surgical specialties.

“These latest collaborations expand Merus’ global efforts to raise awareness of the importance of molecular testing which can lead to potentially better treatment and clinical trial options for cancer patients,” said Dr. Andrew Joe, Chief Medical Officer of Merus. “Merus’ support in the screening of these patients is also a strategic effort to potentially identify and recruit patients with cancer harboring NRG1 fusions for our eNRGy trial.”

Merus has implemented a global approach designed to increase access to molecular screenings for cancer patients and to potentially enhance enrollment in the eNRGy trial by working with private industry, country-specific testing organizations, cooperative groups and disease-specific cancer organizations. Increasing access to molecular screenings may help oncologists and their patients, whose cancers may not be screened routinely for gene mutations, make informed decisions on what treatment and clinical trial options may be available.

With the addition of these collaborations announced today, Merus is now working with more than ten different industry and academic collaborators across Asia, North America and Europe aimed to enhance testing for NRG1 fusions and to raise awareness of the eNRGy trial.

About the eNRGy Clinical Trial
Merus is currently enrolling patients in the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of zenocutuzumab (Zeno) monotherapy in NRG1+ cancers. The eNRGy trial consists of three cohorts: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer; and NRG1+ other solid tumors. Further details, including current trial sites, can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com or by calling 1-833-NRG-1234.

About NRG1 Fusions
The NRG1 gene encodes neuregulin (also known as heregulin), the ligand for HER3. Fusions between NRG1 and partner genes are rare, tumorigenic genomic events occurring in patients with certain cancers.

About Zeno
Zenocutuzumab (Zeno) is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics^® that utilizes the Merus Dock & Block^® mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 gene fusions (NRG1+). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancers. In preclinical studies, Zeno also potently inhibits HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions. Learn more about Zeno Dock & Block^® at https://merus.nl/technology/.

About Merus
Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics^®. Multiclonics^® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus’ website, www.merus.nl and https://twitter.com/MerusNV.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, performance under the agreements, use of molecular screening aimed to identify patients with tumors harboring NRG1 gene fusions, the ability of private industry, country-specific testing organizations, cooperative groups and disease-specific cancer organizations to raise awareness of Merus’ eNRGy clinical trial or identify eligible patients with NRG1+ cancer for enrollment; the opportunity that offering molecular screening may provide for patients and to physicians involved in the treatment of pancreatic cancer to help patients know their NRG1 fusion status and to potentially match patients with clinical trial opportunities that specifically target their unique tumor profiles and potential to lead to better treatment and clinical trial options for cancer patients; Merus’ strategic effort to potentially identify and recruit patients with cancer harboring NRG1 fusions for our eNRGy trial; the design and treatment potential for Zeno and its mechanism of action and its potential to be particularly effective against NRG1+ cancers; the Zeno clinical study design and occurrence of NRG1 fusion cancers. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or Biclonics^®, Triclonics^® and multispecific antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the COVID-19 pandemic; we may not identify suitable Biclonics^® or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.

These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended March 31, 2021 filed with the Securities and Exchange Commission, or SEC, on May 6, 2021, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

CONTACT: Investor and Media Inquiries:
Kathleen Farren
Merus N.V.
Communications Specialist
k.farren@merus.nl