UTRECHT, The Netherlands and STAMFORD, CT, USA — December 17, 2020 — Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multi-specific antibodies (Biclonics® and Triclonics™), and Sema4, a patient-centered health intelligence company, today announced they have entered into a strategic agreement to utilize Sema4’s advanced genomic testing to identify patients with tumors harboring neuregulin 1 gene (NRG1) fusions who may be eligible for investigational treatment with the bispecific antibody Zenocutuzumab (“Zeno”) in the Phase 1/2 eNRGy trial sponsored by Merus.
Under the terms of the agreement, Sema4 will perform genomic testing to identify patients with advanced NRG1 positive (NRG1+) solid tumors who might need novel clinical options and raise awareness of Merus’ eNRGy trial.
NRG1 gene fusions are a group of rare genomic alterations emerging as a potential actionable driver of tumorigenesis and growth across many types of solid tumors, including lung, breast, pancreatic, ovarian, and colorectal cancers. Zeno, through its unique mechanism of blocking the interaction of the NRG1 fusion protein with its receptor HER3, has the potential to be particularly effective against NRG1+ cancers.
“Our next-generation genomic testing solutions deliver critical information to oncologists and their patients, enabling them to make informed treatment decisions,” said Eric Schadt, PhD, Founder and Chief Executive Officer of Sema4. “We are pleased to partner with the Merus team to provide clinicians with this advanced molecular analysis of solid tumors, and to increase awareness about emerging investigational care options and patient eligibility for the eNRGy trial.”
“Our agreement with Sema4, and the opportunity to leverage advanced genomic testing solutions for oncology, holds promise to help us accelerate enrollment in our eNRGy clinical trial,” said Dr. Andrew Joe, Chief Medical Officer of Merus. “We look forward to continuing to explore the potential for Zeno to become an effective new treatment option for patients with cancers harboring NRG1 fusions.”
Merus is currently enrolling patients into the Phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of 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.
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.
Sema4 is a patient-centered health intelligence company founded on the idea that more information, deeper analysis, and increased engagement will improve the diagnosis, treatment, and prevention of disease. Sema4 is dedicated to transforming healthcare by building dynamic models of human health and defining optimal, individualized health trajectories, starting in the areas of reproductive health and oncology. Centrellis™, our innovative health intelligence platform, is enabling us to generate a more complete understanding of disease and wellness and to provide science-driven solutions to the most pressing medical needs. Sema4 believes that patients should be treated as partners, and that data should be shared for the benefit of all.
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, Sema4’s performance under the agreement to utilize Sema4’s advanced genomic testing to identify patients with tumors harboring NRG1 gene fusions, who may be eligible for investigational treatment with Zeno in the eNRGy trial; the companies’ plan to support access to next-generation sequencing for eligible patients and raise awareness of Merus’ eNRGy clinical trial; the opportunity to leverage Sema4’s advanced genomic testing solutions for oncology, and its promise to help accelerate enrollment in the eNRGy trial; the potential for Zeno to become an effective new treatment option for patients with cancers harboring NRG1 fusions; the design and treatment potential for Zeno and its mechanism of action and 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 quarterly period ended September 30, 2020 filed with the Securities and Exchange Commission, or SEC, on November 5, 2020, 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.
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