– Robust overall response rate of 34% and median duration of response of 9.1 months across multiple NRG1+ tumor types
– Zenocutuzumab was well tolerated
– Oral presentation with additional patient data at ASCO on June 5, 2022, 9:45-11:15 CT
– Call for investors to discuss clinical results on Sunday, June 5 at 6:00 p.m. CT
UTRECHT, Netherlands and CAMBRIDGE, Mass., May 26, 2022 (GLOBE NEWSWIRE) — Merus NV ( MRUS) (“Merus”, “the Company”, “we” or “our”), a clinical-stage oncologist company developing innovative complete multispecific antibodies (Biclonics® and triclonics®), today announced the publication of the abstract highlighting updated interim data from the ongoing Phase 1/2 eNRGY trial and early access program (EAP) of the bispecific antibody zenocutuzumab (Zeno ) in patients with NRG1 fusion cancer (NRG1+), on the American Society for Clinical Oncology (ASCO) website. The summary includes data as of the data cutoff date of January 12, 2022. At that time, 99 patients with NRG1+ cancer had been treated and efficacy was assessed in 73 patients with the possibility of having a follow-up ≥ 6 months, and which met the population criteria for primary efficacy. The oral presentation will include updated interim data and will be presented by the principal investigator of the eNRGy trial, Dr. Alison Schram of Memorial Sloan Kettering Cancer Center (MSKCC), at the ASCO 2022 Annual Meeting on Sunday 5 June 2022, 9:45 a.m.-11:15 a.m. CT.
“We are pleased to provide a more mature interim clinical data set from the Zeno program and are pleased that Zeno continues to demonstrate activity across different tumor types,” said Dr. Andrew Joe, Chief Medical Officer at Merus. “We continue to be encouraged by Zeno’s potential to help patients with NRG1+ cancer.”
Data reported are from the Phase 1/2 eNRGy and EAP trial evaluating the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer.
Key findings from the summary include:
- As of January 12, 2022, 99 patients were treated with Zeno. 73 patients who were treated as of July 12, 2021 were evaluable for response and had the opportunity for follow-up ≥ 6 months and met the primary efficacy population criteria
- Investigator-assessed overall response rate (ORR) by RECIST 1.1. endpoint was 34% (90% CI: 25; 44)
- The median duration of response (DOR) was 9.1 months (95% CI, 5.2-12.0) and the Kaplan-Meier estimate of the DOR rate at 6 months was 70%.
- Responses have been observed in patients with multiple NRG1+ cancer types
- Zeno continues to be well tolerated
Details of the oral presentation:
Title: Efficacy and Safety of Zenocutuzumab, a Late-Stage HER2 x HER3 Bispecific Antibody NRG1 fusion-positive cancers (NRG1+)
Main author: Alison Schram, MD, Memorial Sloan Kettering Cancer Center, NY
Summary #: 105
Session title: Clinical Science Symposium / Bispecifics: Are two better than one?
Session date and time: June 5, 2022, 9:45 a.m. to 11:15 a.m. CST
Company Conference Call and Webcast Information
Merus will host an investor conference call and webcast on Sunday, June 5, 2022 at 6:00 p.m. CT to discuss Zeno’s clinical data and provide a program update. A replay will be available after the call ends in the Investors and Media section of our website for a limited time.
Date: Sunday, June 5, 6:00 p.m. CT
Webcast link: available on our site
Telephone number: Toll-free number: 18772601463 / International: 17066435907
Conference ID: 7194538
About the eNRGy clinical trial
Merus is currently enrolling patients in the Phase 1/2 eNRGy trial to evaluate the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer. The eNRGy trial includes 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 the Merus trial website at www.nrg1.com or by calling 1-833-NRG-1234.
Zeno is an Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) Biclonics® who uses the Merus Dock & Block® mechanism of inhibition of the neuregulin/HER3 tumor signaling pathway in solid tumors with NRG1 gene fusions (NRG1+ cancer). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its NRG1 ligand or NRG1 fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancer. In preclinical studies, Zeno also potently inhibits HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions.
About Merus SA
Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapies called Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to exhibit many of the same characteristics as conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For more information, please visit Merus website, http://www.merus.nl and https://twitter.com/MerusNV.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that do not relate to historical facts should be considered forward-looking statements, including, without limitation, statements regarding the clinical development of Zeno, future clinical trial results, the clinical activity and safety profile of Zeno in the ongoing eNRGy trial and EAP, and the potential for Zeno to help patients with NRG1+ cancer. These forward-looking statements are based on management’s current expectations. These statements are not promises or 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 future results, performance or achievements. expressed or implied by the forward-looking statements. 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 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 revenues; the long and costly process of clinical drug development, the outcome of which is uncertain; the unpredictable nature of our clinical development efforts for marketable drugs; potential delays in patient recruitment, and our reliance on third parties to conduct our clinical trials, manufacturing and support activities for clinical drug development and potential approval and risk that such third parties will not not operate satisfactorily, which could affect the receipt of necessary regulatory approvals; impacts of the COVID-19 pandemic; we may not identify suitable Biclonics® or bispecific antibody candidates within our collaborations or our collaborators may not work well within our collaborations; our reliance on third parties to manufacture development support for our product candidates, which may delay, prevent or impede 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 patentability rules and regulations; we may not prevail in any lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented, or held to be generic or determined to infringe other trademarks; and risks related to our ceasing to qualify as an emerging growth company and a small reporting company after December 31, 2021.
These and other important factors discussed under “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended March 31, 2022 filed with the Securities and Exchange Commission, or SEC, on May 9, 2022 , 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. These forward-looking statements represent management’s estimates as of the date of this press release. Although we may choose to update these forward-looking statements at some time in the future, we assume no obligation to do so, even if subsequent events change our views, except as required by applicable law. These forward-looking statements should not be taken to represent our views as of any date subsequent to the date of this press release.
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