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Merus met with the U.S. Food and Drug Administration (FDA) regarding a potential Biologics License Application (BLA) filing for Zeno in NRG1 fusion (NRG1+) cancer. Based on the FDA feedback, Merus believes that a potential registrational path remains viable in a NRG1+ cancer tumor agnostic indication or separate applications for NRG1+ lung and NRG1+ pancreatic cancer, which could then be followed by a potential tumor agnostic filing

Merus Announces Financial Results for the Third Quarter and Provides Business Update

Merus N.V. (Nasdaq: MRUS) (“Merus”, the “Company,” “we”, or “our”), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced financial results for the third quarter that ended September 30, 2022 and provided a business update

By Merus N.V.
Published - Nov 03, 2022, 07:52 AM ET
Last Updated - Apr 18, 2024, 10:28 AM EDT

– Clinical update of MCLA-129 presented at the 34th EORTC/NCI/AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics
– Zenocutuzumab (Zeno) Regulatory update: FDA recommends additional enrollment in eNRGy trial to support potential BLA filing
– Clinical update of petosemtamab planned for first half of 2023

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, the “Company,” “we”, or “our”), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced financial results for the third quarter that ended September 30, 2022 and provided a business update.

“We continue to advance numerous programs which now demonstrate important clinical activity across the portfolio,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “For MCLA-129, we have recently shared early efficacy and safety data at the ENA ‘triple’ meeting and are now enrolling expansion cohorts in lung and other cancers; for Zeno, potentially first and best in class for NRG1 fusion cancer, we are continuing to enroll the eNRGy study consistent with recent feedback from the FDA; and for petosemtamab, we are looking forward to providing a clinical update in the first half of 2023. Later this year, Incyte plans to start a clinical study of INCA32459, a novel LAG3xPD-1 bispecific antibody developed in collaboration with Merus.”

Zenocutuzumab (Zeno or MCLA-128: HER3 x HER2 Biclonics®): NRG1+ cancer and other solid tumors
Enrollment continues in the eNRGy trial; enrollment in combination study in NRG1+ NSCLC as well as monotherapy in castration resistant prostate cancer (CRPC) planned to begin enrollment in 4Q2022

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