UTRECHT, Netherlands and CAMBRIDGE, Mass. , Nov. 26, 2023 (GLOBE NEWSWIRE) — Merus N. V. (Nasdaq: MRUS) (Merus, the Company, we, or us), a clinical-stage oncology company that is at the forefront and end-to-end responses (Biclonics and Triclonics), today announced the publication of two abstracts®® for MCLA-129 on the European Society of Medical Oncology (ESMO) Asian Congress website. The abstracts highlight the updated interim clinical knowledge of the expansion cohorts in non-small non-mobile lung cancer (NSCLC) and mobile squamous cell carcinoma of the head and neck (HNSCC) treated in the past, will be presented at the ESMO Asia 2023 congress to be held in Singapore from 1-3 December 2023.
MCLA-129 (EGFR x c-MET Biclonics): Solid Tumors The interim data included in the abstracts describe data from 3 expansion® cohorts in the open-label trial comparing MCLA-129 in combination with osimertinib, a third-generation EGFR TKI, in treatment-naïve patients. EGFR mutant NSCLC (m) and NSCLC mEGFR progressed with osimertinib, as well as MCLA-129 as monotherapy in a previously treated HNSCC.
Up-to-date clinical knowledge, with more patients and an upcoming knowledge deadline, will be included in the NSCLC Oral Mini-Presentation and HNSCC Poster at ESMO Asia next week.
Mini-oral presentation title: Efficacy and safety of MCLA-129, an EGFR x c-MET bispecific antibody, combined with osimertinib, as first-line therapy or after progression on osimertinib in non-small cell lung cancer (NSCLC) Observations in the abstract include:
Presentation Details: Session: Thoracic Cancer Date: Sunday, December 3, 2023 Time: 9:40 -9:45 a.m. SGT Presentation #: 516MO
Presentation details: Session Category: Poster session Date: Saturday, December 2, 2023 Time: 17:50-18:45 p.m. SGT Presentation #: 362P
MCLA-129 Development StrategyIn EGFRm NSCLC, with the strong clinical activity for MCLA-129 shown in the interim data presented today, we are encouraged by the potential for MCLA-129 in the treatment of lung cancer and beyond. We have identified focused investment opportunities. We continue to follow patients with EGFRm NSCLC treated with MCLA-129 in combination with osimertinib, to evaluate potential for biomarkers as a means to maximize efficacy, while proactively addressing safety signals seen to date.
We plan to initiate a cohort of MCLA-129 in combination with chemotherapy at NSCLC 2L EGFRm in the first quarter of next year.
In addition, we remain interested in and continue the examination of cohort B comparing MCLA-129 in patients with MET exon 14 who skip the NSCLC. We also remain interested in exploring a partnership with MCLA-129 with other corporations to sufficiently fund the progression of MCLA-129 and the potential benefits it can bring to patients.
Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3 Biclonics): NRG1 (NRG1) fusion cancer and other falsified tumors® A summary for a review of a recent ESMO 2023 presentation on the interim clinical knowledge of zenocutuzumab from the eNRGy trial and the initial schedule in NRG1 Patients with fusion NSCLC (NRG1) have also been accepted for presentation at ESMO Asia.
Presentation details: Title: Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC) Session Category: Poster session Date: Saturday, December 2, 2023 Time: 17:50-18:45 p.m. SGT Presentation #: 595P
As full presentations become available at the ESMO Asia Congress 2023, they will contemporaneously be available on the Merus website.
Company Conference Call and Webcast InformationMerus will hold a conference call and webcast for investors on November 27, 2023 at 8:00 a.m. ET. A replay will be available after the completion of the call in the Investors and Media section of our website for a limited time.
About Merus N. V. Merus is a clinical-stage oncology company that develops innovative, comprehensive curative antibodies based on bispecific and trispecific human antibodies, called Multiclonics®. Multiclonics® are popular manufacturing processes in the industry and have been observed in preclinical and clinical studies to exhibit many of the same characteristics as traditional human monoclonal antibodies, such as a long half-life and low immunogenicity. For more information, visit the Merus, https://www. merus. nl and https://twitter. com/MerusNV website.
Forward-Looking Statements This press release includes 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 past facts deserve to be considered forward-looking statements. , adding without statements of limitations related to the clinical progression of MCLA-129, long-term clinical trial progress, recruitment, final results, clinical activity and protection profile of MCLA-129; our confidence that MCLA-129 shows strong clinical activity; our plans to adopt a disciplined approach to capital allocation, making targeted investments in the program to identify spaces for potential differentiation; our openness to potential advertising progression opportunities as a means to leverage a potential partner’s additional resources, infrastructure and expertise to more fully benchmark and expand MCLA-129; our progression plans and strategy for MCLA-129, adding ongoing follow-up of patients with EGFR mutant motile non-small lung cancer treated with MCLA-129 in admixture with osimertinib, to compare the biomarker perspective as a means to maximize effectiveness, as we proactively address protective signals detected to date; our plan to initiate a cohort of MCLA-129 in combination with chemotherapy in 2L+ EGFRm NSCLC in the first quarter of next year; our continuing Cohort B investigation comparing MCLA-129 in patients with NSCLC that skips MET exon 14; our interest in exploring MCLA-129’s partnership with other corporations to sufficiently fund the progression of MCLA-129 and the potential benefits it would possibly have for patients; the protection profile of MCLA-129 and its implications for long-term safety; and our confidence that MCLA-129 activity in 2L+ HNSCC is inadequate to ensure further progression in head and neck cancer. These forward-looking statements are based on management’s existing expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other vital issues that could cause our actual outcomes, results or achievements to be materially different from any long-term results, performance or achievements. expressed or implied through the forward-looking statements. statements, adding, among other things, the following: our need for additional financing, which may not be available and which would possibly require us to limit our operations or relinquish rights to our technologies or Biclonics®, Triclonics® and candidates. multispecific antibodies; possible delays in regulatory approval, which would have an effect on our ability to advertise to our product applicants and our ability to generate revenue; the long and expensive procedure of clinical progression of drugs, the final results of which are uncertain; the unpredictable nature of our clinical progression efforts for marketable medicines; possible delays in patient recruitment and our dependence on third parties to conduct our clinical trials, production and activities supporting the progression of clinical medicines and their possible approval and the option of such third parties possibly not carrying them out in an unsatisfactory manner , which can also only the receipt of mandatory standards. approvals; the effects of the COVID-19 pandemic and global instability; we may fail to identify suitable Biclonics® or bispecific antibody applicants in our collaborations or our collaborators may not perform adequately in our collaborations; our dependence on third parties to manufacture applicants for our products, which could potentially delay, save or harm our development and advertising efforts; protect our proprietary technology; our patents would possibly be discovered to be invalid, unenforceable, circumvented through competition and our patent programs would possibly be found to be non-compliant with patentskill regulations and regulations; we may not be successful in prevailing in potential third-party intellectual property infringement claims; and our registered or unregistered trademarks or industrial names would possibly be challenged, infringed, circumvented or declared generic or determined to infringe other industrial trademarks.
These and other vital points are discussed under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended September 30, 2023, filed with the Securities and Exchange Commission, or SEC, on November 2, 2023, and our other reports filed with the SEC may also cause actual effects to differ materially from those indicated in the forward-looking statements made in this press release. These forward-looking statements are estimates of management as of the date of this press release. Although we may elect to update those forward-looking statements at some point in the future, we disclaim any legal responsibility to do so, even if future occasions require us to replace your outlook, as required by applicable law. These forward-looking statements do not deserve to be considered our outlook as of any date after the date of this press release.
Multiclonics, Biclonics and Triclonics are registered® trademarks®® of Merus N. V.