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Merus Announces Publication of Abstract on MCLA-129 at the American Association for Cancer Research 2022 Annual Meeting

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Merus N.V. (MRUS) has announced the upcoming presentation of a poster discussing the mechanism and effectiveness of its drug MCLA-129 at the AACR Annual Meeting 2022 on April 10. MCLA-129 targets EGFR and c-MET, critical in treating non-small cell lung cancer (NSCLC). Currently, MCLA-129 is in a phase 1/2 clinical trial aimed at assessing safety, tolerability, and clinical activity in patients with advanced tumors. Merus has a collaboration with Betta Pharmaceuticals for its development in China while retaining global rights outside the region.

Positive
  • MCLA-129 shows potential in treating EGFR exon20 insertion NSCLC, which is resistant to standard therapies.
  • Collaboration with Betta Pharmaceuticals allows for exclusive development in China, potentially expanding market reach.
Negative
  • The phase 1/2 trial's outcomes remain uncertain as it is still in early development stages.
  • Potential delays in regulatory approvals could hinder commercialization and revenue generation.

- The poster details the mechanism of action of MCLA-129 in vitro and effectiveness in vivo in an EGFR exon20 insertion (ex20ins) non-small cell lung cancer (NSCLC) model

UTRECHT, The Netherlands and CAMBRIDGE, Mass., March 08, 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 the publication of the abstract highlighting the mechanism of action of MCLA-129 on the American Association for Cancer Research (AACR) website. MCLA-129, is a Biclonics®, which binds to EGFR and c-MET; EGFR is an important oncogenic driver in many cancers, and upregulation of c-MET signaling has been associated with resistance to EGFR inhibition. The poster will be on display at the AACR Annual Meeting 2022 in New Orleans, Louisiana on Sunday, April 10, 2022 and available on the e-poster website beginning on Friday, April 8 at 1:00 p.m. ET.

Presentation Details:

Title: Mechanism of action of MCLA-129, a bispecific antibody that targets EGFR and c-MET and impairs growth of EGFR exon 20 insertion mutant non-small cell lung cancer

Session Date and Time: Sunday, April 10, 2022 1:30 p.m. - 5:00 p.m. CT

Session Category: Experimental and Molecular Therapeutics

Session Title: Biological Therapeutic Agents and Novel Drugs

Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 22

Abstract Number: 336 

The full poster will also be available on our website beginning on Friday, April 8 at 1:00 p.m. ET.

MCLA-129 is currently enrolling patients in a phase 1/2, open-label clinical trial consisting of dose escalation followed by a planned dose expansion. Primary objectives of phase 1 are to determine the maximum tolerated dose and/or the recommended phase 2 dose, and the objectives of phase 2 are to evaluate safety, tolerability and potential clinical activity in patients with advanced solid tumors. MCLA-129 is subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to develop MCLA-129 exclusively in China, while Merus retains global rights outside of China. In October 2021, Betta announced that the first patient was dosed in a phase 1/2 trial in China sponsored by Betta, of MCLA-129 in patients with advanced solid tumors. Merus plans to provide a clinical update in the second half of 2022.

About Merus N.V.
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.

About MCLA-129
MCLA-129 is an antibody-dependent cellular cytotoxicity-enhanced Biclonics® that is designed to inhibit the EGFR and c-MET signaling pathways in solid tumors. Preclinical data have shown that MCLA-129 can effectively treat TKI-resistant NSCLC in xenograft models of cancer. MCLA-129 is designed to have two complementary mechanisms of action: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor.

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, the design and treatment potential of MCLA-129, its mechanism of action, the clinical development of MCLA-129, including continuation in the dose escalation phase and planned dose expansion, our planned clinical update in the second half of 2022; and our collaboration and license agreement with Betta, which permits Betta to develop MCLA-129 exclusively in China, while Merus retains full ex-China rights, and any developments that may arise from this agreement. 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 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; our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks; and risks related to our ceasing to qualify as an emerging growth company and a smaller reporting company.

These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the period ended December 31, 2021, filed with the Securities and Exchange Commission, or SEC, on February 28, 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. 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.

Multiclonics®, Biclonics® and Triclonics® are registered trademarks of Merus N.V. 


FAQ

What is the main focus of Merus N.V.'s recent press release?

The press release highlights the upcoming presentation of MCLA-129's mechanism of action and its effectiveness against EGFR exon20 insertion NSCLC.

When will the poster on MCLA-129 be presented?

The poster will be presented on April 10, 2022, at the AACR Annual Meeting.

What are the objectives of the MCLA-129 clinical trial?

The trial aims to determine the maximum tolerated dose and evaluate safety, tolerability, and potential clinical activity in patients with advanced solid tumors.

What is the significance of the collaboration with Betta Pharmaceuticals?

The collaboration allows Betta to develop MCLA-129 exclusively in China while Merus retains global rights outside China.

What challenges does Merus N.V. face regarding MCLA-129?

Merus faces uncertainties related to clinical trial outcomes and potential delays in regulatory approvals that could impact revenue.

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