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Merus Announces First Patient Dosed in Phase 2 Trial of Petosemtamab in 2L CRC

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Merus announced the dosing of the first patient in its phase 2 trial of petosemtamab combined with standard chemotherapy for second-line metastatic colorectal cancer (mCRC). The trial will assess safety and preliminary antitumor activity in approximately 40 patients previously untreated with EGFR inhibitors and without KRAS mutations. This study marks a significant step in Merus' oncology program, expanding from head and neck cancer to mCRC.

Positive
  • First patient dosed in phase 2 trial of petosemtamab in combination with chemotherapy.
  • Trial involves approximately 40 patients with 2L mCRC.
  • Expansion of petosemtamab's clinical development from head and neck cancer to mCRC.
Negative
  • Study will not employ a selection criterion for high EGFR expression, potentially affecting efficacy results.

The initiation of a Phase 2 trial for petosemtamab in combination with standard chemotherapy for second-line metastatic colorectal cancer (mCRC) is noteworthy. Colorectal cancer is a serious disease with limited treatment options, especially for patients in advanced stages. Petosemtamab targets EGFR and LGR5, which are important in cancer growth signaling pathways. The inclusion of patients who have not been treated with EGFR inhibitors and whose tumors are KRAS wild-type is critical, as it targets a specific subset of mCRC patients who might benefit most from this treatment. Furthermore, the non-selective approach to EGFR expression allows for a broader understanding of the drug's effectiveness across varying levels of EGFR. This trial could provide insight into the combination therapy's efficacy and safety, potentially leading to a new treatment paradigm in mCRC if successful.

This trial's design is structured to gather preliminary efficacy and safety data. Given that previous attempts to target EGFR in colorectal cancer have had mixed results, this trial could validate the novel approach of using Biclonics® technology. The fact that the study is open-label means that both clinicians and patients are aware of the treatment being administered, which could help in closely monitoring side effects and efficacy but might introduce some bias. The absence of a high EGFR expression selection criterion might make the results more widely applicable but could also dilute the apparent effectiveness if only a subset of patients responds well.

If the trial demonstrates positive outcomes, it could potentially lead to a larger Phase 3 study, making the current study pivotal in the drug development process. However, investors should also consider the risks involved, as Phase 2 trials often identify unforeseen safety and efficacy issues.

UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 08, 2024 (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 that the first patient has been dosed in the Company’s phase 2 trial evaluating petosemtamab in combination with standard chemotherapy in second line (2L) metastatic colorectal cancer (mCRC). Petosemtamab is a Biclonics® targeting EGFR and LGR5. 

The phase 2, open-label trial will evaluate the safety and preliminary antitumor of petosemtamab and a regimen of chemotherapy (FOLFIRI or FOLFOX) in 2L mCRC. The study will enroll approximately 40 patients not previously treated with EGFR inhibitors and whose tumors do not harbor a KRAS mutation. The level of tumor EGFR expression will be measured, but the study will not employ a selection criterion for high EGFR expression.

“We’re pleased by the progress we are making across the petosemtamab clinical development program,” said Peter Silverman, Chief Operating Officer.  “Petosemtamab continues to demonstrate meaningful clinical activity in head and neck cancer, and we are excited by the opportunity to expand into mCRC and investigate this novel potential treatment for patients struggling with this devastating disease.”

More details of the trial can be found at clinicaltrials.gov.  

About Petosemtamab
Petosemtamab, or MCLA-158, is a Biclonics® low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.

About Merus
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, X and LinkedIn.

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, statements regarding the evaluation of petosemtamab in patients with mCRC, the clinical study design and objectives of the phase 2 study; the progress Merus is making across the petosemtamab clinical development program; our belief that petosemtamab continues to demonstrate meaningful clinical activity in Head and Neck cancer, and the opportunity to expand into mCRC and investigate petosemtamab in patients having mCRC. 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 volatility in the global economy, including global instability, including the ongoing conflicts in Europe and the Middle East; 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 period ended March 31, 2024, filed with the Securities and Exchange Commission, or SEC, on May 8, 2024, 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 Merus' new phase 2 trial about?

Merus' phase 2 trial is assessing petosemtamab in combination with standard chemotherapy for second-line metastatic colorectal cancer.

When did Merus dose the first patient in the phase 2 trial of petosemtamab?

Merus dosed the first patient in the phase 2 trial of petosemtamab on July 08, 2024.

What is petosemtamab targeting in Merus' phase 2 trial?

Petosemtamab targets EGFR and LGR5 in Merus' phase 2 trial for second-line metastatic colorectal cancer.

How many patients will be enrolled in Merus' phase 2 trial of petosemtamab?

Approximately 40 patients will be enrolled in Merus' phase 2 trial of petosemtamab.

What criteria must patients meet to be included in Merus' phase 2 trial of petosemtamab?

Patients must not have been previously treated with EGFR inhibitors and their tumors should not have a KRAS mutation.

Merus N.V.

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