Merus Provides Clinical Updates for MCLA-117 and MCLA-158 Programs
- IND submitted to U.S.
- First CTA approval for MCLA-158 received in European country -
“The filing of an IND for MCLA-117 and the first CTA approval for MCLA-158 represent key steps forward for both programs as we continue to progress our robust pipeline of proprietary bispecific antibodies in the clinic with the goal of addressing significant unmet medical needs,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. “We look forward to the advancement of both Biclonics® in 2018, including the initiation a Phase 1 first-in-human trial of MCLA-158 in
Merus today announced that it has submitted an IND application to the U.S.
The Company also announced approval of a CTA in
About Merus N.V.
Merus is a clinical-stage immuno-oncology company developing innovative full-length human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics®, which are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to have similar features as conventional monoclonal antibodies, such as long half-life and low immunogenicity. Merus’ most advanced bispecific antibody candidate, MCLA-128, is expected to soon be evaluated in a Phase 2 combination trial in two metastatic breast cancer populations. MCLA-128 is also being evaluated in a Phase 1/2 clinical trial in
Forward Looking Statement
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 progress of Merus’ robust pipeline of proprietary bispecific antibodies in the clinic with the goal of addressing significant unmet medical needs, the advancement of MCLA-117 and MCLA-158 through 2018, including the timing of initiating clinical trials, plans to open sites in the U.S. for the ongoing Phase 1 clinical trial of MCLA-117, the initial focus on metastatic colorectal cancer for the Phase 1 clinical trial for MCLA-158 and filing an IND in the U.S. for MCLA-158 in the first quarter of 2018, the timing of the Phase 2 combination trial of MCLA-128 in metastatic breast cancer and the potential of MCLA-158 to treat colorectal cancer and other solid tumors.
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 Biclonics® and bispecific 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; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaboration with
These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 20-F filed with the
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Source: Merus N.V.