Merus Announces First Patient Dosed in a Phase 2 Clinical Trial of MCLA-128 in Two Metastatic Breast Cancer Patient Populations
MCLA-128 is a full-length IgG bispecific antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) targeting HER2 and HER3 receptors. MCLA-128 blocks the HER3 signaling pathway by employing a Dock & Block™ mechanism. MCLA-128 is designed to dock onto a specific region of the HER2 receptor to orientate MCLA-128’s HER3 binding arm to block HER2:HER3 heterodimerization. Oncogenic signaling through the HER3 pathway, even in the presence of high heregulin concentrations, may thus be effectively blocked.
“Initiation of the Phase 2 clinical trial in patients with HER2-positive MBC populations and hormone receptor-positive/HER2-low MBC populations represents another key milestone for Merus,” said Ton Logtenberg, PhD., Chief Executive Officer. “With promising single agent activity observed in heavily-pretreated patients underscoring the potential of MCLA-128 in MBC, this study is designed to elucidate the activity of this important HER2/HER3-targeted candidate in combination with current standards of care in areas of unmet need. Concurrently, our study evaluating single agent activity for MCLA-128 in gastric, ovarian, endometrial and non-small cell lung (NSCL) cancers is ongoing and we anticipate defining a clinical plan for MCLA-128 in solid tumors beyond metastatic breast cancer starting the second quarter of 2018. In addition, we remain committed to the remainder of our pipeline candidates, including MCLA-117 in acute myeloid leukemia, which is currently in the clinic, MCLA-158 for the potential treatment of colorectal cancer, which we expect to enter the clinic in the first quarter of 2018, as well as MCLA-145, which we are developing with
The MCLA-128 Phase 2 clinical trial is expected to enroll approximately 120 patients in total across the U.S. and
MCLA-128 is designed to block HER3/heregulin-dependent tumor growth and survival as well as enhance immune-mediated cytotoxicity in tumors. MCLA-128 employs a Dock and Block™ mechanism in which the mode of HER2 receptor binding orientates the HER3 binding arm to effectively block oncogenic signaling through the HER2:HER3 heterodimer even under high heregulin concentrations. In addition, MCLA-128 is modified for enhanced ADCC in order to recruit and activate immune effector cells to directly kill tumor cells.
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 and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. Merus’ most advanced bispecific antibody candidate, MCLA-128, is being 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 clinical development plans for MCLA-128, including defining a clinical plan for MCLA-128 in other solid tumors in 2018, the expected enrollment for and design of the Phase 2 clinical trial of MCLA-128, expected advancement of MCLA-158 into the clinic in 2018, the clinical development of MCLA-145, and the design and treatment potential of MCLA-128, MCLA-158 and MCLA-145.
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.