UTRECHT, The Netherlands, March 13, 2018 (GLOBE NEWSWIRE) — Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced that it has expanded its intellectual property portfolio with two newly issued U.S. Patents. The first covers clinical drug candidate MCLA-117, a Biclonics® that binds to CD3 and CLEC12A, and the second concerns Merus’ Spleen to Screen® technology that permits efficient screening of common light chain antibodies for generating Biclonics® lead candidates.
On March 13, 2018, the United States Patent and Trademark Office (USPTO) granted U.S. Patent No. 9,914,777 (’777 patent), entitled “Human CD3 Binding Antibody”, covering MCLA-117, a Biclonics® that is designed to bind to CD3, a cell-surface molecule present on all T-cells, and to CLEC12A, a first-in-class target, expressed on the tumor cells and tumor stem cells of patients with acute myeloid leukemia (AML). Due to its prevalence in AML and restricted expression on some normal hematopoietic cells, we believe CLEC12A represents an attractive molecule for targeted therapy. The claims of the ‘777 patent concern Merus’ Biclonics®, and MCLA-117 in particular, that engage T-cells with tumor cells by targeting CD3 and a tumor-antigen, including CLEC12A. MCLA-117 is currently being studied in an ongoing Phase 1, first-in-human, dose escalation clinical trial in Europe in AML patients with relapsed or refractory disease, and obtained acceptance in February 2018 by the U.S. Food and Drug Administration (FDA) of an Investigational New Drug (IND) application filed earlier this year.
On March 6, 2018, the USPTO also granted U.S. Patent No. 9,908,946 (’946 patent) entitled, “Generation of Binding Molecules,” which concerns Merus’ proprietary Spleen to Screen® technology, a part of its Biclonics® technology platform. The ‘946 patent claims techniques to efficiently screen panels of common light chain antibodies, designed to allow Merus to rapidly identify and generate therapeutic candidates with differentiated modes of action.
“The issuance of Merus’ first U.S. Patent covering MCLA-117, marks yet another milestone in the advancement of this promising clinical candidate, which, along with the patent issuance covering our Spleen to Screen® technology, adds further intellectual property protection related to our clinical candidates and bispecific antibody platform based on our proprietary Biclonics® technology,” said Dr. Ton Logtenberg, Chief Executive Officer of Merus.
As of March 13, 2018, Merus’ patent portfolio related to its bispecific antibody candidate MCLA-117 consists of additional pending applications in the U.S., Europe and an array of foreign countries. Merus has also obtained patents around the globe, including throughout Europe, Asia, Australia and the U.S. related to its Spleen to Screen® technology, with other applications still pending in the U.S. and abroad.
These two recent issuances by the USPTO reported here bolster Merus’ substantial patent estate related to the panoply of Biclonics® technologies, including transgenic rodents, production of antibody libraries, screening methods, Fc engineering, antibody host cell expression and preclinical and clinical bispecific antibody candidates.
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 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 gastric, ovarian, endometrial and non-small cell lung cancers. Merus’ second most advanced bispecific antibody candidate, MCLA-117, is being developed in a Phase 1 clinical trial in patients with acute myeloid leukemia. The Company also has a pipeline of proprietary bispecific antibody candidates in preclinical development, including MCLA-158, which is designed to bind to cancer stem cells and is being developed as a potential treatment for colorectal cancer and other solid tumors, as well as MCLA-145, which is designed to bind to PD-L1 and a non-disclosed second immunomodulatory target, which is being developed in collaboration with Incyte Corporation. For additional information, please visit Merus’ website, www.merus.nl.
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 CLEC12A as an attractive molecule for targeted therapy, the depth of our intellectual property portfolio, our ability to efficiently generate Biclonics® candidates, or identify and generate candidates with differentiated biology, and the treatment potential, progress, timing and plans for the clinical development of our candidates, including MCLA-117, MCLA-128, and MCLA-158.
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 Incyte or Incyte may fail to perform adequately under our collaboration; 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 existing and 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 Annual Report on Form 20-F filed with the Securities and Exchange Commission, or SEC, on April 28, 2017, 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.
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