Merus Announces Poster Presentation on Clinical Data on MCLA-145 at the ESMO Immuno-Oncology Congress 2021
Merus N.V. (MRUS) announced interim data from the phase 1/2 trial of its bispecific antibody MCLA-145, targeting CD137 and PD-L1 in solid tumors, as of July 14, 2021. This data will be presented at the ESMO Immuno-Oncology Congress 2021 from December 8-11, 2021. The ongoing trial includes a dose escalation phase followed by planned expansion, marking MCLA-145 as a key candidate co-developed with Incyte. Merus retains commercialization rights in the U.S. and aims to leverage its innovative Bispecific platform for enhanced cancer treatment.
- Interim data from the phase 1/2 trial of MCLA-145 highlighted at ESMO IO Congress.
- MCLA-145 is co-developed with Incyte, allowing potential for up to 11 bispecific/monospecific antibodies.
- Merus retains full U.S. rights for MCLA-145, enhancing strategic control.
- The clinical trial's outcome remains uncertain due to the unpredictable nature of drug development.
- MCLA-145's commercialization faces potential delays in regulatory approvals.
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 02, 2021 (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 interim data, as of a July 14, 2021 cutoff, from the phase 1/2 trial of bispecific antibody MCLA-145 in patients with solid tumors. The e-poster will be presented at the ESMO Immuno-Oncology (ESMO IO) Congress 2021 being held December 8-11, 2021 in Geneva, Switzerland.
Presentation Details:
Title: Phase I Dose Escalation Study of MCLA-145, a Bispecific Antibody Targeting CD137 and PD-L1 in Solid Tumors
Poster #: 136P
The e-poster will be available on the virtual platform, in the e-poster section as of Monday, December 6 at 6:00 am ET and on-site at the e-Poster stations starting on Wednesday, December 8. The poster will also be available on the Merus website.
The phase 1, open-label, single-agent clinical trial of MCLA-145 is ongoing. The trial consists of a dose escalation phase, followed by a planned dose expansion phase. MCLA-145 is the first drug candidate co-developed under Merus’ global collaboration and license agreement with Incyte, which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from the Merus Biclonics® platform. Merus retains full rights to develop and commercialize MCLA-145, if approved, in the United States; and Incyte holds full rights to develop and commercialize MCLA-145 outside the United States.
About MCLA-145
Discovered through an unbiased functional screening of multiple immunomodulatory target combinations, MCLA-145 is a Biclonics® T-cell agonist that binds with high affinity and specificity to human PD-L1 and CD137 in preclinical models. The unique immunostimulatory profile of MCLA-145 derives from the potential to potently activate immune effector cells in the context of the tumor microenvironment while simultaneously blocking inhibitory signals in the same immune cell population.
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, http://www.merus.nl and https://twitter.com/MerusNV.
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 MCLA-145’s mechanism of action and potential of this Biclonics® in preclinical or clinical development to treat cancer, planned clinical studies, our global collaboration and license agreement with Incyte, its progress and potential development and commercialization of up to 11 bispecific and monospecific antibodies from our Biclonics® platform, including 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®, Triclonics® and multispecific 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; 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 September 30, 2021 filed with the Securities and Exchange Commission, or SEC, on November 2, 2021, 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 a registered trademarks of Merus N.V.
FAQ
What is the purpose of the MCLA-145 trial by Merus (MRUS)?
When will the interim data of MCLA-145 be presented?
What are the key findings of the MCLA-145 trial so far?
What rights does Merus have regarding MCLA-145?
What challenges might Merus (MRUS) face with MCLA-145's development?
