Merus Announces Poster Presentations on MCLA-145 at Society for Immunotherapy of Cancer

Rhea-AI Summary

Merus N.V. (Nasdaq: MRUS) announces the presentation of preclinical data for its bispecific antibody MCLA-145 at the Society for Immunotherapy of Cancer (SITC) annual meeting from November 10-15, 2020. MCLA-145 targets CD137 on T cells and PD-L1 on cancer cells, demonstrating a potent anti-tumor effect without the safety issues seen with other CD137 agonists. Currently, MCLA-145 is in a Phase 1 dose escalation study for patients with solid tumors, co-developed with Incyte, which handles commercialization outside the U.S.

Positive

• MCLA-145 shows potent anti-tumor effects in preclinical studies.
• The antibody does not exhibit peripheral toxicity, unlike other CD137 agonists.
• Collaboration with Incyte allows for the development of up to 11 bispecific antibodies.
• Merus retains full rights to MCLA-145 commercialization in the U.S.

Negative

• Risks associated with additional funding needs, impacting operations.
• Potential delays in regulatory approval could affect commercialization.
• Clinical development process is lengthy, with uncertain outcomes.
• Reliance on third parties for clinical trials and manufacturing poses risks.

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 09, 2020 (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 preclinical data from its MCLA-145 program will be presented at the Society for Immunotherapy of Cancer (SITC) annual meeting being held virtually on November 1015, 2020.

“We look forward to sharing data on MCLA-145, our clinical stage Biclonics® bispecific antibody directed at CD137 on T cells and PD-L1 on cancer cells,” said Andrew Joe, M.D., Chief Medical Officer of Merus. “MCLA-145 is the most advanced program in our collaboration with Incyte. In preclinical studies, MCLA-145 demonstrates potent anti-tumor effect and does not appear to exhibit the safety liabilities that have been observed with other potent CD137 agonists.”

E-Poster Presentations:

Title: MCLA-145 (CD137xPD-L1): a potent CD137 agonist and immune checkpoint inhibitor that does not show signs of peripheral toxicity in preclinical models
Poster #: 814

• Authors: Kees Bol, Wilfred Marissen, Jeroen Elassiass-Schaap, Paul Tacken, Steef Engels, Liang-Chuan Wang, Arpita Mondal, Mark Throsby, Alan Roberts, Patrick Mayes, Cecile Geuijen
  
  

Title: MCLA-145 is a bispecific IgG1 antibody that inhibits PD-1/PD-L1 signaling while simultaneously activating CD137 signaling on T cells
Poster #: 820

• Authors:   Paul Tacken, Liang-Chuan Wang, Rinse Klooster, Pieter Fokko van Loo, Jing Zhou, Arpita Mondal, Yao-bin Liu, Arjen Kramer, Thomas Condamine, Alla Volgina, Linda J. A. Hendriks, Hans van der Maaden, Eric Rovers, Steef Engels, Floris Fransen, Renate den Blanken-Smit, Vanessa Zondag-van der Zande, Abdul Basmeleh, Willem Bartelink, Ashwini Kulkarni, Wilfred Marissen, Cheng-Yen Huang, Leslie Hall, Shane Harvey, Chrysi Kanellopoulou, Shaun Stewart, Horacio Nastri, Alexander B. H. Bakker, Ton Logtenberg, Simon Plyte, Patrick A. Mayes, Mark Throsby, Cecile Geuijen
  
  

Posters will be on display from Monday, November 9, 2020 until the virtual poster hall closes on December 31, 2020.

Abstracts are available on the SITC 2020 website at https://www.sitcancer.org/2020.
  
MCLA-145 is currently being evaluated in a Phase 1 open-label, multicenter dose escalation study, including a safety dose expansion phase, in patients with solid tumors. MCLA-145 is the first drug candidate co-developed under Merus’ global collaboration and license agreement with Incyte Corporation, which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from our Biclonics® platform. Merus retains full rights to develop and commercialize MCLA-145, if approved, in the United States, and Incyte is responsible for its development and commercialization outside the United States.

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, 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 potential safety, efficacy, mechanism of action and potential of Biclonics® in preclinical or clinical development to treat cancer. 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, including for the treatment of rare subpopulations such as NRG1 fusions, 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 any of our other collaborators, or Incyte or any of our other collaborators may fail to perform adequately under our collaborations with them; 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 quarterly period ended September 30, 2020 filed with the Securities and Exchange Commission, or SEC, on November 5, 2020, 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.

FAQ

What is MCLA-145 and its significance for Merus (MRUS)?

MCLA-145 is a bispecific antibody developed by Merus that targets CD137 on T cells and PD-L1 on cancer cells. It is significant due to its potent anti-tumor effects and reduced toxicity compared to other CD137 agonists.

What are the upcoming events related to MCLA-145?

MCLA-145's preclinical data will be presented at the SITC annual meeting from November 10-15, 2020.

How is Merus collaborating with Incyte on MCLA-145?

Merus and Incyte have a global collaboration where Incyte is responsible for the development and commercialization of MCLA-145 outside the U.S., while Merus retains rights in the U.S.

What phase is MCLA-145 currently in?

MCLA-145 is being evaluated in a Phase 1 open-label dose escalation study for patients with solid tumors.

What are the risks associated with Merus (MRUS) and MCLA-145?

Key risks include the need for additional funding, potential regulatory delays, and reliance on third parties for clinical trial execution and manufacturing.