fly like an eagle schreef op 12 juli 2016 15:24:
UTRECHT, The Netherlands, July 12, 2016 (GLOBE NEWSWIRE) -- Merus N.V., a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics, today announced financial results for the first quarter ended March 31, 2016 and provided an update on recent accomplishments and clinical development plans.
“The past few months have been transformational for Merus, highlighted by our successful initial public offering in May that strengthens our balance sheet and allows us to further advance our promising pipeline of novel cancer therapeutic candidates,” said Ton Logtenberg, PhD, Chief Executive Officer of Merus. “Additionally, the dosing of the first patient in our Phase 1/2 clinical trial of MCLA-117, our CLEC12A x CD3 bispecific, in patients with AML represents a significant milestone for this program. I look forward to reporting on our continued progress in the coming quarters, including interim results from Part 2 of our Phase 1/2 study of our lead candidate, MCLA-128, our HER2 x HER3 bispecific, in the second half of 2016.”
Recent Clinical Developments
Announced that the first patient has been dosed in a Phase 1/2 clinical trial evaluating Merus’ second Biclonics® therapeutic candidate, MCLA-117, in patients with acute myeloid leukemia (AML).
Presented interim Phase 1/2 clinical data in a poster presentation at the American Association for Cancer Research (AACR) 2016 Annual Meeting demonstrating a favorable safety profile and early signs of anti-tumor activity of MCLA-128 in patients with advanced solid tumors.
Upcoming Milestones
By the end of 2016, Merus expects to report interim results from Part 2 of a Phase 1/2 clinical trial of MCLA-128 in breast cancer.
Also by the end of 2016, Merus expects to file an Investigational New Drug application to the U.S. Food and Drug Administration for a Phase 1/2 trial of MCLA-128.
During the second half of 2017, Merus expects to report topline data from its Phase 1/2 monotherapy trial of MCLA-128 in patients with solid tumors in multiple indications.
By the end of 2017, Merus expects to report interim results from Part 1 of its Phase 1/2 clinical trial evaluating MCLA-117 in patients with AML.Corporate Highlights
Closed a successful initial public offering which raised net proceeds to Merus, after deducting underwriting discounts and commissions and offering expenses, of $53.3 million.
Issued three patents related to the generation of bispecific antibodies and high-throughput functional screening methods of large collections of bispecific antibodies.
Formed a strategic collaboration with Institut Gustave Roussy, a leading Comprehensive Cancer Centre in Europe, to jointly develop bispecific antibodies for therapeutic immuno-oncology applications.
First Quarter 2016 Financial Results
(Euros in millions)
Total revenue for the three months ended March 31, 2016 was €0.8 million compared to €0.1 million for the same period in 2015. Revenue is comprised primarily of research funding and income from grants on research projects.
Research and development expenses for the three months ended March 31, 2016 were €4.4 million compared to €3.4 million for the same period in 2015. The increase in research and development expenses period-over-period was due to higher R&D headcount and other costs related to the development of Merus’ two lead bispecific antibody candidates, MCLA-128 and MCLA-117, as well as manufacturing costs related to MCLA-158.
For the three months ended March 31, 2016, Merus reported a net loss of €(5.5) million, or €(0.63) per basic and diluted share, compared to a net loss of €(4.8) million, or €(1.19) per basic and diluted share, for the same period in 2015.
Merus ended the quarter with cash and cash equivalents of €26.2 million. Subsequent to the end of the quarter, Merus completed an initial public offering of common shares that raised total net proceeds of $53.3 million.
About MCLA-128
MCLA-128 is an ADCC-enhanced Biclonics® that binds to HER2- and HER3- expressing solid tumor cells. MCLA-128 is designed to overcome the inherent and acquired resistance of tumor cells to HER2-targeted therapies using two mechanisms: 1) blocking growth and survival pathways to stop tumor expansion while preventing tumor cells escaping through activation of the HER3/heregulin pathway and 2) recruitment and enhancement of immune effector cells to directly kill the tumor.
About MCLA-117
MCLA-117 is a Biclonics® that is designed to bind to CD3 expressed by T-cells and CLEC12A expressed by acute myeloid leukemia (AML) tumor cells and stem cells. In preclinical studies, MCLA-117 has been shown to recruit and activate the immune system’s own T-cells to kill AML tumor cells and stem cells.About MCLA-158
MCLA-158 is an ADCC-enhanced Biclonics® being developed for the treatment of colorectal cancer and other solid tumors. MCLA-158 is designed to bind to Lgr5 and EGFR expressing cancer stem cells, block growth and survival pathways and enhance the recruitment of immune effector cells to directly kill cancer stem cells that persist in solid tumors causing relapse and metastasis.
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® are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to have several of the same features of conventional monoclonal antibodies, such as long half-life and low immunogenicity. Merus' lead bispecific antibody candidate, MCLA-128, is being evaluated in a Phase 1/2 clinical trial in Europe as a potential treatment for HER2-expressing solid tumors. Merus' second bispecific antibody candidate, MCLA-117, is being developed as a potential treatment for 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, and Biclonics® designed to bind to various combinations of immunomodulatory molecules, including PD-1 and PD-L1.