Tag: Merus B.V.

Company News: Merus reaches pivotal milestone in bispecific antibody collaboration with ONO PHARMACEUTICAL CO., LTD.

– Successful product lead identification underscores the strength of Merus’ platform in delivering human, full-length IgG bispecific antibodies –

Merus B.V., a leader in developing best-in-class bispecific antibody therapeutics, announced today that it has reached a preclinical milestone in a bispecific antibody research and license collaboration with ONO PHARMACEUTICAL CO., LTD. (Osaka, Japan, ”ONO”) triggering a payment. The milestone is for achieving preclinical proof-of-mechanism with a lead bispecific antibody directed against a target combination relevant in the treatment of autoimmune disease.

Company News: Merus starts Phase I/II clinical trial for MCLA-128, an ADCC-enhanced bispecific antibody for solid tumors

– First patient dosed in trial with potent bispecific antibody overcoming resistance to HER2-targeted therapies –

Merus B.V., a leader in developing best-in-class bispecific antibody therapeutics to treat cancer patients, today announced the initiation of a phase I/II clinical study of MCLA-128 for the treatment of solid tumors. MCLA-128 is an ADCC-enhanced, full-length IgG bispecific antibody that simultaneously targets the growth factor receptors HER2 and HER3.

The trial is an open-label, European multi-center dose escalation study to assess the safety, tolerability and anti-tumor activity of MCLA-128. The first part of the study is designed as a dose escalation study, followed by a second part to further characterize the safety, tolerability and clinical efficacy of MCLA-128. Initially, the study will enroll 52 patients with advanced epithelial tumors. Primary endpoint is safety; secondary endpoints include, among others, the immunogenicity of MCLA-128 as well as anti-tumor response and clinical benefit.


Company News: After U.S. court ruling, Merus reaffirms freedom to operate for its MeMo® transgenic mouse for therapeutic human antibodies

– Regeneron’s ‘018 patent’ is considered invalid and Merus not infringing –

Merus B.V., a leader in developing best-in-class antibody therapeutics to treat cancer patients, today announced a series of pivotal events in its litigation with Regeneron Pharmaceuticals Inc. Previously, Regeneron sued Merus accusing it of infringing U.S. Patent No. 8,502,018 (‘018 patent’) directed to a particular method of making a genetically modified mouse, which Regeneron asserted was useful to produce therapeutic antibodies.

Merus argued that Regeneron had interpreted its patent in an overbroad manner, and that the patent claims were indefinite and invalid. On November 21, 2014, in a fifty-nine page decision, the United States District Court for the Southern District of New York agreed with Merus on virtually every issue, stating:  “[t]his Court generally agrees with the constructions Merus proposes, limiting the Patent to a far narrower scope than asserted by Regeneron.”  The court also ruled that Merus has demonstrated “clear and convincing evidence that [a key claim term] lacks reasonable certainty and is therefore indefinite.” On December 19, 2014, Regeneron filed papers with the court conceding that under these rulings, Merus does not infringe any asserted claim of the ‘018 patent, and that these claims are invalid. With this ruling and Regeneron’ s concessions, there are no outstanding claims against Merus. The only remaining issues include Merus’ claim against Regeneron that it unlawfully procured its patent from the U.S. Patent Office and Merus’ request that Regeneron pay the legal fees incurred by Merus.

Company News: Patent Position of Merus’ MeMo® Mouse Strengthened by Ruling of European Patent Office

– Freedom to operate confirmed

– Successful opposition against Regeneron’s patent EP 1 360 287 B1 for transgenic mice producing therapeutic human antibodies

Merus B.V., a biopharmaceutical company focusing on innovative human antibody therapeutics, announced today that it has successfully retained full freedom to operate for its proprietary transgenic MeMo® mouse. In opposition proceedings at the European Patent Office, the opposition division ruled on September 17 that European patent EP 1 360 287 B1, owned by Regeneron Pharmaceuticals Inc., was revoked in its entirety.

In 2012, Regeneron was granted a European patent entitled “Methods of Modifying Eukaryotic Cells”. The patent is part of Regeneron’s IP portfolio around its VelocImmune® mouse for therapeutic human antibodies. Merus filed an opposition against this patent in June 2013, thereby requesting revocation of the patent.

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