Merus' Antibody Candidate In Phase II Breast Cancer Study

Merus N.V. (NASDAQ:MRUS) announced that it has initiated a phase II study to evaluate its most advanced bispecific antibody candidate, MCLA-128, in patients with metastatic breast cancer (“MBC”).

The study comprises two cohorts. The first cohort will evaluate a combination of MCLA-128, Roche’s (OTC:RHHBY) Herceptin and chemotherapy in MBC patients who are HER2-positive and their disease have progressed after treating with anti-HER2 therapies. The second cohort will evaluate MCLA-128 in combination with endocrine therapy in patients with HR+/HER2-low MBC and whose disease has progressed after treatment with hormone therapies and CDK4/6 inhibitors.

Merus’ shares have increased 15% in the past six months, comparing favorably with the industry’s gain of 2.5% in that period.

Data from pre-clinical study demonstrated that the candidate has shown synergy with Herceptin in blocking heregulin-driven tumor cell growth and blocking of signaling through the HER3 pathway with endocrine therapy as well.

The primary endpoint of the study is to achieve clinical benefit (Complete Response, Partial Response or Stable Disease) at 24-weeks in both the arms. The study will also evaluate progression free survival, overall survival, duration of response and overall response rate among others as its secondary endpoints.

The company is also developing MCLA-128 in early stage studies as a treatment for gastric, ovarian, endometrial and NSCL cancers. Apart from MCLA-128, Merus is also developing another bispecific antibody candidate, MCLA-117, in acute myeloid leukemia.

However, the breast cancer segment is getting lot interest from other large as well as small cap pharma companies. We note that earlier this month, the FDA approved line extension of AstraZeneca’s (NYSE:AZN) PARP inhibitor, Lynparza, to include MBC.

Merus has no approved product in its portfolio. However, it earns revenues as part of its research agreement with Japan-based ONO Pharmaceuticals and collaboration and license agreement with Incyte Corporation (NASDAQ:INCY) .

Merus carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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