Eisai and Halozyme Therapeutics said today they will partner to assess Eisai's eribulin mesylate (Halaven®) in combination with Halozyme's drug candidate PEGPH20 (PEGylated recombinant human hyaluronidase) in first-line HER2-negative metastatic breast cancer. The value of the clinical collaboration was not disclosed.

The companies said they will jointly conduct and share the costs of a Phase Ib/II clinical study seeking to determine if the combination therapy of eribulin and PEGPH20 can improve the overall response rate in advanced breast cancer patients with high levels of hyaluronan compared with eribulin alone.

“This agreement marks the first clinical collaboration agreement for Halozyme, and extends the study of PEGPH20 to a substantially wider population of patients with a partner that is a clear leader in the treatment of advanced breast cancer,” Helen Torley, M.B., Ch.B., M.R.C.P, Halozyme’s president and CEO, said in a statement.

PEGPH20 is an investigational drug administered intravenously that targets the degradation of the glycosaminoglycan hyaluronan throughout the body. By degrading hyaluronan, PEGPH20 increases blood flow to the tumor, allowing for more efficient delivery of cancer therapies to their target.

In preclinical animal models of hyaluronan-rich triple-negative breast cancer, addition of PEGPH20 to eribulin showed significantly higher tumor growth inhibition—including tumor regression—compared to eribulin alone.

Eribulin, the first in the class of halichondrin class microtubule dynamics inhibitors, is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics, thus preventing cell division.

Approved by the FDA in 2010, Eribulin is indicated for patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.

Earlier this month, Eisai submitted applications seeking a new indication of soft tissue sarcoma for eribulin in the U.S., Japan, and Europe. Eribulin has been designated as an orphan drug for soft-tissue sarcoma in the U.S. and Japan.

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