Eisai Co., Ltd. and Halozyme Therapeutics, Inc., a biopharmaceutical company, have signed a clinical collaboration agreement to evaluate Eisai’s anticancer agent, Halaven (eribulin mesylate) in combination with Halozyme’s investigational new drug PEGPH20 (PEGylated recombinant human hyaluronidase) in first-line HER2-negative advanced breast cancer.

Eribulin, a halichondrin class microtubule dynamics inhibitor, is currently approved for treating advanced breast cancer in approximately 60 countries worldwide. Structurally, eribulin 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 inhibition of the growth phase of microtubule dynamics which prevents cell division.

PEGPH20 is an investigational drug administered intravenously that targets the degradation of hyaluronan, a glycosaminoglycan or chain of natural sugars throughout the body. Hyaluronan accumulates around cancer cells, increasing tumor interstitial fluid pressure and constricting tumor vasculature, subsequently inhibiting anticancer agents from reaching cancer cells. By degrading hyaluronan, PEGPH20 increases blood flow to the tumor which may allow cancer therapies to be more efficiently delivered to their target.

Under the agreement, the companies will jointly conduct and share the costs of a Phase Ib/II clinical study seeking to determine whether or not the combination therapy of eribulin and PEGPH20 can improve the overall response rate in advanced breast cancer patients with high levels of hyaluronan. In hyaluronan-rich triple-negative breast preclinical animal models, the addition of PEGPH20 to eribulin showed higher tumor growth inhibition including tumor regression when compared to eribulin alone.

Source: Eisai