Acceleron Tests Drugs for Renal Patients

Acceleron Pharma (Cambridge, MA), focuses on designing protein therapeutics for cancer and rare diseases. Two of its new products under development involve patients with renal conditions.

Acceleron and Celgene Corp., based in Summit, NJ, are jointly developing a drug candidate called sotatercept, a fusion protein that acts by increasing the production of mature red blood cells into circulation, which may benefit patients with advanced chronic kidney disease.

Recently, Acceleron reported that it was about to receive a $7 million milestone payment under a collaboration agreement with Celgene, which recently opened a phase 2 clinical trial of sotatercept in patients undergoing hemodialysis.

In previous clinical studies, sotatercept has shown “encouraging activity by increasing red blood cells as well as bone mass in patients,” said Matthew Sherman, MD, Acceleron’s chief medical officer. “We believe that the distinct profile of sotatercept could benefit many patients, including those who have end stage renal disease, the most advanced stage of chronic kidney disease.” He noted that the compound is also being studied in phase 2 trials in people with several rare hematologic diseases, including β-thalassemia and myelodysplastic syndromes.

A year ago, Acceleron started a phase 2 study of dalantercept, a novel blood vessel inhibitor that targets the activin receptor-like kinase 1 (ALK1) pathway. The two-part, randomized phase 2 study is a study of dalantercept in combination with axitinib (Inlyta by Pfizer). Axitinib is a vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor, intended to treat patients with metastatic renal cell carcinoma.

“Many patients with renal cell carcinoma respond to treatment with a VEGF inhibitor yet their disease subsequently progresses,” said Michael B. Atkins, MD, deputy director of the Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center. “My colleagues in the kidney cancer research community and I are optimistic that combining two therapies with distinct anti-angiogenesis (anti-blood vessel growth) mechanisms.…can provide a more effective and durable antitumor response in these patients.”

Acceleron, its partners, and its collaborators have initiated seven phase 2 studies across three of Acceleron’s programs—dalantercept (known first as ACE-041), sotatercept (ACE-011), and ACE-536—since November 2012.