May 5, 2021
WALTHAM —May 5, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announced that the Company has completed patient enrollment in the phase 2 PORT study. The PORT study is an open-label, randomized, cross-over study which compares the safety, tolerability and efficacy of peripheral or central intravenous administration of PEPAXTO® (melphalan flufenamide) in combination with dexamethasone in relapsed refractory multiple myeloma. Oncopeptides expects topline data in Q3 2021. PEPAXTO, in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
“I am very pleased that we have enrolled the final patient in the PORT study,” said Klaas Bakker, MD, PhD, Chief Medical Officer, Oncopeptides. “The data could potentially provide a pathway for us to work with the U.S. Food and Drug Administration to add an additional mode of administration for PEPAXTO.”
“I’m pleased to see the continued development of melphalan flufenamide which could potentially bring forward an additional administration option to physicians and patients,” said Joshua Richter, MD, Assistant Professor of Medicine in The Tisch Cancer Institute, Division of Hematology and Medical Oncology and Director of Multiple Myeloma at the Blavatnik Family- Chelsea Medical Center at Mount Sinai, New York. For more information, please visit our U.S. website at https://www.oncopeptides-us.com/en/pipeline.
Limitation of Use
PEPAXTO is not indicated and is not recommended for use as a conditioning regimen for transplant outside of controlled clinical trials.
To view the full prescribing information please visit https://pepaxto.com/docs/pepaxto_pi.pdf
About Multiple Myeloma
Multiple myeloma is a cancer of plasma cells, a type of white blood cell which produces antibodies to help fight infection. Multiple myeloma causes cancer cells to accumulate in the bone marrow. Approximately 7 per 100,000 Americans per year are diagnosed with multiple myeloma, making it a rare disease. A growing subset of this population is becoming triple-class refractory. The number of patients diagnosed with multiple myeloma is growing and the number of cases diagnosed annually is expected to almost double in 20 years. The average age for diagnosis is 70 years of age, and there is currently no cure.
Oncopeptides is a global biotech company committed to developing targeted therapies for patients facing hard-to-treat hematological diseases. Oncopeptides has one U.S. FDA approved product, PEPAXTO® (melphalan flufenamide), known during clinical development as melflufen. PEPAXTO is approved for some patients with triple-class refractory multiple myeloma and was evaluated in several clinical studies including the pivotal Phase 2 HORIZON study and is currently being evaluated in the confirmatory Phase 3 OCEAN study. Oncopeptides’ headquarters is in Stockholm, Sweden, with a U.S. headquarters in Boston, Massachusetts. In addition to Boston, Oncopeptides has a footprint in San Francisco, California, another U.S. biotech hub. For more information, please visit our corporate website at https://oncopeptides.se/en/. You may also visit our U.S. website at https://www.oncopeptides-us.com/en and follow us on our U.S. social media channels, Twitter and LinkedIn.
PEPAXTO® is a trademark of Oncopeptides AB (publ).