FDA grants Orphan Drug Designation for tasquinimod in myelofibrosis
“The Orphan Drug Designation awarded by the FDA for tasquinimod in myelofibrosis represents an important step forward for Active Biotech”, said Helén Tuvesson, CEO Active Biotech. “It opens an important regulatory pathway and provides us with the potential to rapidly advance the development of tasquinimod in this patient population.”
The FDA Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnoses or prevention of rare diseases or disorders that affects fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period against competition, as well as certain incentives.
In February 2022, Active Biotech entered into an exclusive license agreement with Oncode Institute in the Netherlands, acting on behalf of Erasmus University Medical Center (Erasmus MC), Rotterdam, for the global rights to patents relating to the use of tasquinimod in the treatment of myelofibrosis.
Active Biotech and Erasmus MC have initiated a research collaboration with tasquinimod in myelofibrosis, that includes preclinical studies as well as a clinical proof of concept study in patients with myelofibrosis. The clinical study will be financed by Oncode and is planned to start early 2023.
This information is information that Active Biotech AB is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact person set out above, at 15.00 pm CET on May 18, 2022.
Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company that deploys its extensive knowledge base and portfolio of compounds to develop first-in-class immunomodulatory treatments for specialist oncology and immunology indications with a high unmet medical need and significant commercial potential. Following a portfolio refocus, the business model of Active Biotech aims to advance projects to the clinical development phase and then further develop the programs internally or pursue in partnership. Active Biotech currently holds three projects in its portfolio: The wholly owned small molecule immunomodulators, tasquinimod and laquinimod, both having a mode of actions that includes modulation of myeloid immune cell function, are targeted towards hematological malignancies and inflammatory eye disorders, respectively. Tasquinimod, is in clinical phase Ib/IIa for treatment of multiple myeloma. Laquinimod is in a clinical phase I study with a topical ophthalmic formulation, to be followed by phase II for treatment of non-infectious uveitis. Naptumomab, a targeted anti-cancer immunotherapy, partnered to NeoTX Therapeutics, is in a phase Ib/II clinical program in patients with advanced solid tumors. Please visit www.activebiotech.com for more information.
Active Biotech AB