Taking cancer to TASQ
PARIS, France—Active Biotech AB and Ipsen have entered into a broad partnership to co-develop and commercialize Active Biotech's investigational compound Tasquinimod (TASQ). A global Phase III trial of TASQ in men with metastatic castrate-resistant prostate cancer (CRPC) was recently initiated by Active Biotech, and patient recruitment has begun.
The ongoing clinical trial, funded by Active Biotech, is a global, randomized, double- blind, placebo-controlled Phase III trial in patients with metastatic CRPC. The aim of the study is to confirm TASQ's effect on the disease, with radiological progression-free survival (PFS) as the primary endpoint and overall survival as the secondary endpoint. The study will include about 1,200 patients in more than 250 clinics.
"This new partnership will broaden the scope of our uro-oncology franchise," says Marc de Garidel, chairman and CEO of Ipsen. "Subject to the success of the ongoing Phase III clinical trial for the treatment of metastatic castrate-resistant prostate cancer and following market approval, TASQ will perfectly fit in our current portfolio, alongside the sustained-release formulations of Decapeptyl."
Ipsen has been following the Active Biotech Tasquinimod Phase II program with interest, and the two companies' discussions progressed to another stage when the Phase II data were released and the Tasquinimod Phase III and regulatory strategies were defined, the company says.
The current plan is to present the Phase III results in 2013 and file for approval in 2014.
Tomas Leanderson, president and CEO of Active Biotech, notes that Ipsen has a proven track record and strong R&D capabilities within prostate cancer.
"We consider Ipsen an ideal partner for Active Biotech and with this partnership a powerful development and commercialization strategy for TASQ has been secured," Leanderson says.
TASQ, or ABR-215050, is a drug with a unique mechanism of action targeting angiogenesis and immunomodulation. It binds to a molecule called S100A9 that is expressed in the white blood cells involved in the regulation of immune responses. S100A9 interacts with two known pro-inflammatory receptors, Toll like receptor 4 (TLR4), and receptor of advanced glycation end products (RAGE), and this interaction is inhibited by TASQ. Upregulation of thrombospondin-1 (TSP1) has been identified as one important component in order to understand and explain the anti-angiogenic mechanism of TASQ treatment of prostate cancer.
Under the terms of the agreement, Active Biotech grants Ipsen exclusive rights to commercialize TASQ worldwide, except for North and South America and Japan, where Active Biotech retains all commercial and marketing rights. Asian and Indian clinics will be included in the Phase III trials, and Ipsen foresees commercial opportunities for the drug in these markets.
Both companies will co- develop TASQ for the treatment of castrate-resistant prostate cancer, with the possibility to develop TASQ in other cancer indications.
"The TASQ mechanism of action is general, so in principle, from a theoretical perspective, the therapy can be used for a large number of tumors," says Göran Forsberg, Active Biotech's vice president of investor relations and business development. "We have not disclosed when and in which cancer indication there will be development outside prostate cancer."
Active Biotech is responsible for conducting and funding the Phase III pivotal clinical trial and will receive up to $285 million during the course of the agreement. Although the detailed amounts of the milestones payments cannot be disclosed, an upfront payment of $36 million was paid upon the signing of the agreement, says Ipsen.
Further payments will depend on the advancement and success of the Phase III clinical trial as well as on the regulatory developments. Once the medicine is approved, low-teen royalties on sales will be paid to Active Biotech as well as commercial milestones once certain sales thresholds are achieved.
Additional payments are contingent upon achievement of clinical, regulatory and commercial milestones. In addition, Ipsen will fund and conduct a European supportive study in prostate cancer patients out of its R&D budget. Future costs to develop TASQ in other cancer indications will be shared.